|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第 1 部分 投标书Part 1 Tender                                                                                |

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| 上海朗脉科技有限公司上海市闵行区罗阳路168 号A 座101 室     201100T:021 54306717     F: 021 54306718 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 1. 报价书                                                                                             |   | 3       |
|-------------------------------------------------------------------------------------------------------------------------|--------|---------|
| 1.1. 法定代表人资格证明书                                   |   | 3       |
| 1.2. 法人授权委托书                                                           |   |  4 |
| 1.3. 授权代表人身份证复印件                           |   | 5       |
| 1.4. 投标书                                                                                           |   | 6       |
|                                                                                                                    |   |    |
| 2. 方案一 管材管件为ALFA LAVAL                                          |   | 7       |
| 2.1. 报价一览表                                                                           |   | 7       |
| 2.2. 分项报价一览表                                                           |   | 9       |
| 2.2.1. 纯化水系统材料清单及报价                 |   | 9       |
| 2.2.2. 注射用水系统材料清单及报价         |   | 14      |
| 2.2.3. 纯蒸汽系统材料清单及报价                 |   | 21      |
| 2.2.4. 纯化水、注射用水控制系统报价 |   | 24      |
| 2.2.5. 储罐配置清单                                                                 |   | 26      |
| 2.2.6. 焊点费                                                                                         |   | 30      |
| 2.2.7. 管道保温价格清单                                                 |   | 31      |
| 2.2.8. 系统所用辅材数量清单                                 |   | 32      |
| 2.2.9. 验证服务报价                                                                 |   | 33      |
|                                                                                                                    |   |    |
| 3. 方案二 管材管件为NEUMO                                               |   | 34      |
| 3.1. 报价一览表                                                                           |   | 34      |
| 3.2. 分项报价一览表                                                           |   | 35      |
| 3.2.1. 纯化水系统材料清单及报价                 |   | 36      |
| 3.2.2. 注射用水系统材料清单及报价         |   | 41      |
| 3.2.3. 纯蒸汽系统材料清单及报价                 |   | 48      |
| 3.2.4. 纯化水、注射用水控制系统报价 |   | 51      |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第1页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 3.2.5. 罐体清单说明                                 |   | 53     |
|-----------------------------------------------------------------------------------------|--------|--------|
|                                                                                    |   |   |
| 3.2.6. 焊点费                                                         |   | 57     |
|                                                                                    |   |   |
| 3.2.7. 管道保温价格清单                 |   | 58     |
|                                                                                    |   |   |
| 3.2.8. 系统所用辅材数量清单 |   | 59     |
|                                                                                    |   |   |
| 3.2.9. 验证服务报价                                 |   | 60     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第2页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第3页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第4页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第5页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第6页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Scope of Supply 供货范围                                                                                                                                                                                                                                                                   | Price (RMB) 价格 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 1                     | Price Breakdown for  PW Distribution System 纯化水系统材料清单及报价                                                                                                                                                             | 846,747.18                   |
| 2                     | Price Breakdown for  WFI Distribution System 注射用水系统材料清单及报价                                                                                                                                                    | 3,292,200.05                 |
| 2                     | Price Breakdown for PS Distribution System 纯蒸汽系统材料清单及报价                                                                                                                                                                        | 423,468.40                   |
| 3                     | Automatic Control System 自动化控制系统                                                                                                                                                                                                                                  | 275,825.00                   |
| 4                     | Insulation Fee 保温费                                                                                                                                                                                                                                                                            | 147,500.00                   |
| 5                     | Piping surport 辅助材料,洁净区用不锈钢支架,非洁净区用镀锌角铁                                                                                                    | 188,130.00                   |
|                  | Subtotal 1 for Material 材料费用                                                                                                                                                                                                                                                           | 5,173,870.63                 |
| 6                     | Welding Point Cost 焊点费用                                                                                                                                                                                                                                                                | 351,600.00                   |
| 7                     | Cost of  Welding Point marking  (100% of total welding point ) 20RMB /point焊点刻码费用, 100% 自动焊点刻码,20 元/焊点                                                                           | 46,280.00                    |
| 8                     | Endoscopic Check (20% of total welding point ) 80 RMB /point                   内窥镜检测, 自动焊点的20% 取样, 80 元/焊点 | 37,024.00                    |
| 9                     | X-ray Check (100% of total hand-welding point,all welded samples) 180 RMB /pointX-光检测, (100% 手工焊点,所有焊样), 180 元/焊点,                                                                                               | 32,400.00                    |
| 10                    | Insurance and Transportation 保险和运输                                                                                                                                                                                                                                              | 50,000.00                    |
|                  | Subtotal 2 for Piping fabrication 管道装配                                                                                                                                                                                                                                                 | 517,304.00                   |
| 11                    | Detail Design, Shop Drawings and As-built Drawings      详细设计, 施工图纸和竣工文件                                                                                                                   | 60,000.00                    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第7页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                  |

| 12     | Quotation For Validation Activities 验证服务报价                                                                          | 315,000.00   |
|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 13     | Project Management & Supervision 项目管理&监督                                                                    | 50,000.00    |
| 14     | COMPANY Management    公司管理                                                                                    | 500,000.00   |
|   | Subtotal 3 for Project Service 项目服务                                                                                               | 925,000.00   |
|   | Subtotal 1, 2, 3,        合计                                                                             | 6,616,174.63 |
|   | Tax 税金(主材部分开增值税,其他开工程发票) | 91,607.54    |
|   | Total Price 总价                                                                                                                                  | 6,707,782.17 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第8页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围                                            | Specification 规格                              | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 1                     | 纯化水储罐(包含附件) | 10m3,常压容器,卧式,     | 316L                      | 1                         | RITAI                                 |                      | 185,000.00                                       | 185,000.00                        |
| 2                     | 纯化水循环泵                                         | 20T/hr,55m扬程,带下排口 | 316L                      | 1                         | ALFA LAVAL                            |                      | 36,250.00                                        | 36,250.00                         |
| 3                     | 纯化水循环泵                                         | 30T/hr,55m扬程,带下排口 | 316L                      | 1                         | ALFA LAVAL                            |                      | 41,250.00                                        | 41,250.00                         |
| 4                     | 管式热交换器                                         | 4T,循环加热1h,25C-85C               | 316L                      | 1                         | NEUMO                                 |                      | 156,483.13                                       | 156,483.13                        |
| 5                     | 温度变送器                                                 | 4-20 mA output                                              | 316L                      | 3                         | CHINA                                 |                      | 812.50                                           | 2,437.50                          |
| 6                     | 压力表                                                                 | 0-6 kgf/cm2, 1 1/2”                                   | 316L                      | 2                         | CHINA                                 |                      | 437.50                                           | 875.00                            |
| 7                     | 电导仪                                                                 | 4-20 mA output                                              |                      | 2                         | BURKERT                               |                      | 8,375.00                                         | 16,750.00                         |
| 8                     | 流量计                                                                 | 4-20 mA output,DN50                                         |                      | 2                         | YAKOGAWA                              |                      | 9,375.00                                         | 18,750.00                         |
| 9                     | 变频器                                                                 | 7.5KW                                                       |                      | 1                         | SIEMENS                               |                      | 6,250.00                                         | 6,250.00                          |
| 10                    | 变频器                                                                 | 11KW                                                        |                      | 1                         | SIEMENS                               |                      | 6,750.00                                         | 6,750.00                          |
| 11                    | 疏水器                                                                 | DN20(浮球式)                              | 碳钢          | 1                         | Spirax Sarco                          |                      | 1,500.00                                         | 1,500.00                          |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第9页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准            | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|--------------------------------------|--------------------------------------------------|-----------------------------------|
| 12                    | 气动调节阀      | DN50                           | 316L                      | 1                         | BURKERT                               |                                 | 11,125.00                                        | 11,125.00                         |
| 13                    | 气动隔膜阀      | DN50                           | 316L                      | 2                         | GEMU                                  | 铸造,Ra≤0.4 | 5,992.50                                         | 11,985.00                         |
| 14                    | 气动隔膜阀      | DN40                           | 316L                      | 4                         | GEMU                                  | 铸造,Ra≤0.4 | 4,668.75                                         | 18,675.00                         |
| 15                    | 气动隔膜阀      | DN25                           | 316L                      | 7                         | GEMU                                  | 铸造,Ra≤0.4 | 3,201.25                                         | 22,408.75                         |
| 16                    | 气动角座阀      | DN50                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 3,312.50                                         | 3,312.50                          |
| 17                    | 气动角座阀      | DN25                           | 316L                      | 2                         | GEMU                                  | 铸造,Ra≤0.4 | 1,562.50                                         | 3,125.00                          |
| 18                    | 气动角座阀      | DN20                           | 316L                      | 2                         | GEMU                                  | 铸造,Ra≤0.4 | 1,375.00                                         | 2,750.00                          |
| 19                    | 隔膜阀                      | DN80                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 24,412.50                                        | 24,412.50                         |
| 20                    | 隔膜阀                      | DN65                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 23,075.00                                        | 23,075.00                         |
| 21                    | 隔膜阀                      | DN25                           | 316L                      | 26                        | GEMU                                  | 铸造,Ra≤0.4 | 2,428.75                                         | 63,147.50                         |
| 22                    | 隔膜阀                      | DN15                           | 316L                      | 2                         | GEMU                                  | 铸造,Ra≤0.4 | 1,665.00                                         | 3,330.00                          |
| 23                    | 限流孔板              | DN25                           | 316L                      | 22                        | CHINA                                 |                                 | 218.75                                           | 4,812.50                          |
| 24                    | 法兰                              | DN50                           | 316L                      | 4                         | CHINA                                 |                                 | 306.25                                           | 1,225.00                          |
| 25                    | 卡接头                      | DN76.1                         | 316L                      | 5                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5                | 95.06                                            | 475.29                            |
| 26                    | 卡接头                      | DN63.5                         | 316L                      | 6                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5                | 79.01                                            | 474.07                            |
| 27                    | 卡接头                      | DN51                           | 316L                      | 12                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5                | 62.67                                            | 752.05                            |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第10页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 28                    | 卡接头                      | DN38                           | 316L                      | 8                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 59.28                                            | 474.26                            |
| 29                    | 卡接头                      | DN25                           | 316L                      | 45                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 48.04                                            | 2,161.59                          |
| 30                    | 卡接头                      | DN19                           | 316L                      | 20                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 47.40                                            | 948.00                            |
| 31                    | 卡环                              | DN76.1                         | 304                       | 5                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 81.64                                            | 408.18                            |
| 32                    | 卡环                              | DN63.5                         | 304                       | 6                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 72.04                                            | 432.21                            |
| 33                    | 卡环                              | DN51                           | 304                       | 12                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 58.72                                            | 704.61                            |
| 34                    | 卡环                              | DN38                           | 304                       | 16                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 49.56                                            | 793.04                            |
| 35                    | 卡环                              | DN25                           | 304                       | 80                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 49.56                                            | 3,965.18                          |
| 36                    | 卡环                              | DN19                           | 304                       | 4                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 95.79                                            | 383.15                            |
| 37                    | 密封圈                      | DN76.1                         | PTFE                      | 5                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 67.52                                            | 337.59                            |
| 38                    | 密封圈                      | DN63.5                         | PTFE                      | 6                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 53.38                                            | 320.26                            |
| 39                    | 密封圈                      | DN51                           | PTFE                      | 12                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 46.51                                            | 558.07                            |
| 40                    | 密封圈                      | DN38                           | PTFE                      | 16                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 41.88                                            | 670.12                            |
| 41                    | 密封圈                      | DN25                           | PTFE                      | 80                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 46.51                                            | 3,720.47                          |
| 42                    | 密封圈                      | DN19                           | PTFE                      | 4                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 37.12                                            | 148.47                            |
| 43                    | U型弯                             | DN63.5/25                      | 316L                      | 4                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 503.26                                           | 2,013.04                          |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第11页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 44                    | U型弯                             | DN51/25                        | 316L                      | 13                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 446.07                                           | 5,798.92                          |
| 45                    | 变径三通(WCW)         | DN76.1/38                      | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 303.92                                           | 303.92                            |
| 46                    | 变径三通(WCW)         | DN63.5/51                      | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 264.15                                           | 264.15                            |
| 47                    | 变径三通(WCW)         | DN63.5/38                      | 316L                      | 3                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 255.67                                           | 767.01                            |
| 48                    | 变径三通(WCW)         | DN63.5/25                      | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 306.64                                           | 306.64                            |
| 49                    | 变径三通(WCW)         | DN51/38                        | 316L                      | 5                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 221.58                                           | 1,107.88                          |
| 50                    | 变径三通(WCW)         | DN51/25                        | 316L                      | 3                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 271.68                                           | 815.05                            |
| 51                    | 变径三通(WWW)         | DN63.5/38                      | 316L                      | 2                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 102.27                                           | 204.54                            |
| 52                    | 变径三通(WWW)         | DN51/38                        | 316L                      | 2                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 68.18                                            | 136.35                            |
| 53                    | 正三通(WCW)                 | DN25                           | 316L                      | 11                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 195.25                                           | 2,147.72                          |
| 54                    | 90°弯头                      | DN76.1                         | 316L                      | 5                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 94.15                                            | 470.76                            |
| 55                    | 90°弯头                      | DN63.5                         | 316L                      | 48                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 56.49                                            | 2,711.72                          |
| 56                    | 90°弯头                      | DN51                           | 316L                      | 100                       | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 39.61                                            | 3,961.18                          |
| 57                    | 90°弯头                      | DN38                           | 316L                      | 10                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 34.26                                            | 342.59                            |
| 58                    | 90°弯头                      | DN25                           | 316L                      | 36                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 26.95                                            | 970.31                            |
| 59                    | 90°弯头                      | DN19                           | 316L                      | 20                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 220.33                                           | 4,406.59                          |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第12页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围                                                                                                                                                    | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 60                    | 45°弯头                                                                                                                                                                         | DN63.5                         | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 60.55                                            | 60.55                             |
| 61                    | 45°弯头                                                                                                                                                                         | DN51                           | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 45.29                                            | 45.29                             |
| 62                    | 偏心大小头                                                                                                                                                         | DN63.5/51                      | 316L                      | 3                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 163.62                                           | 490.87                            |
| 63                    | 同心大小头                                                                                                                                                         | DN63.5/38                      | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 191.59                                           | 191.59                            |
| 64                    | 管道                                                                                                                                                                                 | DN76.1                         | 316L                      | 6                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 433.98                                           | 2,603.86                          |
| 65                    | 管道                                                                                                                                                                                 | DN63.5                         | 316L                      | 138                       | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 369.41                                           | 50,978.82                         |
| 66                    | 管道                                                                                                                                                                                 | DN51                           | 316L                      | 330                       | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 234.02                                           | 77,227.76                         |
| 67                    | 管道                                                                                                                                                                                 | DN38                           | 316L                      | 12                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 178.44                                           | 2,141.22                          |
| 68                    | 管道                                                                                                                                                                                 | DN25                           | 316L                      | 18                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 125.53                                           | 2,259.53                          |
| 69                    | 管道                                                                                                                                                                                 | DN19                           | 316L                      | 6                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 102.22                                           | 613.34                            |
|                  | 以上为纯化水洁净管道系统管材,管件配置清单及报价 |                           |                      |                      |                                  | 846,747.18                |
|                  | 可选项                                                                                                                                                                         |                           |                      |                      |                                  |                      |

| Item 序号 | Supply Scope 供货范围    | Specification 规格                | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|--------------------------------------------------|-----------------------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 1                     | 管式热交换器 | 4T,循环加热1h,25C-85C | 316L                      | 1                         | ABC                                   |                      | 159,212.94                                       | 159,212.94                        |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第13页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第14页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第15页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第16页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第17页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第18页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 76                    | 变径三通(WWW)         | DN25/19                        | 316L                      | 4                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 480.72                                           | 1,922.87                          |
| 77                    | 变径三通(WWW)         | DN63.5/38                      | 316L                      | 2                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 480.72                                           | 961.44                            |
| 78                    | 变径三通(WWW)         | DN63.5/25                      | 316L                      | 2                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 480.72                                           | 961.44                            |
| 79                    | 变径三通(WWW)         | DN51/25                        | 316L                      | 2                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 382.70                                           | 765.41                            |
| 80                    | 弯头                              | DN76.1                         | 316L                      | 5                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 366.29                                           | 1,831.47                          |
| 81                    | 弯头                              | DN63.5                         | 316L                      | 32                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 272.24                                           | 8,711.64                          |
| 82                    | 弯头                              | DN51                           | 316L                      | 60                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 183.14                                           | 10,988.19                         |
| 83                    | 弯头                              | DN38                           | 316L                      | 16                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 155.93                                           | 2,494.93                          |
| 84                    | 弯头                              | DN25                           | 316L                      | 108                       | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 150.98                                           | 16,306.22                         |
| 85                    | 弯头                              | DN19                           | 316L                      | 20                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 165.82                                           | 3,316.33                          |
| 86                    | 45°弯头                      | DN63.5                         | 316L                      | 1                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 217.80                                           | 217.80                            |
| 87                    | 45°弯头                      | DN51                           | 316L                      | 1                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 183.14                                           | 183.14                            |
| 88                    | 偏心大小头      | DN63.5/51                      | 316L                      | 3                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 698.39                                           | 2,095.16                          |
| 89                    | 管道                              | DN76.1                         | 316L                      | 6                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 1,265.14                                         | 7,590.85                          |
| 90                    | 管道                              | DN63.5                         | 316L                      | 90                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 1,094.62                                         | 98,515.69                         |
| 91                    | 管道                              | DN51                           | 316L                      | 240                       | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 888.23                                           | 213,175.91                        |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第19页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围                                                                                                                                                            | Specification 规格                                            | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 92                    | 管道                                                                                                                                                                                         | DN38                                                                      | 316L                      | 48                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 672.96                                           | 32,302.02                         |
| 93                    | 管道                                                                                                                                                                                         | DN25                                                                      | 316L                      | 330                       | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 529.34                                           | 174,682.20                        |
| 94                    | 管道                                                                                                                                                                                         | DN19                                                                      | 316L                      | 6                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 690.90                                           | 4,145.37                          |
|                  | 以上为注射用水洁净管道系统管材,管件配置清单及报价 |                                                                      |                      |                      |                                  | 3,292,200.05              |
|                  |                                                                                                                                                                                                     |                                                                      |                      |                      |                                  |                      |
|                  | 可选项                                                                                                                                                                                 |                                                                      |                      |                      |                                  |                      |
| 1                     | 管式热交换器                                                                                                                                                         | 10T/H, 75C-85C.2T,循环加热1h,85°C-121°C | 316L                      | 1                         | ABC                                   |                      | 168,235.29                                       | 168,235.29                        |
| 2                     | 管式热交换器                                                                                                                                                         | 15T/H, 75C-85C.2T,循环加热1h,85°C-121°C | 316L                      | 1                         | ABC                                   |                      | 168,235.29                                       | 168,235.29                        |
| 3                     | 管式热交换器                                                                                                                                                         | 8T/H,85-60C,7C冷媒                                            | 316L                      | 1                         | ABC                                   |                      | 121,435.29                                       | 121,435.29                        |
| 4                     | 管式热交换器                                                                                                                                                         | 4T/H,85-60C,7C冷媒                                            | 316L                      | 1                         | ABC                                   |                      | 97,147.06                                        | 97,147.06                         |
| 5                     | 管式热交换器                                                                                                                                                         | 4T/H,85-30C,7C冷媒                                            | 316L                      | 2                         | ABC                                   |                      | 115,400.00                                       | 230,800.00                        |
| 6                     | 管式热交换器                                                                                                                                                         | 0.6T/H,85-30C,7C冷媒                                          | 316L                      | 1                         | ABC                                   |                      | 95,294.12                                        | 95,294.12                         |
| 7                     | 管式热交换器                                                                                                                                                         | 0.6T/H,85-60C,7C冷媒                                          | 316L                      | 1                         | ABC                                   |                      | 85,952.94                                        | 85,952.94                         |
| 8                     | 管式热交换器                                                                                                                                                         | 1.0T/H,85-30C,7C冷媒                                          | 316L                      | 1                         | ABC                                   |                      | 100,000.00                                       | 100,000.00                        |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第20页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第21页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 15                    | 密封圈                      | DN63.5                         | PTFE                      | 2                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 53.38                                            | 106.75                            |
| 16                    | 密封圈                      | DN38                           | PTFE                      | 2                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 41.88                                            | 83.76                             |
| 17                    | 密封圈                      | DN25                           | PTFE                      | 135                       | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 46.51                                            | 6,278.29                          |
| 18                    | 密封圈                      | DN19                           | PTFE                      | 8                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 37.12                                            | 296.94                            |
| 19                    | 变径三通(WCW)         | DN63.5/38                      | 316L                      | 2                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 519.64                                           | 1,039.29                          |
| 20                    | 变径三通(WWW)         | DN63.5/51                      | 316L                      | 1                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 382.57                                           | 382.57                            |
| 21                    | 变径三通(WWW)         | DN63.5/38                      | 316L                      | 1                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 480.72                                           | 480.72                            |
| 22                    | 变径三通(WWW)         | DN63.5/19                      | 316L                      | 1                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 480.72                                           | 480.72                            |
| 23                    | 变径三通(WWW)         | DN51/25                        | 316L                      | 14                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 382.70                                           | 5,357.87                          |
| 24                    | 变径三通(WWW)         | DN38/25                        | 316L                      | 6                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 304.79                                           | 1,828.75                          |
| 25                    | 变径三通(WWW)         | DN38/19                        | 316L                      | 2                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 286.16                                           | 572.33                            |
| 26                    | 三通(WWW)                         | DN25                           | 316L                      | 25                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 174.18                                           | 4,354.44                          |
| 27                    | 三通(WWW)                         | DN19                           | 316L                      | 3                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 183.35                                           | 550.04                            |
| 28                    | 弯头                              | DN63.5                         | 316L                      | 12                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 272.24                                           | 3,266.87                          |
| 29                    | 弯头                              | DN51                           | 316L                      | 24                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 183.14                                           | 4,395.28                          |
| 30                    | 弯头                              | DN38                           | 316L                      | 18                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 155.93                                           | 2,806.79                          |
| 31                    | 弯头                              | DN25                           | 316L                      | 112                       | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 150.98                                           | 16,910.16                         |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第22页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号                                                                                                                                                                                   | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 32                                                                                                                                                                                                      | 弯头                              | DN19                           | 316L                      | 15                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 165.82                                           | 2,487.25                          |
| 33                                                                                                                                                                                                      | 大小头                      | DN63.5/51                      | 316L                      | 1                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 698.39                                           | 698.39                            |
| 34                                                                                                                                                                                                      | 大小头                      | DN51/25                        | 316L                      | 2                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 479.94                                           | 959.87                            |
| 35                                                                                                                                                                                                      | 大小头                      | DN38/25                        | 316L                      | 2                         | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 475.66                                           | 951.32                            |
| 36                                                                                                                                                                                                      | 管道                              | DN63.5                         | 316L                      | 36                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 1,094.62                                         | 39,406.28                         |
| 37                                                                                                                                                                                                      | 管道                              | DN51                           | 316L                      | 108                       | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 888.23                                           | 95,929.16                         |
| 38                                                                                                                                                                                                      | 管道                              | DN38                           | 316L                      | 60                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 672.96                                           | 40,377.53                         |
| 39                                                                                                                                                                                                      | 管道                              | DN25                           | 316L                      | 150                       | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 529.34                                           | 79,401.00                         |
| 40                                                                                                                                                                                                      | 管道                              | DN19                           | 316L                      | 36                        | ALFA LAVAL                            | ASME BPE,Ra≤0.5     | 690.90                                           | 24,872.23                         |
|   以上为纯蒸汽洁净管道系统管材,管件配置清单及报价 |                                          | 423,468.40                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第23页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第24页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 序号 | 供货范围                                                                                                                                 | 订货号 | 规格 型号                                                                                                        | 厂家 | 数量 | 单价(RMB) | 价格(RMB) |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------|-----------------------|-----------------------|
| Item             | Scope of Supply                                                                                                                                                  | Order No.                | Specification                                                                                                                            | Manufacturer     | Quantity         |  Unit Price      | Price                 |
| 14               | 开关电源                                                                                                                                 | 6EP1 334-3BA00           | SITOP 24V/10A                                                                                                                            | SIEMENS          | 1                | 1,500.00              | 1,500.00              |
| 15               | 控制柜                                                                                                                                         |                     | 2000×800×600(含继电器、端子等柜内电气元件) | shanghai         | 1                | 14,000.00             | 14,000.00             |
| 16               | 上位机电脑                                                                                                                         |                     | Core 2\1024MB\160G\19"LCD                                                                                                                | DELL             | 1                | 7,200.00              | 7,200.00              |
| 17               | 上位机软件                                                                                                                         | 6AV6 381-1BE06-2AV0      | WINCC V6.2 RT(1024 点)                                                                                                             | SIEMENS          | 1                | 32,892.00             | 32,892.00             |
| 18               | 打印机                                                                                                                                         |                     | A4 激光打印机                                                                                              | HP               | 1                | 2,400.00              | 2,400.00              |
| 19               | 触摸屏                                                                                                                                         | 6AV6 643-0CD01-1AX1      | MP 277 10" Touch 64K 颜色                                                                                                    | SIEMENS          | 1                | 12,000.00             | 12,000.00             |
| 20               | 交换机                                                                                                                                         | 6 RJ45 口          | 工业以太网交换机                                                                         | MOXA             | 1                | 1,200.00              | 1,200.00              |
| 21               | 编程电缆                                                                                                                                 | 6ES7 972-0CB20-0XA0      | PLC 编程电缆USB                                                                                                  | SIEMENS          | 1                | 2,646.00              | 2,646.00              |
| 22               | 网线                                                                                                                                                 |                     |                                                                                                                                     |             | 500.00           |
| 23               | 电缆                                                                                                                                                 |                     |                                                                                                                                     |             | 12,000.00        |
| 24               | 电缆                                                                                                                                                 |                     |                                                                                                                                     |             | 12,000.00        |
| 25               | 电缆                                                                                                                                                 |                     |                                                                                                                                     |             | 10,125.00        |
| 26               | 桥架                                                                                                                                                 |                     |                                                                                                                                     |             | 13,750.00        |
| 一、 | 控制系统所用材料                                                                                                 |                     |                                                                                                                                     |             | 200,825.00       |
| 二、 | 编程费 Programme Cost(1 人30 个工作日)                                                             |                     |                                                                                                                                     |             | 35,000.00        |
| 三、 | 安装费用(3人10 个工作日)                                                                     |                     |                                                                                                                                     |             | 40,000.00        |
| 四、 | 调试费 Commissioning Cost(2 人10 个工作日,含住宿交通等) |                     |                                                                                                                                     |             | 275,825.00       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第25页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格                          | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Remarks 备注                                                                                 |
|-----------------------|-----------------------------------------------|---------------------------------------------------------|---------------------------|---------------------------|---------------------------------------|----------------------------------------------------------------------------------------------------------|
| 1                     | 纯化水储罐      | 10m3,常压容器,卧式, | 316L                      | 1                         | RiTai                                 | 内部抛 Ra<0 .5um,外部亚光处理Ra<0.8um |
| 2                     | 呼吸器                      | 10" 0.22um                                              | 316L                      | 1                         | PALL                                  |                                                                                                     |
| 3                     | 喷淋球                      | DN40                                                    | 316L                      | 3                         | Alfa Laval                            | 固定式                                                                                 |
| 4                     | 液位计                      | 4-20 mA output                                          |                      | 1                         | E+H                                   | 电容式                                                                                 |
| 5                     | 温度变送器      | DN40,4-20 mA output                                     |                      | 1                         | CHINA                                 | 卡接                                                                                         |
| 6                     | 压力传感器      | DN40,4-20 mA output                                     |                      | 1                         | CHINA                                 | 卡接                                                                                         |
| 7                     | 气动球阀              | DN40                                                    | 316L                      | 1                         | King Lai                              |                                                                                                     |
| 8                     | 气动球阀              | DN20                                                    | 316L                      | 3                         | King Lai                              |                                                                                                     |
| 9                     | 气动隔膜阀      | DN40                                                    | 316L                      | 1                         | GEMU                                  |                                                                                                     |
| 10                    | 隔膜阀                      | DN15                                                    | 316L                      | 1                         | GEMU                                  |                                                                                                     |
| 11                    | 减压阀                      | DN20                                                    |                      | 1                         | 中国                      |                                                                                                     |
| 12                    | 疏水器                      | DN20(浮球式)                          | 碳钢          | 1                         | Spirax Sarco                          |                                                                                                     |
| 13                    | 卡接头                      | DN40                                                    | 316L                      | 3                         | Alfa Laval                            | ISO 2037                                                                                                 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第26页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围                                                    | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Remarks 备注 |
|-----------------------|--------------------------------------------------------------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|--------------------------|
| 14                    | 卡接头                                                                         | DN19                           | 316L                      | 8                         | Alfa Laval                            | ISO 2037                 |
| 15                    | 卡环                                                                                 | DN40                           | 304                       | 6                         | Alfa Laval                            | ISO 2037                 |
| 16                    | 卡环                                                                                 | DN19                           | 304                       | 10                        | Alfa Laval                            | ISO 2037                 |
| 17                    | 密封圈                                                                         | DN40                           | PTFE                      | 6                         | Alfa Laval                            | ISO 2037                 |
| 18                    | 密封圈                                                                         | DN19                           | PTFE                      | 10                        | Alfa Laval                            | ISO 2037                 |
| 19                    | 变径三通                                                                 | DN38/19                        | 316L                      | 4                         | Alfa Laval                            | ISO 2037                 |
| 20                    | 三通                                                                                 | DN19                           | 316L                      | 2                         | Alfa Laval                            | ISO 2037                 |
|                  | 以上为纯化水储罐配置清单 |                           |                      |                      |                                  |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第27页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Configuration list for WFI Bank                                                  |
|----------------------------------------------------------------------------------|
| 注射水储罐清单及报价 |
| Item序号                                                             | Supply Scope供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Remarks 备注 |
| 1                                                                                | 注射水储罐 | 10m3,压力容器,卧式,保温 | 316L | 1 | RiTai | 内部抛光Ra<0 .5um,外部亚光处理Ra<0.8um |
| 2                                                                                | 呼吸器 | 10“ 0.22um | 316L | 1 | PALL |   |
| 3                                                                                | 电加热套 |   |   | 1 | CHINA |   |
| 4                                                                                | 喷淋球 | DN50 | 316L | 1 | Alfa Laval | 固定式 |
| 5                                                                                | 喷淋球 | DN40 | 316L | 2 | Alfa Laval | 固定式 |
| 6                                                                                | 液位计 | 4-20 mA output | 316L | 1 | E+H | 电容式 |
| 7                                                                                | 压力传感器 | DN40,4-20 mA output | 316L | 1 | CHINA | 卡接 |
| 8                                                                                | 温度变送器 | DN40,4-20 mA output | 316L | 2 | CHINA | 卡接 |
| 9                                                                                | 爆破片 | 0.5-4bar | 316L | 1 | FIKE |   |
| 10                                                                               | 疏水器 | DN20(浮球式) | 碳钢 | 1 | Spirax Sarco |   |
| 11                                                                               | 气动球阀 | DN40 | 316L | 1 | King Lai |   |
| 12                                                                               | 气动球阀 | DN20 | 316L | 1 | King Lai |   |
| 13                                                                               | 球阀 | DN20 | 316L | 1 | King Lai |   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第28页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围                                                            | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Remarks 备注 |
|-----------------------|----------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|--------------------------|
| 14                    | 气动隔膜阀                                                                 | DN40                           | 316L                      | 1                         | GEMU                                  |                     |
| 15                    | 隔膜阀                                                                                 | DN15                           | 316L                      | 1                         | GEMU                                  |                     |
| 16                    | 减压阀                                                                                 | DN20                           |                      | 1                         | 中国                      |                     |
| 17                    | 卡接头                                                                                 | DN40                           | 316L                      | 3                         | Alfa Laval                            | ASME BPE-EP              |
| 18                    | 卡接头                                                                                 | DN19                           | 316L                      | 8                         | Alfa Laval                            | ASME BPE-EP              |
| 19                    | 卡环                                                                                         | DN40                           | 304                       | 6                         | Alfa Laval                            | ASME BPE-EP              |
| 20                    | 卡环                                                                                         | DN19                           | 304                       | 6                         | Alfa Laval                            | ASME BPE-EP              |
| 21                    | 密封圈                                                                                 | DN40                           | PTFE                      | 6                         | Alfa Laval                            | ASME BPE-EP              |
| 22                    | 密封圈                                                                                 | DN19                           | PTFE                      | 6                         | Alfa Laval                            | ASME BPE-EP              |
| 23                    | 变径三通                                                                         | DN38/19                        | 316L                      | 2                         | Alfa Laval                            | ASME BPE-EP              |
| 24                    | 三通                                                                                         | DN19                           | 316L                      | 1                         | Alfa Laval                            | ISO 2037                 |
|                  | 以上为注射用水储罐配置清单 |                           |                      |                      |                                  |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第29页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围    | Location 位置 |                             | Quantity 数量 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|--------------------------------------------------|---------------------------|----------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 1                     | 纯化水系统         |                      | 自动焊点 | 729                       | 150.00                                           | 109,350.00                        |
| 2                     | 注射用水系统 |                      | 自动焊点 | 899                       | 150.00                                           | 134,850.00                        |
| 3                     | 纯蒸汽系统         |                      | 自动焊点 | 716                       | 150.00                                           | 107,400.00                        |
|                  | 总价(元)         |                      |                             |                      |                                             | 351,600.00                        |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第30页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

|                              |                 | 洁净室内保温管套管保温 | 非洁净室保温 |
|-----------------------------------|----------------------|------------------------------------------------------------------------------------------|--------------------------------------------------|
|                              |                 | Clean Area Piping Insulation                                                             | Non-clean Area Piping Insulation                 |
|                              |                 | Pipe-in-Pipe Asbestos Insulated                                                          | Stainless Steel Jacket Asbestos Insulated        |
| 数量(m) | 单价     | 合计                                                                         | 数量(m)                | 单价 | 合计 |
| 1                                 | WFI 管道 | 90                                                                                       | 350.00                                           | 31500.00 | 630 | 100.00 | 63000.00 |
| 2                                 | PS 管道  | 60                                                                                       | 350.00                                           | 21000.00 | 320 | 100.00 | 32000.00 |
|                              |                 |                                                                                     |                                             |   |   |   |   |
|                              |                 | 共计Total:                                                            | 52500.00                                         | 共计Total: | 95000.00 |
|                              |                 | 合计(元)                                                        | 147500.00                                        |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第31页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第32页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 序号 No. | 验证项目Scope                                                                                                                                                                                                                                                                                               | 报价Quotation(RMB)                                               |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 1                    | 纯化水储存和分配系统PW storage and distribution system                                                                                                                                                                                                                  | DQ,TM,RA                                                              | 20,000 |
| 2                    | FAT,SAT                                                                                                                                                                                                                                                                                                                             | 15,000                                                                       |
| 3                    | IQ                                                                                                                                                                                                                                                                                                                                  | 15,000                                                                       |
| 4                    | OQ                                                                                                                                                                                                                                                                                                                                  | 25,000                                                                       |
| 4                    | PQ 方案 PQ protocol                                                                                                                                                                                                                                                                                                     | 10,000                                                                       |
| 6                    | 注射用水储存和分配系统WFI storage and distribution system                                                                                                                                                                                                         | DQ,TM,RA                                                              | 20,000 |
| 7                    | FAT,SAT                                                                                                                                                                                                                                                                                                                             | 10,000                                                                       |
| 8                    | IQ                                                                                                                                                                                                                                                                                                                                  | 15,000                                                                       |
| 9                    | OQ                                                                                                                                                                                                                                                                                                                                  | 25,000                                                                       |
| 9                    | PQ 方案 PQ protocol                                                                                                                                                                                                                                                                                                     | 10,000                                                                       |
| 11                   | 纯蒸汽分配系统 Pure steam distribution system                                                                                                                                                                                                                                             | DQ,TM,RA                                                              | 10,000 |
| 12                   | FAT,SAT                                                                                                                                                                                                                                                                                                                             | 10,000                                                                       |
| 13                   | IQ,OQ                                                                                                                                                                                                                                                                                                                        | 20,000                                                                       |
| 14                   | PQ 方案 PQ protocol                                                                                                                                                                                                                                                                                                     | 10,000                                                                       |
| 11                   | 控制系统 Automatic control system                                                                                                                                                                                                                                                                           | 控制系统验证Validation of control system | 100,000 |
| 15                   | 总价                                                                                                                                                                                                                                                                                                                    | 315,000                                                                      |
|                 | Remarks 备注:                                                                                                                                                                                                                                                                                                    |
|                 | 1) 包含本报价服务范围内的朗脉验证人员在客户现场的差旅食宿费用。The cost of trips and living in client site are included in abo ve price。 |
|                 | 2) 包含验证仪器费用。The fee of validation instruments are included in above price.。                                                                                                                                                                                   |
|                 | 3) 验证不包括系统中仪表和传感器的校准工作。 The calibration work for instruments and sensors in the systems is not validation wor k。                                                                 |
|                 | 4) 本报价有效期:3 个月内。                                                                                                                                                                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第33页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第34页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 12     | Quotation For Validation Activities 验证服务报价                                                                  | 315,000.00   |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 13     | Project Management & Supervision 项目管理&监督                                                            | 50,000.00    |
| 14     | COMPANY Management 公司管理                                                                                                   | 500,000.00   |
|   | Subtotal 3 for Project Service 项目服务                                                                                       | 925,000.00   |
|   | Subtotal 1, 2, 3,合计                                                                                                                     | 6,420,462.14 |
|   | Tax 税金(主材部分开增值税,其他开工程发票 | 91,607.54    |
|   | 总价 Total Price                                                                                                                          | 6,512,069.68 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第35页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围                                            | Specification 规格                               | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准            | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------|---------------------------|---------------------------|---------------------------------------|--------------------------------------|--------------------------------------------------|-----------------------------------|
| 1                     | 纯化水储罐(包含附件) | 10m3,压力容器                        | 316L                      | 1                         | RITAI                                 |                                 | 185,000.00                                       | 185,000.00                        |
| 2                     | 纯化水循环泵                                         | 20T/hr,55m 扬程,带下排口 | 316L                      | 1                         | ALFA LAVAL                            |                                 | 36,250.00                                        | 36,250.00                         |
| 3                     | 纯化水循环泵                                         | 30T/hr,55m 扬程,带下排口 | 316L                      | 1                         | ALFA LAVAL                            |                                 | 41,250.00                                        | 41,250.00                         |
| 4                     | 管式热交换器                                         | 4T ,循环加热1h,25°C-85°C   | 316L                      | 1                         | NEUMO                                 |                                 | 156,483.13                                       | 156,483.13                        |
| 5                     | 温度变送器                                                 | 4-20 mA output                                               | 316L                      | 3                         | CHINA                                 |                                 | 812.50                                           | 2,437.50                          |
| 6                     | 压力表                                                                 | 0-6 kgf/cm2, 1 1/2"                                          | 316L                      | 2                         | CHINA                                 |                                 | 437.50                                           | 875.00                            |
| 7                     | 电导仪                                                                 | 4-20 mA output                                               |                      | 2                         | BURKERT                               |                                 | 8,375.00                                         | 16,750.00                         |
| 8                     | 流量计                                                                 | 4-20 mA output,DN50                                          |                      | 2                         | YAKOGAWA                              |                                 | 9,375.00                                         | 18,750.00                         |
| 9                     | 变频器                                                                 | 7.5KW                                                        |                      | 1                         | SIEMENS                               |                                 | 6,250.00                                         | 6,250.00                          |
| 10                    | 变频器                                                                 | 11KW                                                         |                      | 1                         | SIEMENS                               |                                 | 6,750.00                                         | 6,750.00                          |
| 11                    | 疏水器                                                                 | DN20(浮球式)                               | 碳钢          | 1                         | Spirax Sarco                          |                                 | 1,500.00                                         | 1,500.00                          |
| 12                    | 气动调节阀                                                 | DN50                                                         | 316L                      | 1                         | BURKERT                               |                                 | 11,125.00                                        | 11,125.00                         |
| 13                    | 气动隔膜阀                                                 | DN50                                                         | 316L                      | 2                         | GEMU                                  | 铸造,Ra≤0.4 | 5,992.50                                         | 11,985.00                         |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第36页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准            | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|--------------------------------------|--------------------------------------------------|-----------------------------------|
| 14                    | 气动隔膜阀      | DN40                           | 316L                      | 4                         | GEMU                                  | 铸造,Ra≤0.4 | 4,668.75                                         | 18,675.00                         |
| 15                    | 气动隔膜阀      | DN25                           | 316L                      | 7                         | GEMU                                  | 铸造,Ra≤0.4 | 3,201.25                                         | 22,408.75                         |
| 16                    | 气动角座阀      | DN50                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 3,312.50                                         | 3,312.50                          |
| 17                    | 气动角座阀      | DN25                           | 316L                      | 2                         | GEMU                                  | 铸造,Ra≤0.4 | 1,562.50                                         | 3,125.00                          |
| 18                    | 气动角座阀      | DN20                           | 316L                      | 2                         | GEMU                                  | 铸造,Ra≤0.4 | 1,375.00                                         | 2,750.00                          |
| 19                    | 隔膜阀                      | DN80                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 24,412.50                                        | 24,412.50                         |
| 20                    | 隔膜阀                      | DN65                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 23,075.00                                        | 23,075.00                         |
| 21                    | 隔膜阀                      | DN25                           | 316L                      | 26                        | GEMU                                  | 铸造,Ra≤0.4 | 2,428.75                                         | 63,147.50                         |
| 22                    | 隔膜阀                      | DN15                           | 316L                      | 2                         | GEMU                                  | 铸造,Ra≤0.4 | 1,665.00                                         | 3,330.00                          |
| 23                    | 限流孔板              | DN25                           | 316L                      | 22                        | CHINA                                 |                                 | 218.75                                           | 4,812.50                          |
| 24                    | 法兰                              | DN50                           | 316L                      | 4                         | CHINA                                 |                                 | 306.25                                           | 1,225.00                          |
| 25                    | 卡接头                      | DN76.1                         | 316L                      | 5                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5                | 95.06                                            | 475.29                            |
| 26                    | 卡接头                      | DN63.5                         | 316L                      | 6                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5                | 79.01                                            | 474.07                            |
| 27                    | 卡接头                      | DN51                           | 316L                      | 12                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5                | 62.67                                            | 752.05                            |
| 28                    | 卡接头                      | DN38                           | 316L                      | 8                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5                | 59.28                                            | 474.26                            |
| 29                    | 卡接头                      | DN25                           | 316L                      | 45                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5                | 48.04                                            | 2,161.59                          |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第37页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 30                    | 卡接头                      | DN19                           | 316L                      | 20                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 47.40                                            | 948.00                            |
| 31                    | 卡环                              | DN76.1                         | 304                       | 5                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 81.64                                            | 408.18                            |
| 32                    | 卡环                              | DN63.5                         | 304                       | 6                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 72.04                                            | 432.21                            |
| 33                    | 卡环                              | DN51                           | 304                       | 12                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 58.72                                            | 704.61                            |
| 34                    | 卡环                              | DN38                           | 304                       | 16                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 49.56                                            | 793.04                            |
| 35                    | 卡环                              | DN25                           | 304                       | 80                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 49.56                                            | 3,965.18                          |
| 36                    | 卡环                              | DN19                           | 304                       | 4                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 95.79                                            | 383.15                            |
| 37                    | 密封圈                      | DN76.1                         | PTFE                      | 5                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 67.52                                            | 337.59                            |
| 38                    | 密封圈                      | DN63.5                         | PTFE                      | 6                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 53.38                                            | 320.26                            |
| 39                    | 密封圈                      | DN51                           | PTFE                      | 12                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 46.51                                            | 558.07                            |
| 40                    | 密封圈                      | DN38                           | PTFE                      | 16                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 41.88                                            | 670.12                            |
| 41                    | 密封圈                      | DN25                           | PTFE                      | 80                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 46.51                                            | 3,720.47                          |
| 42                    | 密封圈                      | DN19                           | PTFE                      | 4                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 37.12                                            | 148.47                            |
| 43                    | U 型弯                            | DN63.5/25                      | 316L                      | 4                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 503.26                                           | 2,013.04                          |
| 44                    | U 型弯                            | DN51/25                        | 316L                      | 13                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 446.07                                           | 5,798.92                          |
| 45                    | 变径三通(WCW)         | DN76.1/38                      | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 303.92                                           | 303.92                            |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第38页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 46                    | 变径三通(WCW)         | DN63.5/51                      | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 264.15                                           | 264.15                            |
| 47                    | 变径三通(WCW)         | DN63.5/38                      | 316L                      | 3                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 255.67                                           | 767.01                            |
| 48                    | 变径三通(WCW)         | DN63.5/25                      | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 306.64                                           | 306.64                            |
| 49                    | 变径三通(WCW)         | DN51/38                        | 316L                      | 5                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 221.58                                           | 1,107.88                          |
| 50                    | 变径三通(WCW)         | DN51/25                        | 316L                      | 3                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 271.68                                           | 815.05                            |
| 51                    | 变径三通(WWW)         | DN63.5/38                      | 316L                      | 2                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 102.27                                           | 204.54                            |
| 52                    | 变径三通(WWW)         | DN51/38                        | 316L                      | 2                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 68.18                                            | 136.35                            |
| 53                    | 正三通(WCW)                 | DN25                           | 316L                      | 11                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 195.25                                           | 2,147.72                          |
| 54                    | 90°弯头                      | DN76.1                         | 316L                      | 5                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 94.15                                            | 470.76                            |
| 55                    | 90°弯头                      | DN63.5                         | 316L                      | 48                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 56.49                                            | 2,711.72                          |
| 56                    | 90°弯头                      | DN51                           | 316L                      | 100                       | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 39.61                                            | 3,961.18                          |
| 57                    | 90°弯头                      | DN38                           | 316L                      | 10                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 34.26                                            | 342.59                            |
| 58                    | 90°弯头                      | DN25                           | 316L                      | 36                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 26.95                                            | 970.31                            |
| 59                    | 90°弯头                      | DN19                           | 316L                      | 20                        | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 220.33                                           | 4,406.59                          |
| 60                    | 45°弯头                      | DN63.5                         | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 60.55                                            | 60.55                             |
| 61                    | 45°弯头                      | DN51                           | 316L                      | 1                         | ALFA LAVAL                            | ISO 2037,Ra≤0.5     | 45.29                                            | 45.29                             |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第39页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item             | Supply Scope                                                                                                                                                                                     | Specification    | Material         | Quantity         | Manufacturer             | Standard              | Unit Price                            | Total Price           |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------|------------------|--------------------------|-----------------------|---------------------------------------|-----------------------|
| 序号 | 供货范围                                                                                                                                                                 | 规格 | 材料 | 数量 | 供应商 | 标准      | 单位价格(RMB) | 总价(RMB) |
| 62               | 偏心大小头                                                                                                                                                         | DN63.5/51        | 316L             | 3                | ALFA LAVAL               | ISO 2037,Ra≤0.5 | 163.62                                | 490.87                |
| 63               | 同心大小头                                                                                                                                                         | DN63.5/38        | 316L             | 1                | ALFA LAVAL               | ISO 2037,Ra≤0.5 | 191.59                                | 191.59                |
| 64               | 管道                                                                                                                                                                                 | DN76.1           | 316L             | 6                | ALFA LAVAL               | ISO 2037,Ra≤0.5 | 433.98                                | 2,603.86              |
| 65               | 管道                                                                                                                                                                                 | DN63.5           | 316L             | 138              | ALFA LAVAL               | ISO 2037,Ra≤0.5 | 369.41                                | 50,978.82             |
| 66               | 管道                                                                                                                                                                                 | DN51             | 316L             | 330              | ALFA LAVAL               | ISO 2037,Ra≤0.5 | 234.02                                | 77,227.76             |
| 67               | 管道                                                                                                                                                                                 | DN38             | 316L             | 12               | ALFA LAVAL               | ISO 2037,Ra≤0.5 | 178.44                                | 2,141.22              |
| 68               | 管道                                                                                                                                                                                 | DN25             | 316L             | 18               | ALFA LAVAL               | ISO 2037,Ra≤0.5 | 125.53                                | 2,259.53              |
| 69               | 管道                                                                                                                                                                                 | DN19             | 316L             | 6                | ALFA LAVAL               | ISO 2037,Ra≤0.5 | 102.22                                | 613.34                |
|             | 以上为纯化水洁净管道系统管材,管件配置清单及报价 | 846,747.18       |
|             |                                                                                                                                                                                             |             |
|             | 可选项                                                                                                                                                                         |             |

| 1 | 管式热交换器 | 4T,循环加热1h,25C-85C | 316L | 1 | ABC |   | 159,212.94 | 159,212.94 |
|---|--------------------------------------------------|-----------------------------------------------|------|---|-----|--------|------------|------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第40页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围                                     | Specification 规格                                                         | Material 材料 | Quantity数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------|--------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 1                     | 注射水储罐(包含附件) | 10m3,压力容器                                                  | 316L                      | 1                        | RITAI                                 |                      | 350,000.00                                       | 350,000.00                        |
| 2                     | 注射用水循环泵                          | 20T/hr,55m 扬程,带下排口                           | 316L                      | 1                        | ALFA LAVAL                            |                      | 38,750.00                                        | 38,750.00                         |
| 3                     | 注射用水循环泵                          | 30T/hr,55m 扬程,带下排口                           | 316L                      | 1                        | ALFA LAVAL                            |                      | 43,750.00                                        | 43,750.00                         |
| 4                     | 管式热交换器                                  | 10T/H, 75°C-85°C.2T, 循环加热1h,85°C-121°C | 316L                      | 1                        | NEUMO                                 |                      | 143,879.00                                       | 143,879.00                        |
| 5                     | 管式热交换器                                  | 15T/H, 75°C-85°C.2T, 循环加热1h,85°C-121°C | 316L                      | 1                        | NEUMO                                 |                      | 136,656.50                                       | 136,656.50                        |
| 6                     | 管式热交换器                                  | 8T/H,85-60C,7C冷媒                                                         | 316L                      | 1                        | NEUMO                                 |                      | 152,026.88                                       | 152,026.88                        |
| 7                     | 管式热交换器                                  | 4T/H,85-60C,7C冷媒                                                         | 316L                      | 1                        | NEUMO                                 |                      | 135,135.00                                       | 135,135.00                        |
| 8                     | 管式热交换器                                  | 4T/H,85-30C,7C冷媒                                                         | 316L                      | 2                        | NEUMO                                 |                      | 184,539.38                                       | 369,078.75                        |
| 9                     | 管式热交换器                                  | 0.6T/H,85-30C,7C冷媒                                                       | 316L                      | 1                        | NEUMO                                 |                      | 119,852.13                                       | 119,852.13                        |
| 10                    | 管式热交换器                                  | 0.6T/H,85-60C,7C冷媒                                                       | 316L                      | 1                        | NEUMO                                 |                      | 105,743.13                                       | 105,743.13                        |
| 11                    | 管式热交换器                                  | 1.0T/H,85-30C,7C冷媒                                                       | 316L                      | 1                        | NEUMO                                 |                      | 129,070.00                                       | 129,070.00                        |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第41页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准            | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|----------------------|-----------------------------------------------|--------------------------------|---------------------------|--------------------------------|---------------------------------------|--------------------------------------|--------------------------------------------------|-----------------------------------|
| 12                   | 温度变送器      | 4-20 mA output                 | 316L                      | 11                             | E+H                                   |                                 | 2,375.00                                         | 26,125.00                         |
| 13                   | 压力表                      | 0-6 kgf/cm2,1 1/2"             | 316L                      | 2                              | BRIGHT                                |                                 | 437.50                                           | 875.00                            |
| 14                   | 电导仪                      | 4-20 mA output                 |                      | 2                              | METTLER TOLEDO                        |                                 | 14,000.00                                        | 28,000.00                         |
| 15                   | TOC 测试仪                  |                           |                      | 2                              | METTLER TOLEDO                        |                                 | 137,000.00                                       | 274,000.00                        |
| 16                   | 流量计                      | 4-20 mA output,DN65            |                      | 1                              | YAKOGAWA                              |                                 | 9,625.00                                         | 9,625.00                          |
| 17                   | 流量计                      | 4-20 mA output,DN50            |                      | 1                              | YAKOGAWA                              |                                 | 9,375.00                                         | 9,375.00                          |
| 18                   | 流量计                      | 4-20 mA output,DN40            |                      | 1                              | YAKOGAWA                              |                                 | 9,000.00                                         | 9,000.00                          |
| 19                   | 流量计                      | 4-20 mA output,DN25            |                      | 4                              | YAKOGAWA                              |                                 | 9,000.00                                         | 36,000.00                         |
| 20                   | 变频器                      | 7.5KW                          |                      | 1                              | SIEMENS                               |                                 | 6,250.00                                         | 6,250.00                          |
| 21                   | 变频器                      | 11KW                           |                      | 1                              | SIEMENS                               |                                 | 6,750.00                                         | 6,750.00                          |
| 22                   | 疏水器                      | DN20                           | 316L                      | 2                              | Spirax Sarco                          |                                 | 2,875.00                                         | 5,750.00                          |
| 23                   | 疏水器                      | DN20(浮球式) | 碳钢          | 2                              | Spirax Sarco                          |                                 | 1,500.00                                         | 3,000.00                          |
| 24                   | 气动调节阀      | DN50                           | 不锈钢  | 1                              | Burkert                               |                                 | 11,125.00                                        | 11,125.00                         |
| 25                   | 气动调节阀      | DN40                           | 不锈钢  | 2                              | Burkert                               |                                 | 10,625.00                                        | 21,250.00                         |
| 26                   | 气动调节阀      | DN25                           | 不锈钢  | 6                              | Burkert                               |                                 | 9,375.00                                         | 56,250.00                         |
| 27                   | 气动角座阀      | DN50                           | 316L                      | 1                              | GEMU                                  | 铸造,Ra≤0.4 | 3,312.50                                         | 3,312.50                          |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第42页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围            | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准            | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|----------------------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|--------------------------------------|--------------------------------------------------|-----------------------------------|
| 28                    | 气动角座阀                 | DN40                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 2,725.00                                         | 2,725.00                          |
| 29                    | 气动角座阀                 | DN25                           | 316L                      | 4                         | GEMU                                  | 铸造,Ra≤0.4 | 1,562.50                                         | 6,250.00                          |
| 30                    | 气动角座阀                 | DN20                           | 316L                      | 4                         | GEMU                                  | 铸造,Ra≤0.4 | 1,375.00                                         | 5,500.00                          |
| 31                    | 气动调节隔膜阀 | DN40                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 18,103.75                                        | 18,103.75                         |
| 32                    | 气动调节隔膜阀 | DN25                           | 316L                      | 4                         | GEMU                                  | 铸造,Ra≤0.4 | 15,996.25                                        | 63,985.00                         |
| 33                    | 气动隔膜阀                 | DN65                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 34,375.00                                        | 34,375.00                         |
| 34                    | 气动隔膜阀                 | DN50                           | 316L                      | 2                         | GEMU                                  | 铸造,Ra≤0.4 | 5,992.50                                         | 11,985.00                         |
| 35                    | 气动隔膜阀                 | DN40                           | 316L                      | 3                         | GEMU                                  | 铸造,Ra≤0.4 | 4,668.75                                         | 14,006.25                         |
| 36                    | 气动隔膜阀                 | DN25                           | 316L                      | 17                        | GEMU                                  | 铸造,Ra≤0.4 | 3,201.25                                         | 54,421.25                         |
| 37                    | 隔膜阀                                 | DN80                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 24,412.50                                        | 24,412.50                         |
| 38                    | 隔膜阀                                 | DN65                           | 316L                      | 1                         | GEMU                                  | 铸造,Ra≤0.4 | 23,075.00                                        | 23,075.00                         |
| 39                    | 隔膜阀                                 | DN25                           | 316L                      | 26                        | GEMU                                  | 铸造,Ra≤0.4 | 2,428.75                                         | 63,147.50                         |
| 40                    | 隔膜阀                                 | DN15                           | 316L                      | 2                         | GEMU                                  | 铸造,Ra≤0.4 | 1,665.00                                         | 3,330.00                          |
| 41                    | 冷水点控制盘         |                           | 不锈钢  | 11                        | CHINA                                 |                                 | 525.00                                           | 5,775.00                          |
| 42                    | 法兰                                         | DN65                           | 316L                      | 2                         | CHINA                                 |                                 | 337.50                                           | 675.00                            |
| 43                    | 法兰                                         | DN50                           | 316L                      | 2                         | CHINA                                 |                                 | 306.25                                           | 612.50                            |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第43页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 44                    | 法兰                              | DN40                           | 316L                      | 2                         | CHINA                                 |                      | 262.50                                           | 525.00                            |
| 45                    | 法兰                              | DN25                           | 316L                      | 8                         | CHINA                                 |                      | 225.00                                           | 1,800.00                          |
| 46                    | 限流孔板              | DN25                           | 316L                      | 27                        | CHINA                                 |                      | 218.75                                           | 5,906.25                          |
| 47                    | 卡接头                      | DN76.1                         | 316L                      | 5                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 340.80                                           | 1,704.00                          |
| 48                    | 卡接头                      | DN63.5                         | 316L                      | 12                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 292.09                                           | 3,505.13                          |
| 49                    | 卡接头                      | DN51                           | 316L                      | 12                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 215.40                                           | 2,584.80                          |
| 50                    | 卡接头                      | DN38                           | 316L                      | 12                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 180.46                                           | 2,165.51                          |
| 51                    | 卡接头                      | DN25                           | 316L                      | 60                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 168.86                                           | 10,131.53                         |
| 52                    | 卡接头                      | DN19                           | 316L                      | 12                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 134.06                                           | 1,608.71                          |
| 53                    | 卡环                              | DN76.1                         | 304                       | 5                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 98.96                                            | 494.82                            |
| 54                    | 卡环                              | DN63.5                         | 304                       | 12                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 91.07                                            | 1,092.85                          |
| 55                    | 卡环                              | DN51                           | 304                       | 12                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 83.19                                            | 998.26                            |
| 56                    | 卡环                              | DN38                           | 304                       | 20                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 76.08                                            | 1,521.65                          |
| 57                    | 卡环                              | DN25                           | 304                       | 90                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 76.08                                            | 6,847.41                          |
| 58                    | 卡环                              | DN19                           | 304                       | 4                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 58.14                                            | 232.56                            |
| 59                    | 密封圈                      | DN76.1                         | PTFE                      | 5                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 22.42                                            | 112.12                            |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第44页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 60                    | 密封圈                      | DN63.5                         | PTFE                      | 12                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 20.72                                            | 248.61                            |
| 61                    | 密封圈                      | DN51                           | PTFE                      | 12                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 17.79                                            | 213.46                            |
| 62                    | 密封圈                      | DN38                           | PTFE                      | 30                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 16.08                                            | 482.47                            |
| 63                    | 密封圈                      | DN25                           | PTFE                      | 90                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 14.69                                            | 1,322.47                          |
| 64                    | 密封圈                      | DN19                           | PTFE                      | 4                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 15.62                                            | 62.49                             |
| 65                    | U 型弯                            | DN51/25                        | 316L                      | 6                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 4,543.00                                         | 27,258.00                         |
| 66                    | U 型弯                            | DN38/25                        | 316L                      | 2                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 3,987.58                                         | 7,975.15                          |
| 67                    | U 型弯                            | DN25/25                        | 316L                      | 15                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 3,987.58                                         | 59,813.65                         |
| 68                    | 变径三通(WCW)         | DN76.1/38                      | 316L                      | 1                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 944.94                                           | 944.94                            |
| 69                    | 变径三通(WCW)         | DN63.5/51                      | 316L                      | 1                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 720.73                                           | 720.73                            |
| 70                    | 变径三通(WCW)         | DN63.5/38                      | 316L                      | 7                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 720.73                                           | 5,045.11                          |
| 71                    | 变径三通(WCW)         | DN63.5/25                      | 316L                      | 4                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 720.73                                           | 2,882.92                          |
| 72                    | 变径三通(WCW)         | DN51/38                        | 316L                      | 6                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 528.21                                           | 3,169.27                          |
| 73                    | 变径三通(WCW)         | DN51/25                        | 316L                      | 5                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 528.21                                           | 2,641.06                          |
| 74                    | 变径三通(WCW)         | DN38/25                        | 316L                      | 2                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 419.35                                           | 838.71                            |
| 75                    | 变径三通(WCW)         | DN25                           | 316L                      | 23                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 310.80                                           | 7,148.40                          |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第45页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 76                    | 变径三通(WWW)         | DN25/19                        | 316L                      | 4                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 242.61                                           | 970.45                            |
| 77                    | 变径三通(WWW)         | DN63.5/38                      | 316L                      | 2                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 596.25                                           | 1,192.49                          |
| 78                    | 变径三通(WWW)         | DN63.5/25                      | 316L                      | 2                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 596.25                                           | 1,192.49                          |
| 79                    | 变径三通(WWW)         | DN51/25                        | 316L                      | 2                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 408.69                                           | 817.39                            |
| 80                    | 弯头                              | DN76.1                         | 316L                      | 5                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 582.33                                           | 2,911.65                          |
| 81                    | 弯头                              | DN63.5                         | 316L                      | 32                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 457.54                                           | 14,641.32                         |
| 82                    | 弯头                              | DN51                           | 316L                      | 60                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 310.19                                           | 18,611.29                         |
| 83                    | 弯头                              | DN38                           | 316L                      | 16                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 244.32                                           | 3,909.08                          |
| 84                    | 弯头                              | DN25                           | 316L                      | 108                       | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 197.93                                           | 21,376.38                         |
| 85                    | 弯头                              | DN19                           | 316L                      | 20                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 226.68                                           | 4,533.65                          |
| 86                    | 45°弯头                      | DN63.5                         | 316L                      | 1                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 438.06                                           | 438.06                            |
| 87                    | 45°弯头                      | DN51                           | 316L                      | 1                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 294.41                                           | 294.41                            |
| 88                    | 偏心大小头      | DN63.5/51                      | 316L                      | 3                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 600.74                                           | 1,802.22                          |
| 89                    | 管道                              | DN76.1                         | 316L                      | 6                         | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 1,108.79                                         | 6,652.73                          |
| 90                    | 管道                              | DN63.5                         | 316L                      | 90                        | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 786.26                                           | 70,763.29                         |
| 91                    | 管道                              | DN51                           | 316L                      | 240                       | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 594.69                                           | 142,726.59                        |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第46页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围                                                                                                                                                            | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------|---------------------------|--------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 92                    | 管道                                                                                                                                                                                         | DN38                           | 316L                      | 48                        | NEUMO                                | ASME BPE PM,Ra≤0.5  | 463.75                                           | 22,260.14                         |
| 93                    | 管道                                                                                                                                                                                         | DN25                           | 316L                      | 330                       | NEUMO                                | ASME BPE PM,Ra≤0.5  | 362.89                                           | 119,755.06                        |
| 94                    | 管道                                                                                                                                                                                         | DN19                           | 316L                      | 6                         | NEUMO                                | ASME BPE PM,Ra≤0.5  | 514.11                                           | 3,084.64                          |
|                  | 以上为注射用水洁净管道系统管材,管件配置清单及报价 | 3,162,938.98                   |
|                  |                                                                                                                                                                                                     |                           |                      |
|                  | 可选项                                                                                                                                                                                 |                           |

| 1 | 管式热交换器 | 10T/H, 75C-85C.2T, 循环加热1h,85C-121C | 316L | 1 | ABC |   | 168,235.29 | 168,235.29 |
|---|--------------------------------------------------|----------------------------------------------------------------|------|---|-----|--------|------------|------------|
| 2 | 管式热交换器 | 15T/H, 75C-85C.2T, 循环加热1h,85C-121C | 316L | 1 | ABC |   | 168,235.29 | 168,235.29 |
| 3 | 管式热交换器 | 8T/H,85-60C,7C冷媒                                 | 316L | 1 | ABC |   | 121,435.29 | 121,435.29 |
| 4 | 管式热交换器 | 4T/H,85-60C,7C冷媒                                 | 316L | 1 | ABC |   | 97,147.06  | 97,147.06  |
| 5 | 管式热交换器 | 4T/H,85-30C,7C冷媒                                 | 316L | 2 | ABC |   | 115,400.00 | 230,800.00 |
| 6 | 管式热交换器 | 0.6T/H,85-30C,7C冷媒                               | 316L | 1 | ABC |   | 95,294.12  | 95,294.12  |
| 7 | 管式热交换器 | 0.6T/H,85-60C,7C冷媒                               | 316L | 1 | ABC |   | 85,952.94  | 85,952.94  |
| 8 | 管式热交换器 | 1.0T/H,85-30C,7C冷媒                               | 316L | 1 | ABC |   | 100,000.00 | 100,000.00 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第47页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|----------------------------------------------------|--------------------------------|---------------------------|--------------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 1                     | 压力表                           | 0-6 kgf/cm2,1 1/2"             | 316L                      | 1                              | CHINA                                 |                      | 437.50                                           | 437.50                            |
| 2                     | 温度表                           | 0C-160C,1 1/2"                 | 316L                      | 1                              | CHINA                                 |                      | 525.00                                           | 525.00                            |
| 3                     | 疏水器                           | DN20                           | 316L                      | 16                             | Spirax Sarco                          |                      | 2,875.00                                         | 46,000.00                         |
| 4                     | 气动球阀                   | DN25                           | 316L                      | 8                              | KINGLAI                               |                      | 1,002.98                                         | 8,023.80                          |
| 5                     | 手动球阀                   | DN65                           | 316L                      | 1                              | KINGLAI                               |                      | 1,275.00                                         | 1,275.00                          |
| 6                     | 手动球阀                   | DN25                           | 316L                      | 42                             | KINGLAI                               |                      | 257.03                                           | 10,795.05                         |
| 7                     | 手动球阀                   | DN20                           | 316L                      | 5                              | KINGLAI                               |                      | 232.45                                           | 1,162.25                          |
| 8                     | 卡接头                           | DN63.5                         | 316L                      | 2                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 292.09                                           | 584.19                            |
| 9                     | 卡接头                           | DN25                           | 316L                      | 100                            | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 168.86                                           | 16,885.88                         |
| 10                    | 卡接头                           | DN19                           | 316L                      | 8                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 134.06                                           | 1,072.47                          |
| 11                    | 卡环                                   | DN63.5                         | 304                       | 2                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 91.07                                            | 182.14                            |
| 12                    | 卡环                                   | DN38                           | 304                       | 2                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 76.08                                            | 152.16                            |
| 13                    | 卡环                                   | DN25                           | 304                       | 135                            | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 76.08                                            | 10,271.12                         |
| 14                    | 卡环                                   | DN19                           | 304                       | 8                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 58.14                                            | 465.13                            |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第48页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|--------------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 15                    | 密封圈                      | DN63.5                         | PTFE                      | 2                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 20.72                                            | 41.44                             |
| 16                    | 密封圈                      | DN38                           | PTFE                      | 2                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 16.08                                            | 32.16                             |
| 17                    | 密封圈                      | DN25                           | PTFE                      | 135                            | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 14.69                                            | 1,983.71                          |
| 18                    | 密封圈                      | DN19                           | PTFE                      | 8                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 15.62                                            | 124.99                            |
| 19                    | 变径三通(WCW)         | DN63.5/38                      | 316L                      | 2                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 720.73                                           | 1,441.46                          |
| 20                    | 变径三通(WWW)         | DN63.5/51                      | 316L                      | 1                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 596.25                                           | 596.25                            |
| 21                    | 变径三通(WWW)         | DN63.5/38                      | 316L                      | 1                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 596.25                                           | 596.25                            |
| 22                    | 变径三通(WWW)         | DN63.5/19                      | 316L                      | 1                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 596.25                                           | 596.25                            |
| 23                    | 变径三通(WWW)         | DN51/25                        | 316L                      | 14                             | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 408.69                                           | 5,721.72                          |
| 24                    | 变径三通(WWW)         | DN38/25                        | 316L                      | 6                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 326.41                                           | 1,958.47                          |
| 25                    | 变径三通(WWW)         | DN38/19                        | 316L                      | 2                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 326.41                                           | 652.82                            |
| 26                    | 三通(WWW)                         | DN25                           | 316L                      | 25                             | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 204.56                                           | 5,114.12                          |
| 27                    | 三通(WWW)                         | DN19                           | 316L                      | 3                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 500.22                                           | 1,500.67                          |
| 28                    | 弯头                              | DN63.5                         | 316L                      | 12                             | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 457.54                                           | 5,490.49                          |
| 29                    | 弯头                              | DN51                           | 316L                      | 24                             | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 310.19                                           | 7,444.52                          |
| 30                    | 弯头                              | DN38                           | 316L                      | 18                             | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 244.32                                           | 4,397.72                          |
| 31                    | 弯头                              | DN25                           | 316L                      | 112                            | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 197.93                                           | 22,168.09                         |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第49页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格                                                                                                                                                                   | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Standard 标准 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------------------|---------------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 32                    | 弯头                              | DN19                                                                                                                                                                                             | 316L                      | 15                             | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 226.68                                           | 3,400.24                          |
| 33                    | 大小头                      | DN63.5/51                                                                                                                                                                                        | 316L                      | 1                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 600.74                                           | 600.74                            |
| 34                    | 大小头                      | DN51/25                                                                                                                                                                                          | 316L                      | 2                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 734.34                                           | 1,468.68                          |
| 35                    | 大小头                      | DN38/25                                                                                                                                                                                          | 316L                      | 2                              | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 277.56                                           | 555.13                            |
| 36                    | 管道                              | DN63.5                                                                                                                                                                                           | 316L                      | 36                             | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 786.26                                           | 28,305.32                         |
| 37                    | 管道                              | DN51                                                                                                                                                                                             | 316L                      | 108                            | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 594.69                                           | 64,226.96                         |
| 38                    | 管道                              | DN38                                                                                                                                                                                             | 316L                      | 60                             | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 463.75                                           | 27,825.18                         |
| 39                    | 管道                              | DN25                                                                                                                                                                                             | 316L                      | 150                            | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 362.89                                           | 54,434.12                         |
| 40                    | 管道                              | DN19                                                                                                                                                                                             | 316L                      | 36                             | NEUMO                                 | ASME BPE PM,Ra≤0.5  | 514.11                                           | 18,507.81                         |
|                  |                                          | 以上为纯蒸汽洁净管道系统管材,管件配置清单及报价 |                      | 357,016.99                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第50页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 序号 Item | 供货范围 Scope of Supply         | 订货号 Order No. | 规格 型号 Specification                                | 厂家 Manufacturer | 数量 Quantity | 单价(RMB) Unit Price | 价格(RMB) Price |
|-----------------------|----------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------|-------------------------------|---------------------------|----------------------------------|-----------------------------|
| 1                     | 导轨                                         | 6ES7 390-1AF30-0AA0                | 标准导轨 530mm                                         | SIEMENS                       | 2                         | 228.00                           | 456.00                      |
| 2                     | 电源                                         | 6ES7 307-1EA00-0AA0                | PS 307 电源 5 A                                                    | SIEMENS                       | 2                         | 988.00                           | 1,976.00                    |
| 3                     | CPU                                                      | 6ES7 315-2EH13-0AB0                | 315-2 PN/DP 256KB RAM; MPI/PROFIBUS DP;PROFINET 接口 | SIEMENS                       | 1                         | 13,227.00                        | 13,227.00                   |
| 4                     | 扩展卡                                 | 6ES7 953-8LF11-0AA0                | MMC 64 kB                                                                      | SIEMENS                       | 1                         | 380.00                           | 380.00                      |
| 5                     | 接口模块                         | 6ES7 365-0BA01-0AA0                | IM365 接口模块                                         | SIEMENS                       | 1                         | 838.00                           | 838.00                      |
| 6                     | DI 模块                                      | 6ES7 321-1BH02-0AA0                | 16 点数字输入24V DC(20 针)                 | SIEMENS                       | 2                         | 1,013.00                         | 2,026.00                    |
| 7                     | DO 模块                                      | 6ES7 322-1BH01-0AA0                | 16 点数字输出24V DC(20 针)                 | SIEMENS                       | 3                         | 1,409.00                         | 4,227.00                    |
| 8                     | AI 模块                                      | 6ES7 331-7KF02-0AB0                | 8 通道模拟输入(20 针)                | SIEMENS                       | 5                         | 3,899.00                         | 19,495.00                   |
| 9                     | AO 模块                                      | 6ES7 332-5HF00-0AB0                | 8 通道模拟输出(40 针)                | SIEMENS                       | 3                         | 6,065.00                         | 18,195.00                   |
| 10                    | 连接端子                         | 6ES7 392-1AJ00-0AA0                | 20 针,螺钉型端子                    | SIEMENS                       | 10                        | 149.00                           | 1,490.00                    |
| 11                    | 连接端子                         | 6ES7 392-1AM00-0AA0                | 40 针,螺钉型端子                    | SIEMENS                       | 3                         | 234.00                           | 702.00                      |
| 12                    | 变频器                                 |                               | MM420 7.5KW                                                                    | SIEMENS                       | 4                         | 3,600.00                         | 14,400.00                   |
| 13                    | 变频器操作面板 | 6SE6 400-0BP00-0AA0                | BOP 面板                                                           | SIEMENS                       | 4                         | 300.00                           | 1,200.00                    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第51页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 序号 | 供货范围                                                                                                                                 | 订货号 | 规格 型号                                                                                                        | 厂家 | 数量 | 单价(RMB) | 价格(RMB) |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------|-----------------------|-----------------------|
| Item             | Scope of Supply                                                                                                                                                  | Order No.                | Specification                                                                                                                            | Manufacturer     | Quantity         | Unit Price            | Price                 |
| 14               | 开关电源                                                                                                                                 | 6EP1 334-3BA00           | SITOP 24V/10A                                                                                                                            | SIEMENS          | 1                | 1,500.00              | 1,500.00              |
| 15               | 控制柜                                                                                                                                         |                     | 2000×800×600(含继电器、端子等柜内电气元件) | shanghai         | 1                | 14,000.00             | 14,000.00             |
| 16               | 上位机电脑                                                                                                                         |                     | Core 2\1024MB\160G\19"LCD                                                                                                                | DELL             | 1                | 7,200.00              | 7,200.00              |
| 17               | 上位机软件                                                                                                                         | 6AV6 381-1BE06-2AV0      | WINCC V6.2 RT(1024 点)                                                                                                             | SIEMENS          | 1                | 32,892.00             | 32,892.00             |
| 18               | 打印机                                                                                                                                         |                     | A4 激光打印机                                                                                              | HP               | 1                | 2,400.00              | 2,400.00              |
| 19               | 触摸屏                                                                                                                                         | 6AV6 643-0CD01-1AX1      | MP 277 10" Touch 64K 颜色                                                                                                    | SIEMENS          | 1                | 12,000.00             | 12,000.00             |
| 20               | 交换机                                                                                                                                         | 6 RJ45 口          | 工业以太网交换机                                                                         | MOXA             | 1                | 1,200.00              | 1,200.00              |
| 21               | 编程电缆                                                                                                                                 | 6ES7 972-0CB20-0XA0      | PLC 编程电缆USB                                                                                                  | SIEMENS          | 1                | 2,646.00              | 2,646.00              |
| 22               | 网线                                                                                                                                                 |                     |                                                                                                                                     |             | 500.00           |
| 23               | 电缆                                                                                                                                                 |                     |                                                                                                                                     |             | 12,000.00        |
| 24               | 电缆                                                                                                                                                 |                     |                                                                                                                                     |             | 12,000.00        |
| 25               | 电缆                                                                                                                                                 |                     |                                                                                                                                     |             | 10,125.00        |
| 26               | 桥架                                                                                                                                                 |                     |                                                                                                                                     |             | 13,750.00        |
| 一、 | 控制系统所用材料                                                                                                 |                     |                                                                                                                                     |             | 200,825.00       |
| 二、 | 编程费 Programme Cost(1 人30 个工作日)                                                             |                     |                                                                                                                                     |             | 35,000.00        |
| 三、 | 安装费用(3人10 个工作日)                                                                     |                     |                                                                                                                                     |             | 40,000.00        |
| 四、 | 调试费 Commissioning Cost(2 人10 个工作日,含住宿交通等) |                     |                                                                                                                                     |             | 275,825.00       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第52页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Configuration list for PW Bank 纯化水储罐配置清单 |
|---------------------------------------------------------------------------------------------------------|
| Item 序号                                                                                   | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Remarks 备注 |
| 1                                                                                                       | 纯化水储罐 | 10m3,常压容器,卧式, | 316L | 1 | RiTai | 内部抛光Ra<0 .5um,外部亚光处理Ra<0.8um |
| 2                                                                                                       | 呼吸器 | 10" 0.22um | 316L | 1 | PALL |   |
| 3                                                                                                       | 喷淋球 | DN40 | 316L | 3 | Alfa Laval | 固定式 |
| 4                                                                                                       | 液位计 | 4-20 mA output |   | 1 | E+H | 电容式 |
| 5                                                                                                       | 温度变送器 | DN40,4-20 mA output |   | 1 | CHINA | 卡接 |
| 6                                                                                                       | 压力传感器 | DN40,4-20 mA output |   | 1 | CHINA | 卡接 |
| 7                                                                                                       | 气动球阀 | DN40 | 316L | 1 | King Lai |   |
| 8                                                                                                       | 气动球阀 | DN20 | 316L | 3 | King Lai |   |
| 9                                                                                                       | 气动隔膜阀 | DN40 | 316L | 1 | GEMU |   |
| 10                                                                                                      | 隔膜阀 | DN15 | 316L | 1 | GEMU |   |
| 11                                                                                                      | 减压阀 | DN20 |   | 1 | 中国 |   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第53页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围                                                    | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Remarks 备注 |
|-----------------------|--------------------------------------------------------------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|--------------------------|
| 12                    | 疏水器                                                                         | DN20(浮球式) | 碳钢          | 1                         | Spirax Sarco                          |                     |
| 13                    | 卡接头                                                                         | DN40                           | 316L                      | 3                         | Alfa Laval                            | ISO 2037                 |
| 14                    | 卡接头                                                                         | DN19                           | 316L                      | 8                         | Alfa Laval                            | ISO 2037                 |
| 15                    | 卡环                                                                                 | DN40                           | 304                       | 6                         | Alfa Laval                            | ISO 2037                 |
| 16                    | 卡环                                                                                 | DN19                           | 304                       | 10                        | Alfa Laval                            | ISO 2037                 |
| 17                    | 密封圈                                                                         | DN40                           | PTFE                      | 6                         | Alfa Laval                            | ISO 2037                 |
| 18                    | 密封圈                                                                         | DN19                           | PTFE                      | 10                        | Alfa Laval                            | ISO 2037                 |
| 19                    | 变径三通                                                                 | DN38/19                        | 316L                      | 4                         | Alfa Laval                            | ISO 2037                 |
| 20                    | 三通                                                                                 | DN19                           | 316L                      | 2                         | Alfa Laval                            | ISO 2037                 |
|                  | 以上为纯化水储罐配置清单 |                           |

| Configuration list for WFI Bank 注射水储罐清单及报价 |
|------------------------------------------------------------------------------------------------------------------|
| Item 序号                                                                                            | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Remarks 备注 |
| 1                                                                                                                | 注射水储罐 | 10m3,压力容器,卧式,保温 | 316L | 1 | RiTai | 内部抛光Ra<0 .5um,外部亚光处理Ra<0.8um |
| 2                                                                                                                | 呼吸器 | 10“ 0.22um | 316L | 1 | PALL |   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第54页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围 | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Remarks 备注 |
|-----------------------|-----------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|--------------------------|
| 3                     | 电加热套              |                           |                      | 1                         | CHINA                                 |                     |
| 4                     | 喷淋球                      | DN50                           | 316L                      | 1                         | Alfa Laval                            | 固定式 |
| 5                     | 喷淋球                      | DN40                           | 316L                      | 2                         | Alfa Laval                            | 固定式 |
| 6                     | 液位计                      | 4-20 mA output                 | 316L                      | 1                         | E+H                                   | 电容式 |
| 7                     | 压力传感器      | DN40,4-20 mA output            | 316L                      | 1                         | CHINA                                 | 卡接         |
| 8                     | 温度变送器      | DN40,4-20 mA output            | 316L                      | 2                         | CHINA                                 | 卡接         |
| 9                     | 爆破片                      | 0.5-4bar                       | 316L                      | 1                         | FIKE                                  |                     |
| 10                    | 疏水器                      | DN20(浮球式) | 碳钢          | 1                         | Spirax Sarco                          |                     |
| 11                    | 气动球阀              | DN40                           | 316L                      | 1                         | King Lai                              |                     |
| 12                    | 气动球阀              | DN20                           | 316L                      | 1                         | King Lai                              |                     |
| 13                    | 球阀                              | DN20                           | 316L                      | 1                         | King Lai                              |                     |
| 14                    | 气动隔膜阀      | DN40                           | 316L                      | 1                         | GEMU                                  |                     |
| 15                    | 隔膜阀                      | DN15                           | 316L                      | 1                         | GEMU                                  |                     |
| 16                    | 减压阀                      | DN20                           |                      | 1                         | 中国                      |                     |
| 17                    | 卡接头                      | DN40                           | 316L                      | 3                         | NEUMO                                 | ASME BPE-EP              |
| 18                    | 卡接头                      | DN19                           | 316L                      | 8                         | NEUMO                                 | ASME BPE-EP              |
| 19                    | 卡环                              | DN40                           | 304                       | 6                         | NEUMO                                 | ASME BPE-EP              |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第55页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围                                                            | Specification 规格 | Material 材料 | Quantity 数量 | Manufacturer 供应商 | Remarks 备注 |
|-----------------------|----------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------|---------------------------|---------------------------------------|--------------------------|
| 20                    | 卡环                                                                                         | DN19                           | 304                       | 6                         | NEUMO                                 | ASME BPE-EP              |
| 21                    | 密封圈                                                                                 | DN40                           | PTFE                      | 6                         | NEUMO                                 | ASME BPE-EP              |
| 22                    | 密封圈                                                                                 | DN19                           | PTFE                      | 6                         | NEUMO                                 | ASME BPE-EP              |
| 23                    | 变径三通                                                                         | DN38/19                        | 316L                      | 2                         | NEUMO                                 | ASME BPE-EP              |
| 24                    | 三通                                                                                         | DN19                           | 316L                      | 1                         | NEUMO                                 | ASME BPE-EP              |
|                  | 以上为注射用水储罐配置清单 |                           |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第56页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| Item 序号 | Supply Scope 供货范围    | Location 位置 |                             | Quantity 数量 | Unit Price 单位价格(RMB) | Total Price 总价(RMB) |
|-----------------------|--------------------------------------------------|---------------------------|----------------------------------|---------------------------|--------------------------------------------------|-----------------------------------|
| 1                     | 纯化水系统         |                      | 自动焊点 | 729                       | 150.00                                           | 109,350.00                        |
| 2                     | 注射用水系统 |                      | 自动焊点 | 899                       | 150.00                                           | 134,850.00                        |
| 3                     | 纯蒸汽系统         |                      | 自动焊点 | 716                       | 150.00                                           | 107,400.00                        |
|                  |                                             |                      |                             |                      | 总价(元)         | 351,600.00                        |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第57页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

|                              |                 | 洁净室内保温管套管保温 | 非洁净室保温 |
|-----------------------------------|----------------------|------------------------------------------------------------------------------------------|--------------------------------------------------|
|                              |                 | Clean Area Piping Insulation                                                             | Non-clean Area Piping Insulation                 |
|                              |                 | Pipe-in-Pipe Asbestos Insulated                                                          | Stainless Steel Jacket Asbestos Insulated        |
| 数量(m) | 单价     | 合计                                                                         | 数量(m)                | 单价 | 合计 |
| 1                                 | WFI 管道 | 90                                                                                       | 350.00                                           | 31500.00 | 630 | 100.00 | 63000.00 |
| 2                                 | PS 管道  | 60                                                                                       | 350.00                                           | 21000.00 | 320 | 100.00 | 32000.00 |
|                              |                 |                                                                                     |                                             |   |   |   |   |
|                              |                 | 共计Total:                                                            | 52500.00                                         | 共计Total: | 95000.00 |
|                              |                 | 合计(元)                                                 | 147500.00                                        |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第58页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第59页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                        | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                      | 第 1 部分 投价书Tender                                                                                       |

| 序号 No.                                                                                                                                                                                                                                                                                                                | 验证项目Scope                                                                                       | 报价Quotation(RMB)                                               |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 1                                                                                                                                                                                                                                                                                                                                   | 纯化水储存和分配系统PW storage and distribution system          | DQ,TM,RA                                                              | 20,000 |
| 2                                                                                                                                                                                                                                                                                                                                   | FAT,SAT                                                                                                                     | 15,000                                                                       |
| 3                                                                                                                                                                                                                                                                                                                                   | IQ                                                                                                                          | 15,000                                                                       |
| 4                                                                                                                                                                                                                                                                                                                                   | OQ                                                                                                                          | 25,000                                                                       |
| 4                                                                                                                                                                                                                                                                                                                                   | PQ 方案 PQ protocol                                                                                             | 10,000                                                                       |
| 6                                                                                                                                                                                                                                                                                                                                   | 注射用水储存和分配系统WFI storage and distribution system | DQ,TM,RA                                                              | 20,000 |
| 7                                                                                                                                                                                                                                                                                                                                   | FAT,SAT                                                                                                                     | 10,000                                                                       |
| 8                                                                                                                                                                                                                                                                                                                                   | IQ                                                                                                                          | 15,000                                                                       |
| 9                                                                                                                                                                                                                                                                                                                                   | OQ                                                                                                                          | 25,000                                                                       |
| 9                                                                                                                                                                                                                                                                                                                                   | PQ 方案 PQ protocol                                                                                             | 10,000                                                                       |
| 11                                                                                                                                                                                                                                                                                                                                  | 纯蒸汽分配系统 Pure steam distribution system                                     | DQ,TM,RA                                                              | 10,000 |
| 12                                                                                                                                                                                                                                                                                                                                  | FAT,SAT                                                                                                                     | 10,000                                                                       |
| 13                                                                                                                                                                                                                                                                                                                                  | IQ,OQ                                                                                                                | 20,000                                                                       |
| 14                                                                                                                                                                                                                                                                                                                                  | PQ 方案 PQ protocol                                                                                             | 10,000                                                                       |
| 11                                                                                                                                                                                                                                                                                                                                  | 控制系统 Automatic control system                                                                   | 控制系统验证Validation of control system | 100,000 |
| 15                                                                                                                                                                                                                                                                                                                                  | 总价                                                                                                            | 315,000                                                                      |
| Remarks 备注:                                                                                                                                                                                                                                                                                                    |
| 1) 包含本报价服务范围内的朗脉验证人员在客户现场的差旅食宿费用。 The cost of trips and living in client site are included in above price。 |
| 2) 包含验证仪器费用。The fee of validation instruments are included in above price.。                                                                                                                                                                                   |
| 3) 验证不包括系统中仪表和传感器的校准工作。 The calibration work for instruments and sensors in the systems is not validation work。                                                                  |
| 4) 本报价有效期:3 个月内。                                                                                                                                                                                                                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第60页/共60 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

----

----

| 上海朗脉科技有限公司上海市闵行区罗阳路168 号A 座101 室     201100T:021 54306717     F: 021 54306718 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 1. 资质证明文件 Certificate                                                                | 3      |
|--------------------------------------------------------------------------------------------------------------------------------|--------|
|                                                                                                                           |   |
| 1.1. 资质证书 Certificate                                                                              | 3      |
| 1.1.1. 营业执照复印件 Business license                                               | 3      |
| 1.1.2. 组织机构代码证 Organization code certificate                                  | 4      |
| 1.1.3. 税务登记证 Business Registration                                                          | 5      |
| 1.1.4. 银行开户证明 The opening of bank accounts permits                                   | 6      |
| 1.1.5. 代理证书 Agency                                                                                 | 7      |
| 1.1.6. 协会证书 CAPE Certificate                                                                       | 13     |
|                                                                                                                           |   |
| 1.2. 部分业绩 Part reference                                                                           | 14     |
| 1.2.1. 部分竣工项目一览表 Part finished project List                     | 14     |
| 1.2.2. 部分在建同类工程一览表 Part constructing project List | 19     |
|                                                                                                                           |   |
| 1.3. 2007 年财务报表 Financial statement                                                         | 20     |
|                                                                                                                           |   |
| 2. 公司介绍 Company Introduction                                                                       | 21     |
|                                                                                                                           |   |
| 2.1. 公司概述 Brief introduction                                                                       | 21     |
| 2.1.1. 公司实力 Strength                                                                               | 21     |
| 2.1.2. 公司历史 History                                                                                | 25     |
| 2.1.3. 公司文化 Corporate cuture                                                                       | 26     |
| 2.1.4. 公司组织结构 Organize chart                                                         | 28     |
|                                                                                                                           |   |
| 2.2. 朗脉的服务Service                                                                           | 29     |
| 2.2.1. 专业领域服务 Professional service                                                   | 29     |
| 2.2.2. 工程总承包 Contractor                                                                     | 32     |
| 2.2.3. 植物提取工艺优化 Process optimization                                   | 33     |
| 2.2.4. 自动化控制系统业务 Automation Control system                      | 34     |
| 2.2.5. 过程控制系统 Process Flow                                                           | 35     |
| 2.2.6. 空调自控系统 HVAC automation system                                                 | 36     |
| 2.2.7. 在线清洗系统 Clean in place                                                         | 38     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第1页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 2.3. 洁净管道系统业务Sanitary piping system business               | 39 |
|--------------------------------------------------------------------------------------------------------------------|----|
| 2.3.1. 完善的工艺设计Perfect in process design                           | 39 |
| 2.3.2. 材料选型及采购Material Selection and Procurement                  | 41 |
| 2.3.3. 齐全的施工设备Construction facility                               | 42 |
| 2.3.4. 现场管理及现场施工Project management and construction | 44 |
| 2.3.5. 先进的检测设备Testing equipment                                   | 45 |
| 2.3.6. 系统调试和人员培训Training and system commission      | 45 |
| 2.3.7. 验证服务Validation service                                                          | 46 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第2页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第3页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第4页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第5页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第6页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第7页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第8页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第9页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第10页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第11页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第12页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第13页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 序号 | 客户名称                                                                                                         | 地点 | 项目概况                                                                                                                                                                                                                                                                            | 认证情况                                                        |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| 1                | 北京凯因生物技术有限公司                                         | 北京 | 纯水/注射用水/纯蒸气分配系统/干扰素发酵物料管道转运系统和空调自控(工艺管道) |                                                                                    |
| 2                | 北京万泰制药有限公司                                                         | 北京 | 纯水/注射用水/纯蒸汽/物料分配系统                                                                                                                                                                                 |                                                                                    |
| 3                | 北京三元基因工程有限公司                                         | 北京 | 纯水/注射用水/纯蒸汽/物料分配系统                                                                                                                                                                                 |                                                                                    |
| 4                | 常州四药有限公司                                                                         | 常州 | 注射用水/纯化水管道分配系统                                                                                                                                                                                                   | 依照FDA cGMP 规范,提供IQ/OQ 文件 |
| 5                | 河北恒利药业有限公司                                                         | 河北 | CIP 系统                                                                                                                                                                                                                                                                                        |                                                                                    |
| 6                | 成都普仕医塑公司                                                                         | 成都 | 纯水/注射用水/纯蒸汽及物料管道分配系统                                                                                                                                                          |                                                                                    |
| 7                | 扬子江药业集团广州海瑞药业有限公司 | 广州 | 纯蒸汽/纯水/注射用水/物料分配管道系统                                                                                                                                                                 |                                                                                    |
| 8                | 齐鲁海南药业有限公司                                                         | 海南 | 纯蒸汽/注射用水/纯水以及工艺管道系统                                                                                                                                                                  |                                                                                    |
| 9                | 杭州天元生物制药有限公司                                         | 杭州 | 注射用水/纯蒸汽/纯化水/洁净压缩空气/氮气等工艺管道系统                                                                                                | 依照FDA cGMP 规范,提供IQ/OQ 文件 |
| 10               | 杭州九源基因工程有限公司                                         | 杭州 | 纯蒸汽/注射用水/纯水以及工艺管道系统和空调自控                                                                                                                          | 依照FDA cGMP 规范,提供IQ/OQ 文件 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第14页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 序号 | 客户名称                                                                                                         | 地点 | 项目概况                                                                                                                                                                                                                            | 认证情况                                                                 |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 11               | 上海博莱科信谊制药有限公司                                 | 上海 | (蒸馏水生产装置MS304S,纯蒸汽生产装置PSG500DTS,纯水&蒸馏水&纯蒸汽分配系统) | 依照FDA cGMP 规范,提供IQ/OQ 文件          |
| 12               | 齐鲁安替比奥制药有限公司                                         | 济南 | 纯水& 注射用水分配系统/ 发酵物料转运管道系统(二期)                                                    | 无菌原料药已通过欧盟认证 |
| 13               | 齐鲁制药厂                                                                                                 | 济南 | 纯水/注射用水/纯蒸汽/物料分配系统                                                                                                                                 |                                                                                             |
| 14               | 齐鲁安替比奥制药有限公司                                         | 济南 | 注射用水/纯化水/纯蒸汽管道分配系统                                                                                                                          |                                                                                             |
| 15               | 齐鲁天和惠世制药有限公司                                         | 济南 | 注射用水/纯化水/纯蒸汽管道分配系统                                                                                                                          |                                                                                             |
| 16               | 山东鲁抗辰欣药业有限公司                                         | 济宁 | 注射用水/纯化水/纯蒸汽管道分配系统和空调自控                                                                                  |                                                                                             |
| 17               | 山东鲁抗立科制药有限公司                                         | 济宁 | 注射用水/纯化水/纯蒸汽管道分配系统和空调自控                                                                                  |                                                                                             |
| 18               | 浙江耐斯康制药有限公司                                                 | 金华 | 注射用水/纯蒸汽/纯化水分配系统改造项目                                                                                                          | 依照FDA cGMP 规范,提供IQ/OQ 文件          |
| 19               | 扬子江药业集团南京海陵药业有限公司 | 南京 | 纯蒸汽,注射用水分配系统工艺管道工程                                                                                                                   |                                                                                             |
| 20               | 宝利化(南京)制药有限公司                                 | 南京 | 注射用水/纯化水管道分配系统                                                                                                                                                   | 无菌注射剂已通过TGA 认证             |
| 21               | 青岛生化制药有限公司                                                         | 青岛 | 纯蒸汽/纯水/注射用水/压缩空气分配系统                                                                                                                 |                                                                                             |
| 22               | GE Healthcare                                                                                                                            | 上海 | 纯蒸汽/注射用水工艺管道工程                                                                                                                                                   | 无菌注射剂已通过FDA 认证             |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第15页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 序号 | 客户名称                                                                                                         | 地点         | 项目概况                                                                                                                                                                                    | 认证情况                                                        |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| 23               | 石药集团中润制药有限公司                                         | 石家庄 | 注射用水/纯化水/纯蒸汽及物料分配系统                                                                          |                                                                                    |
| 24               | 上海天士力药业有限公司                                                 | 上海         | 纯蒸汽/注射用水分配系统工艺管道工程                                                                           |                                                                                    |
| 25               | 上海百特医疗用品有限公司                                         | 上海         | 纯水/注射用水/配液分配系统                                                                                                                  |                                                                                    |
| 26               | 上海惠生生物工程有限公司                                         | 上海         | 纯水/注射用水/纯蒸汽管道分配系统                                                                                          |                                                                                    |
| 27               | 上海迪赛诺制药有限公司                                                 | 上海         | 注射用水/纯化水管道分配系统                                                                                                           | 符合WHO 规范                                                    |
| 28               | 上海惠生生物工程有限公司                                         | 上海         | 抗体实验室纯化水分配系统(二期)                                                                                    |                                                                                    |
| 29               | 上海莱士血液制品股份有限公司                         | 上海         | 注射用水分配系统过热水灭菌系统改造项目                                                            | 依照FDA cGMP 规范,提供IQ/OQ 文件 |
| 30               | 深圳海王英特龙生物科技有限责任公司 | 深圳         | 纯蒸汽/注射用水/纯水系统工艺管道系统                                                                          | 依照FDA cGMP 规范,提供IQ/OQ 文件 |
| 31               | 华北制药奥奇德有限公司                                                 | 石家庄 | 纯水/注射用水/纯蒸气分配系统/干扰素发酵物料管道转运系统 |                                                                                    |
| 32               | 华北制药华胜有限公司                                                         | 石家庄 | 纯蒸汽/注射用水/纯水系统及物料工艺管道分配系统                                  |                                                                                    |
| 33               | 华北制药集团北元有限公司                                         | 石家庄 | 注射用水,纯化水,纯蒸汽分配系统改造项目                                                    | 依照FDA cGMP 规范,                                       |
| 34               | 石家庄欧意制药有限公司                                                 | 石家庄 | 纯化水分配系统改造项目                                                                                                                            | 依照FDA cGMP 规范,                                       |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第16页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 序号 | 客户名称                                                                 | 地点 | 项目概况                                                                                                                                                                                                                                                                                                | 认证情况                                                        |
|------------------|--------------------------------------------------------------------------------------------------|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| 35               | 无锡台裕制药有限公司                 | 无锡 | 注射用水/纯化水/纯蒸汽系统及物料分配管道系统                                                                                                                                                      |                                                                                    |
| 36               | 厦门北大之路药业有限公司 | 厦门 | 注射用水/纯化水纯蒸汽系统及物料分配管道系统                                                                                                                                                       |                                                                                    |
| 37               | 苏州东瑞药业有限公司                 | 苏州 | 纯蒸汽/注射用水/纯水系统及物料工艺管道分配系统                                                                                                                                              | 依照FDA cGMP 规范,提供IQ/OQ 文件 |
| 38               | 贝朗医疗(苏州)有限公司 | 苏州 | 纯水/注射用水/配液分配系统                                                                                                                                                                                                                              |                                                                                    |
| 39               | 苏州东瑞制药有限公司                 | 苏州 | 104 车间物料系统改造                                                                                                                                                                                                                                                            | 依照FDA cGMP 规范,提供IQ/OQ 文件 |
| 40               | 苏州东瑞制药有限公司                 | 苏州 | 原料车间物料系统改造                                                                                                                                                                                                                                                | 依照FDA cGMP 规范,提供IQ/OQ 文件 |
| 41               | 贝朗医疗(苏州)有限公司 | 苏州 | 注射用水系统改造项目                                                                                                                                                                                                                                                |                                                                                    |
| 42               | 扬子江药业集团有限公司         | 泰州 | 纯蒸汽,注射用水分配系统工艺管道工程                                                                                                                                                                                       |                                                                                    |
| 43               | 天津天士力药业有限公司         | 天津 | 纯蒸汽/纯水/蒸馏水/压缩空气分配系统                                                                                                                                                                                             |                                                                                    |
| 44               | 天津百特医疗用品有限公司 | 天津 | 纯蒸汽/注射用水分配系统工艺管道工程                                                                                                                                                                                       |                                                                                    |
| 45               | 天津天士力药业有限公司         | 天津 | 实验室纯水管道系统                                                                                                                                                                                                                                                        |                                                                                    |
| 46               | 通化东宝药业                                                 | 通化 | (蒸馏水生产装置MS3005S, 纯蒸汽生产装置PSG500DTS, 纯水&蒸馏水&纯蒸汽分配系统, 大输液配制系统) |                                                                                    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第17页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 序号 | 客户名称                                                                 | 地点 | 项目概况                                                                                                                                                                                                                                                                                                       | 认证情况 |
|------------------|--------------------------------------------------------------------------------------------------|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| 47               | 香港美达制药有限公司                 | 香港 | 纯水分配系统                                                                                                                                                                                                                                                                                       |                             |
| 48               | 厦门科兴生物制品有限公司 | 厦门 | (预处理,二级反渗透,蒸馏水生产装置MS504S, 纯蒸汽生产装置PSG500DTS ,纯水&蒸馏水&纯蒸汽分配系统) |                             |
| 49               | 劲牌有限公司                                                 | 湖北 | 保健酒仪表、计量控制系统                                                                                                                                                                                                                                       |                             |
| 50               | 贝朗医疗(苏州)有限公司               | 苏州 | 改造公用洁净设施工程                                                                                                                                                                                                                                                       |                             |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第18页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 序号 | 客户名称                                                                                         | 地点 | 项目概况                                                                                                         | 认证情况     |
|------------------|--------------------------------------------------------------------------------------------------------------------------|------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| 1                | 成都生物制品所                                                                 | 成都 | 洁净室配套公用工程系统                                                 | 符合WHO 标准 |
| 2                | 株洲千金药业有限公司                                         | 湖南 | 煮提、浓缩自控总包项目                                                 |                                 |
| 3                | 浙江普洛康裕药业有限公司                         | 浙江 | 冻干粉针洁净管道和配料系统工程合同 |                                 |
| 4                | 赣州菊隆高科技食品有限公司                 | 江西 | 萃取、提纯车间自控系统工程项目合同 |                                 |
| 5                | 山东先声麦得津生物制药有限公司 | 山东 | 工艺管道安装工程项目                                                         |                                 |
| 6                | 成都生物制品所                                                                 | 成都 | 乙脑疫苗车间改造                                                                         | 符合WHO 标准 |
| 7                | 成都生物制品所                                                                 | 成都 | 病毒疫苗车间PW/WFI/PS 系统                                                               |                                 |
| 8                | 杭州中美华东制药有限公司                         | 杭州 | 冻干粉针201 车间洁净工艺管道系统工程     |                                 |
| 9                | 苏州东瑞制药有限公司                                         | 苏州 | 103 车间洁净管道系统改造                                                     |                                 |
| 10               | 江苏正大丰海制药有限公司                         | 江苏 | 输液车间注射水及物料洁净管道系统         |                                 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第19页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第20页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第21页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ♦ | GE Healthcare 通用医疗(上海)药业有限公司是美国GE 通用的独资企业,是目前为止国内唯一一家无菌小容量注射剂通过美国FDA 认证的制药企业;GE Healthcare Located in Shanghai City , Sterility injection was certified by USA FDA and also this is the only one which approvaled in China. |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 山东齐鲁安替比奥制药有限公司是意大利安替比奥公司与齐鲁制药有限公司的合资企业,是国内第一家无菌原料药(相当于注射剂)通过欧盟EMEA 认证的制药企业;Qilu Antibiotics Pharmaceutical Co., Ltd. is the joint venture company of Italy Antibiotics and Qilu pharmceutical company, it is the first one of China which Sterile API was certified by EU EMEA. |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第22页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ♦ | Polifarma 宝利化(南京)制药有限公司是意大利Polifarma 公司控股的企业,无菌制剂以及口服固体制剂于2007 年通过了澳大利亚TGA 认证。Polifarma (Nanjing) Co. Ltd. is a holding company of Italy Polifarma, Sterile injection was certified by TGA in 2007. |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 北京凯因生物技术有限公司作为病毒生物技术国家工程研究中心,是由中国疾病预防控制中心病毒所和大连国际合作(集团)股份有限公司共同投资建立,我公司多次承接其洁净管道系统安装工程;Kawin Technology's core R&D organization – National Engineering Research Center for Viral Bio-Technology (NERC) was established with the approval & support of National Development and Reform Commission. Beijing Kawin Technology Share-Holding Co., Ltd. (Kawin Technology) was invested by Beijing Kawin Bio-Tech Co., Ltd. We cooperation in piping system many times. |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 成都生物制品研究所作为我国西南六省、市、自治区计划免疫协作中心,是中国最大的生物制品研究、生产基地之一,我公司先后承接乙脑疫苗车间水系统、病毒性疫苗项目水系统、洁净室配套公用工程系统等多个符合GMP 标准的工程;  The Chengdu Institute of Biological Products (CDIBP), part of the China National Biotec Corporation, is one of the largest research and manufacturing bases for biological products in China.And we are participated in some sanitary piping system with GMP standard. |
|--------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第23页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ♦ | 浙江天元生物药业股份有限公司是中国国内规模最大的流感疫苗生产企业之一。所有的生产车间都通过国家药监局的GMP 认证。我公司先后承接其疫苗车间的洁净管道施工安装项目,按照WHO 的标准实施项目。Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. is one of China's largest private manufacturers of influenza vaccine. All manufacturing lines of Tianyuan have been granted with cGMP certificates from the State Food and Drug Administration (SFDA) of China. Our company carried on some sanitary piping system project in bacterin factory with WHO standard. |
|--------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第24页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ♦ | 上海双赢洁净科技有限公司成立。Shanghai WinWin Process System Co., Ltd was founded |
|--------|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 上海双赢洁净科技有限公司与意大利STILMAS 建立合作关系。Shanghai WinWin Process System Co., Ltd commenced business relationships with Italian STILMAS. |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 上海朗和系统集成有限公司成立,进入到中药现代化领域。Shanghai Longhorn System Integration Co., Ltd was founded with the entry into TCM modernization field. |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 上海双赢洁净科技有限公司将国际化的验证概念融入项目实施。WinWin brought the international validation concept into project execution. |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 聘请国外资深工艺及验证专家。International experienced process and validation experts were recruited. |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | “朗脉”的多名技术成员成为国际制药工程协会(ISPE )会员。Several Macroprocess engineers are members of ISPE |
|--------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 融合工艺、管道、自控、HVAC 及洁净室系统、验证等各专业,成立技术中心。A technical center was operated with integration of process, piping, automation, HVAC and validation sections. |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 双赢与朗和整合,成立上海朗脉科技有限公司。WINWIN and LONGHORN were intergrated into MACROPROCESS. |
|--------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | “朗脉”与国外公司合作开发了连续式真空带式干燥机。Macroprocess invented Vacuum belt dryer with cooperation with foreign enterprises. |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第25页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ● | 朗脉的愿景The Vision of MACROPROCESS: |
|--------|---------|----------------------------------------------------------------------------|

|   | ● | 朗脉的使命 Mission of Macroprocess: |
|--------|---------|--------------------------------------------------------------------------|

|   | ● | 朗脉的核心价值观 Core values of Macroprocess: |
|--------|---------|------------------------------------------------------------------------------------------------------|

|   | ● | 朗脉的核心竞争力 Core Competitiveness of Macroprocess: |
|--------|---------|---------------------------------------------------------------------------------------------------------------|

|   | ♦ | 朗脉的专业能力将永远是我们引以为荣的核心竞争力Expertise of Macroprocess is always our core competitiveness; |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 因为我们专业,完成了一个又一个的高标准项目Owing to our expertise, we have successfully completed a large number of high-standard projects; |
|--------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第26页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ♦ | 因为我们专业,建立了与客户的长久合作关系Owing to our expertise, we have built long-term cooperation relationship with our clients; |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 专业,成就朗脉的未来,也将成就朗脉伙伴的未来Our expertise is creating the future for both MACROPROCESS and our clients! |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第27页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第28页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ● | 洁净管道系统 Sanitary piping system |
|--------|---------|-------------------------------------------------------------------------|

|   | ♦ | 配料系统 Formulation system: |
|--------|---------|-------------------------------------------------------------|

|   | ● | 小容量注射剂配料及输送系统 SVPformulationand distribution system |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ● | 大输液配料及输送系统 LVP formulation and distribution system |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------|

|   | ● | 冻干制剂配料及输送系统 Lyophilized product formulation and distribution system |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ● | 生物工程、血液制品等配料及输送系统 preparation and distribution system for bioengineering and blood products |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第29页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ● | 无菌原料药生产工艺系统等 Sterile raw material production process system etc. |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 工艺用水、汽系统 Process used water and steam system: |
|--------|---------|--------------------------------------------------------------------------------------------------------------|

|   | ● | 纯化水系统、注射用水系统、纯蒸汽系统等 Purified water system, water for injection system and pure steam system etc. |
|--------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 洁净气体(空气、氮气等)输送系统Clean gas( air/nitrogen etc.) delivering system |
|--------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | CIP 在线清洗工作站及系统CIP(Clean In Place)work stations and systems |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | SIP 在线消毒工作站及系统SIP(Sterilization-in-Place)work stations and systems |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 自动化系统 Automation control system |
|---------|--------------------------------------------------------------------|

|   | ♦ | 工艺过程自动化控制系统 Automation control system of process procedure |
|--------|---------|-----------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 洁净室空调自动化控制系统 HVAC automation system |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------|

| ● | 洁净厂房系统 Clean room system |
|---------|--------------------------------------------------------------------|

|   | ♦ |  洁净厂房系统的设计、安装、调试及验证(中国GMP、欧盟EMEA 及美国FDA 等) 。Professional design , installation, commissioning and validation (Chinese GMP, EMEA, FDA , etc.) of clean room system. |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第30页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| ● | 验证服务Validation services |
|---------|-----------------------------------------------------|

|   | ♦ | 编写验证主计划 Writing of VMP (Validation Master Plan) |
|--------|---------|--------------------------------------------------------------------------------------------------|

|   | ♦ | 设计cGMP 审核 Design cGMP Review |
|--------|---------|----------------------------------------------------------|

|   | ♦ | HVAC 系统和洁净室的验证 Validation of HVAC system and Cleanroom |
|--------|---------|-----------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 水系统、纯蒸汽和压缩空气系统的验证 Validation of Water system, Pure steam and compressed air system |
|--------|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 灭菌设备的性能确认 PQ of Sterilization equipments |
|--------|---------|---------------------------------------------------------------------------------------------------------|

|   | ♦ | 关键工艺设备的验证指导 Guiding of Critical Process Equipments Validation |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦ | 清洗验证的指导 Guiding of Cleaning Validation |
|--------|---------|-----------------------------------------------------------------------------------------|

|   | ♦ | 工艺验证的指导 Guiding of Process Validation |
|--------|---------|----------------------------------------------------------------------------------------|

|   | ♦ | 计算机系统的验证 Computer System Validation |
|--------|---------|---------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第31页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ♦ | 验证培训 Validation Training |
|--------|---------|------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第32页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| ● | 植物提取工艺优化 Optimization of Plant extraction |
|---------|---------------------------------------------------------------------------------------------------|

| ● | VBD 系列全自动连续式真空带式干燥机VBD series --fully automatic continuous vaccum band-type dryer “朗脉”在引进消化国外先进技术基础上,研制开发的一种全新概念的高效 |
|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第33页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第34页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第35页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| ● | 工艺状态的实时监控管理 |
|---------|------------------------------------------------------------------------------------------|

| ● | Real time supervision of process situation |
|---------|--------------------------------------------|

| ● | 过程整定使控制过程更加完美 |
|---------|----------------------------------------------------------------------------------------------------------|

| ● | Optimizing control process |
|---------|----------------------------|

| ● | 简单友好的操作界面,操作方便 |
|---------|------------------------------------------------------------------------------------------------------------------|

| ● | Friendly interface, more convenient for operation |
|---------|---------------------------------------------------|

| ● | 过程参数在线检测、实时显示并记录存档Process parameters can be measured online, displaying in real time, recorded and saved. |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 实时在线分析、在线解决问题和历史查询Easy for online analysis, trouble shooting and searching history. |
|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 加强生产数据管理,保证产品质量Enhancement for production data management to ensure product quality. 2.2.6. 空调自控系统HVAC automation system |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第36页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| ● | 可动态图形显示各参数值 |
|---------|------------------------------------------------------------------------------------------|

| ● | 新风、回风风阀的开度控制 |
|---------|--------------------------------------------------------------------------------------------------|

| ● | 过滤网脏堵报警 |
|---------|----------------------------------------------------------|

| ● | 温湿度控制 |
|---------|------------------------------------------|

| ● | 风机变频控制 |
|---------|--------------------------------------------------|

| ● | 送风与排风风机联锁控制 |
|---------|------------------------------------------------------------------------------------------|

| ● | Illustrating display of real-time parameters |
|---------|----------------------------------------------|

| ● | Regulation control of the valve for fresh air and return air |
|---------|--------------------------------------------------------------|

| ● | Alarm for filter block |
|---------|------------------------|

| ● | Temperature control and humidity control |
|---------|------------------------------------------|

| ● | Inverter control of fan |
|---------|-------------------------|

| ● | Interlock control of inlet air fan and discharge fan |
|---------|------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第37页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| ● | 自动调整主机、冷却塔运行数量、达到最佳节能目的 |
|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 旁路压差控制 |
|---------|--------------------------------------------------|

| ● | 故障时备用设备自动切换 |
|---------|------------------------------------------------------------------------------------------|

| ● | 冷机和泵的缺水保护 |
|---------|--------------------------------------------------------------------------|

| ● | 冷冻站设备的顺序启停控制 |
|---------|--------------------------------------------------------------------------------------------------|

| ● | 自动补水控制 |
|---------|--------------------------------------------------|

| ● | Adjusting the quantity of air conditioning units and cooling towers automatically in operation to save energy |
|---------|---------------------------------------------------------------------------------------------------------------|

| ● | Bypass pressure control |
|---------|-------------------------|

| ● | Automatic shift of backup machine in case of machine failure |
|---------|--------------------------------------------------------------|

| ● | Protection of chillers and pumps against lack of water. |
|---------|---------------------------------------------------------|

| ● | Sequence of on-off control for freezing station |
|---------|-------------------------------------------------|

| ● | Automatic control of water feeding |
|---------|------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第38页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| ● | 可分区同时清洗一个或者两个以上区域,大大缩短CIP 清洗时间,使生产计划合理化,提高生产能力CIP system could clean one or more areas simultaneously. It can reduce time for cleaning, and enhance production capacity. |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 减少工艺用水量、节省清洗剂、减低生产成本CIP system conduces to reduce process water consumption, saving detergent and reducing production cost |
|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 对清洗过程进行自动检测、显示和控制CIP system conduces to automatic measurement, display and control in cleaning process. |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 形成电子记录,符合GAMP4 和FDA 21 CFR PART 11 的要求CIP system generates electronic record compliance with the requirement of GAMP4 and 21 CFR PART 11 |
|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第39页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第40页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第41页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ● | 切割端面平整 Flat cutting surface |
|--------|---------|-----------------------------------------------------------------------|

|   | ● | 切割端面无氧化 Non-oxidized cutting surface |
|--------|---------|---------------------------------------------------------------------------------------|

|   | ● | 切割端面无变形 Non-deformed cutting surface |
|--------|---------|---------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第42页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| ● | 全自动轨道焊接设备 World-class automatic orbital welding machinery |
|---------|--------------------------------------------------------------------------------------------------------------------------|

| ● | 焊缝内外充氩气保护,无氧化 Welding is argon-protected without being oxidized |
|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 操作简单、方便 Simple and convenient handling |
|---------|-----------------------------------------------------------------------------------------|

| ● | 避免人为的焊接缺陷 Manual welding defect can be avoided |
|---------|---------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第43页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第44页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

|   | ● | 焊缝质量检测 Welded joint quality test |
|--------|---------|----------------------------------------------------------------------------|

|   | ● | 焊缝质量评定 Welded joint quality assessment |
|--------|---------|----------------------------------------------------------------------------------|

|   | ● | 提供焊接质量检测报告表 Provide welding quality inspection reports |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第45页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第46页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                              | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                            | 第2 部分公司介绍及资质文件Part 2 Company intruduction and Certificate    |

| • | 系统的风险分析System Risk Analysis |
|---------|------------------------------------------------------------------------------|

| • | 确认文件的准备 Preparation of IQ/OQ/PQ protocol |
|---------|-------------------------------------------------------------------------------------------|

| • | 确认执行 Execution of IQ/OQ/PQ |
|---------|--------------------------------------------------------|

| • | 验证报告的编制 Final Qualification Report |
|---------|-------------------------------------------------------------------------------------|

| • | 现有系统的差距分析及整改建议 Gap analysis on existing system and recommendations on retrofits |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| • | 回顾性验证 Retrospective Validation |
|---------|-------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第47页/ 共47 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第 3 部分 技术及控制方案Technical and control system proposal                        |

----

----

| 上海朗脉科技有限公司上海市闵行区罗阳路168 号A 座101 室      201100T:021 54306717      F: 021 54306718 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第 3 部分 技术及控制方案Technical and control system                                 |

| 1. 技术方案 Technical                                                                               |  3  |
|-----------------------------------------------------------------------------------------------------------------------------|----------|
| 1.1. 项目背景 Project Background                                                                    |  3  |
| 1.2. 管道系统设计标准和规范 Design Standards              |  6  |
| 1.3. 施工规范和法规 Construction Regulations and Guidance                         |  9  |
| 1.3.1. GMP 法规 GMP regulations                                                                                 | 9        |
| 1.3.2. ISPE 指南                                                                                                | 10       |
| 1.3.3. 工艺管道标准 Process pipe system standards                                       |  11 |
| 1.4. 生产工艺描述 Process Description                                                   | 11       |
| 1.4.1. 概要 General                                                                                             |  11 |
| 1.4.2. 纯化水的储存和分配系统 PW Storage and Distribution | 12       |
| 1.4.3. 注射用水储存分配系统 WFI storage and distribution        | 17       |
| 1.4.4. 纯蒸汽分配系统 Pure Steam Distribution                                     | 24       |
|                                                                                                                        |     |
| 2. 控制方案 Technical                                                                               | 25       |
| 2.1. 项目配置 Project Configuration                                                                 | 25       |
| 2.1.1. 系统拓扑结构 Topological Structure of System                                     | 25       |
| 2.1.2. 现场仪表层 The Scene Instrument Layer                                                  | 27       |
| 2.1.3. 过程控制层 Process Control Layer                                                       | 28       |
| 2.1.4. 数据监控层 Datamonitor Layer                                                           | 30       |

| 2.2. 注射用水控制系统 WFI Supply Control System | 45 |
|-------------------------------------------------------------------------------------------------|----|
| 2.2.1. 系统功能描述 Function to Control System              | 46 |
| 2.2.2. 主要控制回路 The Main Loop of Control System         | 47 |
| 2.2.3. 联锁逻辑 Logic Diagram of Interlock                              | 48 |
| 2.2.4. 关键控制点 The Critical Control Point                      | 54 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第1页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 23. 纯化水控制系统 PW Supply Control System          | 54 |
|------------------------------------------------------------------------------------------------|----|
| 2.3.1. 系统功能描述 Function to Control System Description | 54 |
| 2.3.2. 主要控制回路 The main loop of Control System        | 56 |
| 2.3.3. 联锁逻辑 Logic Diagram of Interlock                             | 57 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第2页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第3页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | ● | Purified Water system 纯化水系统 |
|--------|---------|----------------------------------------------------------------|

|   | ● | Water for Injection system 注射用水系统 |
|--------|---------|-----------------------------------------------------------------------------|

|   | ● | Pharmceutical Steam system 纯蒸汽系统 |
|--------|---------|---------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第4页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | ● | Related control system 相关的自控系统 |
|--------|---------|---------------------------------------------------------------------------------|

|   | ● | Other related Accessories   其他相关辅助材料系统 |
|--------|---------|-----------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第5页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | • | According to related national and local government pipeline construction standards and stipulations  根据国家及当地政府管道施工的相关标准及规定 |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | WHO about Guidelines for Drinking-water Quality |
|--------|---------|-------------------------------------------------|

|   | • | WHO about water treatment guide & aqueous system |
|--------|---------|------------------------------------------------------|

|   | • | Drugs production quality control in 1998 amended |
|--------|---------|--------------------------------------------------|

|   | • | ASE BPE 2002 Edition |
|--------|---------|----------------------|

|   | • | ICH Q7A GMP of Bulk Pharmaceutical Chemicals, November 2000  ICH Q7A 原料药的GMP, 2000 年11 月 |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | USP-29 2006 Edition |
|--------|---------|---------------------|

|   | • | FDA federation laws & regulations related stipulation |
|--------|---------|-----------------------------------------------------------|

|   | • | European pharmacopoeia |
|--------|---------|------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第6/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | • | According to JBJ23- 96 edition (Code for Construction & acceptance of machinery and equipment installation)  根据JBJ23- 96 版《机械设备安装工程施工及验收规范》 |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | According to HGJ203-83 edition (Code for Construction & acceptance of chemical machinery installation)  根据HGJ203-83 版 《化工机器安装工程施工及验收规范》 |
|--------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ▪ | According to GB50236-98 Edition (Code for Construction & acceptance of field equipment installation & industry pipeline welding)  根据GB50236-98 版《现场设备、工业管道焊接工程施工及验收规范》 |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | According to DL5017-93 Edition (Code for Construction, Manufacturing & acceptance of Pressure Piping)  根据DL5017-93 版 《压力管道制造安装及验收规范》 |
|--------|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | According to (Pharmaceutical chemicals overall examination Guide)  根据《医药化学品总体检验指南》 |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | According to (Code for Drugs production & management)  根据《药品生产管理规范》 |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | According to (Code for Clean room construction and Acceptance)  根据《洁净室施工及验收规范》 |
|--------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第7页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | • | According to Planning & Design Ordinance of Macroprocess Technology  根据朗脉科技设计条例 |
|--------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | According to PW piping system design & standards of Macroprocess Technology  根据朗脉科技高纯度管道系统的设计标准 |
|--------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | According to Construction requirements for Clean Room & High purified water pipeline system of Macroprocess Technology  根据朗脉科技高纯度管道工程洁净厂房施工守则 |
|--------|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | According to guide to Construction safety of Macroprocess Technology  根据朗脉科技安全施工注意事项 |
|--------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | According to Construction procedure for High purified water piping system of Macroprocess Technology  根据朗脉科技高纯度管道系统的施工程序 |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | According to operational procedure for testing of Macroprocess Technology  根据朗脉科技高纯度管道系统的测试作业程序 |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | • | Code & requirements of China, the United States and the European in production of vaccine for Human  用于生产人用疫苗的中国、欧洲和美国的规范和要求 |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第8页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | • | Laws and regulations for Electric appliance & installation |
|--------|---------|----------------------------------------------------------------|

|   | • | Laws & regulations for safety standards |
|--------|---------|---------------------------------------------|

|   | • | According to drawings and relevant requirements of products provided by owner.  根据业主提供的图纸及产品的相关要求 |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第9页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第10页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第11页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|      ● | 概述 General |
|---------------------------------------|--------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第12页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第13页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| ●  | 技术描述Technical Description |
|---------------|-------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第14页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第15页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | ♦ | 卫生级纯化水循环泵 |
|--------|---------|--------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第16页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | ♦  | Sanitary Purified Water centrifugal circulation pump |
|--------|---------------|------------------------------------------------------|

|   | ♦ | 卫生级热交换器 |
|--------|---------|----------------------------------------------------------|

|   | ♦ | Sanitary shell and tube heat exchanger |
|--------|---------|----------------------------------------|

|   | ♦ | 控制系统及各类仪表 |
|--------|---------|--------------------------------------------------------------------------|

|   | ♦ | Quality Monitoring Device |
|--------|---------|---------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第17页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第18页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第19页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第20页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第21页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第22页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第23页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | ♦ | 卫生级注射水离心循环泵 |
|--------|---------|------------------------------------------------------------------------------------------|

|   | ♦ | Ultrapure WFI centrifugal circulation pump (1X100%)) |
|--------|---------|------------------------------------------------------|

|   | ♦ | 卫生级管板式热换器 |
|--------|---------|--------------------------------------------------------------------------|

|   | ♦ | Sanitaryshell and tube heat exchanger |
|--------|---------|---------------------------------------|

|   | ♦ | 控制系统及各类仪表 |
|--------|---------|--------------------------------------------------------------------------|

|   | ♦ | Quality Monitoring Device |
|--------|---------|---------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第24页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第25页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第26页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第27页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| ● | 主要功能 Major Function |
|---------|-------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第28页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | ♦  | 检测各设备的操作模式和状态Check up all devices' operating mode and status. |
|--------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦  | 检测液位、压力、流量、TOC 值等工艺参数;Check up parameters,for example level,pressure,flow,TOC ,and so on. |
|--------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ♦  | 根据工艺参数组态形成控制策略,并据此对处理系统的全过程实现自动控制和关键工序的PID 调节;According to these process parameters,this system's control program is formated. |
|--------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 操作方式 Computed Mode |
|---------|------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第29页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| ● | 显示功能 Display Function |
|---------|---------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第30页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| » | 工艺流程图(Process Flow Diagram)                 |
|--------|----------------------------------------------------------------------------------------------|
| » | 测量值显示(Measurement display)                  |
| » | 趋势图显示(Trend display)                        |
| » | 报警显示(Alarm display)                                |
| » | 生产参数管理(Process parameters mangement) |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第31页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 工艺参数输入存储,工艺参数以文件形式存储在上位机;Process parameters into storage, processing parameters in the form of a document stored in the HMI. |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 生产流程(含指令点)编辑;Production processes (including command points) Editor. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 输入文件名即可打开相应参数;Enter the file name to open the corresponding parameters. |
|--------|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 参数修改,输入新的参数值同配方名存储即可完成文件参数修改;Modify the parameters: Enter the new parameter values and the formula to complete to modify parameters. |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 下载功能,点击下载按钮将文件参数传进PLC, 系统将依据文件参数运行控制;Download function: click the button of download, the file parameters transfromed to PLC, the system will be controlled based on operational control file parameters. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 上载功能,点击上载按钮将PLC 运行控制参数上传到上位机并显示,以此确定当前PLC 运行控制参数,防止因生产参数的不匹配影响生产;Upload function: click the upload button to let the PLC control parameters uploads to the host computer and display in order to determine the current PLC operational control parameters,to prevent production parameters does not match to impact the production. |
|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第32页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 生产程序(生产流程、工艺参数)存储、调用。The production process (the production process, process parameters) to store, call. |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 报警及报警查询Alarm and Alarm Query |
|---------|-------------------------------------------------------------------------------|

|   | » | 报警内容全面,编号、日期、持续时间、报警描述、报警设定值、单位、当前报警值、提示处理、状态确认和操作员姓名;Comprehensive of alarm report : number, date, duration, alarm description, alarm settings, units, the current alarm value, prompt treatment, state to confirm and the names of the operators. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第33页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 报警出现、报警消失、报警确认显示不同颜色区分;Alarm occurred, alarm disappeared, alarm acknowledged that the distinction with different colors. |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 根据报警持续时间和确认时间可以判断出设备自动或操作员报警处理情况;According to the alarm duration time and the recognition time ,judge the equipments' statment or operator handle statement. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 通过报警处理提示操作员可快速、准确的处理报警(不能自动解决情况下);Prompted the adoption of the alarm ,the operator can quickly and accurately deal with the alarm(can not automatically resolve the case). |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 强大的报警存储容量,连续开机记录五年报警信息,当报警存储空间满时系统自动导出存储于用户指定的硬盘上;Powerful alarm storage capacity, boot record consecutive five-year report of alarm information, when the alarm storage space is full,it will automatically export storage to a user-specified hard drive. |
|--------|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 报警信息永久记录不随断电而消失,不可更改,并提供方便而快速的查询,完全符合FDA 要求,做到责任明确化。Permanent record of alarm messages, do not disappear with no power, can not be changed, and provide convenient and speedy inquiry, in full compliance with FDA requirements, and let the responsibility clearly. |
|--------|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第34页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| ● | 工艺控制和手动操作 process control and manual operation |
|---------|---------------------------------------------------------------------------------------------------------------|

| ● | 泵、阀等执行器的点动操作 Pump,valve etc.acutor step operation |
|---------|---------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第35页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| ● | 计算机批量生产数据管理及报表打印 data management of mass production and print statements |
|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 自动采集各批次产品在各工艺阶段的生产过程数据,存储于数据库; Automatic acquisition production process data of the batch process at all stages, store in a database. |
|--------|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 按要求自动生成各批次产品在整个生产报表;According to request, automatically generate the batch statements throughout the production. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 生产报表不可更改、永久电子储存; The production of statements can not be changed, permanent electronic storage. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第36页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 生产数据提供多种查询;Production data provide a wide range of inquiries. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 可按要求提供多种方式打印。It can be requested to print in a variety of ways. |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 操作记录 Operator records |
|---------|---------------------------------------------------|

|   | » | 记录阀门操作、泵电机操作、参数操作、工艺编辑等;  Record valve operation, pump motor operation, parameters operation, process modification. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 记录操作内容、操作时间和操作者;  Record on operational content, operation time and the operator. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 电子永久记录不随断电而消失,不可更改,并提供方便而快速的查询, |
|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |   | 完全符合FDA 要求,做到责任明确化。 |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第37页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| ● | 报警管理 Alarm mangement |
|---------|--------------------------------------------------|

|   | » | 报警值设定;Alarm set value |
|--------|--------|-----------------------------------------------------------------|

|   | » | 报警有效/失效设定;Alarm valid / invalid setting |
|--------|--------|--------------------------------------------------------------------------------------------------------|

|   | » | 报警延迟时间设定;Alarm delay time settings |
|--------|--------|---------------------------------------------------------------------------------------------------|

|   | » | 报警等级设定,通过蜂鸣器与指示灯组合操作员不在控制室的情况下即可判断出报警内容。Alarm level settings.Through the combination of buzzer and light,  operator can judge the alarm contents in the case of operator not in control room. |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ● | 系统安全性 Security of System |
|---------|-------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第38页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| ● | 安全策略 Security Policy |
|---------|--------------------------------------------------|

|   | » | 系统的验证保证准确、可靠、稳定地预期性能,有能力识别无效的和被改变的记录;Verification of system ensures accuration, reliable and stable performance which are expected,.It can identify invalid and changed records. |
|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 确保产生人们易读的电子形式的正确的、完整的记录副本,记录的保护以使记录能够在整个的保护期内是准确的易于检索的;It is to ensure to generate Correct, completed copy of record with the form of electronic document ,which people can read easily. The protection of records ,so that records can be accurate, easy retrieval in the whole protected period. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第39页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| » | 通过授权个人用户以限制系统的登录。使用安全的、计算机产生的、时间印记的审核跟踪以便独立的记录操作者登陆和建立、修改、或删除电子记录的行为的日期和时间。记录的改变不能使先前的记录信息被覆盖。使用验证检查以保证只有被授权用户才可以使用系统,以电子方式署名记录,使用和操作计算机系统的输入输出设备,改变记录或手动执行操作;It is to limit the system registry by empowering individual users. The use of safe, computer-generated, the time of the audit trail ,so that the records of independent operators establish, land, modify, or delete the conduct of electronic records of the date and time. The previous record of information Changed Records can not be covered by the changed records. Using verification check is to ensure that only authorized users can use the system , electronically sign records, use and operation input and output devices of computer systems, change the record or manually operate. |
|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第40页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| » | 电子签名的显示:电子签名记录应能包含清晰显示如下所有与签名相关的信息:Electronic signature display: Electronic signatures should be able to contain all below relevant informations with the signatures recordclearly: |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| » | 用印刷体写出签名者的名字 Write the name of the signer with printing font. |
|--------|---------------------------------------------------------------------------------------------------------------------------------------------------|

| » | 签名生效的日期和时间,和签名相关的含义(例如:批准,职责,或备注等)Sign of the date and time, and signature-related meaning (for example: approval, duties, or notes, etc.) |
|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| » | 电子签名的唯一性 The uniqueness of electronic signatures. |
|--------|-----------------------------------------------------------------------------------------------------------|

| » | 每一个电子签名应是唯一对应单独一个人的并且不能再使用、或再分配给其他任何人;Each electronic signature should be the only corresponding to a single person and can no longer be used by another, or the redistribution to any other person. |
|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| » | 在一个组织建立,分配,证明或者批准一个人的电子签名或者其他的任何这样的电子签名的要素之前,组织将校验个人身份;Before establishment of an organization, distribution, certification or approval of a person's electronic signature, or any other such elements of electronic signatures, the organization will check their personal capacitis. |
|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第41页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| ● | 电子签名成分及管理  Composition and management of electronic signatures |
|---------|------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 使用至少两种截然不同的证明成分,例如识别码和密码;It must be used with two distinct proof components, such as ID and password. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 当一个人在一个独立的持续受控的系统登陆期间内签署一系列的签名,签署的第一个签名将使用所有的电子签名成分。后续签署的签名应使用至少一种的电子签名的成分。该成分只能由个人签署,并且设计只能由个人来使用;When a person signs a series of signatures in an period of independent ,controlled, landing sustained system's time, the sign of the first signature will use all of the electronic signature components. Follow-up signature should be used at least one component of electronic signatures. The ingredients can only be signed by individuals, and designed to be only used by the individual. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 管理和签署以保证任何除其真正所有使用者外的其他尝试使用该电子签名时需要第二个或更多的人的协作;Management and signature are to ensure that another except for real user try to use the electronic signature,which is required a second or more people collaboration. |
|--------|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第42页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第43页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 报警管理及报警处理 Alarm management and alarm deal |
|--------|--------|----------------------------------------------------------------------------------------------------------|

|   | » | 电子权限管理 Electronic Permissions management |
|--------|--------|------------------------------------------------------------------------------------|

|   | » | 根据操作类型、管理层次、安全等级系统实施多权分配 According to the type of operation, management-level, multi-level of security, the system is distributed. |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 根据安全管理和操作权限,分为四个级别:一级:初级操作员(可以进行任何设备的开启或者关闭)。二级:高级操作员(进行系统监督和改变系统参数)。三级:维护工程师(校正和修改工艺仪表参数)。四级:系统管理员(分配和确认每个人的权限和密码和系统管理);权限间互不包含, 系统中任何操作都有相应权限配置,只有经过登录并具有相匹配权限才能对其操作;权限用户的建立统一由车间管理员在管理室建立,操作室只具有操作登录功能不具备权限管理功能,操作员在第一次使用车间配置的用户时系统强制要求操作员对自己操作密码更改,该方式保证了多级权限安全和规范性。According to security management and operation of authority, it is divided into four levels: level1: junior operators (operate all devices to open or close). level2: Senior Operator (monitor system and change the system parameters). level3: maintenance engineer (instrument calibration and modification process parameters). level4: System Administrator (distribution , acknowledge each person's permission and password and system management). |
|--------|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第44页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第45页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 根据注射用水管路流程以及客户要求配置该控制系统;The Monitor and Control System will be configured and constructed according to WFI process requirement and URS. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 控制系统用于注射用水系统的信号检测和过程控制;This Monitor and Control System will be used for WFI supply signal monitoring and process control |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 现场安装控制柜,并附带警报报警装置;Control cabinet will be installed on site, It will be provide with Alarms. |
|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 现场控制系统带有密码权限功能,不同级别的操作人员设有不同的操作权限;Different levels pass word are availably on control system, each operator will be assigned with different levels of access. |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 系统可以设定手动和自动操作,并可以设定管路中各类仪表的参数;Manual and automatic operation modes are availably, It is possible to set parameters for   instruments |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 在注射用水纯蒸汽灭菌过程中,系统自动记录并保存灭菌时间,灭菌过程中的温度、压力、流量、电导率参数以及每次操作人员资料,供以后查询追溯;During the Sterilization of WFI, system will automatically record and store such important data like: Temperature, Pressure, Flow Rate, Conductivity during the Sterilization Time and Operator’s Information for easy tracking in feature. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第46页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 系统可以记录并保存生产过程中的流量变化曲线;During production process, Flow Cycle will be recorded and stored on the system. |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 现场控制系统的各类数据信号,可以上传至总厂监控系统。All data on site system can be uploaded to the control system of factory central monitor office. |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 根据注射用水液位信号,自动控制罐顶的气动隔膜阀开关以及泵的开关;当罐内液位大于最大设定值,罐顶阀门关闭,当罐内液位小于最小设定值,循环泵关闭;According to the filling level signal inside the /WFI tank, system will automatically turn on/off the pneumatic diaphragm valve which on the top of the tank and turn on/off the feed pump. The pneumatic diaphragm valve will be turned off when the filling level reaches the high set point. The feed pump will be turned off when the filling level below the low set point. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第47页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 根据注射用水管路流量信号,自动调整变频泵,保证管路流速大于要求值;According to the WFI loop's flow rate signal, system will modulate the feed pump ensuring the loop's flow rate meets requirement. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 根据注射用水管路电导率信号,自动开关在进水阀和排水阀,保证不合格水不流入罐内,如果电导率一段时间持续大于规定,系统将自动停机,并发出警报信号。According to the loop's conductivity signal, system will automatically turn on/off three-way automatic valve, ensuring range water not flow into tank. If the conductivity is higher than limit for a fixed time, the system will shut down. And send alarm signal to the control system. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| a. | 逻辑图 Logic Diagram |
|----|----------------------------------------|

|   | » | 注射用水循环控制逻辑图WFI's logic diagram for circulation control |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第48页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第49页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第50页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第51页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第52页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| ♦ | 注射用水循环流量控制 WFI's flow control |
|---------|-----------------------------------------------------------------------------------------------------|

| ♦ | 注射用水灭菌控制WFI's Description for disinfection control  进行注射水系统的灭菌,只要将控制柜旋钮打到 "灭菌" 位置,则注射用水进水阀打开,此时打开注射用水纯蒸汽阀,系统灭菌进行。 |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第53页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 注射用水罐内温度 WFI Tank's Temperature |
|--------|--------|-----------------------------------------------------------------------------------------|

|   | » | 注射用水罐内压力 WFI Tank's Pressure |
|--------|--------|--------------------------------------------------------------------------------------|

|   | » | 注射水管路循环温度 WFI Loop's Temperature |
|--------|--------|-------------------------------------------------------------------------------------------------|

|   | » | 注射用水罐内液位WFI Tank's Filling Level |
|--------|--------|------------------------------------------------------------------------------------------|

|   | » | 注射用水水管路电导率 WFI Loop's Conductivity |
|--------|--------|----------------------------------------------------------------------------------------------------------|

|   | » | 注射用水管路流量 WFI Loop's Velocity |
|--------|--------|--------------------------------------------------------------------------------------|

|   | » | 根据纯化水管路流程以及客户要求配置该控制系统;The Monitor and Control System will be configured and constructed according to PW process requirement and URS |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第54页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| » | 控制系统用于纯水系统的信号检测和过程控制;This Monitor and Control System will be used for Entire water supply signal monitoring and process control. |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| » | 现场安装控制柜,并附带警报报警装置;Control cabinet will be installed on site, It will be provide with Alarms. |
|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| » | 现场控制系统带有密码权限功能,不同级别的操作人员设有不同的操作权限;Different levels pass word are availably on control system, each operator will be assigned with different levels of access. |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| » | 系统可以设定手动和自动操作,并可以设定管路中各类仪表的参数;Manual and automatic operation modes are availably, It is possible to set parameters for   instruments |
|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| » | 在纯化水双氧水灭菌和注射水纯蒸汽灭菌过程中,灭菌过程中的温度、压力、流量、电导率参数以及每次操作人员资料,供以后查询追溯;During the Pasteurization of PW and Over Heat Water Sterilization of WFI, system will automatically record and store such important data like: Temperature, Pressure, Flow Rate, Conductivity during the Sterilization Time and Operator's Information for easy tracking in feature. |
|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| » | 系统可以记录并保存生产过程中的流量变化曲线;During production process, Flow Cycle will be recorded and stored on the system. |
|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第55页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 现场控制系统的各类数据信号,可以上传至总厂监控系统。All data on site system can be uploaded to the control system of factory central monitor office. |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 根据纯化水液位信号,自动控制罐顶的气动隔膜阀开关以及泵的开关。当罐内液位大于最大设定值,罐顶阀门关闭,当罐内液位小于最小设定值,循环泵关闭;According to the filling level signal inside the PW/WFI tank, system will automatically turn on/off the pneumatic diaphragm valve which on the top of the tank and turn on/off the feed pump. The pneumatic diaphragm valve will be turned off when the filling level reaches the high set point. The feed pump will be turned off when the filling level below the low set point. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 根据纯化水管路流量信号,自动调整变频泵,保证管路流速大于要求值;According to the PW loop's flow rate signal, system will modulate the feed pump ensuring the loop's flow rate meets requirement. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第56页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | » | 根据纯化水管路电导率信号,自动开关在线两位三通阀,保证不合格水不流入罐内,如果电导率一段时间持续大于规定,系统将自动停机,并发出警报信号。According to the loop's conductivity signal, system will automatically turn on/off three-way automatic valve, ensuring range water not flow into tank. If the conductivity is higher than limit for a fixed time, the system will shut down. And send alarm signal to the control system. |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | » | 纯化水循环控制逻辑图 PW's logic diagram for circulation control |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第57页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第58页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| » | 纯化水灭菌控制逻辑图 PW’s logic diagram for disinfection control |
|--------|------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第59页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第60页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第61页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | ♦ | 纯化水循环流量控制:(PW's flow control) |
|--------|---------|-----------------------------------------------------------------------------------------------------|

|   | ♦ | 纯化水循环时温度控制:(PW's temperture control) |
|--------|---------|-------------------------------------------------------------------------------------------------------------------|

| » | 纯化水灭菌控制 (PW's Description for disinfection control) |
|--------|------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第62页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第3 部分技术及控制方案Technical and control system                                   |

|   | ♦ | 纯化水罐内温度PW Tank's Temperature |
|--------|---------|-------------------------------------------------------------------------------|

|   | ♦ | 纯化水罐内压力PW Tank's Pressure |
|--------|---------|----------------------------------------------------------------------------|

|   | ♦ | 纯化水管路循环温度PW Loop's Temperature |
|--------|---------|-----------------------------------------------------------------------------------------------|

|   | ♦ | 纯化水管路循环压力PW Loop's Pressure |
|--------|---------|--------------------------------------------------------------------------------------------|

|   | ♦ | 纯化水罐内液位PW Tank's Filling Level |
|--------|---------|---------------------------------------------------------------------------------|

|   | ♦ | 纯化水水管路电导率PW Loop's Conductivity |
|--------|---------|------------------------------------------------------------------------------------------------|

|   | ♦ | 纯化水管路流量PW Loop's Velocity |
|--------|---------|----------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第63页/ 共63 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第 4 部分 验证方案Validtion                                                                            |

----

----

| 上海朗脉科技有限公司上海市闵行区罗阳路168 号A 座101 室     201100T:021 54306717     F: 021 54306718 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第 4 部分 验证Validation Service                                                                                   |

| 1. 介绍 Introduction                                                                      | 3      |
|-------------------------------------------------------------------------------------------------------|--------|
|                                                                                                  |   |
| 2. 验证范围 Work scope of validation                                          | 3      |
|                                                                                                  |   |
| 3. 验证方法 Validation approach                                               | 4      |
|                                                                                                  |   |
| 3.1. 总要求 General Requirement                                                     | 4      |
|                                                                                                  |   |
| 3.2. 风险评估 Risk Assessment                                                 | 6      |
|                                                                                                  |   |
| 3.3. 追溯矩阵表 Traceability Matrix                                     | 8      |
|                                                                                                  |   |
| 3.4. 设计确认 Design Qualification                                            | 9      |
|                                                                                                  |   |
| 3.5. 工厂验收测试 Factory Acceptance Test                         | 12     |
|                                                                                                  |   |
| 3.6. 现场验收测试 Site Acceptance Test                            | 14     |
|                                                                                                  |   |
| 3.7. 校准 Calibration                                                                     | 14     |
|                                                                                                  |   |
| 3.8. 安装确认 Installation Qualification                                      | 16     |
|                                                                                                  |   |
| 3.9. IQ 接受标准 IQ Acceptance Criteria:                                      | 18     |
|                                                                                                  |   |
| 3.10. 运行确认 Operation Qualification                                        | 19     |
|                                                                                                  |   |
| 3.11. 控制系统的验证 Validation of Automatic Control System | 22     |
|                                                                                                  |   |
| 3.12. 性能确认 Performance Qualification                                      | 22     |
|                                                                                                  |   |
| 4. 质量项目计划 Quality and Project Plan                          | 23     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第1页/共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第2页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第3页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第4页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第5页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第6页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 了解系统或设备,以及工艺流程 |
|--------|---|------------------------------------------------------------------------------------------------------------------|

|   | - | 识别可能出现风险、产生的原因、带来的影响 |
|--------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | 评估该风险出现的可能性 |
|--------|---|------------------------------------------------------------------------------------------|

|   | - | 评估该风险带来的影响的严重程度 |
|--------|---|--------------------------------------------------------------------------------------------------------------------------|

|   | - | 评估该风险被发现的可能性 |
|--------|---|--------------------------------------------------------------------------------------------------|

|   | - | 建议采取的措施 |
|--------|---|----------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第7页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 目的 |
|--------|---|------------------|

|   | - | 风险评估的参与者 |
|--------|---|------------------------------------------------------------------|

|   | - | 工艺参数、功能、关键组件 |
|--------|---|--------------------------------------------------------------------------------------------------|

|   | - | 潜在的风险 |
|--------|---|------------------------------------------|

|   | - | GMP 关键性的判断 |
|--------|---|------------------------------------------------------|

|   | - | 风险的原因和后果 |
|--------|---|------------------------------------------------------------------|

|   | - | 风险评估(出现的可能性、影响的程度、被发现的可能性) |
|--------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | 处理的措施(如测试要求、特别措施等) |
|--------|---|--------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第8页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第9页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第10页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 设计确保满足GMP 的要求 |
|--------|---|------------------------------------------------------------------------------|

|   | - | 设计符合性能标准 |
|--------|---|------------------------------------------------------------------|

|   | - | 材料材质 |
|--------|---|----------------------------------|

|   | - | 清洗要求 |
|--------|---|----------------------------------|

|   | - | 操作的可靠性和有效性 |
|--------|---|----------------------------------------------------------------------------------|

|   | - | 设备安装 |
|--------|---|----------------------------------|

|   | - | 系统调试 |
|--------|---|----------------------------------|

|   | - | 关键仪表的参数,量程和精度是否满足工艺要求和控制要求 |
|--------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第11页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 关键组件的结构 |
|--------|---|----------------------------------------------------------|

|   | - | 文件要求 |
|--------|---|----------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第12页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 文件确认 |
|--------|---|----------------------------------|

|   | - | 图纸的确认(P&ID、布置图、电子和气路图) |
|--------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | 材料和表面抛光的检查 |
|--------|---|----------------------------------------------------------------------------------|

|   | - | 控制系统图形界面的检查 |
|--------|---|------------------------------------------------------------------------------------------|

|   | - | 报警和联锁 |
|--------|---|------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第13页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第14页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第15页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第16页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 方案批准页 Protocol Review and Approval Sheet |
|--------|---|-----------------------------------------------------------------------------|

|   | - | 目的 Purpose |
|--------|---|--------------------------|

|   | - | 验证范围 Scope of Validation |
|--------|---|------------------------------------------------------|

|   | - | 职责 Responsibility |
|--------|---|---------------------------------|

|   | - | 参考文件 Reference documents |
|--------|---|------------------------------------------------------|

|   | - | 系统描述 System description |
|--------|---|-----------------------------------------------------|

|   | - | 文件检查 Document verification |
|--------|---|--------------------------------------------------------|

|   | - | 系统图和布局图检查 P&ID and Layout verification |
|--------|---|-----------------------------------------------------------------------------------------------------------|

|   | - | 设备确认 Equipment verification |
|--------|---|---------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第17页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 仪表确认 Instrument verification |
|--------|---|----------------------------------------------------------|

|   | - | 材质和表面抛光的检查 Materials and Surface finishes verification |
|--------|---|------------------------------------------------------------------------------------------------------------------------------|

|   | - | 组件结构的检查 Components construction verification |
|--------|---|-----------------------------------------------------------------------------------------------|

|   | - | 死角的确认 Deadleg verification |
|--------|---|---------------------------------------------------------------|

|   | - | 安装情况的检查 Installation verification |
|--------|---|------------------------------------------------------------------------------------|

|   | - | 公用设施的检查 Utilitites verification |
|--------|---|----------------------------------------------------------------------------------|

|   | - | 人员的确认 Personnel identification |
|--------|---|-------------------------------------------------------------------|

|   | - | 偏差报告 Deivation report |
|--------|---|---------------------------------------------------|

|   | - | 实施结果批准 Execution review and approval |
|--------|---|--------------------------------------------------------------------------------|

|   | - | 所有的参与IQ 执行的人员在实施前须经相关培训。 All personnel participation in IQ execution must pass through the correlation pre-job training. |
|--------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | 所有文件(如操作手册,维修手册,焊点图,焊接记录,焊接检查,坡度确认,压力测试文件,内窥镜检查测试记录等)将被检查,文档位置将被记录。 |
|--------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第18页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 所有的图纸(如管道和仪表流程图,管道轴测图,电气图,气动图等)和材质证明等将被检查,文档位置将被记录。 |
|--------|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | 特定系统的备件清单须完备  The detailed list of spare parts for specific system must be completed |
|--------|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | 所有的设备,仪表和配套将被检查并须符合预设标准  All equipment, instrument and accessory will be inspected and they are required to meet the pre-set standards |
|--------|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | 仪表的校正已经成功完成  Instrument calibration has been successfully completed |
|--------|---|-------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第19页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 方案批准页 Protocol Review and Approval Sheet |
|--------|---|-----------------------------------------------------------------------------|

|   | - | 目的 Purpose |
|--------|---|--------------------------|

|   | - | 验证范围 Scope of Validation |
|--------|---|------------------------------------------------------|

|   | - | 职责 Responsibility |
|--------|---|---------------------------------|

|   | - | 参考文件 Reference documents |
|--------|---|------------------------------------------------------|

|   | - | 系统描述 System description |
|--------|---|-----------------------------------------------------|

|   | - | 验证仪器的检查 Validation Instruments verification |
|--------|---|----------------------------------------------------------------------------------------------|

|   | - | 功能检查 Function Verification |
|--------|---|--------------------------------------------------------|

|   | - | 报警和联锁的检查 Alarms and interlocks verification |
|--------|---|-----------------------------------------------------------------------------------------------------|

|   | - | 人员的确认 Personnel identification |
|--------|---|-------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第20页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 偏差报告 Deivation report |
|--------|---|---------------------------------------------------|

|   | - | 实施结果批准 Execution review and approval |
|--------|---|--------------------------------------------------------------------------------|

|   | - | 所有的参与IQ 执行的人员在实施前须经相关培训。  All personnel participation in IQ execution must pass through the correlation pre-job training. |
|--------|---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | 所有的OQ 工作将按照已批准的方案执行  All OQ activities should be conducted according to approved protocols. |
|--------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | OQ 测试仪器应被校准过的, 相关的证书应可溯源NIST 或中国国家计量基准, 并附在相应的方案中OQ  Test instruments should be calibrated; the relevant certificate should be NIST or Chinese National measurement standards traceable to the National Institute of Standard Technology and attached to the relevant protocol. |
|--------|---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | 系统报警和联锁的情况应符合设计标准  The system’s alarms and interlocks should operate in accordance with the design specification. |
|--------|---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | 系统功能运行应符合设计标准  The system’s function should operate in accordance with the design specification. |
|--------|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第21页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

|   | - | 系统所用的公用设施应当在规定范围以内( 温度、压力、流量) Utilities, used by the system, should be available at the battery limit within the specified range (temperature, pressure, flow-rate). |
|--------|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第22页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第4 部分验证Validation Service                                                                                     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第23页/ 共23 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 1 of 21 |

| User 用户:                         | Shenyang Sunshine Pharmaceutical Co., Ltd.                                                       |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------|
|                                                  | 沈阳三生制药有限责任公司 |
| Department 部门:                   |                                                                                             |
| Location 位置:                     |                                                                                             |
| Document No. 文件编号: | 3SBIO-01-QPP                                                                                     |
| Revision 版本:                     | 00                                                                                               |

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 2 of 21 |

|             | Name 名字 | Company 公司 | Function 职能                | Signature 签名 | Date 日期(yyyy.mm.dd) |
|------------------|-----------------------|--------------------------|------------------------------------------|----------------------------|-----------------------------------|
|             |                  |                     |                                     |                       |                              |
| Prepared by      |                  | Macroprocess             | Project Manager                          |                       |                              |
| 编写 |                  | 朗脉         | 项目经理         |                       |                              |
| Reviewed by      |                  | Macroprocess             | Validation Director                      |                       |                              |
| 审核 |                  | 朗脉         | 验证总监         |                       |                              |
| Reviewed by      |                  | 3SBIO                    | Production Manager                       |                       |                              |
| 审核 |                  | 三生         | 生产经理         |                       |                              |
| Reviewed by      |                  | 3SBIO                    | Engineering Manager                      |                       |                              |
| 审核 |                  | 三生         | 工程部经理 |                       |                              |
| Reviewed by      |                  | 3SBIO                    | Validation Manager                       |                       |                              |
| 审核 |                  | 三生         | 验证经理         |                       |                              |
| Approved by      |                  | 3SBIO                    | QA Manager                               |                       |                              |
| 批准 |                  | 三生         | QA 经理                      |                       |                              |

| Revision         | Date             | Name of Author(s)        | Description of Changes           |
|------------------|------------------|--------------------------|----------------------------------|
| 版本 | 日期 | 编写人 | 变更描述 |
| 00               | 2009-01-12       |                     | Draft 草案           |
|             |             |                     |                             |

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 3 of 21 |

| 1. Introduction 介绍                                                                                                         |   | 4      |
|------------------------------------------------------------------------------------------------------------------------------------------|--------|--------|
|                                                                                                                                     |   |   |
| 2. Overview 概况                                                                                                             |   | 4      |
|                                                                                                                                     |   |   |
| 3. Quality Plan 质量计划                                                                                         |   | 4      |
|                                                                                                                                     |   |   |
| 3.1. User Quality Requirements 用户质量要求                                                          |   | 4      |
|                                                                                                                                     |   |   |
| 3.2. Quality System 质量体系                                                                                     |   | 6      |
|                                                                                                                                     |   |   |
| 3.2.1. References 参考文件                                                                                       |   | 6      |
|                                                                                                                                     |   |   |
| 3.2.2. Work Flow 工作流程                                                                                        |   | 7      |
|                                                                                                                                     |   |   |
| 3.2.3. Kick off meeting 项目启动会                                                                         |   | 8      |
|                                                                                                                                     |   |   |
| 3.2.4. Design Review and Design Qualification 设计审核和设计确认                   |   | 8      |
|                                                                                                                                     |   |   |
| 3.2.5. Receiving Inspection 收货检查                                                                             |   | 8      |
|                                                                                                                                     |   |   |
| 3.2.6. Construction Control 施工控制                                                                             |   | 8      |
|                                                                                                                                     |   |   |
| 3.2.6.1. Welding Documentation and Inspection 焊接文件和检查                                   |   | 8      |
|                                                                                                                                     |   |   |
| 3.2.6.2. Slope Inspection 坡度检查                                                                               |   | 10     |
|                                                                                                                                     |   |   |
| 3.2.6.3. Hydraulic Testing 水压测试                                                                              |   | 10     |
|                                                                                                                                     |   |   |
| 3.2.6.4. Cleaning and Passivation 清洗和钝化                                                               |   | 11     |
|                                                                                                                                     |   |   |
| 3.2.7. Acceptance Test 验收测试                                                                                  |   | 12     |
|                                                                                                                                     |   |   |
| 3.2.7.1. Factory Acceptance Test 工厂验收测试                                                        |   | 12     |
|                                                                                                                                     |   |   |
| 3.2.7.2. Site Acceptance Test 现场验收测试                                                           |   | 13     |
|                                                                                                                                     |   |   |
| 3.2.8. Installation Qualification and Operational Qualification 安装确认和运行确认 |   | 13     |
|                                                                                                                                     |   |   |
| 3.2.9. Documentation Management 文件管理                                                                         |   | 15     |
|                                                                                                                                     |   |   |
| 3.2.10. Change Control 变更控制                                                                                  |   | 16     |
|                                                                                                                                     |   |   |
| 3.2.11. Deviation Handling 偏差处理                                                                              |   | 16     |
|                                                                                                                                     |   |   |
| 4. Project Plan 项目计划                                                                                         |   | 17     |
|                                                                                                                                     |   |   |
| 4.1. Project Organization 项目组织                                                                               |   | 17     |
|                                                                                                                                     |   |   |
| 4.2. Deliverable Items 移交清单                                                                                  |   | 18     |
|                                                                                                                                     |   |   |
| 4.3. Project Schedule 项目进度表                                                                           |   | 20     |
|                                                                                                                                     |   |   |
| 5. Glossary 词汇                                                                                                             |   | 20     |
|                                                                                                                                     |   |   |
| 6. Attachment 附件                                                                                                           |   | 20     |
|                                                                                                                                     |   |   |
| 6.1. Attach.1- Project Organization Chart 项目组织结构图                                       |   | 21     |
|                                                                                                                                     |   |   |
| 6.2. Attach.2- Project Schedule 项目进度表                                                                 |   | 21     |

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 4 of 21 |

| 1. | Introduction |
|----|--------------|

| 2. | Overview |
|----|----------|

|   | - | Purified water storage and distribution system |
|--------|---|------------------------------------------------|

|   | - | Water for Injection storage and distribution system |
|--------|---|-----------------------------------------------------|

|   | - | Pure steam distribution system |
|--------|---|--------------------------------|

| 3. | Quality Plan |
|----|--------------|

| 3.1. | User Quality Requirements |
|------|---------------------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 5 of 21 |

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 6 of 21 |

| 3.2. | QualitySystem |
|------|---------------|

| 3.2.1. | References |
|--------|------------|

| No. 序号 | Document Name 名称                                                                                                                                                                             | Document Number 编号 | Revision/date 版本/日期 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------|
| 1                    | User requirement specification (tender technical part) 用户需求说明(URS)(招标文件技术部分) | NA                               | 2008.12.31                                      |
| 2                    | Chinese GMP 2005 中国GMP(1998 年修订版)                                                                                                                  | NA                               | 1998 revised                                    |
| 3                    | US cGMP 美国cGMP                                                                                                                                                                               | 21 CFR part 210-211              | Current 现行                        |
| 4                    | Eu GMP 欧盟GMP                                                                                                                                                                                 | NA                               | 2008                                            |
| 5                    | ISPE Baseline Volume 4: water and steam system ISPE 指南第4 卷:水和蒸汽系统                                                             | NA                               | First edition/January, 2001                     |
| 6                    | GAMP 5                                                                                                                                                                                                     | NA                               | 2008 年                                   |

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 7 of 21 |

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 8 of 21 |

| 3.2.3. | Kick off meeting |
|--------|------------------|

| 3.2.4. | Design Review and Design Qualification |
|--------|----------------------------------------|

| 3.2.5. | Receiving Inspection |
|--------|----------------------|

|   | -  | packaging inspection外观检查,是否完好 |
|--------|---------|----------------------------------------------------------------------------------------------|

|   | -  | check if the name, model and quantity of goods conform with purchase orders |
|--------|---------|-----------------------------------------------------------------------------|

|   | - | documentation,such as material certificate |
|--------|---|--------------------------------------------|

| 3.2.6. | Construction Control |
|--------|----------------------|

| 3.2.6.1. | Welding Documentation and Inspection |
|----------|--------------------------------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 9 of 21 |

|   | - | Daily at at the beginning and finishing of each work shift| |
|--------|---|-------------------------------------------------------------|

|   | - | when changing welding machine, pipe size or pipe lot. |
|--------|---|-------------------------------------------------------|

|   | -  | Visual inspection of external surface on 100% of the welds |
|--------|---------|------------------------------------------------------------|

|   | -  | Borescopic Inspections of internal surface on 20% of the welds |
|--------|---------|----------------------------------------------------------------|

|   | -  | Borescopic Inspections of internal surface on 100% of the welds |
|--------|---------|-----------------------------------------------------------------|

|   | -  | 100% of sample welds |
|--------|---------|----------------------|

|   | -  | 100% of manual welds |
|--------|---------|----------------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 10 of 21 |

|   | -  | Isometric drawing with welds marked and numbered |
|--------|---------|--------------------------------------------------|

|   | -  | Welding report for sample welds |
|--------|---------|---------------------------------|

|   | -  | Welding report |
|--------|---------|----------------|

|   | -  | Welding machine print-out |
|--------|---------|---------------------------|

|   | - | Borescopic inspection report and photograph or video |
|--------|---|------------------------------------------------------|

|   | -  | X-ray inspection report and radiograph (if applicable) |
|--------|---------|--------------------------------------------------------|

|   | -  | Welder’s certificates |
|--------|---------|-----------------------------|

| 3.2.6.2. | Slope Inspection |
|----------|------------------|

| 3.2.6.3. | Hydraulic Testing |
|----------|-------------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 11 of 21 |

| 3.2.6.4. | Cleaning and Passivation |
|----------|--------------------------|

|   | 1) Degreasing and cleaning 脱脂清洗 |
|--------|-------------------------------------------------------------|

|   | 2)DI water rinse 去离子水冲洗 |
|--------|-------------------------------------------------------------------|

|   | 3) Passivation 钝化处理 |
|--------|-------------------------------------------------|

|   | 4)DI water rinse 去离子水冲洗 |
|--------|-------------------------------------------------------------------|

| Chemical 化学品 | NaOH                                                                    |
|-----------------------------------|-------------------------------------------------------------------------|
| Cleaning Solution                 | 2% NaOH                                                                 |
| 清洗溶液  | 98% DI water                                                            |
| Procedure 程序        | Recirculate at 0.1-0.3 MPa 泵压循环 0.1-0.3 MPa |
| Temperature 温度      | Ambient 室温                                                |
| Time 时间             | 45 min                                                                  |

| Chemical 化学品                     | HNO3, HF                                                                |
|-------------------------------------------------------|-------------------------------------------------------------------------|
| Passivation solution 钝化溶液 | 20% HNO33% HF 77% DI water                                              |
| Procedure 程序                            | Recirculate at 0.1-0.3 MPa 泵压循环 0.1-0.3 MPa |
| Temperature 温度                          | Ambient 室温                                                |
| Time 时间                                 | 30 min                                                                  |

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 12 of 21 |

| Chemical 化学品 | NaOH                               |
|-----------------------------------|------------------------------------|
| Cleaning Solution                 | 2% NaOH                            |
| 清洗溶液  | 98% DI water                       |
| Procedure 程序        | Completely filled 浸泡 |
| Temperature 温度      | Ambient 室温           |
| Time 时间             | 60 min                             |

| Chemical 化学品                  | HNO3, HF                           |
|----------------------------------------------------|------------------------------------|
| Cleaning Solution 清洗溶液 | 20% HNO33% HF 77% DI water         |
| Procedure 程序                         | Completely filled 浸泡 |
| Temperature 温度                       | Ambient 室温           |
| Time 时间                              | 45 min                             |

| 3.2.7. | Acceptance Test |
|--------|-----------------|

| 3.2.7.1. | Factory Acceptance Test |
|----------|-------------------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 13 of 21 |

| 3.2.7.2. | Site Acceptance Test |
|----------|----------------------|

| 3.2.8. | Installation Qualification and Operational Qualification |
|--------|----------------------------------------------------------|

|   | -  | All personnel participation in IQ execution must pass through the correlation pre-job training.所有的参与IQ 执行的人员在实施前须经相关培训。 |
|--------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | -  | All documents (such as operating manuals, maintenance manuals, solder joint plans, records of welding, welding inspection, slope confirmation, pressure test document, endoscopies test records, etc.) will be examined, file location will be recorded. |
|--------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 14 of 21 |

|   | - | All drawings (For example pipeline and measuring appliance flow chart, three dimensional pipeline schematic drawing, electrical chart, pneumatic operated chart and so on) and with the material quality proved and inspection file location will be recorded. |
|--------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | All equipment, instrument and accessory will be inspected and they are required to meet the pre-set standards |
|--------|---|---------------------------------------------------------------------------------------------------------------|

|   | - | Instrument calibration has been successfully completed仪表的校正已经成功完成 |
|--------|---|------------------------------------------------------------------------------------------------------------------------------------------------|

|   | -  | All personnel participation in IQ execution must pass through the correlation pre-job training.所有的参与IQ 执行的人员在实施前须经相关培训。 |
|--------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | -  | All OQ activities should be conducted according to approved protocols. |
|--------|---------|------------------------------------------------------------------------|

|   | -  | OQ Test instruments should be calibrated; the relevant certificate should be NIST or Chinese National measurement standards traceable to the National Institute of Standard Technology and attached to the relevant protocol. OQ测试仪器应被校准过的,相关的证书应可溯源NIST 或中国国家计量基准,并附在相应的方案中 |
|--------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | -  | The system’s alarms and interlocks should operate in accordance with the design specification. |
|--------|---------|------------------------------------------------------------------------------------------------------|

|   | - | Thesystem’s function should operate in accordance with the design specification. |
|--------|---|----------------------------------------------------------------------------------------|

|   | - | Utilities, used by the system, should be available at the battery limit within the specified range (temperature, pressure, flow-rate). |
|--------|---|----------------------------------------------------------------------------------------------------------------------------------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 15 of 21 |

| 3.2.9. | Documentation Management |
|--------|--------------------------|

|   | - | Design documents 设计文件 |
|--------|---|---------------------------------------------------|

|   | - | Project management documents 项目管理文件 |
|--------|---|-------------------------------------------------------------------------------|

|   | - | Contract documents 合同文件 |
|--------|---|-----------------------------------------------------|

|   | - | All other documents that affect or control the quality of the Project |
|--------|---|-----------------------------------------------------------------------|

|   | - | Abbreviation for the project 项目缩写词 |
|--------|---|-----------------------------------------------------------------------|

|   | - | Abbreviation for system/equipment, if applicable 系统或设备的缩写词(如果适用) |
|--------|---|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | - | Abbreviation for different project phase 项目活动缩写词 |
|--------|---|---------------------------------------------------------------------------------------------------|

|   | - | Serial Number (three digitals), if applicable 三位数字的顺序号(如果适用) |
|--------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 16 of 21 |

| 3.2.10. | Change Control |
|---------|----------------|

| 3.2.11. | Deviation Handling |
|---------|--------------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 17 of 21 |

| 4. | Project Plan |
|----|--------------|

| 4.1. | Project Organization |
|------|----------------------|

| Title 职务                   | Name 姓名 | Contact 联系方式 |
|------------------------------------------|-----------------------|------------------------------------------|
| Macroprocess                             |                  |                                     |
| 上海朗脉         |                  |                                     |
| Project manager                          |                  |                                     |
| 项目经理         |                  |                                     |
| Site manager                             |                  |                                     |
| 现场经理         |                  |                                     |
| Design engineer                          |                  |                                     |
| 设计                         |                  |                                     |
| Procurement engineer 采购    |                  |                                     |
| Automatic engineer 自控      |                  |                                     |
| Electrical engineer 电气     |                  |                                     |
| Validation 验证              |                  |                                     |
| 3SBIO 三生                   |                  |                                     |
| Project manger                           |                  |                                     |
| 项目负责人 |                  |                                     |
| Project coordinator                      |                  |                                     |
| 项目协调员 |                  |                                     |
| Production manager                       |                  |                                     |
| 生产部经理 |                  |                                     |
| Engineering manager                      |                  |                                     |
| 工程部经理 |                  |                                     |
| QA manager                               |                  |                                     |
| QA 经理                      |                  |                                     |

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 18 of 21 |

| 4.2. | Deliverable Items |
|------|-------------------|

| No. 序号 | Document Number 文件编号                         | Document Name 文件名称                                                                                                                                                                    | Macroprocess 朗脉 | 3SBIO 三生 |
|----------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|------------------------|
|                 | General 通用部分                                 |                                                                                                                                                                                                              |                          |
| 1                    | 3SBIO-01-QPP                                                             | Quality and Project Plan 质量项目计划                                                                                                                                    | W                             | A                      |
|                 | 标准和说明                                 |                                                                                                                                                                                                              |                          |
| 2                    | 3SBIO-PW-FS                                                              | Functional Specification of Purified water Storage and Distribution 纯化水储存和分配系统的功能说明                      | W                             | A                      |
| 3                    | 3SBIO-WFI-FS                                                             | Functional Specification of Water for Injection Storage and Distribution 注射用水储存和分配系统的功能说明         | W                             | A                      |
| 4                    | 3SBIO-PS-FS                                                              | Functional Specification of Pure Steam Distribution 纯蒸汽分配系统的功能说明                                                              | W                             | A                      |
|                 | Design 设计-Mechanical Part 机械部分 |                                                                                                                                                                                                              |                          |
| 5                    | 3SBIO-PW-PID-01                                                          | P&ID of Purified water Storage and Distribution 纯化水储存和分配系统的管道仪表流程图              | W                             | A                      |
| 6                    | 3SBIO-WFI-PID-01                                                         | P&ID of Water for Injection Storage and Distribution 注射用水储存和分配系统的管道仪表流程图 | W                             | A                      |
| 7                    | 3SBIO-PS-PID-01                                                          | P&ID of Pure Steam Distribution 纯蒸汽分配系统的管道仪表流程图                                                      | W                             | A                      |
| 8                    | 3SBIO-PL-01                                                              | Pipe Layout of sanitary pipe system 洁净管道平面布置图                                                                                                      | W                             | A                      |
|                 | Design 设计-Control Part 自控部分    |                                                                                                                                                                                                              |                          |
| 9                    | 3SBIO-HDS                                                                | Hardware Design Specification硬件设计说明                                                                                                                                     | W                             | A                      |
| 10                   | 3SBIO-SDS                                                                | Software Design Specification 软件设计说明                                                                                                                                    | W                             | A                      |
|                 | Construction Documents 施工文件                  |                                                                                                                                                                                                              |                          |
| 11                   | QMS-SOP-SP-03-F01                                                        | Welding Report of sample welds 焊样的焊接报告                                                                                                                           | W                             | A                      |
| 12                   | QMS-SOP-SP-03-F02                                                        | Welding Report 焊接报告                                                                                                                                                                   | W                             | A                      |
| 13                   | QMS-SOP-SP-03-F03                                                        | Borescopic Inspection Report 内窥镜检查报告                                                                                                                             | W                             | A                      |

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 19 of 21 |

| No. 序号 | Document Number 文件编号         | Document Name 文件名称                                                                                        | Macroprocess 朗脉 | 3SBIO 三生 |
|----------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------|
| 14                   | QMS-SOP-SP-03-F04                                        | X-Ray Inspection Report X 光探伤检查报告                                                    | W                             | A                           |
| 15                   | QMS-SOP-SP-04-F01                                        | Slope Test Report 坡度测试报告                                                                    | W                             | A                           |
| 16                   | QMS-SOP-SP-05-F01                                        | Hydraulic Test Report 水压测试报告                                                                | W                             | A                           |
| 17                   | QMS-SOP-SP-06-F01                                        | Cleaning and Passivation Report 清洗和钝化报告                                              | W                             | A                           |
|                 | Qualification Documents 确认文件 |                                                                                                                                  |                          |
| 18                   | 3SBIO-PW-DQ                                              | DQ of PW Storage and Distribution 纯化水储存和分配系统的DQ          | W, E                          | A                           |
| 19                   | 3SBIO-WFI-DQ                                             | DQ of WFI Storage and Distribution 注射用水储存和分配系统的DQ | W, E                          | A                           |
| 20                   | 3SBIO-PS-DQ                                              | DQ of PS Distribution 纯蒸汽分配系统的DQ                                              | W, E                          | A                           |
| 21                   | 3SBIO-PW-RA                                              | RA of PW Storage and Distribution 纯化水储存和分配系统的RA          | W, E                          | A                           |
| 22                   | 3SBIO-WFI- RA                                            | RA of WFI Storage and Distribution 注射用水储存和分配系统的RA | W, E                          | A                           |
| 23                   | 3SBIO-PS- RA                                             | RA of PS Distribution 纯蒸汽分配系统的RA                                              | W, E                          | A                           |
| 24                   | 3SBIO-PW-TM                                              | TM of PW Storage and Distribution 纯化水储存和分配系统的TM          | W, E                          | A                           |
| 25                   | 3SBIO-WFI-TM                                             | TM of WFI Storage and Distribution 注射用水储存和分配系统的TM | W, E                          | A                           |
| 26                   | 3SBIO-PS-TM                                              | TM of PS Distribution 纯蒸汽分配系统的TM                                              | W, E                          | A                           |
| 27                   | 3SBIO-PW-IQ                                              | IQ of PW Storage and Distribution 纯化水储存和分配系统的IQ          | W, E                          | A                           |
| 28                   | 3SBIO-WFI-IQ                                             | IQ of WFI Storage and Distribution 注射用水储存和分配系统的IQ | W, E                          | A                           |
| 29                   | 3SBIO-PW-OQ                                              | OQ of PW Storage and Distribution 纯化水储存和分配系统的OQ          | W, E                          | A                           |
| 30                   | 3SBIO-WFI-OQ                                             | OQ of WFI Storage and Distribution 注射用水储存和分配系统的OQ | W, E                          | A                           |
| 31                   | 3SBIO-PS-IQOQ                                            | IQOQof PS Distribution 纯蒸汽分配系统的IQOQ                                           | W, E                          | A                           |
| 32                   | 3SBIO-PW-PQ                                              | PQ of PW Storage and Distribution 纯化水储存和分配系统的PQ          | W                             | E, A                        |
| 33                   | 3SBIO-WFI-PQ                                             | PQ of WFI Storage and Distribution 注射用水储存和分配系统的PQ | W                             | E, A                        |
| 34                   | 3SBIO-PS-PQ                                              | PQ of PS Distribution 纯蒸汽分配系统的PQ                                              | W                             | E, A                        |

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 20 of 21 |

| 4.3. | Project Schedule |
|------|------------------|

|   | - | Detailed design 二次设计 |
|--------|---|--------------------------------------------------|

|   | - | Design review 设计评审 |
|--------|---|------------------------------------------------|

|   | - | Procurement 采购 |
|--------|---|------------------------------|

|   | - | Construction 现场施工 |
|--------|---|-----------------------------------------------|

|   | - | Commissioning 调试 |
|--------|---|--------------------------------|

|   | - | Qualification 确认 |
|--------|---|--------------------------------|

| 5. | Glossary |
|----|----------|

| CFR  | Code of Federal Regulations 美国联邦法规                                                   |
|------|--------------------------------------------------------------------------------------------------------------------------------|
| FAT  | Factory Acceptance Test 工厂验收测试                                                       |
| FS   | Functional Specification 功能说明                                                                      |
| GAMP | Good Automated Manufacturing Practice 良好的控制系统生产规范 |
| GMP  | Good Manufacturing Practice 药品生产质量管理规范                   |
| HDS  | Hardware Design Specification 硬件设计说明                                                 |
| IQ   | Installation Qualification 安装确认                                                                    |
| OQ   | Operational Qualification 运行确认                                                                     |
| PQ   | Performance Qualification 性能确认                                                                     |
| QP   | Qualification Protocol 确认方案                                                                        |
| QPP  | Quality and Project Plan 质量和项目计划                                              |
| QR   | Qualification Report 确认报告                                                                          |
| RA   | Risk Assessment 风险评估                                                                               |
| SAT  | Site Acceptance Test 现场验收测试                                                          |
| SDS  | Software Design Specification 软件设计说明                                                 |
| SOP  | Standard Operating Procedure 标准操作规程                                                  |
| TM   | Traceability Matrix 追溯矩阵表                                                                   |
| URS  | User Requirement Specification 用户需求说明                                                |
| VP   | Validation Plan 验证计划                                                                               |
| VR   | Validation Report 验证报告                                                                             |

| 6. | Attachment |
|----|------------|

----

| Quality and Project Plan                         | Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Doc# 文件编号:           | 3SBIO-01-QPP                                                                                                                                                                            |
| Revision 版本:                       | 00                                                                                                                                                                                      |
| 质量项目计划 | Page 页码:                                                                                                                                                                  | 21 of 21 |

| 6.1. | Attach.1- Project Organization Chart 项目组织结构图(见标书 see bidding document) |
|------|----------------------------------------------------------------------------------------------------------------------------------------------|

| 6.2. | Attach.2- Project Schedule 项目进度表 (见标书see bidding document) |
|------|--------------------------------------------------------------------------------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分 施工组织Construction Scheme                                                                   |

----

----

| 上海朗脉科技有限公司上海市闵行区罗阳路168 号A 座101 室      201100T:021 54306717      F: 021 54306718 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分 施工组织Construction Scheme                                                                   |

| 1.工程施工人员组织设计 Staff organization                            | 2      |
|----------------------------------------------------------------------------------------------------------------------------------|--------|
|                                                                                                                             |   |
| 1.1. 人员组成结构图 Organization Chart                                                 | 2      |
|                                                                                                                             |   |
| 1.2. 项目组成人员角色及职责  team and responsibility | 2      |
|                                                                                                                             |   |
| 1.3. 验证经理资质 Validation manager qualification                                           | 5      |
|                                                                                                                             |   |
| 1.4. 施工人员组织 Construction organize                                                      | 10     |
|                                                                                                                             |   |
| 1.5. 项目经理负责人资质 project manager qualification                      | 11     |
|                                                                                                                             |   |
| 1.6. 质量控制组织图 Quality control                                                    | 15     |
|                                                                                                                             |   |
| 2.施工设备材料投入计划Tools list                                     | 16     |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第1页/共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

|   | ● | 项目经理 Project manager |
|--------|---------|--------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第2页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| ● | 项目组 project team |
|---------|---------------------------------------|

| ● | 施工经理 construction manager |
|---------|-------------------------------------------------------|

| ● |  品质管理和质量 quality manager |
|---------|--------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第3 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| ·   | 采购经理 purchase manager |
|--------------------|---------------------------------------------------|

| ·   | 验证经理 Validation manager |
|--------------------|-----------------------------------------------------|

| ·   | 用户项目经理 owner project manager |
|--------------------|------------------------------------------------------------------------|

| ·   | 用户工程组 user team |
|--------------------|----------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第4 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| ·   | 用户工程师代表 Engineer representation |
|--------------------|----------------------------------------------------------------------------------|

----

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第5 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

|   | ü | 熟悉中国、美国和欧盟GMP 法规和指南。Be familiar with Chinese, USA and EU GMP Regulations and Guidance. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ü | 有GMP 培训和验证的经验,如HVAC 系统的确认、水系统的确认、设备确认、清洗验证和工艺验证等。Experience in GMP training and validation (i.e. HVAC system qualification, water system qualification, equipment qualification, cleaning validation, process validation etc.). |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ü | 有在制药公司进行生产和质量管理的经验。Experience in Production and Quality Management in Pharmaceutical Company. |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ● | 石家庄欧意药业口服固体制剂 Shijiazhuang Ouyi Pharma. |
|--------|---------|------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第6 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

|   | ·   | 杭州九源基因 原料药 Hangzhou Jiuyuan Bio-Gene. API 验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。 纯化水和注射用水系统的设计审核。纯化水和注射用水系统的IQOQ 方案的审核。 Validation Manager Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP. Design review of Purified water, WFI systems. Review of IQOQ protocols of purified water, WFI systems. |
|--------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ·   | 齐鲁安替制药 无菌原料药 Qilu Antibiotics Pharma SterileAPI 验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。 纯化水、注射用水和纯蒸汽系统的设计审核。 Validation Manager Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP. Design review of Purified water, WFI system and pure steam system. |
|--------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ·   | 成都生物研究所 疫苗 |
|--------|--------------------|---------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第7 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

|   | ·  | 浙江华海药业 口服固体制剂 |
|--------|--------------|---------------------------------------------------------------------------------------------------|

|   | ·  | 大连美罗制药厂 滴眼剂 |
|--------|--------------|-----------------------------------------------------------------------------------|

|   | ·  | 北京四环生物 疫苗 |
|--------|--------------|-------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第8 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

|   | ·  | 石家庄恩必普药业 软胶囊 |
|--------|--------------|-------------------------------------------------------------------------------------------|

|   | ·  | 北京费森尤斯卡比医药 片剂 |
|--------|--------------|---------------------------------------------------------------------------------------------------|

|   | ·  | 上海莱士 血制品 |
|--------|--------------|-----------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第9 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第10 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| • | Bachelor of Science,Mechanic Design (1992-1996) 理学学士,机械设计(1992-1996)Shandong University 山东大学 |
|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第11页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| Feb 2005– | CHENGDU INSTITUTE OF BIOLOGICAL PRODUCTS 2005 |
|-----------------|-----------------------------------------------|

| 年2 月至今 | 成都生物制品研究所 |
|------------------------------------|--------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第12页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第13 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第14 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第15 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第16 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第17 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|

----

|                                                                                                                                                                                                         | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                       | 第5 部分施工组织Construction Scheme                                                                    |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第18 页/ 共18 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第 6 部分 施工工艺Construction Technics                                                                |

----

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| 上海朗脉科技有限公司上海市闵行区罗阳路168 号A 座101 室      201100T:021 54306717      F: 021 54306718 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分 施工工艺Construction Technics                                                                 |

| 1 主要施工工艺 Construction Technics                                       | 2       |
|----------------------------------------------------------------------------------------------------------------|---------|
|                                                                                                           |    |
| 1.1. 施工准备 Construction preparations                                                | 2       |
|                                                                                                           |    |
| 1.2. 施工步骤 Construction Flow                                                        | 4       |
|                                                                                                           |    |
| 1.3. 配管质量检查流程  Pipline Quality Testing flow chart |  6 |
|                                                                                                           |    |
| 1.4. 安全施工管理规范 Safety and Good Engineering Plan         |  6 |
|                                                                                                           |    |
| 1.4.1. 安全目标 safety target                                                          | 6       |
|                                                                                                           |    |
| 1.4.2. 安全管理机构 management organization chart                          | 6       |
|                                                                                                           |    |
| 1.4.3. 安全管理规范 health and safety guidance                             | 7       |
|                                                                                                           |    |
| 1.4.4. 安全管理措施 safety management measures                             | 11      |
|                                                                                                           |    |
| 1.5. 施工质量管理 Construction quality management                          | 16      |
|                                                                                                           |    |
| 1.5.1. 质量保证体系 quality assurance system                               | 16      |
|                                                                                                           |    |
| 1.5.2. 质量保证措施 quality assurance measures                             | 18      |
|                                                                                                           |    |
| 1.6. 施工进度管理 schedule manage                                          | 27      |
|                                                                                                           |    |
| 1.6.1. 进度管理及程序 progress management and procedure              | 27      |
|                                                                                                           |    |
| 1.6.2. 全面资源保障 Strategy for Deploying All Resources                   | 28      |
|                                                                                                           |    |
| 1.6.3. 应急预案 emergency preparation                                                  | 28      |
|                                                                                                           |    |
| 1.6.4. 排除施工干扰之政策 Strategy to Expel Interference | 30      |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第1页/共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 直观检查Visual inspection |
|--------|--|---------------------------------------------------|

|   |  | 抽样检查,确认无损伤并符合要求,检查是否有塑料帽密封10% random checks, confirmed no damage and meet requirements, check whether there are any sealed plastic caps 10% |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 检查型号,数量及证书Check model No., quantities & Certificates |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------|

|   |  | 核对定货单Verification with materials order form |
|--------|--|--------------------------------------------------------------------------------|

|   |  | 加工现场的准备Preparations for field fabrication |
|--------|--|--------------------------------------------------------------------------------------------|

|   |  | 验收及接收由负责人完成确认 Acceptance and receipt of completion to be recognize by the person in charge |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 材料储存在指定区域内并根据型号,尺寸,洁净级别分类保存 Materials stored in the designated areas under the model, size and sanitary class for preservation & identification |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 材料运输不可弯曲,撞击,挤压等 When transport materials do not bending, impact and have other extrusion. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 材料取用需有详细记录 Material shall be released from storage with detailed records |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 现场测量,相关设备的检查 Field survey and inspection of Related Equipment |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第2 页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 样本制作Samples production |
|--------|--|----------------------------------------------------|

|   |  | 材料预制:管道切割,面处理,弯曲及预制焊接。Prefabricated materials: Pipeline Cutting, surface treatment. Bending and prefabricated welding |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第3页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第4 页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 管道定位,现场焊接,质量检查。为保证每一焊缝内表面无氧化变色。必须使用高纯度保护气体,保证冲气时间不小于30 分钟。Pipeline positioning; field welding; quality inspection. To ensure that no surface oxidation color on inner weld surfaces; protection must use high-purity gases, air time is guaranteed – not less than 30 minutes. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 非焊接连接:配件、设备连接 Non-Welding connection: accessories, equipment connection |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 施工后处理:管道检查。气密性测试。Procedure after Construction: pipeline inspection, gas tightness test. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 文件移交:样本记录,施工记录及测试报告 Documents submission: samples records, test reports and construction records |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第5页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 项目经理Project Manager: |
|--------|--|---------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第6 页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 安全员Safety Officer: 协助项目经理管理和执行健康安全环保计划,为健康安全环保工作的具体负责人。Assist the project manager to manage and execute safety plan. He is the specific person in charge for the safety work. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 施工现场应有专职安全员,每天应定期、不定期巡查,发现安全隐患可责令相关人员停工整顿。In the constructing site, there should have full time safety inspectors who go on a tour of inspection periodically or aperiodically. If any hidden problem is found, order relative personnel shutdown and make amendment. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 进入施工现场应戴好安全帽,系紧帽扣,穿好工作服,工作鞋,并佩带工作牌。When entering the constructing site, wear safety helmet, tie the helmet buckle tightly, wear working clothes and shoes and carry working tablet. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 严禁穿拖鞋、高跟鞋、泡沫底鞋在工地行走、作业;特别是高空作业(高空作业是指操作点高度在离地面或楼面 1.5m 以上的施工作业)。Strictly forbidden walking and working on the constructing site with slipper and high-heel shoe on, especially high altitude working (high altitude working indicates working at a position more than 1.5mhigh from the ground or floor). 在现场作业 |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 在现场作业人员严禁与其它施工队发生纠打等现象。Forbidden in site working personnel fighting with other construction team. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 施工现场人员在工作期间严禁赌博、喝酒。No gambling and drinking is allowed during working time for the in site construction personnel. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第7页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 施工机械(设备)进场前,应检查设备的完好状态;重要的工具在每次使用前,应检查其是否完好。Check the construction mechanism before entering the construction place. Important tools should be checked each time before usage. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 施工现场应规范用电,严禁私拉乱接,所有接线应由电工进行;电箱内应有漏电保护开关,保险丝。每一个用电回路均应由单一的断路器(或刀闸) 控制。Regulate electricity usage in the construction site. No private electricity connection is allowed. All the wire connection should be carried out by electrician. The electricity box should be equipped with leakage protection switch and fuse. Each electric loop should be controlled by signal switch (or brake). |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有电气工具操作人员应穿绝缘鞋或带绝缘手套。All electric facility operators should wear insulating gloves or shoes. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 电焊机、手工氩弧焊机、自动轨迹焊机均应有可靠接地,接线端子有防护罩,在雷雨天气应暂停焊接作业。 Electric weld machine, manual argon arc weld machine and automatic orbit weld machine should all reliably connected to the earth. The connection should have protective cover. Stop welding in thunder storm situation. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 高速旋转的电动工具(如型材切割机、砂轮机、台钻)在操作时严禁带纱质手套。工件的夹持应牢固,不得松动,防止随转动轴旋转或飞出。Wearing gauze gloves when operating the electric equipments with high revolving (such as cutting machine, grinding wheel machine) is forbidden. Hold the tools tightly to prevent their revolving or flying out along the revolving of axis. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 各种气品在存放使用时,要距离明火 10 米以上,并且避免在阳光下爆晒,钢瓶在搬动过程中应轻拿轻放,严禁在地面上滚动或拖拉,严禁抛掷。All kinds of gases shall be over 10 meters away from open flame and avoid being insolated in the sun when they are stored or used. Slightly lift and put sown the steel tank. No rolling, dragging and throwing is allowed. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第8页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | \登高作业时(高度超过 1. 5 米),应有专人配合,配合人员负责工具,材料的接送,并负责看护;作业人员应佩带安全带,安全带的搭扣应系在操作点的上方的牢固构件上。 Climbing work should be assisted by special person who is in charge of delivering materials and tools and watching. Working person should wear safety belt with its agraffe tied to substantial component on top of the operating point. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 撑梯的张角应合适(一般为 60-70°为宜),梯子在摆放前应先清理地面,梯子严禁接长使用。Folding ladder should have a suitable open angle (60-70°preferred). Make up the ground before placing the ladder. Prolonging the ladder for usage is forbidden. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 严禁病时酒后作业,严禁有恐高症、高血压等疾病的人员进行高空作业。Do not work when in sickness or after drinking alcohol. High altitude working is forbidden if operated by people with acrophobia, high blood pressure, etc. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 在施工现场动火,应得到业主、工地安全员的书面批准,并在火源处摆放手提式灭火器。Making fire in the construction site should be approved by written permission given by the owner or safety personnel in construction place and a portable fire extinguisher should be put on the fire place. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 动火前应先清理操作点附近的易燃易爆品,并由专业人员进行。Remove the flammable and explosive material around the fire place. This should be operated by professionals. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有操作人员应按规定在进入施工现场施工时,签定安全施工责任书,实行安全奖惩制度。 All the operation personnel should sign safe construction duty sheet before entering construction site. Put the safety rewards and punishments regulation into use. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第9页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 在彩钢板上施工时。应先检查彩钢板是否已安装完成,(特别是彩钢板加强吊筋是否已安装。人员在行走时应尽量在隔墙、隔断、吊筋处或附近,重物应摆放在隔墙、隔断处。Before constructing on the colored steel sheet, first inspect if it has been completely installed (especially whether the reinforced hanger has been installed). People should walk on or near the partition, obstruct and hanger. Heavy things should be put at the place of partition and obstruct. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 严禁在彩钢板开口处(如风口、灯孔等)行走、作业。 Walking and working at the colored steel sheet opening (e.g. air pot, lamp hole) are forbidden. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 在容器和狭小管道内焊接时,应加强通风,严格执行双人监护制,监护人必须坚守岗位,发现问题要及时采取措施。When welding in containers or small-spaced pipes, ventilation shall be reinforced. Strictly execute the double-guardian system. The guardians shall stick to their post and take necessary measures once finding problems. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 受压容器、密封容器、各种油桶、管道沾有可燃气体和溶液的工作进行时,必须先进行检查,并经过冲洗除掉有害、易燃、易爆物质并解除容器管道压力,清除容器 (包括密封空心、工件、管子 )的密封状态 (敞开口旋开盖)再进行工作,禁止在已做油漆或喷漆塑料的容器内焊接。When performing operations involving combustible gas and solution on the pressurized tanks, sealed tanks, various oil tanks and pipes, you should check them first, remove the harmful, combustive, and explosive material by flushing them, release the pressure of tanks and pipes, and remove the seals of the tanks (including the sealed cavity, work pieces, and pipes) before any work is done. To weld in the painted tanks is forbidden. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第10页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 在做酸洗时,先试压,保压后用碱液试纸擦抹每一个焊缝,观察有无泄漏,严格执行双人坚督制、签字确认制,应穿带好防酸手套及防毒面具防酸胶鞋等防护用品。有关硝酸、盐酸、硫酸的化学用品使用中应注意:配比稀释时应逐渐地缓慢地小剂量的混合,切忌大剂量强制溶合,防止爆溅伤人。When performing pickling, have a pressure test first. Then keep the pressure and erase each weld seam with alkali test paper to check if there is any leakage. Strictly execute the double-guardian system and signature-conforming system. Protective articles should be worn, such as acidproof gloves, gas mask, and acidproof rubber shoes. When using chemicals such as nitric acid, hydrochloric acid, and sulfuric acid, take care: When carrying out dilution practices, gradually and slowly mix with small volume. Do not mix with large volume, or it will cause explosion, spattering and damage. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 废料、废水应妥善处理、不应污染工作环境Waste material and waste water should be treated properly without polluting the working environment. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 进入甲方施工现场,应遵守甲方的一切安全规章制度。Obey party A‘s all safety regulations while entering party A’s construction site. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 未尽事宜,应按国家有关规定的标准执行。Unmentioned matters are carried out in accordance with relative national criteria. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 健康安全管理措施 health and safety management measures 总的原则是执行业主的健康安全计划,执行我公司安全管理的制度及政府 |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第11页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 安全教育safety education 安全教育的目的是提高职工的安全意识和自我保护的能力,避免各类事故的发生。 The safety education aims to improve employee’s safety awareness and self-protection ability and avoid accidents. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 安全教育的形式 forms of safety education |
|--------|--|------------------------------------------------------------------------------------|

|   |  | 进场安全教育*(*表示教育后需进行考试) |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 方案技术交底教育 Technical notification on design proposal |
|--------|--|------------------------------------------------------------------------------------------------------------|

|   |  | 星期一安全例会的教育 Regular safety meeting on Mondays |
|--------|--|--------------------------------------------------------------------------------------------------------------------|

|   |  | 班前安全教育 Safety education before work |
|--------|--|-------------------------------------------------------------------------------|

|   |  | 每一次教育都必须记录 ,记录教育的时间、地点、参加人员名单、教育的内容,进行考试的还应保存好考试成绩及试卷。 Each time the education should have a record to note the education time, location, person list and contents. Keep the test scores and test papers if test is taken. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 安全作业单元与安全许可证safety operation unit and safety license |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 安全作业单 ,施工任务的布置通过安全作业单的方式下达 , 以保证安全工作与施工过程 ”五同时 ”(即计划、布置、检查、总结、评比五同时)Safety operation sheet. The construction tasks are assigned by safety operation sheets, which ensure the “five simultaneous” (simultaneous plan, assign, inspect, summarize, compare) of safety work and construction procedures |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第12页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 安全许可证,以下特殊作业必须有安全许可证:Safety license. The following special operations require safety licenses: |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | § | 进入设备作业许可证Equipment entry operation license |
|--------|--------|-----------------------------------------------------------------------------------------------------------|

|   | § | 电工作业许可证 Electrician operation license |
|--------|--------|----------------------------------------------------------------------------------------|

|   | § | 有毒有害作业许可证 Poisonous and deleterious  operation license |
|--------|--------|---------------------------------------------------------------------------------------------------------------------------------|

|   |  | 安全检查safety inspection |
|--------|--|---------------------------------------------------|

|   |  | 安全检查是做好健康安装工作的重要手段之一,能及时发现事故隐患,及时制止三违”(违章作业、违章指挥、违反劳动纪律)的行为发生,保证各项安全管理规章制度落到实处,从而杜绝事故的发生。Safety inspection is one of the key measures in safe installation. It can timely find the potential accident, prevent the "three breaches" activities (regulation-breaching operation, regulation-breaching direction, breach labor laws), and ensure all the safety regulations can be executed, so as to prevent the possibility of accidents. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 安全检查的内容是:查领导、查制度、查机械设备、查安全设施、查教育培训、查操作行为、查劳保用品使用、查事故处理等。Contents of safety inspection: inspect the leaders, inspect the system, inspect the equipment, inspect the safety devices, inspect the education and training, inspect the operation, inspection the labor protection appliance, inspect the accident reasons, etc. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 季节性安全检查。冬季应以防雪、解冻、跑漏、防临时建筑物倒塌为重点,秋季以防火防爆为重点。Seasonal safety inspection. In winters focus on snowproof, defreezing, and preventing the building collapse. In autumns focus on fireprotection and blameproof. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第13页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 所有检查均必须按安全检查表进行,并做好记录。 All the inspections should be taken as per safety inspection sheet with relative records done. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 基层检查均必须按安全检查表进行,并做好记录。Grass roots inspection should accord with safety inspection sheet with relative records done. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 代表性的安全检查种类 Typical Safety Inspection Category |
|--------|--|---------------------------------------------------------------------------------------------------------------------|

|   |  | 领导检查中发现的隐患应下达书面的《事故隐患整改通知单》限期整改。If any hidden trouble is found during leader inspection, send out a Modification Notification on Hidden Trouble and ask them to modify it within a certain time. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 隐患整改 hidden trouble modification |
|--------|--|--------------------------------------------------------------|

|   |  | 接《事故隐患整改通知单》后,责任人应立即组织整改,做到“三定”(定具体整改人员、定整改措施、定整改完成时间); After receiving the Modification Notification on Hidden Trouble, the person in charge should arrange modification immediately, accomplishing “three establishes” (establish the persons involved in modification, establish the modification measures, and establish the finish time) |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 隐患整改完毕及时将整改结果书面反馈给通知单发出人。After finishing modifying the hidden troubles, timely feedback the modification results in paper to the person who sends out the modification notification. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 通知发出人收到反馈情况后,要复验整改结果。The notification sender should re-inspect the modification results after having received the feedback. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第14页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 应急计划 emergency |
|--------|--|--------------------------------------------|

|   |  | 目的正确、及时处理意外情况,防止事故扩大,将事故损失控制在最小范围内。 The plan aims to correctly and timely treat the accidental conditions, prevent the accident from extending, and control the damages to a smallest limit. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第15页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 恰当的控制各项工程步骤;连续的保持各项质量的有效性。Control all the construction procedures correctly. Maintain all the quality indexes effective continuously. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 要具有及时预防和及时纠偏的能力。Have the ability to timely prevent and correct the errors. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 具有可追溯性,能正确方便的追溯到各项质量、生产状况、检验情况,能追溯到事和人,便于分析改进不断完善体系和提高工程质量。Traceability. We can trace back to quality, manufacturing, and checking status as well as matters and persons for the convenience of analyse and improving system and project quality. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第16页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 确保整个工程能顺利通过国家 GMP 验证,并达到美国 FDA 中要求的相应水平。 Ensure the whole project can pass the national GMP validation and FDA standards. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 项目质量实行公司经理负责制,对现场项目质量负有全面监督和保证职责。The project quality is ensured by manager responsibility system, which will monitor the on-site project quality. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 现场项目经理对现场质量负有组织、全面管理的职责。 The field project manager is responsible to organize and manage the field construction quality. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 建立以自检、互检和专职检查相结合的检验体系,把检验工作贯穿于预制、安装的全过程。对各个质量控制点,一定要按有关规范要求进行严格的检查、验收,验收不合格的工序坚决不允许转入下道工序。Establish a checking system combining self-check, cross check, and special check. The checking operation should be implemented through the prefabrication and installation. The quality control points should be checked and accepted by all relative regulations. Do not turn to the next procedure of the process if the previous procedure is unqualified. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 质量员负责现场项目施工中的质量的检查监督、检验和试验、质量记录和不合格品的控制,以及推动、监督现场质量保证体系的正常运行。Quality officer is in charge of the quality supervision, inspection, experiment, quality record, and unqualified product control during field project construction, so as to promote and monitor the normal operation of on-site quality assurance system. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 材料员负责自行采购和业主提供设备、材料的质量控制。The material officer is in charge of on-site purchasing and the quality control of the equipment and materials provided by the owner |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第17页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 现场作业层的各专业、施工单位,统一在现场质量保证机构领导和控制下进行质量活动。All the construction companies will carry out activities involving quality under the united supervision and control of on-site quality assurance organization. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 恰当的控制各项工程步骤;连续的保持各项质量的有效性。Correctly control all the engineering steps. Maintain all the quality index continuously effective. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 具有及时预防和及时纠偏的能力。This system has the capacity to timely prevent and correct errors. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 具有可追溯性,能正确方便的追溯到各项质量、生产状况、检验情况,能追溯到事和人,便于分析改进不断完善体系和提高工程质量。This system is traceable. We can trace back to quality, manufacturing, and checking status as well as matters and persons for the convenience of analyse and improving system and project quality. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 确保整个工程能顺利通过国家 GMP 验证,并达到美国 FDA 中要求的相应水平。Ensure the whole project can pass the national GMP validation and FDA standards |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第18页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 材料方面的资料由材料员管理,如产品合格证、材质说明书、收发料单等。根据专业技术负责人审核过单线图,材料表和预算并填写限额领料单到仓库领料时,对材质、规格、数量进行核实和验收。并且有合格证件(或复印件)确认无误,并在计算机上进行消料处理。收货人签字。领回后入库时应规格、型号、材质、分类挂牌存放并计入帐卡,按上述程序材料员向班组发料,每天将领、发料单装订成册备查,领回后不入库直接运到现场的材料,也应计入帐卡,交接清楚,按指定地方堆放整齐。The data concerning material, such as product certificates, material specification, material accepting and delivery sheet, are administered by material officer. Check the material, specification, and quality when receive material in the warehouse after fill in a material receiving sheet according to the drawings, material list, and budget. Check whether the certificates (or their copies) are valid and input it into the computer. The person who receives the material should sign on the receiving sheet. After accepting the material, put it into the inventory. Separate and store them according to the specifications, models, materials and category. Distribute the material to the construction teams according to the above procedures. Compile a material receiving and distribution booklet each day. If a certain material is moved to the construction field instead of being put into the warehouse after being received, it should also be registered with clear notes to identify its location. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第19页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 对所有材料特别是不锈钢,在切割后必须进行材质标识移置。The material marks should be moved after welding for all the materials, especially stainless steel. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 项目部设置焊接专业工程师、焊接组长及系统验证专职人员,具体负责焊接工作,包括在单线图上标注焊口号、焊工代号、无损检验部位,填写无损检验委托单,联系与配合试验室无损检验。焊缝预热和热处理记录,透视报告的保管,焊接及热处理施工记录,管理焊条的烘烤、存放和保管记录等验证文件都由专职人员进行处理。Project department possesses the welding technician, welding team leader, and system validation personnel. They are in charge of welding, including note welding port number, welder code, non-destruction inspection parts on the single line diagram, fill in the non-destruction inspection sheet, contact and coordination with the lab non-destruction inspection, welding seam preheating and heat treatment record, perspective report maintenance, welding and heat treatment record, welding rot roasting, and record storage and maintenance. These works will be done by special personnel. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第20页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 每个焊工均有一个固定的代号。公司焊接试验室应把经考试合格的焊工姓名、代号及合格项目表及时发给焊工所在的施工队及检验部门备查。焊后在其所焊的焊缝旁用记号笔写上代号,并要标注在单线图上。 Each welder has his own stable code. Our company will hand over the welder’s name, code, and qualified project sheet to the construction team and inspection department for reference in time. The welder will mark his code close to the weld seam and note on the single line diagram after welding. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 焊好的管线经自检、互检合格后按规定的 X 射线透视比例由施工队委托试验进行透视,X光底片以区域为单位,以管线号为依据,建立流水号。同一焊口在透视委托单、底片、透视记录、检验报告以及在单线图上的标注必须一致,使抽查任何一张底片就可知道焊接位置。透视一定要及时,未经透视或抽透不足及需要重新返修的管线一般不要去安装,以减少高空作业,对透视不合格的焊口应立即在管线上作出明显标志,并及时组织返修,直至合格为止。返修次数不锈钢管不超过两次,并作好返修记录。 Self-check and cross check the pipelines after welding. If it is qualified, the construction team shall carry out perspective operation according to the specified X-ray perspective ratio. The X-ray negative film is divided by units of area. Set up a numerical order according to the pipeline number. The marks should be unified for the same weld port on perspective sheet, negative file, perspective record, inspection record, and single line diagram for the convenience of knowing the welding position just by checking only one negative film. The perspective should be taken in time. The pipeline without perspective or with less insufficient perspective or repair needed should not be installed so as to reduce aloft work. Make obvious marks on the pipelines that have welding ports with unqualified perspective. Arrange repairs timely, until it is qualified. The repair times should not be more than twice for stainless steel pipes. Do not forget to make repair records. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第21页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 对所有预制完并经检验合格的管段,暂不安装的,管口应予以封闭。To all the pipes that have being prefabricated and qualified, but will not be installed immediately, seal the pipe ends. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 对不锈钢管道,在预制和安装时不得与其它管道接触。 To the stainless steel pipes, do not contact them with other pipes when under prefabracation and installation. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 建立以自检、互检和专职检查相结合的检验体系,把检验工作贯穿于预制、安装的全过程。对各个质量控制点,一定要按有关规范要求进行严格的检查、验收,验收不合格的工序坚决不允许转入下道工序。Establish a checking system combining self-check, cross check, and special check. The checking operation should be implemented through the prefabrication and installation. The quality control points should be checked and accepted by all relative regulations. Do not turn to the next procedure of the process if the previous procedure is unqualified. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 项目质量控制重点参照业主工艺的要求,结合本公司在类似工程的  施工经历,初步明确下列质量控制重点:  according to the owner’s requirements and our similar construction experiences in the past, we’ve established the following key quality control points: |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 设备、材料的选择与采购 The selection and purchasing of equipment and material |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第22页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 焊接工程 Welding |
|--------|--|------------------------------------------|

|   |  | 电气、仪表 Electricity and instruments |
|--------|--|----------------------------------------------------------------------|

|   |  | 清洁清扫Cleaning |
|--------|--|------------------------------------------|

|   |  | 资料管理 Documentation management |
|--------|--|-----------------------------------------------------------|

|   |  | 质量控制的原则 the principles for quality control |
|--------|--|---------------------------------------------------------------------------------------------|

|   |  | 预防为主、检验把关; Focus on prevention and inspection |
|--------|--|---------------------------------------------------------------------------------------------------------------------|

|   |  | 以 FD A、SFDA 的标准作为项目施工和验收的依据;Set FDA and SFDA criteria as the standards for project construction and acceptance |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 设备、材料的选择和采购必须经过技术部检验合格后方可使用;The equipment and material can be used only after being verified by the technique department |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 工序质量否决制:即上一道工序不合格,坚决不允许进入下一道工序;Process quality veto system: Namely no entrance to the next procedure if the previous one is unqualified. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 施工记录、质量记录与施工同步,确保施工过程得到有效控制;Construction record and quality record should be simultaneous with the construction, ensuing the construction procedure can be effectively controlled. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有施工机具、检验、检测、计量设备符合项目施工技术、施工质量要求;All the construction devices and checking, measuring, and accounting instruments accord with the technical and quality requirements |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 参加和参与施工的人员必须符合施工技术的要求,主要工种须持证上岗,所有人员须经技术、安全培训合格。People who are involved in the construction should meet the technical requirements for construction. Person at important job position shall have certificate. All the staff must pass technical and safety training. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第23页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 焊接质量保证措施 Welding quality assurance measures 焊接质量是施工质量中关键的组成部分。本工程为制药项目,有洁净度要求,为保证管道焊接质量,我们采取以下措施:Welding quality is the key in construction quality. This is a pharmaceutical project, which have high requirement on sanitation. To ensure the pipe welding quality, we will take the following measures: |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 不锈钢管道采用全自动氩气保护焊接;The stainless steel pipes are auto welded with argon gas protection |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 设置专门的不锈钢材料堆放场所;Set up special stainless steel storage place |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 成立专门的不锈钢管道施工队;Establish a special stainless steel pipe engineering team |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 每个焊工均有一个固定的代号。公司焊接试验室应把经考试合格的焊工姓名、代号及合格项目表及时发给焊工所在的施工队及检验部门备查。焊后在其所焊的焊缝旁用记号笔写上代号,并要标注在单线图上;Each welder has his own code. Our company will hand over the welder’s name, code, and qualified project sheet to the construction team and inspection department for reference in time. The welder will mark his code close to the weld seam and note on the single line diagram after welding. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 对所有预制完并经检验合格的管段,暂不安装的,管口应予以封闭。To all the pipes that have being prefabricated and qualified, but will not be installed immediately, seal the pipe ends. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第24页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 对不锈钢管道,在预制和安装时不得与其它管道接触。To the stainless steel pipes, do not contact them with other pipes when under prefabracation and installation. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 试压时使用的水源必须为纯化水,必须有效控制游离氯和氯离子的含量. The source water for pressure test should be purified water, which can effectively control the free chlorine and chlorine ion. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 保温工程质量保证措施 Quality assurance measures for heat preservation |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------|

|   |  | 管道保温须进行错缝连接;Breaking joints for pipe heat preservation |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 保温层的包扎应严密不漏,符合规范的要求。The bandage for heat insulating layer should be tight and accords with the specification。 |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 清洁文明保证措施 Assurance measures for cleaning |
|--------|--|--------------------------------------------------------------------------------------------------|

|   |  | 施工现场保持清洁文明,特别是有洁净要求的厂房,每个工种完成工作后,清理干净工作区域;Keep the construction field clean. Especially in the plant building that have special requirements on sanitation, clean the working area each time after finish operation. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 进入洁净厂房施工前,工具、设备、材料、防护用品都必须进行清洁,经检查后方可进入洁净厂房施工;Before entering the sanitary plant for construction, the tools, equipment, materials, and protective articles should be cleaned and inspected. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 洁净厂房管道施工内外壁清理干净,焊口内外清除干净,并及时封闭,室内所有缝隙、电仪管口、接线盒必须清扫干净。Clean the inner and outer pipe walls. Clean the weld ports and timely seal them. Clean all the seams, electric instrument pipe ports, and connection box |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第25页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 对下发到各部门的图纸、方案、技术规范联络笺、材料代用单等必须指定专人统一管理,并登记收发,各技术员应做好施工原始资料,交工资料的整理工作,并协助施工班组填写各种施工记录表、卡,施工技术员每天必须记录施工日记。All the drawings, proposals, technical standards, contact list, material sheet should be unitedly managed by a special person and have a registration record. The technicians should compile and pack all the original construction data and project handing over data, and assist the construction group to fill in all kinds of construction records and cards. The technicians should write the construction log daily. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 项目部设立专职验证员和资料员,专门负责相关文件的填写、交接、整理、归档等管理工作,使在施工过程中的每一道工序、每一个变更、每一次变更等都有相应的记录,具有可追溯性。施工过程中材料的质量证明文件,材料的自查、委托检查记录;施工方案的确定;施工人员的安排、施工机械的调配以及所有施工资源的分配全部有案可查。施工过程中与建设单位,其他施工单位的协调也相应作详尽的记录。最终目标使工程顺利通过建设单位、国家职能部门等检查,验证。The project department has verification officer and data officer to be specially in charge of document filling handing over, management and filing. Each procedure or each change should have relative record and is traceable.We have the history documents for material quality certificates, material self-check and cross check record, construction proposal determination, construction personnel arrangement, construction mechanics arrangement, and construction resources deployment. The detailed record of coordination with the constructed company and other construction companies should also be available. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第26页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 向业主及工程总包递交的进度文件清单:The Progress list supplied to the owner: |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |   | 进度周报、进度月报、进度计划(总体计划、季度计划、月度计划)、纠偏计划 Progress Weekly, Progress Monthly, Progress Plan (whole plan, quarterly plan, monthly plan), Correction Plan |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 进度管理职责表:Progress Management Responsibility Sheet |
|--------|--|----------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第27页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 进度管理程序图 Progress Management Process Chart |
|--------|--|--------------------------------------------------------------------------------------------|

|   |  | 充分调动公司内部的资源 Sufficiently Deploy Resources in Our Company |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 我们充分认识到此项目的重要性,公司总部将从各个方面对此项目进行支持政策的倾斜 We fully understand the importance of this project. Our headquarter will offer privileged support on this project |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 项目经理长驻现场。Project manager will stay at the construction field for a long time. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 向此项目选择经验的项目经理,优秀的工程师,有丰富经验的工人和完好的施工设备。We will select experienced project manager, excellent engineers, skillful workers, and whole package of engineering equipment |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 我们已做好劳动力的充分保障。We have sufficient labor insurance |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 充分调动当地资源 Sufficiently Deploy Local Resources |
|--------|--|------------------------------------------------------------------------------------------------------|

|   |  | 充分与兄弟施工单位加强联系,利用当地在水、电、气、材料供应,人力资源,加工能力,运输能力等优势。Sufficiently contact with other construction companies and make advantages of local water, electricity, gas, material, labor, and machining ability |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 冬季施工工期保证措施 Assuring Measures for Construction in Winter |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------|

|   |  | 因工程主要施工时间在主体厂房施工完成之后,且装修、装饰基本施工完成之后,所以在冬季施工的寒冷气候对工程施工的影响并不是特别大。Our construction will start after the main part of the plant building is finished and its decoration is done, therefore the cold weather won’t have big influences to our construction |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第28页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 尽量避免室外施工,应全面检查防冻保暖工作,充分做好防寒、防冻、防滑、防火和防止一氧化碳中毒的措施。Try to avoid outdoor construction. Fully check the antifreeze and heat protection measures. Take measures for anti-cold, anti-freeze, skid proof, fire proof, and carbon monoxide poisoning proof. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 尽量避免冬季登高作业。Try to avoid ascending work |
|--------|--|---------------------------------------------------------------------------------------------------------------------|

|   |  | 遇暴风雪应停止室外工作,严禁在冰冻的湿地上施工。Stop working at snowstorm. Do not work on cold and moist field. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 首先调整作息时间,使施工的主要时间集中在早晚比较凉爽的时间进行。 Adjust the work and rest time at first to focus the engineering time on morning and evening, when it is cold. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 要配备必要的防暑降温设施、器材、药品和茶水饮料。Prepare necessary heatstroke preventative devices, equipment, drugs, and waters. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 高温作业场所,应加强通风和降温措施。Reinforce ventilation and cooling measures for |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 通风机和排风扇等设备应由防护网罩。The ventilator and exhaust fan should have protection shield |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 要加强食堂的清洁卫生工作,严格执行检查消毒制度,防止职工食物中毒。Strengthen the sanitary conditions in dining room. Strictly execute the disinfection system. Avoid food poisoning. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 雨季施工工期保证措施Assuring Measures in Rain Season |
|--------|--|------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第29页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 暴雨前后,要检查工地临时设施,脚手架、机电设备、临时用电线路等,发现倾斜、变形、下沉、漏雨、漏电等现象应及时修理加固,有严重危险的应立即排除;After rainstorm, check the temporary equipment, scaffold, electric devices, temporary electric loop, etc. Repair it if any incline, deformation, sinking, rain leakage, and electricity leakage is found. Remove it if it is severely dangerous. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 雷雨时,严禁管道焊接工作。Pipe welding is strictly forbidden at thunder storm. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 当设备材料、设计图纸因特殊原因不能正点到位时,立即调整施工计划,制定补救工期的对策。一旦到位,立即施工,将失去的工期补回来。If the equipment, material, or design drawings can not arrive in place in time, adjust the construction plan immediately and set up countermeasure. Once they arrive, carry out construction immediately to offset the time limit. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 自供的材料合理安排采购计划,确保不影响施工进度计划,对于因施工计划改变可能需紧急采购的材料,应在施工前做工供应商的评估。 For the materials that are supposed to be purchased by ourselves, reasonably arrange the purchasing plan. Verify the supplier before construction if urgent purchasing is necessary because of construction plan changes. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 与生产运行有交叉的,在施工开始前做好防护隔离措施,保证施工与生产的安全顺利进行。 Take protective measures before construction if production operation is involved, so as to ensure the successful operation of construction and manufacturing. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 坚持逐月检查,警惕和预防传染病的袭击,发现病员,立即隔离。 |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第30页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第6 部分施工工艺Construction Technics                                                                  |

|   |  | 管线及其它设施的加固措施 Solidifying Measures for Pipes and Other Devices |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 管道在安装过程中,严格执行工艺作业规程,一般现做支架固定,并手工点焊固定,并在短期内施焊完成。During installation procedures, strictly implement the process working specifications. Normally use a bracket for the sake of solidifying and weld it in short time. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第31页/ 共31 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第 7 部分 管道系统施工规范Construction Regulation for Piping System            |

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| 上海朗脉科技有限公司上海市闵行区罗阳路 168 号 A 座101 室     201100T:021 54306717     F: 021 54306718 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第 7 部分 管道系统施工规范Construction Regulation for Piping System            |

| 1. 管道系统施工规范 Construction Regulation              |   | 3  |
|----------------------------------------------------------------------------------------------------------|--------|----|
| 1.1. 焊接总则 General                                                            |   | 3  |
| 1.2. 焊接规范 Welding regulation                                                 |   | 4  |
| 1.2.1. 总体要求 General requirements                                             |   | 4  |
| 1.2.2. 材料 Material                                                                         |   | 5  |
| 1.2.3. 焊接准备 Weld joint preparation and fit-up                                |   | 6  |
| 1.2.4. 预热温度 Preheating temperature                                           |   | 8  |
| 1.2.5. 供电 Electrical characteristics                                                       |   | 8  |
| 1.2.6. 焊接程序 Welding procedure                                                |   | 8  |
| 1.2.7. 焊接修补 Weld repair                                                      |   | 8  |
| 1.2.8. 自动焊接程序 Automatic welding program                        |   | 9  |
| 1.2.9. 文档 Documentation                                                                    |   | 10 |
| 1.2.10. 非破坏性检查 Non destructive examination                     |   | 11 |
| 1.2.11. 每日焊接样品 Weld daily samples                              |   | 11 |
| 1.3. 装配和安装 Fabrication and erection                                   |   | 11 |
| 1.3.1. 范围 Scope                                                                            |   | 11 |
| 1.3.2. 管件材料接收储存 Tubing materials receipt storage |   | 12 |
| 1.3.3. 分类 Identification                                                                   |   | 13 |
| 1.3.4. 装配 Fabrication                                                                      |   | 13 |
| 1.3.5. 布管,切割和装备 Lay-out, cutting and fitting up  |   | 13 |
| 1.3.6. 焊接程序和资格 Welding procedure and qualifications     |   | 14 |
| 1.3.7. 安装 Erection                                                                         |   | 14 |
| 1.3.8. 焊接接口 Welded joints                                                    |   | 15 |
| 1.3.9. 法兰接口 Flanged joints                                                   |   | 15 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第1页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

| 1.3.10. 快装接口 Clamped joints                                                                                |   | 15 |
|----------------------------------------------------------------------------------------------------------------------------------------|--------|----|
| 1.3.11. 支撑和穿管 Support of tubing and penetrations                                                    |   | 15 |
| 1.4. 检查 Inspection                                                                                                       |   | 16 |
| 1.4.1. 范围Scope                                                                                                           |   | 16 |
| 1.4.2. 配件和焊接编号 Component & weld identification                                    |   | 17 |
| 1.4.3. 焊接准备 Weld preparation                                                                               |   | 18 |
| 1.4.4. 焊接检验 Weld inspection                                                                                |   | 20 |
| 1.4.5. 预装配件的保护 Protection of prefabricated spools                                     |   | 21 |
| 1.4.6. 验收 Acceptance                                                                                                     |   | 22 |
| 1.4.7. 其它要求 Other requirements                                                                             |   | 22 |
| 1.5. 水压测试与清洁 water pressure test and cleaning                                         |   | 23 |
| 1.5.1. 压力测试 Pressure testing                                                                               |   | 23 |
| 1.5.2. 测试报告 Test reports                                                                                   |   | 25 |
| 1.5.3. 水压压力测试 Hydrostatic test pressure                                                      |   | 25 |
| 1.5.4. 系统清洁和清洗 System cleaning and flushing                                           |   | 26 |
| 1.6. 管道系统脱脂、酸洗和钝化 Chemical treatment               |   | 26 |
| 1.6.1. 安全 Safty                                                                                                          |   | 27 |
| 1.6.2. 处理方法Method Treatment                                                                                |   | 28 |
| 1.6.3. 纯水和分配系统的化学处理 treatment for PW and WFI       |   | 28 |
| 1.6.4. 蒸汽管道的化学处理 solution for pure steam distribution loop.             |   | 30 |
| 1.7. 水压、酸洗以及焊接报告 Report                                   |   | 32 |
| 1.7.1. 水压测试报告表 Certificate hydraulic test                                             |   | 32 |
| 1.7.2. 管道系统脱脂、酸洗、钝化报告表 Report |   | 33 |
| 1.7.3. 焊接报告表 Welding inspection sheet                                                               |   | 34 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第2页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 本规范适用于卫生管道的焊接、装配和安装。The specification applies for welding, fabrication and erection of sanitary piping. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 本规范特别用于不锈钢316L 管件间之圆周对接焊头之连接 In particular such specification is to be used for circumferential butt joints between sanitary piping components made of stainless steel type AISI 316 L. 。 |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 在项目中与本规范有冲突的其它规格必须与朗脉公司讨论,以便澄清和定义。Existing discrepancies between this specification and others applicable for the project, must be discussed with MACROPROCESS for clarification and definition |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 本规范中的焊接连接将需要符合FDA 的验收标准和3A 标准。Welded joints in the scope of this specification shall require the acceptance by FDA and shall comply with Sanitary Standard 3A. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 本规范中术语装配者是指朗脉公司,她负责管道的装配和安装。In the scope of this specification the term FABRICATOR is referred to MACROPROCESS, who is encharged for fabrication and erection of piping. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  |  “业主”是指用户或其代表。the term OWNER is referred to CUSTOMER or his representative. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第3页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 焊接检查员” 是指业主或用户代表,他将负责检查管道承建商的焊接操作。the term WELDING INSPECTOR is referred to the Owner or Customer representative who is en charged to inspect the welding operation and examination performed by piping construction Contractor. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 采用这些程序的手动TIG 焊接工,将用实际工作材料作焊接试样测试以确认合格。这些焊接试样和自动焊接试样进行同样的独立检验。Manual Tungsten Inert Gas (TIG) welders using these procedure shall be qualified by making coupon test welds using actual job material. These coupons shall be subject to the same Independent examination as the automatic welds. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 自动焊接机的操作人员将用样品材料做焊接测试以确认其资格。焊接测试应该选用项目常用的管材尺寸材料。Automatic welding machine operators shall be qualified by making acceptable test welds on sample materials. The welds shall be made on the prevalent job size tube material. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第4页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 组件的定位点焊必须避免对完全焊接的不良影响。Tack welding of the components must avoid deleterious effect on the complete weld. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 定位点焊应该尽可能的轻,以降低过热而导致材料的内部结构变化。Tack should be as light as possible to reduce over heat that might cause structural changes to the granular composition of the material. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 定位点焊不应焊透内表面。Tacks should not penetrate the inner surfaces. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 定位点焊完成后,需要检查线定位焊接的对准性和缝隙。After the tack welding completion it’s necessary to check the alignment and gap |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 用于焊接的材料须符合甲方的技术规格。The material to be welded shall comply with the owner specification, . |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有管道和配件须完全焊透。All tubing and fittings shall have complete weld penetration. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 采用的焊接电极为2%涂钍平头钨焊电极。Welding electrode to be used shall be a pointed 2% thoriated tungsten electrode with a flat tip. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 焊接电极如有污染须更换。The electrode shall be replaced if contaminated.。 |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 焊接管道内、外部保护氩气的最低纯度为99.99%。Welding grade argon gas shall be use inside the pipe for back-up purge and shall be 99.99%minimum purity. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第5页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 焊接过程中必须要通入氩气进行保护,以防止焊接的内表面被氧化。在开始焊接前,吹走焊接区域的所有氧气。Argon gas back-up has to be provided to prevent oxidative attack of the inner weld surface.Before starting the welding all oxygen is purged from the welding area. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 当焊接表面潮湿时,不得进行任何焊接。除非有适当的保护措施,在严酷气候或风速高或不良大气条件下不得进行室外焊接。No weld is carried out when surfaces to be welded are wet. No outside welding is carried cut during inclement weather or during periods of high wind or negative atmospheric agent unless the work is properly protected. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 焊接接头两端面的清洁,圆整和平直是重要的。It is essential that the two surfaces of the joint are clean, circular and squared. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 金属加工方法应确保焊接端表面光滑,无划痕或其它有害的不规则形状。The machining method of base metal preparation shall leave the weld end with smooth surfaces, free from notches or other harmful irregularities. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 建议采用G+F 或同类设备来处理切割和最终处理。It is recommended to carry out the cut-off and final preparation using a G+F equipment or equivalent. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 切割必须平直和不会造成管件变形或损坏。砂轮切割的管件端面必须清洁以除去磨屑。Cut-off must be squared and not cause any distortion or damage to the tubing. The pipe cut-off by an abrasive wheel must be cleaned to remove the abrasive dust. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第6页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 碳钢切割工具在任何情况下都不得使用。Carbon steel cutting tools are not admitted in any circumstance, |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 用于焊接端面的处理、装配和安装工具,在使用前须检查是否是没有生锈的认可合金钢,清洁无油脂,和无其它污染残留物。Tools used for weld joint and preparation, fabrication and installation, shall be stainless of approved alloy steel, cleaned free of oil, grease and other contamination residuals before they are used. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 不得使用硫基切割油,除非在焊接前管件的内外表面都被彻底清除所有残留油渍。Non sulphur based cutting oil may be used, provided all traces of such oil are completely removed from both the interior and exterior surfaces on the tubing prior to welding. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 需与焊接检查员一起设定焊接设备。The welding equipment shall be set up together with WELDING INSPECTOR. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 此检查员将检查所有设置是否符合主程序。他将签署焊接日志和注明日期。The inspector will check that all settings comply with the master program. He shall sign and date the welding log to that effect. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 每天的开始时,每个操作人员要作焊接测试。这些焊样将编号,并呈交给焊接检查员。每台自动焊接机都需做测试。At the start of each day, each operator shall make acceptable test welds on plain tubing, These pieces shall be identified and made available to the welding inspector. Test shall be made for each automatic welding machine. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第7页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 在焊接材料的温度不得低于10 oC。一般来说,不需要预热。The minimum base material temperature shall not be less than 10 0 C prior to welding. In general, no preheating shall be required. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 电流应与注明在相应的焊接表相符。Current shall be as specified on the applicable welding schedule. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 焊接工艺,如焊接次序,焊接程序设置,焊极位置等,都将与相应的焊接表相符。The welding technique, such as weld sequence, welding program settings, electrode positioning etc., shall be as shown in the applicab le welding schedule。 |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 经检查,如发现不符合标准的缺陷并且此缺陷是可修复的,有必要进行修复焊接。最可能的修复是在已有的焊接上进行再焊接;A weld repair is required when, through inspection, it is determined that an unacceptable defect exists and that the defect is correctable . The first repair may be a re-weld over one existing. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 可做修补的缺陷包括不佳的准备,不良线性,过量或不适当的焊接穿透,多孔性和沙眼;The allowable defects which may be repaired include poor fit up, misalignment, excessive or inadequate weld penetration, porosity and pin holes. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有有裂纹的焊接将被视为不合格,并须与受热区一起去除。All welds with cracks shall be rejected and removed together with the heat affected zone. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第8页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 所有主程序都规定了不同尺寸管件焊接的一组参数;Calibration of the automated tube welding system shall be in accordance with the procedures to be defined by the welding operator together with the inspector. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 自动管道焊接系统的焊接程序都须符合焊接操作员与检查员一起制定的程序; Any master program defined a set of parameters for different size of tubing to be welded. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 正式和测试焊接需采用已认可的焊接程序;Production and test welds shall be made only using approved welding programs. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 焊接样品必须按顺序编号(如T1,T2 等)。焊接样品,具备完全的可追朔性,将备独立机构检验;Welding samples must be numbered in sequence ( ex.: T1, T2, etc.). Welding samples, with complete traceability, are subject to independent laboratory examination. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 在整个施工阶段,所有每天的现场样品将留予业主;All daily samples will be available in site to the owner, during all the construction period. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 自动管道焊接系统的校正都须符合焊接操作员与检查员一起制定的程序。Welding programs of the automated tube welding system shall be in accordance with the procedures to be defined by the welding operator together with the inspector. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第9页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 朗脉将提供此系统所有焊接记录报告。此焊接记录报告表格,必须完全填写,最少包含:MACROPROCESS will provide a written log on all welds carried out on the system. The weld log forms, that must be fully filled, will minimally contain : |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |   | 系统名称 system name |
|--------|--------|----------------------------------------------|

|   |   | 焊接号 weld number |
|--------|--------|--------------------------------------|

|   |   | 焊接工姓名 welder name |
|--------|--------|------------------------------------------------------|

|   |   | 设备编号 machine identification |
|--------|--------|---------------------------------------------------------|

|   |   | 焊接日期 welding date |
|--------|--------|-----------------------------------------------|

|   |   | 焊接程序编号 welding program number |
|--------|--------|-------------------------------------------------------------------------|

|   |   | 焊接操作工(如有,还加上检查员)签名 welding operator ( and in addition inspector, if any ) signature |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 设备将打印相应自动焊接的报告。在此焊接报告中要有焊接编号。In addition the machine will print out an automatic log that will refer to the weld carried. This weld number shall be then identified on the welding log. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 透视简图 (标示相应的坡度,尺寸和长度,所有焊点编号)将在整个施工期间使用并且更新,在工程完成生成竣工图。Each weld shall be numbered in progressive way. All welds will be shown on isometric sketches and on the related Welding Report ( FORMAT 5, already mentioned ). |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 每个焊点以累进方式编号。所有焊点标示在透视简图和焊接报告中。Isometrics sketches (showing installed elevations for proper sloping, dimensions and lengths, all weld numbers) will be available during site activity and will be updated ( “ as-built” issue ) at the end of job. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第10页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 当相应的条例或合同规格要求时,非破坏性检查将在符合条例或合同规格下进行。须考虑到因此而造成的时间延误。Non destructive examination, when required by the applicable by the applicable code or contract specification, shall be performed in accordance with the code rules of contract specification. The time delay due to these controls must be considered. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 每日焊接样品应采用设备焊接程序。这些样品必须按顺序编号(如P1,P2 等)。所有这些焊接样品将在整个施工期间提供给业主;Weld daily samples shall be made using the machine welding programs. These samples must be numbered in sequence ( ex.: P1, P2, etc.). All of those will be available to the owner in site during all the construction period. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 每日样品结果必须收集在完全填写的自动焊接设备测试报告中。The daily samples results must be collected in the Automatic Welding Machine Test Report that must be fully f illed。 |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 本节和引用的图纸标准以及条例将适合所有管道现场装配和安装。This section and drawings standard and codes referenced shall apply to the field fabrication and erection of all tubing. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 本规格中的内容不得用于解释使供应商从完全符合引用条例的责任中解脱。Nothing in this specification shall be interpreted as in any way relieving SUPPLIER from the responsibility for complete compliance with the referenced codes wherever they apply. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第11页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 管件材料需由其他人确认和检验;Tubing materials shall be identified and inspected by others. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 管材和预装配件的存放应注意不会被油脂,潮湿或其它物质污染;管材和预装配件应处理得当,以避免变形,刮伤或任何有形损伤;It shall be taken care to keep all tubing materials and prefabricated assemblies free from contamination by grease, moisture or other matter does not occur, Tubing materials and prefabricated assemblies must be handed in order to avoid any denting, scraping or any other physical damage. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有不锈钢材料应与其它施工材料分开检查和储存。储存区必须在建筑物内,并且有防护任何腐蚀性环境和温度变化的措施;All stainless steel materials should be checked and stocked separately from other construction materials. The storage area must be located inside a building and protected from any corrosive atmosphere and temperature changes. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 通道应严格限制以确保材料不会受损伤和丢失。只有在施工需要时才能从储存区提取材料。Access shall be strictly limited in order to guarantee a protection against physical damage and losses. Material shall be released from storage only when needed for construction purposes. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第12页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 所有材料将按规格进行分类,并且适当储存和处理以便于辨认。All materials will be identified in accordance with the applicable specification and shall be stored and handled in order to allow their proper identification. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 装配应按照此规格的要求和如有的详细安装要求(图纸或其它)进行。Fabrication shall be in accordance with the requirements of this specification and with installation specific details ( drawings or others ), if any. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 管件应按图纸上的尺寸精确切割以适应现场情况。Tubing shall be cut accurately to measurements shown on drawing to suit field conditions. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有待焊接的管件端面需清理毛刺,并且切割面应平直,边角无切割园弧。管件边缘的端面处理和清理毛刺应使用终端处理工具,并且其公差与配件一致以确保适当的焊接线性。All tube ends to be welded shall be deburred and have square cut edges, free of shear radii at the corner. Tube edge facing and deburring shall be done with an end prep tool and be of equal tolerance as the fittings to assure proper alignment for welding. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 检查切割管件终端,以确保其平直。The end of the cutted pipe shall be checked to insure its squareness. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 清除毛刺应避免破坏内外径,或损伤管件的内抛光。Burs shall be removed in such a manner as not to level I.D. or O.D. or damage polished interior of the tubing. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第13页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 在管件端口积聚的磨屑必须擦拭干净。Abrasive dust accumulated near the end of the tube must be wiped clean. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有安装在管线上的管件不应受过分弹力和受力下装配。All tubing shall be worked in place without excessive springing or forcing. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 不允许通过管件加热和弯曲以达到线性整齐。Heating and bending tubing to achieve alignment is not allowed. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有焊工应具备6 个月现场工作经验经过工厂培训 All welders shall be qualified either by 6 months field experience or by factory training.; |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 在开始焊接前,焊接程序应提交给焊接检查员核准 Welding procedures shall be submitted to welding inspector for approval before starting the welding activities. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有组装管件应在不受过分弹力和受力下装配。不允许有切割或弱化的支撑物作管道安装;All assembled tubing shall be installed without excessive springing of forcing . Cutting or other weakening of structural members to facilitate tubing installation will be not permitted. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有管件安装应可以自由膨胀和收缩,而不至于损坏连接和支撑;All tubing shall be installed to permit free expansion and contraction without damage to joints or supports. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第14页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 所有管道必须有适当的坡度(0.3% 最大0.5% )以确保完全排水。All lines must guarantee the complete drainage with proper slope (0.3% max. 0.5%). |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有焊接应按照本规格所述的要求进行准备和装配。All welded joints shall be prepared and made in accordance with described of this specification. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有法兰接口,应用全新的密封圈和螺栓。在拧紧螺栓前应确保所有密封圈定位准确。应注意防止将螺栓拧的过紧。所有被拧得过紧的螺栓螺帽都应更换;All flanged joints, if any, shall be made with gaskets and bolting materials brand new. It shall be taken care to assure that all gaskets are properly positioned prior to bolts tightening. It shall be taken care to avoid overtorquing any bolts. All bolts and nuts which are overtorqued shall be replaced. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 法兰螺栓孔应跨骑于管道中心线,除非图纸上另有说明。 Flange bolt holes shall straddle pipe center lines except when noted otherwise on drawings. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 不得使用螺纹接口。Threated joints shall not be used. |
|--------|--|------------------------------------------------------------------------------------------------------------|

|   |  | 管件的支撑应按管件支撑图纸上的参数和细节设计、装配和安装。Support to tubing shall be designed, fabricated and installed in accordance with the details and parameters of the pipe support drawings. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第15页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 不锈钢管件的安装按制造商的建议进行。Stainless steel tubing is to be installed in accordance with manufacturers recommendations. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 吊架和支撑的安装应尽量的经济,并符合支撑图纸或规格上的描述。Hangers and/or support should be installed as economically possible and be in accordance with the charts and notes on the pipe support drawings or specifications. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 管道的支撑应符合管道图纸上要求的坡度。Tubing shall be supported in such a way to comply with the slope required on piping drawings. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有装配的管道应最少符合检查,检验和测试要求规格。All fabricated tubing shall as a minimum meet the examination, inspection and testing requirements specifications. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 本技术规格适用于不锈钢管件自动焊接检查,该焊接检查按照技术规格中的焊接要求;This specification covers the inspection of automatic welding stainless steel tube and fittings, in accordance with the welding specification. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 焊接日志检查清单将用于查核主要信息,准备和质量要求;The weld log inspection check list shall be used to verify the principal information, preparation and quality requirements. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第16页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 焊接检查员按照焊接要求,检视分包商的焊接记录、检查和设置、非破坏性测试,以及目检。在双方同意并理解相应的时间延误下,此工作须在任何时间进行;The welding inspector shall witness the required subcontractor records, checks and setups, non-destructive tests, and visually inspect the welds, as specified herein and in accordance with the welding specification. This activity must be carried out at any time with the agreement of both parties involved and knowing the related time delay. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 焊接检查员或其指定代表应目检所有焊接。The welding inspector or his appointed representative shall visually examine all welds . |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 每个焊接应在其立体图中编号;Each weld shall be numbered on his isometrics. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 检查员应保留焊接检查清单,而且实际的焊点以此编号辨别;The inspector shall maintain a weld inspection check list and the actual weld shall be identified primarily by this number. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 每个焊点的记录应包括所有相关的条目。The record for each weld which shall include all items listed |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第17页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 管道截面确认 Tube section verification |
|--------|--|----------------------------------------------------------------------------|

|   |   | 管道的长度按要求在管道图纸中标示;The length of tube is as required to give dimensions as shown on the piping drawings. |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |   | 要去掉管道端口切割产生的任何可能之污物;Tube ends are removed any possible contamination from the cut off. |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |   | 工具不得被碳钢所污染;No tool has been contaminated by contact with carbon steel. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第18页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |   | 确认管道圆度公差。Verify tube roundness to tolerance. |
|--------|--------|-------------------------------------------------------------------------------------------------------------|

|   |  | 清洁确认 Cleaning verification |
|--------|--|--------------------------------------------------------|

|   |   | 用认可的溶剂清洁配件。Components are cleaned with approved solvent. |
|--------|--------|---------------------------------------------------------------------------------------------------------------------------------------|

|   |   | 在焊接前,已清洁和准备好的端口不得接触皮肤。The cleaned and prepared ends should not come into contact with the skin prior to welding. |
|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |   | 在部件的端口不得有可目见的异物,此包括清洁布的纤维。No visible foreign material is acceptable at the weld ends of the components. This includes lint from cleaning cloths. |
|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |   | 钨焊极必须清洁和无污染。Tungsten electrode must be clean and uncontaminated. |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 接口准备 Joint fit-up |
|--------|--|-----------------------------------------------|

|   |   | 焊接组件端口间隙用厚度塞尺测量,不得超过0.25 mm。The gap between ends of welding components shall not exceed 0.25 mm as checked by thickness gauge. |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |   | 钨焊极应置于焊点中央。The tungsten electrode shall be centered on the joint。 |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 焊机设置Weld machine settings |
|--------|--|-------------------------------------------------------|

|   |   | 参数的设置应按焊接程序中相应的焊接表进行。Parameters shall be set in accordance with appropriate welding schedule as shown in the welding procedure. |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第19页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |   | 确认气源就位。Verify that purge bladder is in place. |
|--------|--------|------------------------------------------------------------------------------------------------|

|   |  | 对每日样品,用选定的焊接程序完成一个焊接,进行X 射线检验 For each daily sample a weld carried out with the same welding program will be chosen. The check will be done with Rx will be carried out. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 对于所有完成的自动焊接,含有焊接参数的焊机打印报告 For all executed automatic welds, a welding machine print out with welding parameters will be annexed. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 10%的自动焊接,进行X 射线检验 10% of executed automatic welds, Rx will be carried out. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第20页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|    | A                                                                                |     | B                                                                                                                                                          |
|--------------|----------------------------------------------------------------------------------|----------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
|         | 须进行重新焊接的缺陷 |     | 不合格的缺陷:须与受热区(棕色)一起切除: |
|         | Defects for which rewelding may be                                               |     | Defects to be rejected : Cut out                                                                                                                           |
|         | attempted                                                                        |     | required together with its heat affected                                                                                                                   |
|         |                                                                             |     | zone ( brown color ):                                                                                                                                      |
| 1.           | 未焊透 incomplete penetration                                  | 1.  | 裂纹 cracks                                                                                                           |
| 2.           | 多孔 porosity                                                        | 2.  | 过烧 burn out                                                                                                                                  |
| 3.           | 沙眼 pin hole                                                        | 3.       | 解块 sugaring                                                                                                                                  |
| 4.           | 冷隔 cold lap                                                        | 4.       | 冷隔 cold lap                                                                                                                                  |
| 5.           | 过度穿透( <0.4 mm ) excessive penetration             | 5.       | 过度穿透(>0.4 mm ) excessive penetration                                                                                        |
| 6.           | 未对准( <0.55 mm) misalignment                              | 6.       | 未对准(> 0.55 mm) misalignment                                                                                                        |

|   |  | 所有开口应有适当的保护,保持密封;All openings shall be kept sealed at all times with proper protection. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第21页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 快装接口和法兰端面应有保护措施以防止损坏;Clamp ends and flange face shall be protected from damage in handling by approved protective devices. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 除了在工作台上,在处理和存放期间,预装配件应置于保护区内的木支架上。 During handling and storage other than on work tables, spools shall be on wooden skids of racks in a protected area. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 焊接检查员应完成焊接检查清单并须在完成的清单上共同签署和注明日期。如在任何地方有不合格焊接,则不合格原因应被记录。焊接检查员应在焊接完成时签署清单。The welding inspector shall complete the weld inspection check-list. When it has been completed.  It shall be jointly signed and dated. If at any place the weld is rejected, the reason for rejection shall be recorded. The welding supervisor shall sign each list at the time the weld is made. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 检查员应确认吹刷气体和后备气体流量计处于准确工作状态。The inspector shall insure that the flow gauges on the purge gas and back up gas be in accurate working condition, where applicable. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 如任何工具或组件被怀疑有污染,应按ASTM 标准程序进行清洁和测试。If any tool or component is suspected of having contamination, it shall be cleaned and tested in accordance with ASTM standard procedures. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第22页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 所有压力测试应当同检查员一起进行;All pressure tests shall be complete system tests carried out together with the inspector. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有测试进行时应对操作人员的安全作好预防,要进行水压测试的系统应该带有合适的表和压力安全泻载装置;Every test shall be carried out with all the precaution needed to insure the safety of the operator, Systems to be hydraulically tested will be provided with appropriate gauges and pressure relieving devices. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有连接点,包含焊缝应该去除绝热保温以便在测试过程中观察;All joints, including welds, are to be left un-insulated and exposed for examination during testing. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 不需要进行压力测试的设备,在测试过程中应该与系统断开或使用其他合适的方式与测试系统隔离开;Equipment which is not to be subjected to the pressure test shall be either disconnected from the tubing or isolated by proper means during the test. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 可以安装测试过程需要的阀门;Valves may be used provided that they are suitable for the proposed test procedure. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第23页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 在管线上的压力计不应在超过量程的压力下测试。没有表明测试压力的部件和设备应排除在测试内容之外;In line pressure gauges shall not be subjected to pressure in excess of their scale range. All pieces of equipment which do not have their test pressures indicated or declared or not proper shall be excluded from these tests. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 在进行所有测试之前,需目测管线系统以保障没有可见的缺陷且所有连接紧密;Before every test the tubing systems shall have visually inspected to assure that there are no visual defects and that all connections are tightened. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 控制阀门只要不是正在被测试,应该打在全开的位置;Control valves, unless being tested, shall be set and maintained in the wide open position. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 只要有可能应将所有在管线上的设备,表玻璃,流量计,漂浮液位计和所有其他受压部分包含在测试之内;All in-line instruments, gauge glasses, flow meters, liquid level float gauges and all other pressure parts of instruments shall be included in these test, where feasible. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 水压测试的压力应由测试压力在其量程一半处的计量表测量;Hydrostatic test pressure must be measured by gauges having the test pressure value approximately in its mid-range. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 有缺陷的连接点应该被移除并重新测试;Joints found to be defective shall be removed and retested. |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第24页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 在修复后重新进行测试后测试压力需和原来指定测试压力相同。Retesting of lines after repair shall be done at pressures originally specified for the test |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 测试编号 test number; |
|--------|--|------------------------------------------------------|

|   |  | 测试日期 date of test |
|--------|--|-----------------------------------------------|

|   |  | 系统名称 system name; |
|--------|--|------------------------------------------------------|

|   |  | 测试媒介,压力和相应压力下维持的时间 test media, pressure applied and length of time at test pressure 。 |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 水压测试压力需根据项目技术要求进行,不需进行压力测试的容器和组件应被隔离。The hydrostatic test pressure shall be calculated in accordance with the project specifications: vessels or components which are not designed for the testing pressure shall be isolated. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有水压测试系统应在设计压力的1.5倍和至少3.5巴的压力下进行测试。在进行连接点目测前测试压力需维持至少15分钟。All hydrostatically tested systems shall be tested to a one-half ( 1 1/2 ) times the design pressure or to a minimum pressure for 3.5 bar whichever is greater.  All test pressures shall be maintained a minimum of 15 minutes before visual examination of joints beings. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第25页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 在待测试的管线系统和测试的媒介达到热平衡之后再进行水压测试。Hydrostatic test pressure shall not be applies until the tubing system and the testing medium reached thermal equilibrium. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 在测试过程中需对所有连接点进行目测。All joints shall be visually examinated for leakage during the test. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 水压测试压力至少需维持两个小时。Hydrostatic test pressure will be maintained for at least two hours. |
|--------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 在含有水的管线部分不能做任何修复焊接。No repairs welding shall be done on any section of tubing that contains water. |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 所有不锈钢管线在水压测试结束后需立即排空。All stainless steel lines shall be emptied immediately after hydrostatic tests completion. |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 清洗和清洁全部安装好的管线,应按照供应商要求:不锈钢清洗,酸洗和钝化规程执行。Washing and cleaning of the whole piping installed will be carried out according to Supplier document requirement : |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | STAINLEES STEEL WASHING, PICKLING AND PASSIVATION”. |
|--------|--|-----------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第26页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 脱脂 DEGREASING |
|--------|--|-----------------------------|

|   |  | 酸洗 PICKLING |
|--------|--|---------------------------|

|   |  | 钝化 PASSIVATION |
|--------|--|------------------------------|

|   |  | 操作者需配戴透明面或眼镜 The operators shall wear a transparent face mask or suitable glasses.。 |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第27页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |  | 操作者需配戴手套和围裙 The operators shall also wear gloves and apron or track resistant to the chemicals。 |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 在加入和溶解化学品时必须连续搅拌 All chemical must be stirred continuously during addition and dissolution of the chemicals。 |
|--------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 准备几袋石灰或碳酸氢钠,防备在有滴漏的地方中和溶液 Some bags of lime or sodium bicarbonate must be available to neutralize the acid solution in case leakage。 |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第28页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第29页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |   | 排放并用去离子水冲洗直到PH 中性 discharge and wash by demi water until neutral ph is reached |
|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 脱脂 |
|--------|--|------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第30页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

|   |   | 排放并用去离子水冲洗直到PH 中性 Discharge and wash by demi water until neutral ph is reached 。 |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第31页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

| CERTIFICATE HYDRAULIC TEST水 压 测 试 |
|---------------------------------------------------------------|
| CUSTOMER : 用户 :                                 | PROJECT : 项目 : |
| SYSTEM : 系统 :                                   | SERIAL NUMBER : 系列号 : |
| DATE : 日期 :                                     | DRAWING NUMBER : 图号 : |
| CERTIFICATION CODE : Cer-001                                  | Page 1 of 36 |

| PRESSURE 压力 | TIME 时间 | MANOMETER 压力表读数 | RESULT 结果 | OPERATOR 操作者 |
|---------------------------|-----------------------|----------------------------------------------------|-------------------------|-----------------------------------|
|                      |                  |                                               |                    |                              |
|                      |                  |                                               |                    |                              |

| PLACE :                                          | DATE :                                           |
|--------------------------------------------------|--------------------------------------------------|
| 地点                                 | 日期                                 |
| OPERATOR :                                       | INSPECTOR :                                      |
| 操作者                         | 检查者                         |
| MACROPROCESS SIGNATURE :                         | CLIENT SIGNATURE:                                |
| 朗脉代表签字 | 客户代表签字 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第32页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

| CERTIFICATE LOOP DEGREASING, PICKLING & PASSIVATION 管道系统脱脂、酸洗、钝化报告表 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CUSTOMER : 用户 :                                                                                                                                                    | PROJECT : 项目 : |
| SYSTEM : 系统                                                                                                                                                        | DATE : 日期 : |
| CERTIFICATION CODE :                                                                                                                                                             | Page    of |

| PLACE :                                            | DATE :                                           |
|----------------------------------------------------|--------------------------------------------------|
| 地点:                                  | 日期 :                               |
| OPERATOR :                                         | INSPECTOR :                                      |
| 操作者 :                         | 检查者 :                       |
| MACROPROCESS SIGNATURE :                           | CLIENT SIGNATURE:                                |
| 朗脉代表签字 : | 客户代表签字 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第33页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

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|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

| FORMAT 1 表1 WELDING INSPCETION DATA SHEET 焊接检查单                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 用户CUSTOMER :                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | 项目PROJECT : |
| 系统SYSTEM :                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | 日期DATE : |
| CERTIFICATION CODE :                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Page    of |
| 焊接程序说明                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
| 焊接程序号 焊接方式 管道 材质 连接方式 直径 壁厚 焊机型号 制造商 焊头型号 管道切割设备 端面清洁 焊接时间 焊头氩气 收弧氩气 管内氩气 电极缝隙 | # |
| 自动                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
| ISO  2037                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| AISI 316L                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
| 管/管                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
| mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
| mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
| COBRATIG 150                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| 美国MK                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
| 5002                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |
| G+F 切割机                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| 乙醇                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
| SEC                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| lt/min                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
| lt/min                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
| lt/min                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
| 1.0 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |

| 地点PLACE :                            | 日期DATE :                           |
|----------------------------------------------------|--------------------------------------------------|
| OPERATOR :                                         | INSPECTOR :                                      |
| 操作者 :                         | 检查者 :                       |
| MACROPROCESS SIGNATURE :                           | CLIENT SIGNATURE:                                |
| 朗脉代表签字 : | 客户代表签字 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第34页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

| FORMAT 2表2                |
|----------------------------------|
| WELDING REPORT                   |
| 焊接报告 |
| CUSTOMER :                       | PROJECT : |
| 用户 :               | 项目 : |
| SYSTEM :                         | DATE : |
| 系统 :               | 日期 : |
| CERTIFICATION CODE :             | Page 1 of 36 |

|      焊接打印单粘贴处                                    |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 结果:接受□              拒绝□ |

| PLACE :                                           | DATE :                                                   |
|---------------------------------------------------|----------------------------------------------------------|
| 地点:                                 | 日期:                                        |
| OPERATOR :                                        | INSPECTOR :                                              |
| 操作者:                         | 检查者:                                |
| MACROPROCESS SIGNATURE :                          | CLIENT SIGNATURE:                                        |
| 朗脉代表签字: | 客户代表签字: |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第35页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第7 部分管道系统施工规范Construction Regulation for Piping System              |

| FORMAT 3 表3               |
|----------------------------------|
| WELDING REPORT                   |
| 焊接报告 |
| CUSTOMER :                       | PROJECT : |
| 用户 :               | 项目 : |
| SYSTEM :                         | DATE : |
| 系统 :               | 日期 : |
| CERTIFICATION CODE :             | Page   of |

| 日期 | 焊接编号 | 直径 | 焊接类型 | 焊接程序 | 焊样编号 | 结果 | 签名 |
|------------------|----------------------------------|------------------|----------------------------------|----------------------------------|----------------------------------|------------------|------------------|
|             |                             |             |                             |                             |                             |             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |
|             |                             |             |                             |                             |                             |             |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第36页/ 共36 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第 8 部分 售后服务和技术承诺Technical Promise and after-sale Service     |

----

----

| 上海朗脉科技有限公司上海市闵行区罗阳路168 号A 座101 室     201100T:021 54306717     F: 021 54306718 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第 8 部分 售后服务和技术承诺Technical Promise and after-sale Service     |

| 1.售后服务和承诺 Technical Promise and after-sale Service | 2      |
|-----------------------------------------------------------------------------------------------------|--------|
|                                                                                                |   |
| 1.1. 技术承诺 Technical Promise                                             | 2      |
|                                                                                                |   |
| 1.2. 售后服务 After-sale Service                                            | 2      |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第1页/共3 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第8 部分售后服务和技术承诺Technical Promise and after-sale Service       |

|   |  | 售后服务联络:买方可直接与卖方联系,并将派自己的维修人员到买方工厂进行售后服务。After-sale service contact: The Buyer can contact the Seller directly. The seller will dispatch its’ own technicians to provide after-sale service on the Buyer’s site. |
|--------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 售后服务的响应时间:接到买方报修传真后2 天内 (公共假日除外)。Responding time: within two day from the receipt of written report from the Buyer (public holidays are excluded). |
|--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   |  | 售后服务的质量要求:卖方应派遣有实际工作经验的工程技术人员来买方工厂进行维修。卖方技术人员需在接到通知后48 小时内到达买方现场 (公共假日除外)。Requirement of service quality: The seller shall dispatch engineers with good experience to the Buyer’s premise. The seller should arrive the buyer’s site within 48 hours after receipt of notice (public holidays are excluded). |
|--------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第2页/ 共3 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第8 部分售后服务和技术承诺Technical Promise and after-sale Service       |

|   |  | 售后服务的费用:质保期内免费维修,维修人员的差旅费、人工费、食宿费等由卖方承担 (因买方操作不当、未采用合同文件中规定的主材和操作环境条件、合同供货范围以外的工作除外)。质保期外的维修费由买方承担,收费标准由双方友好协商。Expense for after-sale service: The seller is responsible to provide free technical service within the Quality Guarantee Period. All the travel and accommodation expenses as well as the labor costs of the service engineer are to be born by the seller (exclusive of situations that problems are brought by incorrect operation and works beyond the scope of supply). The Buyer should be responsible for the service expenses after the guarantee period and the price is determined through friendly discussion. |
|--------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第3页/ 共3 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第9 部分偏离和图纸Deviation and Drawings                                                         |

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----

| 上海朗脉科技有限公司上海市闵行区罗阳路168 号A 座101 室     201100T:021 54306717     F: 021 54306718 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第 9 部分 偏离和图纸Deviation and Drawings                                                       |

| 9. 偏离及图纸 Deviation and Drawings                        |   | 2      |
|-------------------------------------------------------------------------------------------|--------|--------|
|                                                                                      |   |   |
| 9.1. 商务偏离表 Deviation Form for Commercial Terms         |   | 2      |
|                                                                                      |   |   |
| 9.2. 技术偏离表 Deviation Form for Technical Specifications |   | 3      |
|                                                                                      |   |   |
| 9.3. 图纸 Drawings                                                            |   | 4      |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第1页/共4 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第 9 部分 偏离和图纸 Deviation and Drawings                                                      |

| 项目名称 | 纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmceutical Steam storage and Distributions System |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 数 量                | 1 套                                                                                                                                                                                                             | 规格型号 |   |

| 标 书要求                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 投标参数及其它                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 付款方式: 合同签订后10 日内,甲方支付合同总额10%给乙方,同时乙方向甲方提供相同金额的发票; 乙方根据甲方提供的设计资料完成工程的二次设计,并经甲方书面确认后10 日内,甲方支付合同总额20%给乙方,同时乙方向甲方提供相同金额的发票;全部设备和材料运输到施工现场指定位置,甲乙双方开箱验收完毕,10 日内甲方支付合同总额30%给乙方, 同时乙方向甲方提供相同金额的发票。安装、调试、验收、验证合格并交付甲方使用后,10日内甲方再支付合同总价30%,同时乙方向甲方提供相同金额的发票;余合同总价10%的作为质量保证金,质量保证期1 年, 质保期满,无质量问题,10 日内甲方付清全部余款,同时乙方向甲方提供相同金额的发票。 | 付款方式: 合同签订后,10日内甲方支付合同总额30%预付款;全部设备和材料运输到施工现场指定位置前,甲方支付合同总额40%; 安装、调试、验收合格并交付甲方使用后,10 日内甲方再支付合同总额25%, 余合同总价5%作为质量保证金,质量保证期1 年, 质保期满,无质量问题,10日内甲方付清全部余款。 |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第2页/ 共4 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第 9 部分 偏离和图纸 Deviation and Drawings                                                      |

| 项目名称                                                                                                                          | 纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmceutical Steam storage and Distributions System |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 数 量                                                                                                                                         | 1 套                                                                                                                                                                                                             | 规格型号 |   |
| 标 书要求                                                                                                                         | 投标参数及其它                                                                                                                                                               |
| 1. 纯化水:管件的外部抛光度Ra<0.8um,内部为Ra<0.5um | 1. 纯化水:管件外部 Ra<1.0um 内部 Ra<0.5um                                                                                                           |

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第3页/ 共4 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

----

|                                                                                                                                                                                                                    | 沈阳三生制药有限责任公司Shenyang Sunshine Pharmaceutical Company Limited |  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 纯化水、注射用水、纯蒸汽系统Purified water、water for Injection、Steam  storage and Distributions System |
| 投标文件Bidding Documents                                                                                                                                                                  | 第 9 部分 偏离和图纸 Deviation and Drawings                                                      |

| ● | PID 流程图 PID |
|---------|----------------------------------|

| ● | 项目进度表 Schedule |
|---------|---------------------------------------------------|

| 上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100T:021 54306717    F: 021 54306718 | 第4页/ 共4 页 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|

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