Document:

Unassociated Document

Exhibit 4.7.8 - Appendix 4 URS Clarification

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	  	
URS Document: User Requirements on the Storage and Distribution System of Purifyed Water

	  	
URS Document: User Requirements on the Distribution System of Purified Steam

	  	
URS Document: User Requirements on the Storage and Distribution System of Water for Injection

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document

No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	
URS Document:User Requirements on the Storage and Distribution System of Purifyed Water

	
2

	
Scope of Supply of Party B

	  	  	  
	  	  	
The goods and works supplied by Party B shall be completely in accordance with the user requirements and appendices as well as related standards and specifications.

	
Y

	  	  
	  	  	
The scope of supply of Party B shall include the materials, auxiliary spare parts, auxiliary equipments, and all necessary materials and spare parts required to guarantee good performance of the whole project in accordace with this user requirement description.

	
Y

	  	  
	  	  	
Scope of supply is as follows:

	  	  	  
	  	  	
→  Supply and installation construction (including installation, welding connection, welding seam detection and treatment, pressurizing, degrease, acid cleaning and passivation, etc) of all installation materials (including pipeline, pipe fittings, water pump, storage tank, heat exchanger, valve, support, thermal insulation of pipeline and related auxiliary fittings, etc) used for the purified water storage and distribution system in this project.

	
Y

	  	  
	  	  	
→  Provide the as-built documents and validation documents (including the validation and confirmation documents required for certification).

	
Y

	  	
Provide all validation documents.

	  	  	
→  Necessary expenses for approval by the government supervising department.(if necessary, it shall be included in the bidding documents).

	
?

	  	
Normally there is no other cost, but the cost resulting from regional difference shall be borne by Party A.

	
3

	
Scope of Work of Party B

	  	  	  
	  	  	
→  Design and calculation,  mainly including the design of pipeline layout as well as design of storage and distribution system of purified water.

	
Y

	  	
Refer to the attached schedule for designs

	  	  	
→  Provide the data information and drawings relating to the disciplines of process, civil engineering, water supply & drainage, electization and instrument control, etc.

	
Y

	  	  
	  	  	
→  Packaging and transporting of materials used in the project.

	
Y

	  	  
	  	  	
→  Installation, inspection, testing and related debugging.

	
Y

	  	  
	  	  	
→  Related instructions and reviews on the taking over of public system.

	
Y

	  	  
	  	  	
→  All fittings, instruments and tools required for installation, inspection and debuging shall be provided by Party B.

	
Y

	  	  
	  	  	
→  Provide the completion documents and validation documents

	
Y

	  	  
	  	  	
→  Training on the operation, maintenance & repairing, and validation.

	
Y

	  	  
	  	  	
→  After-sales service

	
Y

	  	  
	
4

	
Standards and Specifications to be based on

	  	  	  
	  	  	
a.  Design, material, installation, inspection and testing shall be based the requirements of this project and shall also satisfy the standards of FDA, EU and China CGMP.

	
Y

	  	  
	  	  	
b.  Automatic control system shall conform to GAMP5.

	
Y

	  	  
	  	  	
c.  Related construction and acceptance specifications of pipeline works.

	
Y

	  	  
	  	  	
d.  GMP Specification:.

	
Y

	  	  
	  	  	
a)  FDA - 21 CFR Part 210, 211

	  	  	  
	  	  	
b)  SFDA -Good Manufacturing Practices,1998 version and and new version to be released.

	  	  	  
	  	  	
c)  Current lastest GMP in EU

	  	  	  
	  	  	
d)  Related GMP Implementation Guidance

	  	  	  
	  	  	
e)  The latest version of Chinese pharmacopoeia, EU pharmacopoeia, and U.S. Pharmacopoeia.

	  	  	  
	  	  	
f) ISPE,Volume 4,water and steam system,2005 version.

	  	  	  
	  	  	
g)  The latest version of ASME BPE Standards.

	
N

	  	
The purified water system conforms to ISO Standard

	  	  	
h)  ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities

	
Y

	  	  
	  	  	
i)  V3 Sterile Manufacturing Facilities.

	
Y

	  	  
	  	  	
j)  V6 Biopharmaceutical Manufacturing Facilities.

	
Y

	  	  
	  	  	
Party B shall detail the standards and specifications to be based on in his tender documents.

	  	  	  
	
5

	
GMP Requirements

	  	  	  
	  	  	
→  Conform to the requirements of current FDA, EU and China GMP

	
Y

	  	  
	  	  	
→  All water system pipeline shall be able to be completely discharged, cleaned and sterilized.

	
Y

	  	  
	  	  	
→  All materials contacting with the products, purified water pipeline and pipe fittings must be 316L stainless steel.

	
Y

	  	  
	  	  	
→  All materials, instruments and equipments shall conform to cGMP.

	
Y

	  	  
	  	  	
→  All water systems shall have suitable sampling points which shall be easy to control, monitor and record the system status.

	
Y

	  	  
	  	  	
→  The purified water system shall be free of water backflow, and deal area shall also be avoided.

	
Y

	  	  
	  	  	
→  DQ, IQ, OQ and PQ shall be provided.

	
Y

	  	  
	  	  	
→  Welders shall hold related qualification certificates applicable to corrsponding works.

	
Y

	  	  
	  	  	
→  Welding machine and instrument are within the valid calibration period.

	
Y

	  	  
	  	  	
→  The clean pipeline shall adopt the automatic track welding method as far as possible.

	
Y

	  	  
	
6

	
Storage and Distribution System of Purified Water

	  	  	  
	  	  	
Pipelines shall be installed through the welding connection method as far as possible to achieve the 3D standard, but welding seams shall be minimized and convenience of strilizing and operating shall also be taken into consideration. Installation of pipeline shall take account of simple and smooth connection for convenience of installation, maintenance and operation, and the requirements of safety and human environment shall also be taken into consideration.

	
Y

	  	
All of them are less than 3D.

	  	  	
Intallation of pipellines shall be carried out strictly in accordance with the established and approved operation regulations (qualification confirmation of operators; cutting; welding connection; slope detection; endoscopy, ray detection; degrease; acid cleaning; passivation; pressurizing test, etc)

	
Y

	  	  
	  	  	
Sufficient support shall be made to the pipeline to avoid drooping or other deformations.

	
Y

	  	  
	  	  	
Method of sterilization:superheated water (121oC) sterilization or purified steam sterilization is suitable to this system, and the method of sterilization can be controlled and selected from the control system interface.

	
N

	  	
PW system pasteurization

	  	  	
Sanitary type distribution pipeline must be of hydraulics design to ensure that the ryznar index is not less than 4000 or flow rate is not less than 1m/s when each point of use of water has the minimum flow rate.

	
N

	  	
The standard value shall be 0.914m/s.

	  	  	
The sampling point shall be equipped at least at the initial stage of distribution pipeline.

	
Y

	  	  
	  	  	
The fixed pipeline must be clearly indicated with the medium and flow direction in the pipeline.

	
Y

	  	  
	  	  	
The connection gasket shall be sandwich PTFE gasket.

	
Y

	  	  
	  	  	
a) Requirements of the purified water storage and distribution system.

	  	  	
Connect the equipment to each loading and sampling valve

 

第1页/共9页

  

  

  

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	  	
URS Document: User Requirements on the Storage and Distribution System of Purifyed Water

	  	
URS Document: User Requirements on the Distribution System of Purified Steam

	  	
URS Document: User Requirements on the Storage and Distribution System of Water for Injection

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document

No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	  	  	
Pipeline and Pipe Fittings

	  	  	  
	  	  	
316L stainless steel material, outer Ra<0.8μm, inner Ra<0.8μm, mechanical polishing, ISO 2037 standard (this standard shall be applicable to other parts unless otherwise specified).

	
N

	  	
Outer Ra<1.0μm

	  	  	
Storage Tank

	  	  	  
	  	  	
 All parts of tan contacting with the clean medium shall adoopt the 316L stainless steel material;

	
Y

	  	  
	  	  	
 The manhole shall adopt the sanitary type manhole, with matt finishing outer surface. Other interfaces are required to be free of dead area.

	
Y

	  	  
	  	  	
The tank shall have thermal insulation function, and the outer layer shall be 304 stainless steel material.

	
Y

	  	  
	  	  	
The inner surface of tank shall be mechanical polishing Ra<0.8μm, and outer surface Ra<0.8μm.

	
N

	  	
Outer surface Ra<1.0μm

	  	  	
 The spray ball in tank shall adopt the fixed type spray ball.

	
N

	  	
Rotary-type

	  	  	
The applicable standards of tank shall be the same with those applicable to corresponding pipelines and pipe fittings.

	
Y

	  	  
	  	  	
Bursting discs shall be applied.

	
N

	  	
Non-pressure vessel is unnecessary

	  	  	
Heat Exchanger

	  	  	  
	  	  	
Adopt the straight way type double tube-sheet exchanger, free of dead area and with complete emptying function. Inner pipeline Ra<0.5μm. Integral material is 316L stainless steel.

	
Y

	  	  
	  	  	
Sanitation Ball Valve

	  	  	  
	  	  	
Adopt the GEMU sanitation ball valve, 316L material, and two-piece type diaphragm PTFE/EPDM; the material of diaphragm shall conform to the requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided; mechanical polishing of the surface contacting with medium Ra<0.8μm; quick clamp interface (welding connection shall be used as far as possible), and the interface size shall be matching with the pipeline system; gasket of clamp shall be PTFE material and shall also conform to the requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided. The outer surface shall be glass bead blasting treated. The pneumatic valve shall be equipped with the opening and closing indicator.

	
Y

	  	  
	  	  	
 Liquidometer

	  	  	  
	  	  	
 Adopt the E+H electric capacity type liquidometer. The part contacting with the medium shall be 316L stainless steel or other materials conforming to requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided. The material system shall be Mettler weighing module, while the support shall use 304 stainless steel.

	
Y

	  	  
	  	  	
Conductivity Meter

	  	  	  
	  	  	
Adopt the BURKERT or G+F. The precision shall not be less than 0.1μS/cm.

	
Y

	  	  
	  	  	
Flowmeter

	  	  	  
	  	  	
Adopt the Vortex Flowmeter.

	
Y

	  	  
	  	  	
Filter

	  	  	  
	  	  	
All filters and inspirator shall be 0.22μ, for all of which the on-line bubble point tests shall be taken into consideration; purified steam shall be connected to the front and reat simutaneously in sterilization. Adopt the PALL or Millipore products.

	
N

	  	
Electrical heating to avoid blocking in pasteurization; in-situ sterilization; providing positive pressure protection in discharge.

	  	  	
Sanitary Pump

	  	  	  
	  	  	
316L material, quick clamp interface (the interface size shall match with the pipeline system), mechanical polishing inner surface, Ra<0.8μm,with bottom discharge opening, sealing SiC/SiC。

	
Y

	  	  
	  	  	
Thermal Insulation

	
N

	  	
Purified water system does not have the thermal insulation

	  	  	
Stainless steel sheet or PV + rock wool (volume weight is more than 65kg/m3) shall be applied in water preparation room.

	  	  	  
	  	  	
Iron sheet + rock wool (volume weight is more than 65kg/m3) shall be applied in the technical sanwich layer.

	  	  	  
	  	  	
 The clean room shall adopt the casng (pipe-in-pipe) form. The material of casing shall be 304 stainless steel, with outer surface Ra<0.8um.

	  	  	  
	  	  	
Support Material

	  	  	  
	  	  	
The possibly used support type materials include various specifications of movable support, stainless steel support, fixed plate, decorating plate, stainless steel square tube, angle bar, galvanized lead screw, and stainless steel screw bolt, etc; 304 stainless steel materials shall be applied in the clean area. Soft contact shall be made between the support and pipeline.

	
N

	  	
Self-developed supports shall be adopted in the clean room

	  	  	
Welding Seam Detection

	  	  	  
	  	  	
Sanitary pipeline of the whole system shall be connected through automatic welding as fas as possible, and manual welding connection (if necessary) shall be approved by Party A. X-ray fault detection and endoscopy shall be applied for all manual welding connections. X-ray fault detection shall be done for all welding samples of the automatic welding connection part while endoscopy shall be applied for 20% of other automatic welding spots. The inspected welding spots layout shall be approved by Party A.

	
Y

	  	  
	  	  	
Degrease, Acid Cleaning, Passivation and Pressure Test

	  	  	  
	  	  	
Degrease, acid cleaning and passivation treatment shall be applied for all pipes, and then test the effects. Pressure test shall be applied for all pipes, with the testing pressure at least 1.5 times of the working pressure, and if the working pressure is less than 4bar, the pressure of 6bar shall be applied for testing.

	
Y

	  	  
	  	  	
Control Device

	  	  	  
	  	  	
The control system for the distribution system of water for injection, purified water and steam generator shall be combined with the control system ofpreparation equipment to adopt one set of control system.Two workshops of the material system shall adopt separate set of contron system respectively. The control system shall adopt the SIMENS brand.

	
N

	  	
Water system shall has one separate control system, but it can communicate with the equipment, and the equipment and system can be connected with the host computer.

	  	  	
Electric control cabinet includes:PLC (CPU, Input/Output Module), touch screen (colorful) and other control components; power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components; cabinet body, terminal strip, cable and trunking, control software, recording instrument (8 channels), DP communication module, and other necessary components and parts.

	
N

	  	
Recording machine is not applied; data can be recorded and printed through computer.

	  	  	
The sterilzing process of purified water system shall be full automatic control, and the sterilizing time shall be included in the PLC time counting. Recording curve shall be made for the key parameters (such as the electrical conductivity, flow rate and temperature, etc).

	
Y

	  	  
	  	  	
Sewerage, Funnel and Discharge

	  	  	  
	  	  	
Make the best use of non- immersive instrument, and if not available,  it must be of sanitary design.

	
Y

	  	  
	  	  	
The connection part of plug-type instrument must be of sanitary clamp connection type.

	
Y

	  	  
	  	  	
Filling material in the instrument shall not be mixed into the products in ccase of occurring leakage of the instrument.

	
Y

	  	  
	  	  	
Mark

	  	  	  
	  	  	
Each welding spot shall be marked.

	
Y

	  	  
	  	  	
 b) Construction Specification and Acceptance

	  	  	  

 

第2页/共9页

  

  

  

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	  	
URS Document: User Requirements on the Storage and Distribution System of Purifyed Water

	  	
URS Document: User Requirements on the Distribution System of Purified Steam

	  	
URS Document: User Requirements on the Storage and Distribution System of Water for Injection

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document

No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	  	  	
Party B shall describe the organization and implementation specifications and procedures as well as acceptance procedures and standards for various works in the bidding documents.

	
Y

	  	  
	
7

	
Design

	  	  	  
	  	  	
Party B' work must enable the complete set system meet the requirements of current GMP specifications prevailing in China, EU and the United States and also pass corresponding GMP Certifications.

	  	  	
The original designed pipe diameter is wrong, and please refer to the drawings and calculation sheet for specific designs.

	
8

	
Control, Debugging and Validation of Purified Water Storage and Distribution System

	  	  	  
	  	  	
Control, debugging and validation of operating control, debugging and validation of purified water storage and distribution system shall be completed by Party B.

	
Y

	  	  
	  	  	
In addition, supply, related documents and validation of instruments (including necessary pressure gauge and pressure transmitter, thermometer and temperature transmitter, flowmeter and flow transmitter, and conductivity meter, etc) and control devices (electric control cabinet including PLC, touch screen, recording instrument and other control components; and power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components) in the storage and distribution system of compressed air and process gas shall be completed by Party B.

	
Y

	  	  
	  	  	
The instruments shall be accurate and reliable and need to be calibrated, and the calibration shall be traceable.

	
Y

	  	  
	
9

	
Traceability of Raw Materials, Spare Parts and Control System

	  	  	  
	  	  	
For all raw materials, spare parts, equipments, electricity, instrument and control system, original data shall be reserved and all of these items shall be tested to establish files for them to ensure their traceability. Traceability Matrix (TM) documents shall be established for each aspect of project implementation.

	
Y

	  	  
	  	  	
Each spare part, equipment, electric and intrument part shall be equipped with metal tag (with corresponding location number) for convenience of identification and operating.

	
Y

	  	  
	
10

	
Process Guarantee

	  	  	  
	  	  	
Party B' work shall be sure to meet this user requirement as well as requirements specified in the appendices in the following aspects (include but not limited to):

	
Y

	  	  
	  	  	
ð  Meet the requirements of GMP specifications in China, EU and the United States as well as various industry codes.

	  	  	  
	  	  	
ð Quality of water in circulation pipeline, storage tank and point of use.

	  	  	  
	  	  	
ð Quality of purified stram in distribution pipeline and point of use.

	  	  	  
	  	  	
ð Flow rate, pressure and temperature at the outlet of point of use.

	  	  	  
	  	  	
ð Flow rate and flow velocity of main circluation pipeline and distribution circulation pipeline in the water system.

	  	  	  
	  	  	
ð Temperature of water circulating pipeline;

	  	  	  
	  	  	
ð Functional testing of the distribution pipeline;

	  	  	  
	  	  	
ð Functional testing of PLC and control system.

	  	  	  
	
11

	
Quality Project Plan (QPP)

	
Y

	  	  
	  	  	
In order to ensure compliance with the requirements of Party A, Party B shall implement the quality project plan and construction organization design at all stages of design, installation, testing, debugging and handing over, including the quality testing and control over the materials and spare parts supplied by partner-suppliers.

	  	  	  
	  	  	
Party B shall submit its quality project plan to Party A for recognition and approval within two weeks from the effective date of contract.

	  	  	  
	  	  	
Quality project plan shall include the non-destructive test, identification ad identification of raw materials, stage acceptance and final testing.

	  	  	  
	  	  	
Party B shall clearly indicate which tests need eye-witness of the representatives of Party A. Party A shall also decide which testing items need to be witnessed by his representatives.

	  	  	  
	  	  	
Party B shall issue test report and test certificate for each inspection and test (witnessed or not witnessed by the representatives of Party A), and these documents will be included in the final completion file package.

	  	  	  
	  	  	
All design, procurement, installation, testing, debugging, and implementation of document system  shall take consideration to meet the requirements of validation and certification.

	  	  	  
	  	  	
a)  Project Schedule Diagram

	  	  	  
	  	  	
Party B must prepare and analyze the detailed schedule diagram (including the design, procurement, installation, testing, debugging and handing over, etc) through a reasonable manner, which will be favorable to:  1 quality control, 2 determination of critical working procedure and stage, optimization of working procedure, and 3 frequent inspection of working progress.

	  	  	  
	
12

	
Quality Guarantee and Responsibility

	
Y

	  	  
	  	  	
→  The quality guarantee period of all goods supplied by Party B shall be at least one year (from the day of qualified final acceptance and debugging)

	  	  	  
	  	  	
→  Party B shall guarantee the safety, reliability, normativity and reasonableness of the design, procurement, installation, testing and debugging and shall bear full responsibility for them.

	  	  	  
	  	  	
→  Party B shall guarantee that all working contents and implementation must take account of the requirements and validation of Party B as well as related (China, EU and the United States) GMP Certification requirements.

	  	  	  
	
13

	
Documents & Drawings

	
Y

	  	  
	  	  	
Documents will an integral part of the scope of work of Party B, so Party B shall pay the liquidated damages if submittal of documents is delayed or the submitted documents are incomplete. In case of failing to submit the documents even if a part of them, it is also deemed that the contract is not performed completely, which will be unacceptable.

	  	  	  
	  	  	
The goods and documents supplied by Party B must conform to the requirements of Party A and must also meet the requirements of current GMP Certification of China, the United States and EU.

	  	  	  
	  	  	
 a)  Form of Documents

	  	  	  
	  	  	
All documents and drawings shall clearly show the order number, work number, customer number and related drawing number, location number of equipment, pipe number, valve number and instrument number.

	  	  	  
	  	  	
The documents and drawings must be submitted to Party A in accordance with the requirements of attached schedule for recognition and approval. Documents and drawings shall be submitted in the form of hardcopy and softcopy in accordance with the time specified in the attached schedule. The softcopy of drawings shall be CAD form.

	  	  	  
	  	  	
The drawings shall adopt the metric unit.

	  	  	  
	  	  	
Language: All documents, drawings, instructions and operation maintenance manuals, etc shall be prepared in simplified Chinese and English.

	  	  	  
	  	  	
  b)  Document establishment / submittal time (progress) table.

	  	  	  
	
14

	
After-sales Service and Training

	
Y

	  	  
	  	  	
The after-sales service must be in time and detailed and also solve the problems completely.

	  	  	  
	  	  	
During the quality guarantee period, Party B shall be responsible for repairing or replacement free of charge if the goods and working contents specified in the contract occur any problems within the scope of operating regulations; Party B shall provide lifelong repairing and maintenance in time after the quality guarantee period, and only material cost will be charged for the repairing work.

	  	  	  

 

第3页/共9页

  

  

  

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	  	
URS Document: User Requirements on the Storage and Distribution System of Purifyed Water

	  	
URS Document: User Requirements on the Distribution System of Purified Steam

	  	
URS Document: User Requirements on the Storage and Distribution System of Water for Injection

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document

No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	  	  	
Party B shall provide training to the staff of Party A free of charge (including training in factory and installation site), and the training contents shall include the working principle, framework, flow process, operation, maintenance & repairing, calibration and resolving of faults, etc of the whole system.

	  	  	  
	  	  	
Party B shall describe the method and manner of his technical commitment and after-sales service in his tendering documens.

	  	  	  
	
15

	
Construction Period of the System

	
Y

	  	  
	  	  	
Installation and construction of the system is approximately to be commenced on July 1, 2009 and completed on September 30, 2009.

	  	  	  
	
16

	
Quotation

	  	  	  
	  	  	
The quotation shall include all costs occurred within the scope of supply of the seller and the scope of work.

	  	  	  
	  	  	
The quotation shall include the separate price for each time and total price.

	  	  	  
	  	  	
The quotation of all equipments and main materials shall clearly show the main technical specification and manufacturer.

	  	  	  
	
URS Document: User Requirements on the Storage and Distribution System of Water for Injection

	
2

	
Scope of Supply of Party B

	  	  	  
	  	  	
The goods and works supplied by Party B shall be completely in accordance with the user requirements and appendices as well as related standards and specifications.

	
Y

	  	  
	  	  	
The scope of supply of Party B shall include the materials, auxiliary spare parts, auxiliary equipments, and all necessary materials and spare parts required to guarantee good performance of the whole project in accordace with this user requirement description.

	
Y

	  	  
	  	  	
Scope of supply is as follows:

	  	  	  
	  	  	
●  Supply and installation construction (including installation, welding connection, welding seam detection and treatment, pressurizing, degrease, acid cleaning and passivation, etc) of all installation materials (including pipeline, pipe fittings, water pump, storage tank, heat exchanger, valve, support, thermal insulation of pipeline and related auxiliary fittings, etc) used for the storage and distribution system of water for injection in this project.

	  	  	  
	  	  	
●  Provide the as-built documents and validation documents (including the validation and confirmation documents required for certification).

	  	  	  
	  	  	
●  Necessary expenses for approval by the government supervising department.(if necessary, it shall be included in the bidding documents).

	
N

	  	
Normally there is no other cost, but the cost resulting from regional difference shall be borne by Party A.

	
3

	
Scope of Work of Party B

	  	  	  
	  	  	
●  Design and calculation,  mainly including the design of pipeline layout as well as design of storage and distribution system of water for injection.

	
Y

	  	
Calculation and and design have been made, and refer to the attached schedules for details.

	  	  	
●  Provide the data information and drawings relating to the disciplines of process, civil engineering, water supply & drainage, electization and instrument control, etc.

	
Y

	  	
It would be more reasonable to design the flow path and diameter of pipes in later period.

	  	  	
●  Packaging and transporting of materials used in the project.

	
Y

	  	  
	  	  	
●  Installation, inspection, testing and related debugging.

	
Y

	  	  
	  	  	
●  Related instructions and reviews on the taking over of public system.

	
Y

	  	  
	  	  	
●  All fittings, instruments and tools required for installation, inspection and debuging shall be provided by Party B.

	
Y

	  	  
	  	  	
●  Provide the completion documents and validation documents

	
Y

	  	  
	  	  	
●  Training on the operation, maintenance & repairing, and validation.

	
Y

	  	  
	  	  	
●  After-sales service

	
Y

	  	  
	
4

	
Standards and Specifications to be based on

	  	  	  
	  	  	
●  Design, material, installation, inspection and testing shall be based the requirements of this project and shall also satisfy the standards of FDA, EU and China CGMP.

	
Y

	  	  
	  	  	
●  Automatic control system shall conform to GAMP5.

	
Y

	  	  
	  	  	
●  Related construction and acceptance specifications of pipeline works.

	
Y

	  	  
	  	  	
●  GMP Specification:

	
Y

	  	  
	  	  	
■  FDA - 21 CFR Part 210, 211

	  	  	  
	  	  	
■  SFDA -Good Manufacturing Practices,1998 version and and new version to be released.

	  	  	  
	  	  	
■  Current lastest GMP in EU

	  	  	  
	  	  	
■  Related GMP Implementation Guidance

	  	  	  
	  	  	
■  The latest version of Chinese pharmacopoeia, EU pharmacopoeia, and U.S. Pharmacopoeia.

	  	  	  
	  	  	
■  ISPE,Volume 4,water and steam system,2005 version.

	  	  	  
	  	  	
■  The latest version of ASME BPE Standards.

	  	  	  
	  	  	
■  ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities

	  	  	  
	  	  	
■  V3 Sterile Manufacturing Facilities.

	  	  	  
	  	  	
■  V6 Biopharmaceutical Manufacturing Facilities.

	  	  	  
	  	  	
Party B shall detail the standards and specifications to be based on in his tender documents.

	  	  	  
	
5

	
GMP Requirements

	  	  	  
	  	  	
● Conform to the requirements of current FDA, EU and China GMP

	
Y

	  	  
	  	  	
● All water system pipeline shall be able to be completely discharged, cleaned and sterilized.

	
Y

	  	  
	  	  	
● All materials contacting with the products, purified water pipeline and pipe fittings must be 316L stainless steel.

	
Y

	  	  
	  	  	
● All materials, instruments and equipments shall conform to cGMP.

	
Y

	  	  
	  	  	
● All water systems shall have suitable sampling points which shall be easy to control, monitor and record the system status.

	
Y

	  	
Each point of equipment connection is equipped with sampling valve.

	  	  	
● The water for injection system shall be free of water backflow, and deal area shall also be avoided.

	
Y

	  	  
	  	  	
● DQ, IQ, OQ and PQ shall be provided.

	
Y

	  	  
	  	  	
● Welders shall hold related qualification certificates applicable to corrsponding works.

	
Y

	  	  
	  	  	
● Welding machine and instrument are within the valid calibration period.

	
Y

	  	  
	  	  	
l● The clean pipeline shall adopt the automatic track welding method as far as possible.

	
Y

	  	  

 

第4页/共9页

  

  

  

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	  	
URS Document: User Requirements on the Storage and Distribution System of Purifyed Water

	  	
URS Document: User Requirements on the Distribution System of Purified Steam

	  	
URS Document: User Requirements on the Storage and Distribution System of Water for Injection

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document

No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	
6

	
Storage and Distribution System of Water for Injection

	  	  	  
	  	  	
Pipelines shall be installed through the welding connection method as far as possible to achieve the 3D standard, but welding seams shall be minimized and convenience of strilizing and operating shall also be taken into consideration. Installation of pipeline shall take account of simple and smooth connection for convenience of installation, maintenance and operation, and the requirements of safety and human environment shall also be taken into consideration.

	
Y

	  	  
	  	  	
Intallation of pipellines shall be carried out strictly in accordance with the established and approved operation regulations (qualification confirmation of operators; cutting; welding connection; slope detection; endoscopy, ray detection; degrease; acid cleaning; passivation; pressurizing test, etc)

	
Y

	  	  
	  	  	
Sufficient support shall be made to the pipeline to avoid drooping or other deformations.

	
Y

	  	  
	  	  	
Method of sterilization:superheated water (121oC) sterilization or purified steam sterilization is suitable to this system, and the method of sterilization can be controlled and selected from the control system interface.

	
Y

	  	
Superheated water

	  	  	
Sanitary type distribution pipeline must be of hydraulics design to ensure that the ryznar index is not less than 4000 or flow rate is not less than 1m/s when each point of use of water has the minimum flow rate.

	
N

	  	
The flow velocity is more than 0.914m/s (standard calculation)

	  	  	
The sampling point shall be equipped at least at the initial stage of distribution pipeline.

	
Y

	  	
Sampling shall be made for each point of equipment connection.

	  	  	
The fixed pipeline must be clearly indicated with the medium and flow direction in the pipeline.

	
Y

	  	  
	  	  	
The connection gasket shall be sandwich PTFE gasket.

	  	  	  
	  	  	
a)  Requirements of the storage and distribution system of water for injection.

	  	  	  
	  	  	
Pipeline and Pipe Fittings of Water for Injection   and Installation

	  	  	  
	  	  	
316L stainless steel material, outer Ra<0.8μm, inner Ra<0.5μm, mechanical polishing + electro polishing, ASME BPE standard (this standard shall be applicable to other parts unless otherwise specified).

	
Y

	  	  
	  	  	
Storage Tank

	
Y

	  	  
	  	  	
■  All parts of tank contacting with the clean medium shall adopt the 316L stainless steel material;

	  	  	  
	  	  	
■  The manhole shall adopt the sanitary type manhole, with matt finishing outer surface. Other interfaces are required to be free of dead area.

	  	  	  
	  	  	
■  The tank shall have thermal insulation function, and the outer layer shall be 304 stainless steel material.

	  	  	  
	  	  	
■  The spray ball in storage tank shall adopt the fixed type spray ball.

	  	  	  
	  	  	
■  The applicable standards of tank shall be the same with those applicable to corresponding pipelines and pipe fittings.

	  	  	  
	  	  	
■  Bursting discs shall be applied.

	  	  	  
	  	  	
■  Electro polishing inner face of storage tank Ra<0.5μm, outer surface Ra<0.8μm。

	  	  	  
	  	  	
Heat Exchanger

	  	  	  
	  	  	
Adopt the straight way type double tube-sheet exchanger, free of dead area and with complete emptying function. Inner pipeline Ra<0.5μm. Integral material is 316L stainless steel.

	
Y

	  	  
	  	  	
Sanitation Ball Valve

	  	  	  
	  	  	
Adopt the GEMU sanitation ball valve, 316L material, and two-piece type diaphragm PTFE/EPDM; the material of diaphragm shall conform to the requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided; mechanical polishing of the surface contacting with medium Ra<0.5μm; quick clamp interface (welding connection shall be used as far as possible), and the interface size shall be matching with the pipeline system; gasket of clamp shall be PTFE material and shall also conform to the requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided. The outer surface shall be glass bead blasting treated. The pneumatic valve shall be equipped with the opening and closing indicator.

	
Y

	  	  
	  	  	
 Liquidometer

	  	  	  
	  	  	
Adopt the E+H electric capacity type liquidometer. The part contacting with the medium shall be 316L stainless steel or other materials conforming to requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided. The material system shall be Mettler weighing module, while the support shall use 304 stainless steel.

	
Y

	  	  
	  	  	
Conductivity Meter

	  	  	  
	  	  	
Adopt the E+H or Mettler type. The precision shall not be less than 0.1μS/cm.

	
Y

	  	  
	  	  	
Flowmeter

	  	  	  
	  	  	
Adopt the Vortex Flowmeter.

	
Y

	  	  
	  	  	
Filter

	  	  	  
	  	  	
All filters and inspirators shall be 0.22μ, for all of which the on-line bubble point tests shall be taken into consideration; purified steam shall be connected to the front and reat simutaneously in sterilization. Adopt the PALL or Millipore products. The inspirator shall adopt electrical heating.

	
Y

	  	  
	  	  	
TOC

	  	  	  
	  	  	
Installed at the water return end.

	
Y

	  	  
	  	  	
Sanitary Pump

	  	  	  
	  	  	
316L material, quick clamp interface (the interface size shall match with the pipeline system), mechanical polishing inner surface, Ra<0.5μm,with bottom discharge opening, sealing SiC/SiC。

	
Y

	  	  
	  	  	
Thermal Insulation

	  	  	  
	  	  	
Stainless steel sheet or PV + rock wool (volume weight is more than 65kg/m3) shall be applied in water preparation room.

	
Y

	  	  
	  	  	
Iron sheet + rock wool (volume weight is more than 65kg/m3) shall be applied in the technical sanwich layer

	
Y

	  	  
	  	  	
 The clean room shall adopt the casng (pipe-in-pipe) form. The material of casing shall be 304 stainless steel, with outer surface Ra<0.8um.

	
N

	  	
Outer surface Ra<1.6um

	  	  	
Support Material

	  	  	  
	  	  	
The possibly used support type materials include various specifications of movable support, stainless steel support, fixed plate, decorating plate, stainless steel square tube, angle bar, galvanized lead screw, and stainless steel screw bolt, etc; 304 stainless steel materials shall be applied in the clean area. Soft contact shall be made between the support and pipeline.

	
N

	  	
Specially developed bakelite support shall be applied in the clean room.

	  	  	
Welding Seam Detection

	  	  	  
	  	  	
Sanitary pipeline of the whole system shall be connected through automatic welding as fas as possible, and manual welding connection (if necessary) shall be approved by Party A. X-ray fault detection and endoscopy shall be applied for all manual welding connections. X-ray fault detection shall be done for all welding samples of the automatic welding connection part while endoscopy shall be applied for 20% of other automatic welding spots. The inspected welding spots layout shall be approved by Party A.

	
Y

	  	  
	  	  	
Degrease, Acid Cleaning, Passivation and Pressure Test

	  	  	  
	  	  	
Degrease, acid cleaning and passivation treatment shall be applied for all pipes, and then test the effects. Pressure test shall be applied for all pipes, with the testing pressure at least 1.5 times of the working pressure, and if the working pressure is less than 4bar, the pressure of 6bar shall be applied for testing.

	
Y

	  	  

 

第5页/共9页

  

  

  

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	  	
URS Document: User Requirements on the Storage and Distribution System of Purifyed Water

	  	
URS Document: User Requirements on the Distribution System of Purified Steam

	  	
URS Document: User Requirements on the Storage and Distribution System of Water for Injection

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document

No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	  	  	
Control Device

	  	  	  
	  	  	
The control system for the distribution system of water for injection, purified water and steam generator shall be combined with the control system ofpreparation equipment to adopt one set of control system.Two workshops of the material system shall adopt separate set of contron system respectively. The control system shall adopt the SIMENS brand.

	
N

	  	
Water system shall has one separate control system, but it can communicate with the equipment, and the equipment and system can be connected with the host computer.

	  	  	
Electric control cabinet includes:PLC (CPU, Input/Output Module), touch screen (colorful) and other control components; power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components; cabinet body, terminal strip, cable and trunking, control software, recording instrument (8 channels), DP communication module, and other necessary components and parts.

	
N

	  	
Recording machine is not applied; data can be recorded and printed through computer.

	  	  	
The sterilzing process of purified water system and water for injection distribution system shall be full automatic control, and the sterilizing time shall be included in the PLC time counting. Recording curve shall be made for the key parameters (such as the electrical conductivity, flow rate and temperature, etc).

	
Y

	  	  
	  	  	
Sewerage, Funnel and Discharge

	  	  	  
	  	  	
Make the best use of non- immersive instrument, and if not available,  it must be of sanitary design.

	
Y

	  	  
	  	  	
The connection part of plug-type instrument must be of sanitary clamp connection type.

	
Y

	  	  
	  	  	
Filling material in the instrument shall not be mixed into the products in ccase of occurring leakage of the instrument.

	
Y

	  	  
	  	  	
Mark

	  	  	  
	  	  	
Each welding spot shall be marked.

	
Y

	  	  
	  	  	
b)  Construction Specification and Acceptance

	  	  	  
	  	  	
Party B shall describe the organization and implementation specifications and procedures as well as acceptance procedures and standards for various works in the bidding documents.

	
Y

	  	  
	
7

	
Design

	  	  	  
	  	  	
Party B' work must enable the complete set system meet the requirements of current GMP specifications prevailing in China, EU and the United States and also pass corresponding GMP Certifications.

	
Y

	  	
Refer to the drawings for designs

	
8

	
Control, Debugging and Validation of the Storage and Distribution System of Water for Injection

	  	  	  
	  	  	
Control, debugging and validation of operating control, debugging and validation of purified water storage and distribution system shall be completed by Party B.

	
Y

	  	  
	  	  	
In addition, supply, related documents and validation of instruments (including necessary pressure gauge and pressure transmitter, thermometer and temperature transmitter, flowmeter and flow transmitter, and conductivity meter, etc) and control devices (electric control cabinet including PLC, touch screen, recording instrument and other control components; and power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components) in the storage and distribution system of compressed air and process gas shall be completed by Party B.

	  	  	  
	  	  	
The instruments shall be accurate and reliable and need to be calibrated, and the calibration shall be traceable.

	  	  	  
	
9

	
Traceability of Raw Materials, Spare Parts and Control System

	
Y

	  	  
	  	  	
For all raw materials, spare parts, equipments, electricity, instrument and control system, original data shall be reserved and all of these items shall be tested to establish files for them to ensure their traceability. Traceability Matrix (TM) documents shall be established for each aspect of project implementation.

	  	  	  
	  	  	
Each spare part, equipment, electric and intrument part shall be equipped with metal tag (with corresponding location number) for convenience of identification and operating.

	  	  	  
	
10

	
Process Guarantee

	
Y

	  	  
	  	  	
Party B' work shall be sure to meet this user requirement as well as requirements specified in the appendices in the following aspects (include but not limited to):

	  	  	  
	  	  	
● Meet the requirements of GMP specifications in China, EU and the United States as well as various industry codes.

	  	  	  
	  	  	
● Quality of water in circulation pipeline, storage tank and point of use.

	  	  	  
	  	  	
● Quality of purified steam in distribution pipeline and point of use.

	  	  	  
	  	  	
● Flow rate, pressure and temperature at the outlet of point of use.

	  	  	  
	  	  	
● Flow rate and flow velocity of main circluation pipeline and branch circulation pipeline in the water system.

	  	  	  
	  	  	
● Temperature of water circulating pipeline;

	  	  	  
	  	  	
● Functional testing of the distribution pipeline;

	  	  	  
	  	  	
● Functional testing of PLC and control system.

	  	  	  
	
11

	
Quality Project Plan (QPP)

	
Y

	  	  
	  	  	
In order to ensure compliance with the requirements of Party A, Party B shall implement the quality project plan and construction organization design at all stages of design, installation, testing, debugging and handing over, including the quality testing and control over the materials and spare parts supplied by partner-suppliers.

	  	  	  
	  	  	
Party B shall submit its quality project plan to Party A for recognition and approval within two weeks from the effective date of contract.

	  	  	  
	  	  	
Quality project plan shall include the non-destructive test, identification ad identification of raw materials, stage acceptance and final testing.

	  	  	  
	  	  	
Party B shall clearly indicate which tests need eye-witness of the representatives of Party A. Party A shall also decide which testing items need to be witnessed by his representatives.

	  	  	  
	  	  	
Party B shall issue test report and test certificate for each inspection and test (witnessed or not witnessed by the representatives of Party A), and these documents will be included in the final completion file package.

	  	  	  
	  	  	
All design, procurement, installation, testing, debugging, and implementation of document system  shall take consideration to meet the requirements of validation and certification.

	  	  	  
	  	  	
a)  Project Schedule Diagram

	  	  	  
	  	  	
Party B must prepare and analyze the detailed schedule diagram (including the design, procurement, installation, testing, debugging and handing over, etc) through a reasonable manner, which will be favorable to: 1 quality control, 2 determination of critical working procedure and stage, optimization of working procedure, and 3 frequent inspection of working progress.

	  	  	  
	
12

	
Quality Guarantee and Responsibility

	
Y

	  	  
	  	  	
●  The quality guarantee period of all goods supplied by Party B shall be at least one year (from the day of qualified final acceptance and debugging)

	  	  	  
	  	  	
●  Party B shall guarantee the safety, reliability, normativity and reasonableness of the design, procurement, installation, testing and debugging and shall bear full responsibility for them.

	  	  	  
	  	  	
●  Party B shall guarantee that all working contents and implementation must take account of the requirements and validation of Party B as well as related (China, EU and the United States) GMP Certification requirements.

	  	  	  
	
13

	
Documents & Drawings

	
Y

	  	  
	  	  	
Documents will an integral part of the scope of work of Party B, so Party B shall pay the liquidated damages if submittal of documents is delayed or the submitted documents are incomplete. In case of failing to submit the documents even if a part of them, it is also deemed that the contract is not performed completely, which will be unacceptable.

	  	  	  

 

第6页/共9页

  

  

  

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	  	
URS Document: User Requirements on the Storage and Distribution System of Purifyed Water

	  	
URS Document: User Requirements on the Distribution System of Purified Steam

	  	
URS Document: User Requirements on the Storage and Distribution System of Water for Injection

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document

No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	  	  	
The goods and documents supplied by Party B must conform to the requirements of Party A and must also meet the requirements of current GMP Certification of China, the United States and EU.

	  	  	  
	  	  	
a)  Form of Documents

	  	  	  
	  	  	
All documents and drawings shall clearly show the order number, work number, customer number and related drawing number, location number of equipment, pipe number, valve number and instrument number.

	  	  	  
	  	  	
The documents and drawings must be submitted to Party A in accordance with the requirements of attached schedule for recognition and approval. Documents and drawings shall be submitted in the form of hardcopy and softcopy in accordance with the time specified in the attached schedule. The softcopy of drawings shall be CAD form.

	  	  	  
	  	  	
The drawings shall adopt the metric unit.

	  	  	  
	  	  	
Language: All documents, drawings, instructions and operation maintenance manuals, etc shall be prepared in simplified Chinese and English.

	  	  	  
	  	  	
b)  Document establishment / submittal time (progress) table.

	  	  	  
	
14

	
After-sales Service and Training

	
Y

	  	  
	  	  	
The after-sales service must be in time and detailed and also solve the problems completely.

	  	  	  
	  	  	
During the quality guarantee period, Party B shall be responsible for repairing or replacement free of charge if the goods and working contents specified in the contract occur any problems within the scope of operating regulations; Party B shall provide lifelong repairing and maintenance in time after the quality guarantee period, and only material cost will be charged for the repairing work.

	  	  	  
	  	  	
Party B shall provide training to the staff of Party A free of charge (including training in factory and installation site), and the training contents shall include the working principle, framework, flow process, operation, maintenance & repairing, calibration and resolving of faults, etc of the whole system.

	  	  	  
	  	  	
Party B shall describe the method and manner of his technical commitment and after-sales service in his tendering documens.

	  	  	  
	
15

	
Construction Period of the System

	
Y

	  	  
	  	  	
Installation and construction of the system is approximately to be commenced on July 1, 2009 and completed on September 30, 2009.

	  	  	  
	
16

	
Quotation

	
Y

	  	  
	  	  	
The quotation shall include all costs occurred within the scope of supply of the seller and the scope of work.

	  	  	  
	  	  	
The quotation shall include the separate price for each time and total price.

	  	  	  
	  	  	
The quotation of all equipments and main materials shall clearly show the main technical specification and manufacturer.

	  	  	  
	
URS Document: User Requirements on the Purified Steam Storage and Distribution System

	
2

	
Scope of Supply of Party B

	
Y

	  	  
	  	  	
The goods and works supplied by Party B shall be completely in accordance with the user requirements and appendices as well as related standards and specifications.

	  	  	  
	  	  	
The scope of supply of Party B shall include the materials, auxiliary spare parts, auxiliary equipments, and all necessary materials and spare parts required to guarantee good performance of the whole project in accordace with this user requirement description.

	  	  	  
	  	  	
Scope of supply is as follows:

	  	  	  
	  	  	
→ Supply and installation construction (including installation, welding connection, welding seam detection and treatment, pressurizing, degrease, acid cleaning and passivation, etc) of all installation materials (including pipeline, pipe fittings, water pump, storage tank, heat exchanger, valve, support, thermal insulation of pipeline and related auxiliary fittings, etc) used for the purified steam storage and distribution system in this project.

	  	  	  
	  	  	
→  Provide the as-built documents and validation documents (including the validation and confirmation documents required for certification).

	  	  	  
	  	  	
→  Necessary expenses for approval by the government supervising department.(if necessary, it shall be included in the bidding documents).

	  	  	  
	
3

	
Scope of Work of Party B

	
Y

	  	  
	  	  	
→  Design and calculation,  mainly including the design of pipeline layout as well as design of storage and distribution system of purified steam.

	  	  	  
	  	  	
→  Provide the data information and drawings relating to the disciplines of process, civil engineering, water supply & drainage, electization and instrument control, etc.

	  	  	  
	  	  	
→  Packaging and transporting of materials used in the project.

	  	  	  
	  	  	
→  Installation, inspection, testing and related debugging.

	  	  	  
	  	  	
→  Related instructions and reviews on the taking over of public system.

	  	  	  
	  	  	
→  All fittings, instruments and tools required for installation, inspection and debuging shall be provided by Party B.

	  	  	  
	  	  	
→  Provide the completion documents and validation documents

	  	  	  
	  	  	
→  Training on the operation, maintenance & repairing, and validation.

	  	  	  
	  	  	
→  After-sales service

	  	  	  
	
4

	
Standards and Specifications to be based on

	
Y

	  	  
	  	  	
a.  Design, material, installation, inspection and testing shall be based the requirements of this project and shall also satisfy the standards of FDA, EU and China CGMP.

	  	  	  
	  	  	
b.  Automatic control system shall conform to GAMP5.

	  	  	  
	  	  	
c.  Related construction and acceptance specifications of pipeline works.

	  	  	  
	  	  	
d.  GMP Specification:

	  	  	  
	  	  	
a)  FDA - 21 CFR Part 210, 211

	  	  	  
	  	  	
b) SFDA -Good Manufacturing Practices,1998 version and and new version to be released.

	  	  	  
	  	  	
c) Current lastest GMP in EU

	  	  	  
	  	  	
d) Related GMP Implementation Guidance

	  	  	  
	  	  	
e) The latest version of Chinese pharmacopoeia, EU pharmacopoeia, and U.S. Pharmacopoeia.

	  	  	  
	  	  	
f) ISPE,Volume 4,water and steam system,2005 version.

	  	  	  
	  	  	
g) The latest version of ASME BPE Standards.

	  	  	  
	  	  	
h) ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities

	  	  	  
	  	  	
i)  V3 Sterile Manufacturing Facilities.

	  	  	  
	  	  	
j)  V6 Biopharmaceutical Manufacturing Facilities.

	  	  	  
	  	  	
Party B shall detail the standards and specifications to be based on in his tender documents.

	  	  	  

 

第7页/共9页

  

  

  

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	  	
URS Document: User Requirements on the Storage and Distribution System of Purifyed Water

	  	
URS Document: User Requirements on the Distribution System of Purified Steam

	  	
URS Document: User Requirements on the Storage and Distribution System of Water for Injection

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document

No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	
5

	
GMP Requirements

	
Y

	  	  
	  	  	
→  Conform to the requirements of current FDA, EU and China GMP

	  	  	  
	  	  	
→  All purified steam system pipeline shall be able to be completely discharged, cleaned and sterilized.

	  	  	  
	  	  	
→  All materials contacting with the products, purified steam pipeline and pipe fittings must be 316L stainless steel.

	  	  	  
	  	  	
→  All materials, instruments and equipments shall conform to cGMP.

	  	  	  
	  	  	
→  The system shall have suitable sampling points which shall be easy to control, monitor and record the system status.

	  	  	  
	  	  	
→  The purified steam system shall be free of water backflow, and deal area shall also be avoided.

	  	  	  
	  	  	
→  DQ, IQ, OQ and PQ shall be provided.

	  	  	  
	  	  	
→  Welders shall hold related qualification certificates applicable to corrsponding works.

	  	  	  
	  	  	
→  Welding machine and instrument are within the valid calibration period.

	  	  	  
	  	  	
→  The clean pipeline shall adopt the automatic track welding method as far as possible.

	  	  	  
	
6

	
Distribution System of Purified Steam

	  	  	  
	  	  	
Pipelines shall be installed through the welding connection method as far as possible to achieve the 3D standard, but welding seams shall be minimized and convenience of strilizing and operating shall also be taken into consideration. Installation of pipeline shall take account of simple and smooth connection for convenience of installation, maintenance and operation, and the requirements of safety and human environment shall also be taken into consideration.

	
Y

	  	  
	  	  	
Intallation of pipellines shall be carried out strictly in accordance with the established and approved operation regulations (qualification confirmation of operators; cutting; welding connection; slope detection; endoscopy, ray detection; degrease; acid cleaning; passivation; pressurizing test, etc).

	
Y

	  	  
	  	  	
Sufficient support shall be made to the pipeline to avoid drooping or other deformations.

	
Y

	  	  
	  	  	
The sampling point shall be equipped at least at the initial stage of distribution pipeline.

	
Y

	  	  
	  	  	
The fixed pipeline must be clearly indicated with the medium and flow direction in the pipeline.

	
Y

	  	  
	  	  	
The connection gasket shall be sandwich PTFE gasket.

	
Y

	  	  
	  	  	
The lowest point and end of the system shall be equipped with steam trap and condensed water drainage.

	
Y

	  	  
	  	  	
a)  Requirements of the purified steam distribution system.

	  	  	  
	  	  	
Pipeline & Pipe Fittings and Installation

	  	  	  
	  	  	
316L stainless steel material, outer Ra<0.8μm, inner Ra<0.5μm, mechanical polishing, ASME BPE standard (this standard shall be applicable to other parts unless otherwise specified).

	
Y

	  	  
	  	  	
Sanitation Ball Valve

	  	  	  
	  	  	
Adopt King Lai brand, 316L material, PTFE sealing material, mechanical polishing, inner surface Ra<0.5μm, outer Ra<0.8μm, quick clamp interface  (interface size shall matched with the pipeline system).

	
Y

	  	  
	  	  	
Thermal Insulation

	  	  	  
	  	  	
Stainless steel sheet or PV + rock wool (volume weight is more than 65kg/m3) shall be applied in water preparation room.

	
Y

	  	  
	  	  	
Iron sheet + rock wool (volume weight is more than 65kg/m3) shall be applied in the technical sanwich layer.

	
Y

	  	  
	  	  	
The clean room shall adopt the casng (pipe-in-pipe) form. The material of casing shall be 304 stainless steel, with outer surface Ra<0.8um.

	
N

	  	
Outer surface Ra<1.6um

	  	  	
Support Material

	  	  	  
	  	  	
The possibly used support type materials include various specifications of movable support, stainless steel support, fixed plate, decorating plate, stainless steel square tube, angle bar, galvanized lead screw, and stainless steel screw bolt, etc; 304 stainless steel materials shall be applied in the clean area. Soft contact shall be made between the support and pipeline.

	
N

	  	
Specially developed bakelite support (high temperature resistance) shall be applied in the clean room.

	  	  	
Welding Seam Detection

	
Y

	  	  
	  	  	
Sanitary pipeline of the whole system shall be connected through automatic welding as fas as possible, and manual welding connection (if necessary) shall be approved by Party A. X-ray fault detection and endoscopy shall be applied for all manual welding connections. X-ray fault detection shall be done for all welding samples of the automatic welding connection part while endoscopy shall be applied for 20% of other automatic welding spots. The inspected welding spots layout shall be approved by Party A.

	  	  	  
	  	  	
Degrease, Acid Cleaning, Passivation and Pressure Test

	
Y

	  	  
	  	  	
Degrease, acid cleaning and passivation treatment shall be applied for all pipes, and then test the effects. Pressure test shall be applied for all pipes, with the testing pressure at least 1.5 times of the working pressure, and if the working pressure is less than 4bar, the pressure of 6bar shall be applied for testing.

	  	  	  
	  	  	
Control Device

	  	  	  
	  	  	
The control system for the distribution system of water for injection, purified water and steam generator shall be combined with the control system ofpreparation equipment to adopt one set of control system.Two workshops of the material system shall adopt separate set of contron system respectively. The control system shall adopt the SIMENS brand.

	
N

	  	
Separate system, and data transmit and host computer control is available.

	  	  	
Electric control cabinet includes:PLC (CPU, Input/Output Module), touch screen (colorful) and other control components; power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components; cabinet body, terminal strip, cable and trunking, control software, recording instrument (8 channels), DP communication module, and other necessary components and parts.

	
N

	  	
Record and print data through computer

	  	  	
The sterilzing process of purified water system and water for injection system shall be full automatic control, and the sterilizing time shall be included in the PLC time counting. Recording curve shall be made for the key parameters (such as the electrical conductivity, flow rate, temperature, TOC, etc).

	
Y

	  	  
	  	  	
Sewerage, Funnel and Discharge

	
Y

	  	  
	  	  	
Make the best use of non- immersive instrument, and if not available,  it must be of sanitary design.

	  	  	  
	  	  	
The connection part of plug-type instrument must be of sanitary clamp connection type.

	  	  	  
	  	  	
Filling material in the instrument shall not be mixed into the products in ccase of occurring leakage of the instrument.

	  	  	  
	  	  	  	  	  	  
	  	  	
Mark

	
Y

	  	  
	  	  	
Each welding spot shall be marked.

	  	  	  
	  	  	
b)  Construction Specification and Acceptance

	
Y

	  	  
	  	  	
Party B shall describe the organization and implementation specifications and procedures as well as acceptance procedures and standards for various works in the bidding documents.

	  	  	  
	
7

	
Design

	
Y

	  	  
	  	  	
Party B' work must enable the complete set system meet the requirements of current GMP specifications prevailing in China, EU and the United States and also pass corresponding GMP Certifications.

	  	  	  
	
8

	
Control, Debugging and Validation of Storage and Distribution of Purified Steam System

	
Y

	  	  
	  	  	
Control, debugging and validation of operating control, debugging and validation of purified steam distribution system shall be completed by Party B.

	  	  	  

 

第8页/共9页

  

  

  

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	  	
URS Document: User Requirements on the Storage and Distribution System of Purifyed Water

	  	
URS Document: User Requirements on the Distribution System of Purified Steam

	  	
URS Document: User Requirements on the Storage and Distribution System of Water for Injection

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document

No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	  	  	
In addition, supply, related documents and validation of instruments (including necessary pressure gauge and pressure transmitter, thermometer and temperature transmitter, etc) and control devices (electric control cabinet including PLC, touch screen, recording instrument and other control components; and power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components) in the purified steam distribution system shall be completed by Party B.

	  	  	  
	  	  	
The instruments shall be accurate and reliable and need to be calibrated, and the calibration shall be traceable.

	  	  	  
	
9

	
Traceability of Raw Materials, Spare Parts and Control System

	
Y

	  	  
	  	  	
For all raw materials, spare parts, equipments, electricity, instrument and control system, original data shall be reserved and all of these items shall be tested to establish files for them to ensure their traceability. Traceability Matrix (TM) documents shall be established for each aspect of project implementation.

	  	  	  
	  	  	
Each spare part, equipment, electric and intrument part shall be equipped with metal tag (with corresponding location number) for convenience of identification and operating.

	  	  	  
	
10

	
Process Guarantee

	
Y

	  	  
	  	  	
Party B' work shall be sure to meet this user requirement as well as requirements specified in the appendices in the following aspects (include but not limited to):

	  	  	  
	  	  	
→  Meet the requirements of GMP specifications in China, EU and the United States as well as various industry codes.

	  	  	  
	  	  	
→  Quality of purified steam in distribution pipeline and point of use.

	  	  	  
	  	  	
→ Flow rate, pressure and temperature at the outlet of point of use.

	  	  	  
	  	  	
→  Functional testing of the distribution pipeline;

	  	  	  
	  	  	
→ Functional testing of PLC and control system.

	  	  	  
	
11

	
Quality Project Plan (QPP)

	
Y

	  	  
	  	  	
In order to ensure compliance with the requirements of Party A, Party B shall implement the quality project plan and construction organization design at all stages of design, installation, testing, debugging and handing over, including the quality testing and control over the materials and spare parts supplied by partner-suppliers.

	  	  	  
	  	  	
Party B shall submit its quality project plan to Party A for recognition and approval within two weeks from the effective date of contract.

	  	  	  
	  	  	
Quality project plan shall include the non-destructive test, identification ad identification of raw materials, stage acceptance and final testing.

	  	  	  
	  	  	
Party B shall clearly indicate which tests need eye-witness of the representatives of Party A. Party A shall also decide which testing items need to be witnessed by his representatives.

	  	  	  
	  	  	
Party B shall issue test report and test certificate for each inspection and test (witnessed or not witnessed by the representatives of Party A), and these documents will be included in the final completion file package.

	  	  	  
	  	  	
All design, procurement, installation, testing, debugging, and implementation of document system  shall take into consideration to meet the requirements of validation and certification.

	  	  	  
	  	  	
a)  Project Schedule Diagram

	  	  	  
	  	  	
Party B must prepare and analyze the detailed schedule diagram (including the design, procurement, installation, testing, debugging and handing over, etc) through a reasonable manner, which will be favorable to: 1 quality control, 2 determination of critical working procedure and stage, optimization of working procedure, and 3 frequent inspection of working progress.

	  	  	  
	
12

	
Quality Guarantee and Responsibility

	
Y

	  	  
	  	  	
→  The quality guarantee period of all goods supplied by Party B shall be at least one year (from the day of qualified final acceptance and debugging)

	  	  	  
	  	  	
→  Party B shall guarantee the safety, reliability, normativity and reasonableness of the design, procurement, installation, testing and debugging and shall bear full responsibility for them.

	  	  	  
	  	  	
→  Party B shall guarantee that all working contents and implementation must take account of the requirements and validation of Party B as well as related (China, EU and the United States) GMP Certification requirements.

	  	  	  
	
13

	
Documents & Drawings

	
Y

	  	  
	  	  	
Documents will an integral part of the scope of work of Party B, so Party B shall pay the liquidated damages if submittal of documents is delayed or the submitted documents are incomplete. In case of failing to submit the documents even if a part of them, it is also deemed that the contract is not performed completely, which will be unacceptable.

	  	  	  
	  	  	
The goods and documents supplied by Party B must conform to the requirements of Party A and must also meet the requirements of current GMP Certification of China, the United States and EU.

	  	  	  
	  	  	
a)  Form of Documents

	  	  	  
	  	  	
All documents and drawings shall clearly show the order number, work number, customer number and related drawing number, location number of equipment, pipe number, valve number and instrument number.

	  	  	  
	  	  	
The documents and drawings must be submitted to Party A in accordance with the requirements of attached schedule for recognition and approval. Documents and drawings shall be submitted in the form of hardcopy and softcopy in accordance with the time specified in the attached schedule. The softcopy of drawings shall be CAD form.

	  	  	  
	  	  	
The drawings shall adopt the metric unit.

	  	  	  
	  	  	
Language: All documents, drawings, instructions and operation maintenance manuals, etc shall be prepared in simplified Chinese and English.

	  	  	  
	  	  	
Document establishment / submittal time (progress) table.

	  	  	  
	
14

	
After-sales Service and Training

	  	  	  
	  	  	
The after-sales service must be in time and detailed and also solve the problems completely.

	  	  	  
	  	  	
During the quality guarantee period, Party B shall be responsible for repairing or replacement free of charge if the goods and working contents specified in the contract occur any problems within the scope of operating regulations; Party B shall provide lifelong repairing and maintenance in time after the quality guarantee period, and only material cost will be charged for the repairing work.

	  	  	  
	  	  	
Party B shall provide training to the staff of Party A free of charge (including training in factory and installation site), and the training contents shall include the working principle, framework, flow process, operation, maintenance & repairing, calibration and resolving of faults, etc of the whole system.

	  	  	  
	  	  	
Party B shall describe the method and manner of his technical commitment and after-sales service in his tendering documens.

	  	  	  
	
15

	
Construction Period of the System

	  	  	  
	  	  	
Installation and construction of the system is approximately to be commenced on July 1, 2009 and completed on September 30, 2009.

	  	  	  
	
16

	
Quotation

	  	  	  
	  	  	
The quotation shall include all costs occurred within the scope of supply of the seller and the scope of work.

	  	  	  
	  	  	
The quotation shall include the separate price for each time and total price.

	  	  	  
	  	  	
The quotation of all equipments and main materials shall clearly show the main technical specification and manufacturer.

	  	  	  

 

第9页/共9页

  

  

  

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	
Reference 

	
URS Document: User Requirements on the Storage and Distribution System of Compressed Air and Process Gas

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	
URS Document:User Requirements on the Storage and Distribution System of Compressed Air and Process Gas

	
3

	
Scope of Work of Party B

	  	  	  
	  	  	
● Design and calculation, mainly including the design of pipeline layout as well as design of storage and distribution system of compressed air and process gas.

	  	  	  
	  	  	
● Provide the data information and drawings relating to the disciplines of process, civil engineering, water supply & drainage, electization and instrument control, etc.

	  	  	  
	  	  	
● Packaging and transporting of materials used in the project.

	  	  	  
	  	  	
● Installation, inspection, testing and related debugging.

	  	  	  
	  	  	
● Related instructions and reviews on the taking over of public system.

	  	  	  
	  	  	
● All fittings, instruments and tools required for installation, inspection and debuging shall be provided by Party B.

	  	  	  
	  	  	
● Provide the completion documents and validation documents

	  	  	  
	  	  	
● Training on the operation, maintenance & repairing, and validation.

	  	  	  
	  	  	
● After-sales service

	  	  	  
	
4

	
Standards and Specifications to be based on

	
Y

	  	  
	  	  	
● Design, material, installation, inspection and testing shall be based the requirements of this project and shall also satisfy the standards of FDA, EU and China CGMP.

	  	  	  
	  	  	
● Automatic control system shall conform to GAMP5.

	  	  	  
	  	  	
● Related construction and acceptance specifications of pipeline works.

	  	  	  
	  	  	
● GMP Specification.

	  	  	  
	  	  	
■ FDA - 21 CFR Part 210, 211

	  	  	  
	  	  	
■ SFDA -Good Manufacturing Practices,1998 version and and new version to be released.

	  	  	  
	  	  	
■ Current lastest GMP in EU

	  	  	  
	  	  	
■ Related GMP Implementation Guidance

	  	  	  
	  	  	
■ The latest version of Chinese pharmacopoeia, EU pharmacopoeia, and U.S. Pharmacopoeia.

	  	  	  
	  	  	
■ The latest version of ASME BPE Standards.

	  	  	  
	  	  	
■  ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities

	  	  	  
	  	  	
■  V3 Sterile Manufacturing Facilities.

	  	  	  
	  	  	
■  V6 Biopharmaceutical Manufacturing Facilities.

	  	  	  
	
5

	
GMP Requirements

	
Y

	  	  
	  	  	
●  Conform to the requirements of current FDA, EU and China GMP

	  	  	  
	  	  	
●  All materials, instruments and equipments shall conform to cGMP.

	  	  	  
	  	  	
●  DQ, IQ, OQ and PQ shall be provided.

	  	  	  
	  	  	
●  Welders shall hold related qualification certificates applicable to corrsponding works.

	  	  	  
	  	  	
●  Welding machine and instrument are within the valid calibration period.

	  	  	  
	  	  	
●  Pipeline shall adopt the automatic track welding method as far as possible.

	  	  	  
	
6

	
Storage and Distribution System of Compressed Air and Process Gas

	  	  	  
	  	  	
a) Requirements of Storage and Distribution System of Compressed Air and Process Gas

	  	  	  
	  	  	
Material of Pipeline and Pipe Fittings

	
N

	  	
316L material for those lower than DN19

	  	  	
304 stainless steel materials, outer Ra<0.8μm, inner Ra<0.8μm, mechanical polishing, ISO 2037 Standard (the following contents shall also adopt this standard, unless otherwise specified)

	
N

	  	
ISPO standard outer Ra<1.0μm

	  	  	
Air Holder

	
Y

	  	  
	  	  	
304 stainless steel material, outer Ra<0.8μm, inner Ra<0.8μm

	  	  	  
	  	  	
Sanitation Ball Valve

	
Y

	  	  
	  	  	
Fluid media: compressed air and process gas. Adopt King Lai brand, 304 material, sealings material PTFE, mechanical polishing, inner surface Ra<0.8μm, outer Ra<0.8μm .

	  	  	  
	  	  	
Support Material

	  	  	  
	  	  	
The possibly used support type materials include various specifications of movable support, stainless steel support, fixed plate, decorating plate, stainless steel square tube, angle bar, galvanized lead screw, and stainless steel screw bolt, etc; 304 stainless steel materials shall be applied in the clean area. Soft contact shall be made between the support and pipeline.

	
N

	  	
Adopt the specially designed bakelite support

	  	  	
Welding Seam Detection

	  	  	  
	  	  	
Pipeline of the whole system shall be connected through automatic welding as fas as possible, and manual welding connection (if necessary) shall be approved by Party A. X-ray fault detection and endoscopy shall be applied for all manual welding connections. X-ray fault detection shall be done for all welding samples of the automatic welding connection part while endoscopy shall be applied for 20% of other automatic welding spots. The inspected welding spots layout shall be approved by Party A.

	
Y

	  	  
	  	  	
Degrease, Acid Cleaning, Passivation and Pressure Test

	
Y

	  	  
	  	  	
Degrease, acid cleaning and passivation treatment as well as pressure test shall be applied for all pipes.

	  	  	  
	  	  	
Control Device

	  	  	  
	  	  	
Compressed air and process gas system shall adopt one set of control system. The control system shall adopt the SIMENS brand.

	
Y

	  	  
	  	  	
Electric control cabinet includes:PLC (CPU, Input/Output Module), touch screen (colorful) and other control components; power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components; cabinet body, terminal strip, cable and trunking, control software, recording instrument (8 channels), DP communication module, and other necessary components and parts.

	  	  	  
	  	  	
Mark

	
Y

	  	  
	  	  	
Each welding spot shall be marked.

	  	  	  
	  	  	
b) Construction Specification and Acceptance

	  	  	  
	  	  	
Party B shall describe the organization and implementation specifications and procedures as well as acceptance procedures and standards for various works in the bidding documents.

	  	  	  
	
7

	
Design

	  	  	  
	  	  	
Party B' work must enable the complete set system meet the requirements of current GMP specifications prevailing in China, EU and the United States and also pass corresponding GMP Certifications.

	
N

	  	
Wide differences were found in the scope of design requirements after communication, so the design is being revised.

	
8

	
Control, Debugging and Validation

	
Y

	  	  
	  	  	
Operating control, debugging and validation of the storage and distribution system of compressed air and process gas shall be completed by Party B.

	  	  	  
	  	  	
In addition, supply, related documents and validation of instruments (including necessary pressure gauge and pressure transmitter, thermometer and temperature transmitter, flowmeter and flow transmitter, and conductivity meter, etc) and control devices (electric control cabinet including PLC, touch screen, recording instrument and other control components; and power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components) in the storage and distribution system of compressed air and process gas shall be completed by Party B.

	  	  	  
	  	  	
The instruments shall be accurate and reliable and need to be calibrated, and the calibration shall be traceable.

	  	  	  

 

第1页/共2页

  

  

  

URS DEVIATION FORM

 

	
Project Name 

	
Storage and Distribution System of Compressed Air and Process Gas

	

	
Reference 

	
URS Document: User Requirements on the Storage and Distribution System of Compressed Air and Process Gas

	
Tenderer 

	
Shanghai Macroprocess Co., Ltd

 

	
Document No.

	
Name

	
Requirements

	
Compliance

	
Non-compliance

	
Remark and Deviation Description

	
9

	
Traceability of Raw Materials, Spare Parts and Control System

	
Y

	  	  
	  	  	
For all raw materials, spare parts, equipments, electricity, instrument and control system, original data shall be reserved and all of these items shall be tested to establish files for them to ensure their traceability. Traceability Matrix (TM) documents shall be established for each aspect of project implementation.

	  	  	  
	  	  	
Each spare part, equipment, electric and intrument part shall be equipped with metal tag (with corresponding location number) for convenience of identification and operating.

	  	  	  
	
10

	
Process Guarantee

	
Y

	  	  
	  	  	
ð  Meet the requirements of GMP specifications in China, EU and the United States as well as various industry codes.

	  	  	  
	  	  	
ð  Flow rate and pressure at the outlet of air holder and points of use of gas.

	  	  	  
	  	  	
ð  Functional testing of PLC and control system.

	  	  	  
	
11

	
Quality Project Plan (QPP)

	
Y

	  	  
	  	  	
In order to ensure compliance with the requirements of Party A, Party B shall implement the quality project plan and construction organization design at all stages of design, installation, testing, debugging and handing over, including the quality testing and control over the materials and spare parts supplied by partner-suppliers.

	  	  	  
	  	  	
Party B shall submit its quality project plan to Party A for recognition and approval within two weeks from the effective date of contract.

	  	  	  
	  	  	
Quality project plan shall include the non-destructive test, identification ad identification of raw materials, stage acceptance and final testing.

	  	  	  
	  	  	
Party B shall clearly indicate which tests need eye-witness of the representatives of Party A. Party A shall also decide which testing items need to be witnessed by his representatives.

	  	  	  
	  	  	
Party B shall issue test report and test certificate for each inspection and test (witnessed or not witnessed by the representatives of Party A), and these documents will be included in the final completion file package.

	  	  	  
	  	  	
All design, procurement, installation, testing, debugging, and implementation of document system  shall take consideration to meet the requirements of validation and certification.

	  	  	  
	  	  	
a)  Project Schedule Diagram

	  	  	  
	  	  	
Party B must prepare and analyze the detailed schedule diagram (including the design, procurement, installation, testing, debugging and handing over, etc) through a reasonable manner, which will be favorable to: 1 quality control, 2 determination of critical working procedure and stage, optimization of working procedure, and 3 frequent inspection of working progress.

	  	  	  
	
12

	
Quality Guarantee and Responsibility

	
Y

	  	  
	  	  	
●  The quality guarantee period of all goods supplied by Party B shall be at least one year (from the day of qualified final acceptance and debugging)

	  	  	  
	  	  	
●  Party B shall guarantee the safety, reliability, normativity and reasonableness of the design, procurement, installation, testing and debugging and shall bear full responsibility for them.

	  	  	  
	  	  	
●  Party B shall guarantee that all working contents and implementation must take account of the requirements and validation of Party B as well as related (China, EU and the United States) GMP Certification requirements.

	  	  	  
	
13

	
Documents & Drawings

	
Y

	  	  
	  	  	
Documents will an integral part of the scope of work of Party B, so Party B shall pay the liquidated damages if submittal of documents is delayed or the submitted documents are incomplete. In case of failing to submit the documents even if a part of them, it is also deemed that the contract is not performed completely, which will be unacceptable.

	  	  	  
	  	  	
The goods and documents supplied by Party B must conform to the requirements of Party A and must also meet the requirements of current GMP Certification of China, the United States and EU.

	  	  	  
	  	  	
a)  Form of Documents

	  	  	  
	  	  	
All documents and drawings shall clearly show the order number, work number, customer number and related drawing number, location number of equipment, pipe number, valve number and instrument number.

	  	  	  
	  	  	
The documents and drawings must be submitted to Party A in accordance with the requirements of attached schedule for recognition and approval. Documents and drawings shall be submitted in the form of hardcopy and softcopy in accordance with the time specified in the attached schedule. The softcopy of drawings shall be CAD form.

	  	  	  
	  	  	
The drawings shall adopt the metric unit.

	  	  	  
	  	  	
Language: All documents, drawings, instructions and operation maintenance manuals, etc shall be prepared in simplified Chinese and English.

	  	  	  
	  	  	
b)  Document establishment / submittal time (progress) table.

	  	  	  
	
14

	
After-sales Service and Training

	
Y

	  	  
	  	  	
The after-sales service must be in time and detailed and also solve the problems completely.

	  	  	  
	  	  	
During the quality guarantee period, Party B shall be responsible for repairing or replacement free of charge if the goods and working contents specified in the contract occur any problems within the scope of operating regulations; Party B shall provide lifelong repairing and maintenance in time after the quality guarantee period, and only material cost will be charged for the repairing work.

	  	  	  
	  	  	
Party B shall provide training to the staff of Party A free of charge (including training in factory and installation site), and the training contents shall include the working principle, framework, flow process, operation, maintenance & repairing, calibration and resolving of faults, etc of the whole system.

	  	  	  
	  	  	
Party B shall describe the method and manner of his technical commitment and after-sales service in his tendering documens.

	  	  	  
	  	  	  	  	  	  
	
15

	
Construction Period of the System

	
Y

	  	  
	  	  	
Installation and construction of the system is approximately to be commenced on July 1, 2009 and completed on August 30, 2009.

	  	  	  
	
16

	
Quotation

	
Y

	  	  
	  	  	
The quotation shall include all costs occurred within the scope of supply of the seller and the scope of work.

	  	  	  
	  	  	
The quotation shall include the separate price for each time and total price.

	  	  	  
	  	  	
The quotation of all equipments and main materials shall clearly show the main technical specification and manufacturer.

	  	  	  

 

第2页/共2页Unassociated Document

 

 

Exhibit 4.7.9 - Appendix 5 - Bidding Document 1

 

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

 

第 1 部分

Part 1 

投 标 书

Tender

 

 

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co., Ltd

	
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      201100

T:021 54306717      F: 021 54306718

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

目 录

 

	
1. 报价书

	
2

	  	  
	
1.1. 法定代表人资格证明书

	
2

	
1.2. 法人授权委托书

	
3

	
1.3. 授权代表人身份证复印件

	
4

	
1.4. 投标书

	
5

	  	  
	
2.方案一 管材管件主为ALFA LAVAL

	
6

	  	  
	
2.1. 报价一览表

	
6

	
2.2. 分项报价清单

	
8

	
2.2.1. 物料系统材料清单及报价

	
8

	
2.2.2. CIP 站材料清单及报价

	
15

	
2.2.3. EPO 线配液控制系统报价

	
18

	
2.2.4. TPO 配液控制系统报价

	
20

	
2.2.5. 罐体

	
22

	
2.2.6. 焊点费

	
34

	
2.2.7. 系统所用辅材数量清单

	
35

	
2.2.8. 验证服务报价

	
36

	 	 
	
3.方案二 管材管件主为NEUMO

	
37

	  	  
	
3.1. 报价一览表

	
37

	
3.2. 分项报价清单

	
39

	
3.2.1. 物料系统材料清单及报价

	
39

	
3.2.2. CIP 站材料清单及报价

	
45

	
3.2.3. EPO 线配液控制系统报价

	
48

	
3.2.4. TPO 配液控制系统报价

	
50

	
3.2.5. 罐体

	
52

	
3.2.6. 焊点费

	
65

	
3.2.7. 系统所用辅材数量清单

	
66

	
3.2.8. 验证服务报价

	
67

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第1页/ 共67 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

 

1. 报价书

1.1. 法定代表人资格证明书

法定代表人资格证明书

单位名称:上海朗脉科技有限公司

单位地址:上海市闵行区罗阳路168 号A 座1 层

经营期限:2007年7 月26 日到2017 年7 月25 日

姓    名:王伟

性    别: 男

年    龄: 36

职    务:法人代表

王伟先生系上海朗脉科技有限公司 的法定代表人,签署本招标项目的投 标文件,进行合同谈判,签署合同和处理与之有关的一切事务。

特此证明。

投标单位(盖章): 上海朗脉科技有限公司

 

日期:2009-1-15

 

	
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 201100

T:021 54306717    F: 021 54306718

	
第2页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

1.2. 法人授权委托书

法人授权委托书

沈阳三生制药有限责任公司:

本授权委托书声明: 我王伟先生系上海市闵行区罗阳路168 号A 座101 室的上海朗脉科技有限公司的法定代表人,现代表公司授权委托下面签字的 上海朗脉科技有限公司 的 销售经理张松为本公司的合法代理人,代表本公司参加沈阳三生制药有限责任公司组织的工艺配料系统项目的投标活动。代理人在本次投标中所签署的一切文件和处理与之相关的一切事务,我均予以承认。

代理人无转委权

本授权于2009 年1 月15 日签字生效,特此声明。 

代理人:张松         性别:男         年龄:35 

单位:上海朗脉科技有限公司         职务:销售经理

地址:上海市闵行区罗阳路168 号A 座101 室

投标人:(公章)上海朗脉科技有限公司

法定代表人:(印鉴)

2009 年1 月15 日

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第3页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

1.3. 授权代表人身份证复印件

 

 

	
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 201100

T:021 54306717    F: 021 54306718

	
第4页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

1.4. 投标书

 

投标书

致沈阳三生制药有限责任公司:

我们收到贵方   工艺配料系统 招标文件,经详细研究,我们决定参加该项目投标。并授权 张松销售经理 ,全权代表我投标方提交下述文件正本一份,副本叁份。并同时宣布愿意遵守下列条款:

1、承认和愿意按照招标文件中的各项规定和要求,提供工艺配料系统的供货、安装、调试及维保等。

2、投标总报价方案一 5,523,961.99 元(管件管材主选Alfa Laval),方案二· 5,502,881.38 元(管件管材主选NEUMO) 供货周期承诺 120 日历天,安装周期承诺 70 日历天,安装质量承诺 符合GMP 要求。

3、愿意按照《合同法》和《中华人民共和国招标投标法》履行自己的责任和义务。

4、如果我们投标函被接受,我们将履行招标文件中规定的每一项要求,按期、按质、按量完成任务。

5、我们愿意提供招标方在招标文件中要求的所有资料。

6、我们理解,最低报价不是中标的唯一条件。

7、我们同意按招标文件规定,交纳投标保证金,遵守有关招标的各项规定。

8、我方的投标书在开标后60 天内有效。

9、与本投标有关的一切往来通讯请寄:

地址:   上海市闵行区罗阳路168 号A 座101 室   邮编:201100

电话: 021-54306717/ 13901375676 传真: 021-54306718  

投标方(公章): 上海朗脉科技有限公司 

授权代表人(签字或盖章):          

日期:                  

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第5页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

2.方案一 管材管件主为ALFA LAVAL

2.1. 报价一览表

	
Item 序号

	
Scope of Supply 供货范围

	
Price (RMB) 价格

	
1

	
Price Breakdown for PRO Distribution System 配料系统材料清单及报价

	
1,727,854.53

	
2

	
Price Breakdown for CIP Distribution SystemCIP 系统材料清单及报价

	
1,453,306.31

	
3

	
EPO Automatic Control SystemEPO 自动化控制系统

	
228,195.00

	
3

	
TPO Automatic Control SystemTPO 自动化控制系统

	
216,195.00

	
4

	
Piping surport 辅助材料,洁净区用不锈钢支架,非洁净区用镀锌角铁

	
237,505.00

	  	
Subtotal 1 for Material 材料费用

	
3,863,055.84

	
5

	
Welding Point Cost 焊点费用

	
287,100.00

	
6

	
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

	
35,880.00

	
7

	
Endoscopic Check ( 20% of total welding point ) 120 RMB /point 内窥镜检测,自动焊点的20%取样,80 元/焊点

	
31,104.00

	
8

	
X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point X -光检测,(100%手工焊点,所有焊样),180 元/ 焊点,

	
28,800.00

	
9

	
Insurance and Transportation 保险和运输

	
60,000.00

	  	
Subtotal 2 for Piping fabrication 管道装配

	
442,884.00

	
11

	
Detail Design, Shop Drawings and As-built Drawings 详细设计,施工图纸和竣工文件

	
150,000.00

	
12

	
Quotation For Validation Activities 验证服务报价

	
425,000.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第6页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
13

	
COMPANY Management & Supervision 公司管理&监督

	
400,000.00

	
13

	
Project Management & Supervision 项目管理&监督

	
100,000.00

	
14

	
Commissioning 调试

	
50,000.00

	  	
Subtotal 3 for Project Service 项目服务

	
1,125,000.00

	  	
Subtotal 1, 2, 3,合计

	
5,430,939.84

	  	
Tax 税金(主材部分开增值税,其他开工程发票)

	
93,022.15

	  	
Total Price 总价

	
5,523,961.99

 

	
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 201100

T:021 54306717    F: 021 54306718

	
第7页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

2.2. 分项报价清单

2.2.1. 物料系统材料清单及报价

Price Breakdown for PRO Distribution System

	
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	
培养基配制罐1106

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
150,000.00

	
150,000.00

	  2	
培养基配制罐1109

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
120,000.00

	
120,000.00

	  3	
缓冲液配制罐1421

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
122,000.00

	
122,000.00

	  4	
缓冲液暂存罐1301

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
80,000.00

	
80,000.00

	  5	
气动隔膜阀

	
DN25

	
316L

	
13

	
GEMU

	  	
3,201.25

	
41,616.25

	  6	
隔膜阀

	
DN40

	
316L

	
7

	
GEMU

	  	
3,538.75

	
24,771.25

	  7	
隔膜阀

	
DN25

	
316L

	
32

	
GEMU

	  	
2,428.75

	
77,720.00

	  8	
气动球阀

	
DN25

	
316L

	
4

	
King Lai

	  	
1,002.98

	
4,011.90

	  9	
气动球阀

	
DN20

	
316L

	
4

	
King Lai

	  	
966.30

	
3,865.20

	  10	
球阀

	
DN25

	
316L

	
4

	
King Lai

	  	
257.03

	
1,028.10

	  11	
疏水器

	
DN20

	
316L

	
4

	
Spirax Sarco

	  	
2,875.00

	
11,500.00

	  12	
过滤器

	
1.5T/h, 0.22um

	  	
1

	
PALL

	  	
12,250.00

	
12,250.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第8页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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)

	
13

	
过滤器

	
0.6T/h, 0.22um

	  	
3

	
PALL

	  	
8,125.00

	
24,375.00

	
14

	
温度变送器

	
DN20

	
316L

	
4

	
E+H

	  	
2,375.00

	
9,500.00

	
15

	
隔膜压力表

	
0~4kgf/cm2, 1′′卡箍接口

	
316L

	
8

	
Bright

	  	
437.50

	
3,500.00

	
16

	
卫生软管

	
DN25

	
PTFE

	
12

	
SAINT-GOBAIN

	  	
2,293.75

	
27,525.00

	
17

	
卡接头

	
38

	
316L

	
8

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
123.95

	
991.62

	
18

	
卡接头

	
25

	
316L

	
110

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
118.73

	
13,060.24

	
19

	
卡环

	
38

	
304

	
8

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
49.56

	
396.52

	
20

	
卡环

	
25

	
304

	
118

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
49.56

	
5,848.64

	
21

	
密封圈

	
38

	
PTFE

	
8

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
41.88

	
335.06

	
22

	
密封圈

	
25

	
PTFE

	
118

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
46.51

	
5,487.69

	
23

	
焊接三通

	
DN25

	
316L

	
28

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
174.19

	
4,877.27

	
24

	
焊接四通

	
DN25

	
316L

	
7

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
1,030.28

	
7,211.98

	
25

	
90°弯头

	
38

	
316L

	
6

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
155.94

	
935.65

	
26

	
90°弯头

	
25

	
316L

	
90

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
150.99

	
13,588.94

	
27

	
管道

	
φ38

	
316L

	
6

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
672.96

	
4,037.79

	
28

	
管道

	
φ25

	
316L

	
138

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
529.34

	
73,049.08

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第9页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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 201100

T:021 54306717    F: 021 54306718

	
第10页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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

	
管道

	
φ25

	
316L

	
12

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
125.53

	
1,506.35

	
47

	
管道

	
φ19

	
316L

	
12

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
102.22

	
1,226.68

	
一、

	
以上为EPO 工艺管线管材、管件配置及安装报价

	  	  	  	  	
866,550.11

	  1	
培养基配制罐2106

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
150,000.00

	
150,000.00

	  2	
培养基配制罐2109

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
120,000.00

	
120,000.00

	  3	
缓冲液配制罐2421

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
122,000.00

	
122,000.00

	  4	
缓冲液暂存罐2301

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
80,000.00

	
80,000.00

	  5	
气动隔膜阀

	
DN25

	
316L

	
13

	
GEMU

	  	
3,201.25

	
41,616.25

	  6	
隔膜阀

	
DN40

	
316L

	
7

	
GEMU

	  	
3,538.75

	
24,771.25

	  7	
隔膜阀

	
DN25

	
316L

	
32

	
GEMU

	  	
2,428.75

	
77,720.00

	  8	
气动球阀

	
DN25

	
316L

	
4

	
King Lai

	  	
1,002.98

	
4,011.90

	  9	
气动球阀

	
DN20

	
316L

	
4

	
King Lai

	  	
966.30

	
3,865.20

	  10	
球阀

	
DN25

	
316L

	
4

	
King Lai

	  	
257.03

	
1,028.10

	  11	
疏水器

	
DN20

	
316L

	
4

	
Spirax Sarco

	  	
2,875.00

	
11,500.00

	  12	
过滤器

	
1.5T/h, 0.22um

	  	
1

	
PALL

	  	
12,250.00

	
12,250.00

	  13	
过滤器

	
0.6T/h, 0.22um

	  	
3

	
PALL

	  	
8,125.00

	
24,375.00

	  14	
温度变送器

	
DN20

	
316L

	
4

	
E+H

	  	
2,375.00

	
9,500.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第11页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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

	
隔膜压力表

	
0~4kgf/cm2,1′′卡箍接口

	
316L

	
8

	
WIKA

	  	
437.50

	
3,500.00

	
16

	
卫生软管

	
DN25

	
PTFE

	
12

	
SAINT-GOBAIN

	  	
2,293.75

	
27,525.00

	
17

	
卡接头

	
38

	
316L

	
8

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
123.95

	
991.62

	
18

	
卡接头

	
25

	
316L

	
110

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
118.73

	
13,060.24

	
19

	
卡环

	
38

	
304

	
8

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
49.56

	
396.52

	
20

	
卡环

	
25

	
304

	
118

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
49.56

	
5,848.64

	
21

	
密封圈

	
38

	
PTFE

	
8

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
41.88

	
335.06

	
22

	
密封圈

	
25

	
PTFE

	
118

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
46.51

	
5,487.69

	
23

	
焊接三通

	
DN25

	
316L

	
28

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
174.19

	
4,877.27

	
24

	
焊接四通

	
DN25

	
316L

	
7

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
1,030.28

	
7,211.98

	
25

	
90°弯头

	
38

	
316L

	
6

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
155.94

	
935.65

	
26

	
90°弯头

	
25

	
316L

	
90

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
150.99

	
13,588.94

	
27

	
管道

	
φ38

	
316L

	
6

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
672.96

	
4,037.79

	
28

	
管道

	
φ25

	
316L

	
120

	
Alfa Laval

	
ASME BPE-PM,Ra≤0.5

	
529.34

	
63,520.94

	
29

	
卡接头

	
38

	
316L

	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
59.28

	
948.52

	
30

	
卡接头

	
25

	
316L

	
18

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
48.04

	
864.64

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第12页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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 201100

T:021 54306717    F: 021 54306718

	
第13页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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 201100

T:021 54306717    F: 021 54306718

	
第14页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

2.2.2. CIP 站材料清单及报价

 

Price Breakdown for CIP Distribution System

 

	
 

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

	
CIP 清洗罐

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
95,000.00

	
95,000.00

	
2

	
CIP 酸碱罐

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
79,000.00

	
79,000.00

	
3

	
气动球阀

	
DN40

	
316L

	
1

	
King Lai

	  	
1,280.80

	
1,280.80

	
4

	
气动隔膜阀

	
DN40

	
316L

	
15

	
GEMU

	  	
4,668.75

	
70,031.25

	
5

	
气动隔膜阀

	
DN25

	
316L

	
8

	
GEMU

	  	
3,201.25

	
25,610.00

	
6

	
隔膜阀

	
DN40

	
316L

	
2

	
GEMU

	  	
3,538.75

	
7,077.50

	
7

	
板式换热器一套

	
0.5m3,循环加热0.5 小时,40-80oC

	
316L

	
4

	
Alfa Laval

	  	
33,750.00

	
135,000.00

	
8

	
温度变送器

	
DN20

	
316L

	
2

	
E+H

	  	
2,375.00

	
4,750.00

	
9

	
隔膜压力表

	
0~4kgf/cm21′′卡箍接口

	
316L

	
1

	
CHINA

	  	
437.50

	
437.50

	
10

	
压力传感器

	
0~4kgf/cm21′′卡箍接口

	
316L

	
1

	
CHINA

	  	
1,500.00

	
1,500.00

	
11

	
卫生离心泵

	
5T/h, 32m

	
316L

	
1

	
Alfa Laval

	  	
26,500.00

	
26,500.00

	
12

	
CIP 回流泵

	
8T/h, 25m

	
316L

	
3

	
Alfa Laval

	  	
62,500.00

	
187,500.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第15页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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 201100

T:021 54306717    F: 021 54306718

	
第16页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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)

	
30

	
90°弯头

	
38

	
316L

	
46

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
34.26

	
1,575.91

	
31

	
90°弯头

	
25

	
316L

	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
26.95

	
431.25

	
32

	
管道

	
φ38

	
316L

	
96

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
178.44

	
17,129.79

	
33

	
管道

	
φ25

	
316L

	
6

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
125.53

	
753.18

	
一、

	
以上为CIP 清洗站管材、管件配置及报价

	  	  	  	  	  	
726,653.16

	  	
两套合计

	  	  	  	  	  	
1,453,306.31

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第17页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

  

2.2.3. EPO 线配液控制系统报价

 

Quotation for Control System

	
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

	
1976.00

	
3

	
CPU

	
6ES7 315-2EH13-0AB0

	
315-2 PN/DP 256KB RAM; MPI/PROFIBUS DP;PROFINET 接口

	
SIEMENS

	
1

	
13227.00

	
13227.00

	
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

	
1

	
1013.00

	
1013.00

	
7

	
DO 模块

	
6ES7 322-1BH01-0AA0

	
16 点数字输出24V DC(20 针)

	
SIEMENS

	
5

	
1409.00

	
7045.00

	
8

	
AI 模块

	
6ES7 331-7KF02-0AB0

	
8 通道模拟输入(20 针)

	
SIEMENS

	
4

	
3899.00

	
15596.00

	
9

	
AO 模块

	
6ES7 332-5HF00-0AB0

	
8 通道模拟输出(40 针)

	
SIEMENS

	
1

	
6065.00

	
6065.00

	
10

	
连接端子

	
6ES7 392-1AJ00-0AA0

	
20 针,螺钉型端子

	
SIEMENS

	
10

	
149.00

	
1490.00

	
11

	
连接端子

	
6ES7 392-1AM00-0AA0

	
40 针,螺钉型端子

	
SIEMENS

	
1

	
234.00

	
234.00

	
12

	
变频器

	  	
MM420 1.5KW

	
SIEMENS

	
4

	
2400.00

	
9600.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第18页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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 201100

T:021 54306717    F: 021 54306718

	
第19页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

2.2.4. TPO 配液控制系统报价 

 

Quotation for Control System

	
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

	
1976.00

	
3

	
CPU

	
6ES7 315-2EH13-0AB0

	
315-2 PN/DP 256KB RAM; MPI/PROFIBUS DP;PROFINET 接口

	
SIEMENS

	
1

	
13227.00

	
13227.00

	
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

	
1

	
1013.00

	
1013.00

	
7

	
DO 模块

	
6ES7 322-1BH01-0AA0

	
16 点数字输出24V DC(20 针)

	
SIEMENS

	
5

	
1409.00

	
7045.00

	
8

	
AI 模块

	
6ES7 331-7KF02-0AB0

	
8 通道模拟输入(20 针)

	
SIEMENS

	
4

	
3899.00

	
15596.00

	
9

	
AO 模块

	
6ES7 332-5HF00-0AB0

	
8 通道模拟输出(40 针)

	
SIEMENS

	
1

	
6065.00

	
6065.00

	
10

	
连接端子

	
6ES7 392-1AJ00-0AA0

	
20 针,螺钉型端子

	
SIEMENS

	
10

	
149.00

	
1490.00

	
11

	
连接端子

	
6ES7 392-1AM00-0AA0

	
40 针,螺钉型端子

	
SIEMENS

	
1

	
234.00

	
234.00

	
12

	
变频器

	  	
MM420 1.5KW

	
SIEMENS

	
4

	
2400.00

	
9600.00

	
13

	
变频器操作面板

	
6SE6 400-0BP00-0AA0

	
BOP 面板

	
SIEMENS

	
4

	
300.00

	
1200.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第20页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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

	
14

	
开关电源

	
6EP1 334-3BA00

	
SITOP 24V/10A

	
SIEMENS

	
1

	
1500.00

	
1500.00

	
15

	
控制柜

	  	
2000×800× 600(含继电器、端子等柜内电气元件)

	
shanghai

	
1

	
14000.00

	
14000.00

	
16

	
控制箱

	  	
壁挂式(含按钮、端子等柜内电气元件)

	
shanghai

	
1

	
5000.00

	
5000.00

	
17

	
触摸屏

	
6AV6 643-0CD01-1AX1

	
MP 277 10" Touch 64K 颜色

	
SIEMENS

	
2

	
12000.00

	
24000.00

	
18

	
交换机

	
6 RJ45 口

	
工业以太网交换机

	
MOXA

	
1

	
1200.00

	
1200.00

	
19

	
网线

	  	
超五类双绞线

	
安普

	
100

	
5.00

	
500.00

	
20

	
电缆

	  	
RVV 2*1.0(米)

	
WUXI

	
4000

	
3.00

	
12000.00

	
21

	
电缆

	  	
RVVp 2*1.0( 米)

	
WUXI

	
2000

	
4.00

	
8000.00

	
22

	
电缆

	  	
RVVP3*6+1( 米)

	
WUXI

	
300

	
33.75

	
10125.00

	
23

	
桥架

	  	
150*75(米)

	
WUXI

	
200

	
68.75

	
13750.00

	
一、

	
控制系统所用材料

	  	  	
149195.00

	
二、

	
编程费 Programme Cost(1 人30 个工作日)

	  	  	
20000.00

	
三、

	
安装费用(3人10 个工作日)

	  	  	
15000.00

	
四、

	
调试费 Commissioning Cost(2 人10 个工作日,含住宿交通等)

	  	  	
32000.00

	  	
总价 Total Price(RMB) :贰拾壹万陆仟壹佰玖拾伍 圆整

	  	  	
216195.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第21页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

2.2.5. 罐体 

 

Configuration list for Bank

 

	  Configuration list for   PW Bank 培养基配制罐(1106)配置清单
	
Item

	
Supply Scope

	
Specification

	
Material

	
Quantity

	
Manufacturer

	
Remarks

	
序号

	
供货范围

	
规格

	
材料

	
数量

	
供应商

	
备注

	
1

	
培养基配制罐(1106)

	
1.5m3,压力容器,立式,带罐底阀,夹套冷却,磁力搅拌

	
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

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第22页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

 

	
13

	
卡接头

	
DN25

	
316L

	
3

	
Alfa Laval

	
ASME BPE-EP

	
14

	
卡接头

	
DN19

	
316L

	
6

	
Alfa Laval

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
Alfa Laval

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
Alfa Laval

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
Alfa Laval

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
Alfa Laval

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
Alfa Laval

	
ASME BPE-EP

	  	
以上为培养基配制罐(1106)配置清单

	  	  	  
	
Configuration list for PW Bank 培养基配制罐(1109)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

	
培养基配制罐(1109)

	
0.5m3,压力容器,立式,带罐底阀,夹套冷却,磁力搅拌

	
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

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第23页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

 

	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	 
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	 
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	 
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	 
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	 
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	 
	
13

	
卡接头

	
DN25

	
316L

	
3

	
Alfa Laval

	
ASME BPE-EP

	
14

	
卡接头

	
DN19

	
316L

	
6

	
Alfa Laval

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
Alfa Laval

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
Alfa Laval

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
Alfa Laval

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
Alfa Laval

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
Alfa Laval

	
ASME BPE-EP

	
以上为培养基配制罐(1109)配置清单

	  	  
	Configuration list for PW Bank	
缓冲液配制罐(1421)配置清单

	  	  
	
Item

	
Supply Scope

	
Specification

	
Material

	
Quantity

	
Manufacturer

	
Remarks

	
序号

	
供货范围

	
规格

	
材料

	
数量

	
供应商

	
备注

	
1

	
缓冲液配制罐(1421)

	
0.6m3,压力容器,立式,带罐底阀,磁力搅拌,带保温

	
316L

	
1

	
RiTai

	
内部抛光Ra<0.5um,外部亚光处理Ra<0.8um

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第24页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
2

	
呼吸器

	
10" 0.22um

	
316L

	
1

	
PALL

	  
	
3

	
喷淋球

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
Alfa Laval

	
ASME BPE-EP

	
14

	
卡接头

	
DN19

	
316L

	
6

	
Alfa Laval

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
Alfa Laval

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
Alfa Laval

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
Alfa Laval

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
Alfa Laval

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
Alfa Laval

	
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 201100

T:021 54306717    F: 021 54306718

	
第25页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	  	
以上为缓冲液配制罐(1421)配置清单

	  	  	  
	
Configuration list for PW Bank 缓冲液暂存罐(1301)配置清单

	  	  	  
	
Item

	
Supply Scope

	
Specification

	
Material

	
Quantity

	
Manufacturer

	
Remarks

	
序号

	
供货范围

	
规格

	
材料

	
数量

	
供应商

	
备注

	
1

	
缓冲液暂存罐(1301)

	
0.6m3,压力容器,立式,带罐底阀,带保温

	
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

	
喷淋球

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
温度变送器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
5

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
6

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
7

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
8

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
9

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
10

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
11

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
12

	
卡接头

	
DN25

	
316L

	
3

	
Alfa Laval

	
ASME BPE-EP

	
13

	
卡接头

	
DN19

	
316L

	
6

	
Alfa Laval

	
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 201100

T:021 54306717    F: 021 54306718

	
第26页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
14

	
卡环

	
DN25

	
304

	
6

	
Alfa Laval

	
ASME BPE-EP

	
15

	
卡环

	
DN19

	
304

	
8

	
Alfa Laval

	
ASME BPE-EP

	
16

	
密封圈

	
DN25

	
PTFE

	
6

	
Alfa Laval

	
ASME BPE-EP

	
17

	
密封圈

	
DN19

	
PTFE

	
8

	
Alfa Laval

	
ASME BPE-EP

	
18

	
变径三通

	
DN25/19

	
316L

	
1

	
Alfa Laval

	
ASME BPE-EP

	
以上为缓冲液暂存罐(1301)配置清单及报价

	  	  
	Configuration list for PW Bank	
培养基配制罐(2106)配置清单

	  	  
	
Item

	
Supply Scope

	
Specification

	
Material

	
Quantity

	
Manufacturer

	
Remarks

	
序号

	
供货范围

	
规格

	
材料

	
数量

	
供应商

	
备注

	
1

	
培养基配制罐(2106)

	
1.5m3,压力容器,立式,带罐底阀,夹套冷却,磁力搅拌

	
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

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第27页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
Alfa Laval

	
ASME BPE-EP

	
14

	
卡接头

	
DN19

	
316L

	
6

	
Alfa Laval

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
Alfa Laval

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
Alfa Laval

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
Alfa Laval

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
Alfa Laval

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
Alfa Laval

	
ASME BPE-EP

	  	
以上为培养基配制罐(2106)配置清单

	  	  	  
	
Configuration list for PW Bank 培养基配制罐(2109)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

	
培养基配制罐(2109)

	
0.5m3,压力容器,立式,带罐底阀,夹套冷却,磁力搅拌

	
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

	
1

	
Alfa Laval

	
旋转式

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第28页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
Alfa Laval

	
ASME BPE-EP

	
14

	
卡接头

	
DN19

	
316L

	
6

	
Alfa Laval

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
Alfa Laval

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
Alfa Laval

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
Alfa Laval

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
Alfa Laval

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
Alfa Laval

	
ASME BPE-EP

	  	
以上为培养基配制罐(2109)配置清单

	  	  	  
	
Configuration list for PW Bank 缓冲液配制罐(2421)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 201100

T:021 54306717    F: 021 54306718

	
第29页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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

	
缓冲液配制罐(2421)

	
0.6m3,压力容器,立式,带罐底阀,带保温,磁力搅拌

	
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

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
Alfa Laval

	
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 201100

T:021 54306717    F: 021 54306718

	
第30页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
14

	
卡接头

	
DN19

	
316L

	
6

	
Alfa Laval

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
Alfa Laval

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
Alfa Laval

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
Alfa Laval

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
Alfa Laval

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
Alfa Laval

	
ASME BPE-EP

	  	
以上为缓冲液配制罐(2421)配置清单

	  	  	  
	
Configuration list for PW Bank 缓冲液暂存罐(2301)配置清单

	  	  	  
	
Item

	
Supply Scope

	
Specification

	
Material

	
Quantity

	
Manufacturer

	
Remarks

	
序号

	
供货范围

	
规格

	
材料

	
数量

	
供应商

	
备注

	
1

	
缓冲液暂存罐(2301)

	
0.6m3,压力容器,立式,带罐底阀,带保温

	
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

	
喷淋球

	
DN40

	
316L

	
1

	
Alfa Laval

	
旋转式

	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
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 201100

T:021 54306717    F: 021 54306718

	
第31页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
Alfa Laval

	
ASME BPE-PL

	
14

	
卡接头

	
DN19

	
316L

	
6

	
Alfa Laval

	
ASME BPE-PL

	
15

	
卡环

	
DN25

	
304

	
6

	
Alfa Laval

	
ASME BPE-PL

	
16

	
卡环

	
DN19

	
304

	
8

	
Alfa Laval

	
ASME BPE-PL

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
Alfa Laval

	
ASME BPE-PL

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
Alfa Laval

	
ASME BPE-PL

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
Alfa Laval

	
ASME BPE-PL

	  	
以上为缓冲液暂存罐(2301)配置清单

	  	  	  	  
	
Configuration list for CIP Bank   CIP 清洗罐配置清单

	  	  	  	  
	
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

	
CIP 清洗罐

	
0.6m3,常压容器,立式,

	
316L

	
1

	
RiTai

	
内部抛光Ra<0.5um

	
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 201100

T:021 54306717    F: 021 54306718

	
第32页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
3

	
喷淋球

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
6

	
卡接头

	
DN25

	
316L

	
2

	
Alfa Laval

	
ISO 2037

	
7

	
卡环

	
DN25

	
304

	
2

	
Alfa Laval

	
ISO 2037

	
8

	
密封圈

	
DN25

	
PTFE

	
2

	
Alfa Laval

	
ISO 2037

	  	
以上为CIP 清洗罐配置清单

	  	  	  
	
Configuration list for CIP Bank   CIP 酸碱配制罐配置清单

	  	  	  
	
Item

	
Supply Scope

	
Specification

	
Material

	
Quantity

	
Manufacturer

	
Remarks

	
序号

	
供货范围

	
规格

	
材料

	
数量

	
供应商

	
备注

	
1

	
CIP 酸碱罐

	
0.6m3,常压容器,立式,

	
316L

	
1

	
RiTai

	
保温,内部抛光Ra<0.5um

	
2

	
呼吸器

	
10 “ 0.22um

	
316L

	
1

	
PALL

	  
	
3

	
喷淋球

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
5

	
卡接头

	
DN25

	
316L

	
2

	
Alfa Laval

	
ISO 2037

	
6

	
卡环

	
DN25

	
304

	
2

	
Alfa Laval

	
ISO 2037

	
7

	
密封圈

	
DN25

	
PTFE

	
2

	
Alfa Laval

	
ISO 2037

	  	
以上为CIP 酸碱罐配置清单

	  	  	  

	
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 201100

T:021 54306717    F: 021 54306718

	
第33页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

2.2.6. 焊点费 

 

Welding Point Cost

 

	
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

	
配液系统

	  	
自动焊点

	
1312

	
150.00

	
196,800.00

	
2

	
CIP 系统

	  	
自动焊点

	
602

	
150.00

	
90,300.00

	
3

	
罐的安装

	  	  	
12

	  	
60,000.00

	  	  	  	
总价

	  	  	
287,100.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第34页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

2.2.7. 系统所用辅材数量清单 

 

Accessories List

 

	  	  	
胶木支架(套包含连接件)

Bakelite Bracket(set)

	
不锈钢底板(套)

Stainless steel Plate (set)

	
穿墙套管(套)

Ceiling Access Pipe(set)

	
固定用支架(个)

V Bar carbon steel(Piece)

	
氩气费 

	  	
钢平台 

	
酸洗费 

	
数量

	
单价

	
合计

	
数量

	
单价

	
合计

	
数量

	
单价

	
合计

	
数量 

	
单价

	
合计

	
价格 

	  	
价格 

	
价格 

	
1

	
配料管道系统

	
85

	
45.00

	
3825.00

	
85

	
50.00

	
4250.00

	
14

	
120.00

	
1680.00

	
25

	
45.00

	
1125.00

	
18000.00

	  	
0.00

	
9000.00

	
2

	
CIP 管道系统

	
18

	
45.00

	
810.00

	
18

	
50.00

	
900.00

	
 2

	
120.00

	
240.00

	
15

	
45.00

	
675.00

	
9000.00

	  	
180000.00

	
8000.00

	  	  	
共计:Total

	
4635.00

	
共计:Total

	
5150.00

	
共计:Total

	
1920.00

	
共计:Total

	
1800.00

	
27000.00

	  	
180000.00

	
17000.00

	  	  	  	
合计 Total: 

	  	
237505.00

	  	  

	
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 201100

T:021 54306717    F: 021 54306718

	
第35页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

2.2.8. 验证服务报价 

 

Quotation For Validation Activities

 

	
序号 

No.

	
验证项目

Scope

	
报价

Quotation(RMB)

	
1

	
EPO 配制系统 

EPO preparation system

	
DQ,TM,RA

	
20,000

	
2

	
FAT,SAT

	
15,000

	
3

	
IQ

	
15,000

	
4

	
OQ

	
25,000

	
6

	
TPO 配制系统 

TPO preparation system

	
DQ,TM,RA

	
20,000

	
7

	
FAT,SAT

	
15,000

	
8

	
IQ

	
15,000

	
9

	
OQ

	
25,000

	
11

	
CIP 站

CIP system

	
DQ,TM,RA

	
20,000

	
12

	
FAT,SAT

	
15,000

	
13

	
IQ

	
15,000

	
14

	
OQ

	
25,000

	
11

	
控制系统 Automatic control system

	
控制系统验证Validation of control system

	
200,000

	
15

	
总价

	
425,000

	  	
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 201100

T:021 54306717    F: 021 54306718

	
第36页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

3.方案二 管材管件主为NEUMO

 

3.1. 报价一览表

	
Item 序号

	
Scope of Supply 供货范围

	
Price (RMB) 价格

	
1

	
Price Breakdown for PRO Distribution System 配料系统材料清单及报价

	
1,706,773.92

	
2

	
Price Breakdown for CIP Distribution SystemCIP 系统材料清单及报价

	
1,453,306.31

	
3

	
EPO Automatic Control SystemEPO 自动化控制系统

	
228,195.00

	
3

	
TPO Automatic Control SystemTPO 自动化控制系统

	
216,195.00

	
4

	
Piping surport 辅助材料,洁净区用不锈钢支架,非洁净区用镀锌角铁

	
237,505.00

	  	
Subtotal 1 for Material 材料费用

	
3,841,975.23

	
5

	
Welding Point Cost 焊点费用

	
287,100.00

	
6

	
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

	
35,880.00

	
7

	
Endoscopic Check ( 20% of total welding point ) 120 RMB /point 内窥镜检测,自动焊点的20%取样,80 元/焊点

	
31,104.00

	
8

	
X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point X -光检测,(100%手工焊点,所有焊样),180 元/ 焊点,

	
28,800.00

	
9

	
Insurance and Transportation 保险和运输

	
60,000.00

	  	
Subtotal 2 for Piping fabrication 管道装配

	
442,884.00

	
11

	
Detail Design, Shop Drawings and As-built Drawings 详细设计,施工图纸和竣工文件

	
150,000.00

	
12

	
Quotation For Validation Activities 验证服务报价

	
425,000.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第37页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
13

	
COMPANY Management & Supervision 公司管理&监督

	
400,000.00

	
13

	
Project Management & Supervision 项目管理&监督

	
100,000.00

	
14

	
Commissioning 调试

	
50,000.00

	  	
Subtotal 3 for Project Service 项目服务

	
1,125,000.00

	  	
Subtotal 1, 2, 3,合计

	
5,409,859.23

	  	
Tax 税金(主材部分开增值税,其他开工程发票)

	
93,022.15

	  	
Total Price 总价

	
5,502,881.38

	
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 201100

T:021 54306717    F: 021 54306718

	
第38页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

3.2. 分项报价清单

 

3.2.1. 物料系统材料清单及报价 

 

Price Breakdown for PRO Distribution System

	
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	
培养基配制罐1106

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
150,000.00

	
150,000.00

	2	
培养基配制罐1109

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
120,000.00

	
120,000.00

	3	
缓冲液配制罐1421

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
122,000.00

	
122,000.00

	4	
缓冲液暂存罐1301

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
80,000.00

	
80,000.00

	5	
气动隔膜阀

	
DN25

	
316L

	
13

	
GEMU

	  	
3,201.25

	
41,616.25

	6	
隔膜阀

	
DN40

	
316L

	
7

	
GEMU

	  	
3,538.75

	
24,771.25

	7	
隔膜阀

	
DN25

	
316L

	
32

	
GEMU

	  	
2,428.75

	
77,720.00

	8	
气动球阀

	
DN25

	
316L

	
4

	
King Lai

	  	
1,002.98

	
4,011.90

	9	
气动球阀

	
DN20

	
316L

	
4

	
King Lai

	  	
966.30

	
3,865.20

	10	
球阀

	
DN25

	
316L

	
4

	
King Lai

	  	
257.03

	
1,028.10

	11	
疏水器

	
DN20

	
316L

	
4

	
Spirax Sarco

	  	
2,875.00

	
11,500.00

	12	
过滤器

	
1.5T/h, 0.22um

	  	
1

	
PALL

	  	
12,250.00

	
12,250.00

 

	
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 201100

T:021 54306717    F: 021 54306718

	
第39页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
13

	
过滤器

	
0.6T/h, 0.22um

	  	
3

	
PALL

	  	
8,125.00

	
24,375.00

	
14

	
温度变送器

	
DN20

	
316L

	
4

	
E+H

	  	
2,375.00

	
9,500.00

	
15

	
隔膜压力表

	
0~4kgf/cm2,1′′卡箍接口

	
316L

	
8

	
Bright

	  	
437.50

	
3,500.00

	
16

	
卫生软管

	
DN25

	
PTFE

	
12

	
SAINT-GOBAIN

	  	
2,293.75

	
27,525.00

	
17

	
卡接头

	
38

	
316L

	
8

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
180.46

	
1,443.67

	
18

	
卡接头

	
25

	
316L

	
110

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
168.86

	
18,574.47

	
19

	
卡环

	
38

	
304

	
8

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
76.08

	
608.66

	
20

	
卡环

	
25

	
304

	
118

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
76.08

	
8,977.72

	
21

	
密封圈

	
38

	
PTFE

	
8

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
16.08

	
128.66

	
22

	
密封圈

	
25

	
PTFE

	
118

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
14.69

	
1,733.91

	
23

	
焊接三通

	
DN25

	
316L

	
28

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
204.56

	
5,727.81

	
24

	
焊接四通

	
DN25

	
316L

	
7

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
1,206.54

	
8,445.79

	
25

	
90°弯头

	
38

	
316L

	
6

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
244.32

	
1,465.91

	
26

	
90°弯头

	
25

	
316L

	
90

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
197.93

	
17,813.65

	
27

	
管道

	
φ38

	
316L

	
6

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
463.75

	
2,782.52

	
28

	
管道

	
φ25

	
316L

	
138

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
362.89

	
50,079.39

	
29

	
卡接头

	
38

	
316L

	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
59.28

	
948.52

	
30

	
卡接头

	
25

	
316L

	
18

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
48.04

	
864.64

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第40页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
31

	
卡接头

	
19

	
316L

	
20

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
47.40

	
948.00

	
32

	
卡环

	
38

	
304

	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
49.56

	
793.04

	
33

	
卡环

	
25

	
304

	
18

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
49.56

	
892.16

	
34

	
卡环

	
19

	
304

	
20

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
95.79

	
1,915.76

	
35

	
密封圈

	
38

	
PTFE

	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
41.88

	
670.12

	
36

	
密封圈

	
25

	
PTFE

	
18

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
46.51

	
837.11

	
37

	
密封圈

	
19

	
PTFE

	
20

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
37.12

	
742.35

	
38

	
三通

	
DN38

	
316L

	
2

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
87.88

	
175.76

	
39

	
三通

	
DN25

	
316L

	
4

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
65.08

	
260.33

	
40

	
异径三通

	
DN25/19

	
316L

	
4

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
81.60

	
326.40

	
41

	
三通

	
DN19

	
316L

	
4

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
262.44

	
1,049.74

	
42

	
90°弯头

	
38

	
316L

	
12

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
34.26

	
411.11

	
43

	
90°弯头

	
25

	
316L

	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
26.95

	
431.25

	
44

	
90°弯头

	
19

	
316L

	
12

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
220.33

	
2,643.95

	
45

	
管道

	
φ38

	
316L

	
36

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
178.44

	
6,423.67

	
46

	
管道

	
φ25

	
316L

	
12

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
125.53

	
1,506.35

	
47

	
管道

	
φ19

	
316L

	
12

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
102.22

	
1,226.68

	
一、

	
以上为EPO 工艺管线管材、管件配置及安装报价

	  	  	  	  	
854,511.78

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第41页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	1	
培养基配制罐2106

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
150,000.00

	
150,000.00

	2	
培养基配制罐2109

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
120,000.00

	
120,000.00

	3	
缓冲液配制罐2421

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
122,000.00

	
122,000.00

	4	
缓冲液暂存罐2301

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
80,000.00

	
80,000.00

	5	
气动隔膜阀

	
DN25

	
316L

	
13

	
GEMU

	  	
3,201.25

	
41,616.25

	6	
隔膜阀

	
DN40

	
316L

	
7

	
GEMU

	  	
3,538.75

	
24,771.25

	7	
隔膜阀

	
DN25

	
316L

	
32

	
GEMU

	  	
2,428.75

	
77,720.00

	8	
气动球阀

	
DN25

	
316L

	
4

	
King Lai

	  	
1,002.98

	
4,011.90

	9	
气动球阀

	
DN20

	
316L

	
4

	
King Lai

	  	
966.30

	
3,865.20

	10	
球阀

	
DN25

	
316L

	
4

	
King Lai

	  	
257.03

	
1,028.10

	11	
疏水器

	
DN20

	
316L

	
4

	
Spirax Sarco

	  	
2,875.00

	
11,500.00

	12	
过滤器

	
1.5T/h, 0.22um

	  	
1

	
PALL

	  	
12,250.00

	
12,250.00

	13	
过滤器

	
0.6T/h, 0.22um

	  	
3

	
PALL

	  	
8,125.00

	
24,375.00

	14	
温度变送器

	
DN20

	
316L

	
4

	
E+H

	  	
2,375.00

	
9,500.00

	
15

	
隔膜压力表

	
0~4kgf/cm2,1′′卡箍接口

	
316L

	
8

	
WIKA

	  	
437.50

	
3,500.00

	
16

	
卫生软管

	
DN25

	
PTFE

	
12

	
SAINT-GOBAIN

	  	
2,293.75

	
27,525.00

	
17

	
卡接头

	
38

	
316L

	
8

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
180.46

	
1,443.67

	
18

	
卡接头

	
25

	
316L

	
110

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
168.86

	
18,574.47

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第42页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
19

	
卡环

	
38

	
304

	
8

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
76.08

	
608.66

	
20

	
卡环

	
25

	
304

	
118

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
76.08

	
8,977.72

	
21

	
密封圈

	
38

	
PTFE

	
8

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
16.08

	
128.66

	
22

	
密封圈

	
25

	
PTFE

	
118

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
14.69

	
1,733.91

	
23

	
焊接三通

	
DN25

	
316L

	
28

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
204.56

	
5,727.81

	
24

	
焊接四通

	
DN25

	
316L

	
7

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
1,206.54

	
8,445.79

	
25

	
90°弯头

	
38

	
316L

	
6

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
244.32

	
1,465.91

	
26

	
90°弯头

	
25

	
316L

	
90

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
197.93

	
17,813.65

	
27

	
管道

	
φ38

	
316L

	
6

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
463.75

	
2,782.52

	
28

	
管道

	
φ25

	
316L

	
120

	
NEUMO

	
ASME BPE-PM,Ra≤0.5

	
362.89

	
43,547.29

	
29

	
卡接头

	
38

	
316L

	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
59.28

	
948.52

	
30

	
卡接头

	
25

	
316L

	
18

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
48.04

	
864.64

	
31

	
卡接头

	
19

	
316L

	
20

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
47.40

	
948.00

	
32

	
卡环

	
38

	
304

	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
49.56

	
793.04

	
33

	
卡环

	
25

	
304

	
18

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
49.56

	
892.16

	
34

	
卡环

	
19

	
304

	
20

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
95.79

	
1,915.76

	
35

	
密封圈

	
38

	
PTFE

	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
41.88

	
670.12

	
36

	
密封圈

	
25

	
PTFE

	
18

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
46.51

	
837.11

	
37

	
密封圈

	
19

	
PTFE

	
20

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
37.12

	
742.35

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第43页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
38

	
三通

	
DN38

	
316L

	  	
2

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
87.88

	
175.76

	
39

	
三通

	
DN25

	
316L

	  	
4

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
65.08

	
260.33

	
40

	
异径三通

	
DN25/19

	
316L

	  	
4

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
81.60

	
326.40

	
41

	
三通

	
DN19

	
316L

	  	
4

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
262.44

	
1,049.74

	
42

	
90°弯头

	
38

	
316L

	  	
12

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
34.26

	
411.11

	
43

	
90°弯头

	
25

	
316L

	  	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
26.95

	
431.25

	
44

	
90°弯头

	
19

	
316L

	  	
12

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
220.33

	
2,643.95

	
45

	
管道

	
φ38

	
316L

	  	
60

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
178.44

	
10,706.12

	
46

	
管道

	
φ25

	
316L

	  	
12

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
125.53

	
1,506.35

	
47

	
管道

	
φ19

	
316L

	  	
12

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
102.22

	
1,226.68

	
二、

	
以上为TPO 工艺管线管材、管件配置及安装报价

	  	  	  	  	
852,262.14

	  	
以上为工艺配料洁净管道系统管材,管件配置清单及报价

	  	  	  	  	
1,706,773.92

	
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 201100

T:021 54306717    F: 021 54306718

	
第44页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

3.2.2. CIP 站材料清单及报价 

 

Price Breakdown for CIP Distribution System

 

	
 

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

	
CIP 清洗罐

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
95,000.00

	
95,000.00

	
2

	
CIP 酸碱罐

	
详细配置见罐清单

	
316L

	
1

	
RITAI

	  	
79,000.00

	
79,000.00

	
3

	
气动球阀

	
DN40

	
316L

	
1

	
King Lai

	  	
1,280.80

	
1,280.80

	
4

	
气动隔膜阀

	
DN40

	
316L

	
15

	
GEMU

	  	
4,668.75

	
70,031.25

	
5

	
气动隔膜阀

	
DN25

	
316L

	
8

	
GEMU

	  	
3,201.25

	
25,610.00

	
6

	
隔膜阀

	
DN40

	
316L

	
2

	
GEMU

	  	
3,538.75

	
7,077.50

	
7

	
板式换热器一套

	
0.5m3,循环加热0.5 小时,

40-80oC

	
316L

	
4

	
Alfa Laval

	  	
33,750.00

	
135,000.00

	
8

	
温度变送器

	
DN20

	
316L

	
2

	
E+H

	  	
2,375.00

	
4,750.00

	
9

	
隔膜压力表

	
0~4kgf/cm2 

1′′卡箍接口

	
316L

	
1

	
CHINA

	  	
437.50

	
437.50

	
10

	
压力传感器

	
0~4kgf/cm2 

1′′卡箍接口

	
316L

	
1

	
CHINA

	  	
1,500.00

	
1,500.00

	
11

	
卫生离心泵

	
5T/h, 32m

	
316L

	
1

	
Alfa Laval

	  	
26,500.00

	
26,500.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第45页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
12

	
CIP 回流泵

	8T/h, 25m	
316L

	
3

	
Alfa Laval

	 	
62,500.00

	
187,500.00

	
13

	
酸碱计量泵

	0.1T/h, 18m	
316L

	
1

	
Prominent

	 	
33,125.00

	
33,125.00

	
14

	
电导率仪

	
4-20 mA output

	  	
1

	
Mettler toledo

	  	
14,000.00

	
14,000.00

	
15

	
PH 计

	
4-20 mA output

	  	
1

	
Mettler toledo

	  	
14,625.00

	
14,625.00

	
16

	
卡接头

	
63.5

	
316L

	
1

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
79.01

	
79.01

	
17

	
卡接头

	
51

	
316L

	
1

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
62.67

	
62.67

	
18

	
卡接头

	
38

	
316L

	
36

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
59.28

	
2,134.16

	
19

	
卡接头

	
25

	
316L

	
18

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
48.04

	
864.64

	
20

	
卡环

	
63.5

	
304

	
1

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
72.04

	
72.04

	
21

	
卡环

	
51

	
304

	
1

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
58.72

	
58.72

	
22

	
卡环

	
38

	
304

	
38

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
49.56

	
1,883.46

	
23

	
卡环

	
25

	
304

	
24

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
49.56

	
1,189.55

	
24

	
密封圈

	
63.5

	
PTFE

	
1

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
53.38

	
53.38

	
25

	
密封圈

	
51

	
PTFE

	
1

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
46.51

	
46.51

	
26

	
密封圈

	
38

	
PTFE

	
38

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
41.88

	
1,591.53

	
27

	
密封圈

	
25

	
PTFE

	
24

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
46.51

	
1,116.14

	
28

	
三通

	
DN38

	
316L

	
18

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
65.08

	
1,171.48

	
29

	
异径三通

	
DN38/25

	
316L

	
10

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
100.27

	
1,002.71

	
30

	
90°弯头

	
38

	
316L

	
46

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
34.26

	
1,575.91

	
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 201100

T:021 54306717    F: 021 54306718

	
第46页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

 

	
31

	
90°弯头

	
25

	
316L

	
16

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
26.95

	
431.25

	
32

	
管道

	
φ38

	
316L

	
96

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
178.44

	
17,129.79

	
33

	
管道

	
φ25

	
316L

	
6

	
Alfa Laval

	
ISO 2037,Ra≤0.5

	
125.53

	
753.18

	
一、

	
以上为CIP 清洗站管材、管件配置及报价

	  	  	  	  	  	
726,653.16

	  	
两套合计

	  	  	  	  	  	
1,453,306.31

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第47页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

3.2.3. EPO 线配液控制系统报价

 

Quotation for Control System

	
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

	
1976.00

	
3

	
CPU

	
6ES7 315-2EH13-0AB0

	
315-2 PN/DP 256KB RAM; MPI/PROFIBUS DP;PROFINET 接口

	
SIEMENS

	
1

	
13227.00

	
13227.00

	
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

	
1

	
1013.00

	
1013.00

	
7

	
DO 模块

	
6ES7 322-1BH01-0AA0

	
16 点数字输出24V DC(20 针)

	
SIEMENS

	
5

	
1409.00

	
7045.00

	
8

	
AI 模块

	
6ES7 331-7KF02-0AB0

	
8 通道模拟输入(20 针)

	
SIEMENS

	
4

	
3899.00

	
15596.00

	
9

	
AO 模块

	
6ES7 332-5HF00-0AB0

	
8 通道模拟输出(40 针)

	
SIEMENS

	
1

	
6065.00

	
6065.00

	
10

	
连接端子

	
6ES7 392-1AJ00-0AA0

	
20 针,螺钉型端子

	
SIEMENS

	
10

	
149.00

	
1490.00

	
11

	
连接端子

	
6ES7 392-1AM00-0AA0

	
40 针,螺钉型端子

	
SIEMENS

	
1

	
234.00

	
234.00

	
12

	
变频器

	  	
MM420 1.5KW

	
SIEMENS

	
4

	
2400.00

	
9600.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第48页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
13

	
变频器操作面板

	
6SE6 400-0BP00-0AA0

	
BOP 面板

	
SIEMENS

	
4

	
300.00

	
1200.00

	
14

	
开关电源

	
6EP1 334-3BA00

	
SITOP 24V/10A

	
SIEMENS

	
1

	
1500.00

	
1500.00

	
15

	
控制柜

	  	
2000×800× 600(含继电器、端子等柜内电气元件)

	
shanghai

	
1

	
14000.00

	
14000.00

	
16

	
控制箱

	  	
壁挂式(含按钮、端子等柜内电气元件)

	
shanghai

	
1

	
5000.00

	
5000.00

	
17

	
触摸屏

	
6AV6 643-0CD01-1AX1

	
MP 277 10" Touch 64K 颜色

	
SIEMENS

	
3

	
12000.00

	
36000.00

	
18

	
交换机

	
6 RJ45 口

	
工业以太网交换机

	
MOXA

	
1

	
1200.00

	
1200.00

	
19

	
网线

	  	
超五类双绞线

	
安普

	
100

	
5.00

	
500.00

	
20

	
电缆

	  	
RVV 2*1.0(米)

	
WUXI

	
4000

	
3.00

	
12000.00

	
21

	
电缆

	  	
RVVp 2*1.0( 米)

	
WUXI

	
2000

	
4.00

	
8000.00

	
22

	
电缆

	  	
RVVP3*6+1( 米)

	
WUXI

	
300

	
33.75

	
10125.00

	
23

	
桥架

	  	
150*75(米)

	
WUXI

	
200

	
68.75

	
13750.00

	
一、

	
控制系统所用材料

	  	  	
161195.00

	
二、

	
编程费 Programme Cost(1 人30 个工作日)

	  	  	
20000.00

	
三、

	
安装费用(3人10 个工作日)

	  	  	
15000.00

	
四、

	
调试费 Commissioning Cost(2 人10 个工作日,含住宿交通等)

	  	  	
32000.00

	  	
总价 Total Price(RMB) :贰拾贰万捌仟壹佰玖拾伍 圆整

	  	  	
228195.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第49页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

3.2.4. TPO 配液控制系统报价 

 

Quotation for Control System

 

	
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

	
1976.00

	
3

	
CPU

	
6ES7 315-2EH13-0AB0

	
315-2 PN/DP 256KB RAM; MPI/PROFIBUS DP;PROFINET 接口

	
SIEMENS

	
1

	
13227.00

	
13227.00

	
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

	
1

	
1013.00

	
1013.00

	
7

	
DO 模块

	
6ES7 322-1BH01-0AA0

	
16 点数字输出24V DC(20 针)

	
SIEMENS

	
5

	
1409.00

	
7045.00

	
8

	
AI 模块

	
6ES7 331-7KF02-0AB0

	
8 通道模拟输入(20 针)

	
SIEMENS

	
4

	
3899.00

	
15596.00

	
9

	
AO 模块

	
6ES7 332-5HF00-0AB0

	
8 通道模拟输出(40 针)

	
SIEMENS

	
1

	
6065.00

	
6065.00

	
10

	
连接端子

	
6ES7 392-1AJ00-0AA0

	
20 针,螺钉型端子

	
SIEMENS

	
10

	
149.00

	
1490.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第50页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
11

	
连接端子

	
6ES7 392-1AM00-0AA0

	
40 针,螺钉型端子

	
SIEMENS

	
1

	
234.00

	
234.00

	
12

	
变频器

	  	
MM420 1.5KW

	
SIEMENS

	
4

	
2400.00

	
9600.00

	
13

	
变频器操作面板

	
6SE6 400-0BP00-0AA0

	
BOP 面板

	
SIEMENS

	
4

	
300.00

	
1200.00

	
14

	
开关电源

	
6EP1 334-3BA00

	
SITOP 24V/10A

	
SIEMENS

	
1

	
1500.00

	
1500.00

	
15

	
控制柜

	  	
2000×800× 600(含继电器、端子等柜内电气元件)

	
shanghai

	
1

	
14000.00

	
14000.00

	
16

	
控制箱

	  	
壁挂式(含按钮、端子等柜内电气元件)

	
shanghai

	
1

	
5000.00

	
5000.00

	
17

	
触摸屏

	
6AV6 643-0CD01-1AX1

	
MP 277 10" Touch 64K 颜色

	
SIEMENS

	
2

	
12000.00

	
24000.00

	
18

	
交换机

	
6 RJ45 口

	
工业以太网交换机

	
MOXA

	
1

	
1200.00

	
1200.00

	
19

	
网线

	  	
超五类双绞线

	
安普

	
100

	
5.00

	
500.00

	
20

	
电缆

	  	
RVV 2*1.0(米)

	
WUXI

	
4000

	
3.00

	
12000.00

	
21

	
电缆

	  	
RVVp 2*1.0( 米)

	
WUXI

	
2000

	
4.00

	
8000.00

	
22

	
电缆

	  	
RVVP3*6+1( 米)

	
WUXI

	
300

	
33.75

	
10125.00

	
23

	
桥架

	  	
150*75(米)

	
WUXI

	
200

	
68.75

	
13750.00

	
一、

	
控制系统所用材料

	  	
149195.00

	
二、

	
编程费 Programme Cost(1 人30 个工作日)

	  	
20000.00

	
三、

	
安装费用(3人10 个工作日)

	  	
15000.00

	
四、

	
调试费 Commissioning Cost(2 人10 个工作日,含住宿交通等)

	  	
32000.00

	  	
总价 Total Price(RMB) :贰拾壹万陆仟壹佰玖拾伍 圆整

	  	
216195.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第51页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

3.2.5. 罐体 

 

Configuration list for Bank

 

	
 

Configuration list for PW Bank

	  	  	  	  
	
培养基配制罐(1106)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

	
培养基配制罐(1106)

	
1.5m3,压力容器,立式,带罐底阀,

夹套冷却,磁力搅拌

	
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

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第52页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
NEUMO

	
ASME BPE-EP

	
14

	
卡接头

	
DN19

	
316L

	
6

	
NEUMO

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
NEUMO

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
NEUMO

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
NEUMO

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
NEUMO

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
NEUMO

	
ASME BPE-EP

	  	
以上为培养基配制罐(1106)配置清单

	  	  	  	  
	
Configuration list for PW Bank

	  	  	  	  
	
培养基配制罐(1109)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

	
培养基配制罐(1109)

	
0.5m3,压力容器,立式,带罐底阀,夹套冷却,磁力搅拌

	
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 201100

T:021 54306717    F: 021 54306718

	
第53页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
3

	
喷淋球

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
NEUMO

	
ASME BPE-EP

	
14

	
卡接头

	
DN19

	
316L

	
6

	
NEUMO

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
NEUMO

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
NEUMO

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
NEUMO

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
NEUMO

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
NEUMO

	
ASME BPE-EP

	  	
以上为培养基配制罐(1109)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 201100

T:021 54306717    F: 021 54306718

	
第54页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

 

	Configuration list for PW Bank
	
缓冲液配制罐(1421)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

	
缓冲液配制罐(1421)

	
0.6m3,压力容器,立式,带罐底阀,磁力搅拌,带保温

	
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

	
喷淋球

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
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 201100

T:021 54306717    F: 021 54306718

	
第55页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
14

	
卡接头

	
DN19

	
316L

	
6

	
NEUMO

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
NEUMO

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
NEUMO

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
NEUMO

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
NEUMO

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
NEUMO

	
ASME BPE-EP

	  	
以上为缓冲液配制罐(1421)配置清单

	  	  	  	  
	
Configuration list for PW Bank

	  	  	  	  
	
缓冲液暂存罐(1301)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

	
缓冲液暂存罐(1301)

	
0.6m3,压力容器,立式,带罐底阀,带保温

	
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

	
喷淋球

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
温度变送器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
5

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
6

	
气动球阀

	
DN25

	
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 201100

T:021 54306717    F: 021 54306718

	
第56页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
7

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
8

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
9

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
10

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
11

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
12

	
卡接头

	
DN25

	
316L

	
3

	
NEUMO

	
ASME BPE-PL

	
13

	
卡接头

	
DN19

	
316L

	
6

	
NEUMO

	
ASME BPE-PL

	
14

	
卡环

	
DN25

	
304

	
6

	
NEUMO

	
ASME BPE-PL

	
15

	
卡环

	
DN19

	
304

	
8

	
NEUMO

	
ASME BPE-PL

	
16

	
密封圈

	
DN25

	
PTFE

	
6

	
NEUMO

	
ASME BPE-PL

	
17

	
密封圈

	
DN19

	
PTFE

	
8

	
NEUMO

	
ASME BPE-PL

	
18

	
变径三通

	
DN25/19

	
316L

	
1

	
NEUMO

	
ASME BPE-PL

	  	
以上为缓冲液暂存罐(1301)配置清单及报价

	  	  	  	  
	
Configuration list for PW Bank

	  	  	  	  
	
培养基配制罐(2106)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

	
培养基配制罐(2106)

	
1 .5m3,压力容器,立式,带罐底阀,夹

	
316L

	
1

	
RiTai

	
内部抛光Ra<0.5um, 外

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第57页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	  	  	
套冷却,磁力搅拌

	  	  	  	
部亚光处理Ra<0.8um

	
2

	
呼吸器

	
10 “ 0.22um

	
316L

	
1

	
PALL

	  
	
3

	
喷淋球

	
DN40

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
NEUMO

	
ASME BPE-EP

	
14

	
卡接头

	
DN19

	
316L

	
6

	
NEUMO

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
NEUMO

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
NEUMO

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
NEUMO

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
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 201100

T:021 54306717    F: 021 54306718

	
第58页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

 

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
NEUMO

	
ASME BPE-EP

	  	
以上为培养基配制罐(2106)配置清单

	  
	
Configuration list for PW Bank

	  	  	  	  
	
培养基配制罐(2109)配置清单

	  	  	  	  
	
Item

	
Supply Scope

	
Specification

	
Material

	
Quantity

	
Manufacturer

	
Remarks

	
序号

	
供货范围

	
规格

	
材料

	
数量

	
供应商

	
备注

	
1

	
培养基配制罐(2109)

	
0.5m3,压力容器,立式,带罐底阀,夹套冷却,磁力搅拌

	
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

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	

7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第59页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
NEUMO

	
ASME BPE-EP

	
14

	
卡接头

	
DN19

	
316L

	
6

	
NEUMO

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
NEUMO

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
NEUMO

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
NEUMO

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
NEUMO

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
NEUMO

	
ASME BPE-EP

	  	
以上为培养基配制罐(2109)配置清单

	  	  	  	  
	
Configuration list for PW Bank 缓冲液配制罐(2421)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

	
缓冲液配制罐(2421)

	
0.6m3,压力容器,立式,带罐底阀,带保温,磁力搅拌

	
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

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第60页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

 

	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
2

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
NEUMO

	
ASME BPE-EP

	
14

	
卡接头

	
DN19

	
316L

	
6

	
NEUMO

	
ASME BPE-EP

	
15

	
卡环

	
DN25

	
304

	
6

	
NEUMO

	
ASME BPE-EP

	
16

	
卡环

	
DN19

	
304

	
8

	
NEUMO

	
ASME BPE-EP

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
NEUMO

	
ASME BPE-EP

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
NEUMO

	
ASME BPE-EP

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
NEUMO

	
ASME BPE-EP

	  	
以上为缓冲液配制罐(2421)配置清单

	  	  	  	  
	
Configuration list for PW Bank

	  	  	  	  
	
缓冲液暂存罐(2301)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 201100

T:021 54306717    F: 021 54306718

	
第61页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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

	
缓冲液暂存罐(2301)

	
0.6m3,压力容器,立式,带罐底阀,带保温

	
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

	
喷淋球

	
DN40

	
316L

	
1

	
Alfa Laval

	
旋转式

	
5

	
温度变送器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
6

	
压力传感器

	
DN25,4-20 mA output

	  	
1

	
CHINA

	  
	
7

	
气动球阀

	
DN25

	
316L

	
1

	
King Lai

	  
	
8

	
气动球阀

	
DN20

	
316L

	
1

	
King Lai

	  
	
9

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
10

	
隔膜阀

	
DN15

	
316L

	
1

	
GEMU

	  
	
11

	
爆破片

	
0.5-4bar

	
316L

	
1

	
FIKE

	  
	
12

	
疏水器

	
DN20

	
不锈钢

	
1

	
Spirax Sarco

	  
	
13

	
卡接头

	
DN25

	
316L

	
3

	
NEUMO

	
ASME BPE-PL

	
14

	
卡接头

	
DN19

	
316L

	
6

	
NEUMO

	
ASME BPE-PL

	
15

	
卡环

	
DN25

	
304

	
6

	
NEUMO

	
ASME BPE-PL

	
16

	
卡环

	
DN19

	
304

	
8

	
NEUMO

	
ASME BPE-PL

	
17

	
密封圈

	
DN25

	
PTFE

	
6

	
NEUMO

	
ASME BPE-PL

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第62页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

	
18

	
密封圈

	
DN19

	
PTFE

	
8

	
NEUMO

	
ASME BPE-PL

	
19

	
变径三通

	
DN25/19

	
316L

	
1

	
NEUMO

	
ASME BPE-PL

	 	
以上为缓冲液暂存罐(2301)配置清单

	 	 

	Configuration list for  CIP Bank	  	  
	
CIP 清洗罐配置清单

	  	  
	
Item

	
Supply Scope

	
Specification

	
Material

	
Quantity

	
Manufacturer

	
Remarks

	
序号

	
供货范围

	
 规格

	
材料

	
数量

	
供应商

	
备注

	
1

	
CIP 清洗罐

	
0.6m3,常压容器,立式,

	
316L

	
1

	
RiTai

	
内部抛光Ra<0.5um

	
2

	
呼吸器

	
10“ 0.22um

	
316L

	
1

	
PALL

	  
	
3

	
喷淋球

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
称重模块

	
4-20 mA output

	  	
1

	
Mettler toledo

	  
	
5

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
6

	
卡接头

	
DN25

	
316L

	
2

	
Alfa Laval

	
ISO 2037

	
7

	
卡环

	
DN25

	
304

	
2

	
Alfa Laval

	
ISO 2037

	
8

	
密封圈

	
DN25

	
PTFE

	
2

	
Alfa Laval

	
ISO 2037

	 	
以上为CIP 清洗罐配置清单

	 	 
	Configuration list for  CIP Bank	  	  
	
CIP 酸碱配制罐配置清单

	  	  

	
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 201100

T:021 54306717    F: 021 54306718

	
第63页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 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

	
CIP 酸碱罐

	
0.6m3,常压容器,立式,

	
316L

	
1

	
RiTai

	
保温,内部抛光Ra<0.5um

	
2

	
呼吸器

	
10 “ 0.22um

	
316L

	
1

	
PALL

	  
	
3

	
喷淋球

	
DN25

	
316L

	
1

	
Alfa Laval

	
旋转式

	
4

	
隔膜阀

	
DN25

	
316L

	
1

	
GEMU

	  
	
5

	
卡接头

	
DN25

	
316L

	
2

	
Alfa Laval

	
ISO 2037

	
6

	
卡环

	
DN25

	
304

	
2

	
Alfa Laval

	
ISO 2037

	
7

	
密封圈

	
DN25

	
PTFE

	
2

	
Alfa Laval

	
ISO 2037

	  	
以上为CIP 酸碱罐配置清单

	  	  	  	  

	
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 201100

T:021 54306717    F: 021 54306718

	
第64页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

3.2.6. 焊点费 

 

Welding Point Cost

 

	
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

	
配液系统

	  	
自动焊点

	
1312

	
150.00

	
196,800.00

	
2

	
CIP 系统

	  	
自动焊点

	
602

	
150.00

	
90,300.00

	
3

	
罐的安装

	  	  	
12

	  	
60,000.00

	  	  	  	
总价

	  	  	
287,100.00

	
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 201100

T:021 54306717    F: 021 54306718

	
第65页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

3.2.7. 系统所用辅材数量清单 

 

Accessories List

 

	  	  	
胶木支架(套包含连接件)

Bakelite Bracket(set)

	
不锈钢底板(套)

Stainless steel Plate (set)

	
穿墙套管(套)

Ceiling Access Pipe(set)

	
固定用支架(个)

V Bar carbon steel(Piece)

	
氩气费 

	  	
钢平台 

	
酸洗费 

	
数量

	
单价

	
合计

	
数量

	
单价

	
合计

	
数量

	
单价

	
合计

	
数量 

	
单价

	
合计

	
价格 

	  	
价格 

	
价格 

	
1

	
配料管道系统

	
85

	
45.00

	
3825.00

	
85

	
50.00

	
4250.00

	
14

	
120.00

	
1680.00

	
25

	
45.00

	
1125.00

	
18000.00

	  	
0.00

	
9000.00

	
2

	
CIP 管道系统

	
18

	
45.00

	
810.00

	
18

	
50.00

	
900.00

	
 2

	
120.00

	
240.00

	
15

	
45.00

	
675.00

	
9000.00

	  	
180000.00

	
8000.00

	  	  	
共计:Total

	
4635.00

	
共计:Total

	
5150.00

	
共计:Total

	
1920.00

	
共计:Total

	
1800.00

	
27000.00

	  	
180000.00

	
17000.00

	  	  	  	
合计 Total: 

	  	
237505.00

	  	  

	
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 201100

T:021 54306717    F: 021 54306718

	
第66页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第1 部分投标书

Part 1 Tender

 

3.2.8. 验证服务报价 

 

Quotation For Validation Activities

 

	
序号 

No.

	
验证项目

Scope

	
报价

Quotation(RMB)

	
1

	
EPO 配制系统 

EPO preparation system

	
DQ,TM,RA

	
20,000

	
2

	
FAT,SAT

	
15,000

	
3

	
IQ

	
15,000

	
4

	
OQ

	
25,000

	
6

	
TPO 配制系统 

TPO preparation system

	
DQ,TM,RA

	
20,000

	
7

	
FAT,SAT

	
15,000

	
8

	
IQ

	
15,000

	
9

	
OQ

	
25,000

	
11

	
CIP 站

CIP system

	
DQ,TM,RA

	
20,000

	
12

	
FAT,SAT

	
15,000

	
13

	
IQ

	
15,000

	
14

	
OQ

	
25,000

	
11

	
控制系统 Automatic control system

	
控制系统验证Validation of control system

	
200,000

	
15

	
总价

	
425,000

	  	
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 201100

T:021 54306717    F: 021 54306718

	
第67页/ 共67 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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

 

 

第 2 部分

Part 2

公司介绍及资质文件

 

Company introduction and Certificate

 

 

 

 

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

 

 

	
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      201100

T:021 54306717      F: 021 54306718

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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

 

目 录

Index

	
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

	
31

	
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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

	
40

	
2.3.1. 完善的工艺设计Perfect in process design

	
40

	
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

	
47

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

1.1. 资质证书Certificate

1.1.1. 营业执照复印件Business license

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

1.1.2. 组织机构代码证Organization code 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

  

1.1.3. 税务登记证Business Registration

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

1.1.4. 银行开户证明The opening of bank accounts permits

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

1.1.5. 代理证书Agency

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

1.1.6. 协会证书CAPE 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

1.2. 部分业绩Part reference

1.2.1. 部分竣工项目一览表 Part finished project List

	
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 201100

T: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

	
	

工艺配料系统

Process Formulation 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

1.2.2. 部分在建同类工程一览表 Part constructing project List

	
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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

1.3. 2007 年财务报表Financial statement

 

针对本招标文件,公司提供2007 年度财务审计报告复印件作为参考。 

We provided the copy of 2007 financial statement as reference for the project bidding 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 201100

T:021 54306717    F: 021 54306718

	
第20页/ 共47 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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. 公司介绍Company Introduction

2.1. 公司概述Brief introduction

2.1.1. 公司实力Strength

公司上海朗脉科技有限公司由上海双赢洁净科技有限公司和上海朗和系统集成有限公司整合重组而成,公司注册资金一千万,现有员工一百多人。我们致力于成为中国最好的制药工程专业提供商。

 

Shanghai Macroprocess Co., Ltd. was founded by integrating Shanghai WinWin Process System Co., Ltd. and Shanghai Longhorn System Integration Co., Ltd. We have over one hundred employee with RMB 10 million pay up capital. We are committed to become a leading supplier for the total solution in pharmaceutical industry.

 

“朗脉”本着“以人为本、技术为核心”的原则,聘请多位国内外技术专家,经过长期发展,打造了一支经验丰富的设计、安装、调试及验证的专业队伍。我们为您的药厂建设提供专业的概念设计 、详细设计、工艺设备、洁净管道、暖通空调系统、洁净室系统、自动化系统、采购管理、施工管理、安装调试、验证等一体化服务。

 

Following the principle “ putting employee first, setting technology as core”, Macroprocess has accomplished an experienced professional team made up of experts on design , installation and validation by recuiting many technical experts both from home and abroad after a long-time development. We can provide your

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

pharmaceutical factory contruction with integrated services, including professional conceptual design, detailed design , process equipments , sanitary pipelines , HVAC system, cleanroom system, automation system , procurement management, construction management, installation with commissioning , validation and etc.

 

“朗脉”的客户涵盖了许多国内外知名的制药企业,其中已有多家客户通过FDA 、EME A、TGA 等国外认证,并建立了良好的长期合作关系。

 

Macroprocess has served many famous pharmaceutical enterprises both from home and abroad, of which many enterprises have passed foreign validation ( USA FDA, EU EMEA, Australian TGA and etc.) We are maintaining excellent cooperative relationship with our clients.

 

目前我们用户中已经通过国外验证的有some of our clients have gained International certification:

 

	
    ♦  

	
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

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

pharmceutical company, it is the first one of China which Sterile API was certified by EU EMEA.

 

	
    ♦  

	
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.

 

我公司在生物制药领域的部分客户有as the following there are some reference in bio pharmaceutical domain:

 

	
    ♦  

	
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,

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

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.

 

	
    ♦  

	
 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.

 

 

“朗脉”以“专业成就未来”为使命,打造中国真正意义上的制药领域的专业工程公司,不断增强公司的核心竞争力,推动更多的本土药厂走向世界。

 

With the mission that “expertise for future”, Macroprocess is committed to become a Chinese professional engineering company that can bring more and more local pharmaceutical companies to the world by continuously improving core competiton capability in pharmaceutical industry.

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

2.1.2. 公司历史History

 

	
  

	

♦ 

	
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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

	 	 	 

 

2.1.3. 公司文化Corporate cuture

	 	
·

	
朗脉的愿景The Vision of MACROPROCESS:

我们致力于成为中国最好的制药工程专业提供商。 

We are committed to become a leading supplier for the total solution in pharmaceutical industry.

	 	
·

	
朗脉的使命Mission of Macroprocess:

专业成就未来!Experitise for future!

	 	
·

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

合作、创新、负责、分享 Collaboration, Innovation, Responsibility and Sharing.

	 	
·

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

	 	
a

	
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;

	 	
a

	
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

 

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

	 	
 

	
number of high-standard projects;

	 	
a

	
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;

	 	
a

	
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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

2.1.4. 公司组织结构Organize chart

 

 

 

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

2.2. 朗脉的服务Service

2.2.1. 专业领域服务Professional service

“朗脉”在引进吸收国际先进项目管理理念的基础上,经过多年积累,建立了完善的项目管理体系,对工程整个周期进行全方位的管理,最大限度提高项目的成功率,降低过程控制的成本,规避项目风险。

 

With the introduction of advanced international project management ideology and many years’ experiences, Macroprocess has established a perfect project management system to conduct all-round management to the entire cycle of project. This system can facilitate project success , cost reduction and risk avoidance.

 

“朗脉”真诚的为您提供以下各专业服务Macroprocess can offer the following professional service: 

 

·   洁净管道系统Sanitary piping system

 

	
  

	
a

	
配料系统Formulation system:

	
       

	
·

	
小容量注射剂配料及输送系统 SVP formulation and distribution system

	
       

	
·

	
大输液配料及输送系统LVP formulation and distributionsystem 

	
       

	
·

	
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

	
       

	
·

	
无菌原料药生产工艺系统等Sterile raw material 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

process system etc.

	
  

	
a

	
 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.

	
  

	
a

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

	
  

	
a

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

	
  

	
a

	
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

	
  

	
a

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

	
  

	
a

	
洁净室空调自动化控制系统HVAC automation system

	
·  

	
洁净厂房系统Clean room system

	
  

	
a

	
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.

 

	
· 

	
验证服务Validation services

 

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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”专门的验证部门为您研究全球的认证规范,涉及FDA 、EMEA 、T GA、WHO 等。我们熟悉验证的重要性和复杂性,为顾客提供切实有效的验证服务,确保项目符合国内外GMP 法规要求。我们提供以下专业验证服务    Macroprocess Validation department can provide world class validation service, such as cGMP of SFDA, FDA, EMEA, TGA, WHO and etc. With great familiarity and complexity of validtion, we can provide pragmatic and effective validation services to ensure the uniformity of your project with GMP standards. We can provide the following professional validation services:

 

	
  

	
a

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

	
  

	
a

	
设计cGMP 审核Design cGMP Review

	
  

	
编写URS Writing of URS

	
  

	
a

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

	
  

	
a

	
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

	
  

	
a

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

	
  

	
a

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

	
  

	
a

	
清洗验证的指导Guiding of Cleaning Validation

	
  

	
a

	
工艺验证的指导Guiding of Process Validation

	
  

	
a

	
计算机系统的验证Computer System Validation

	
  

	
a

	
验证培训Validation Training

 

2.2.2. 工程总承包Contractor

 

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

对于任何一个项目,工程设计、安装调试、投资控制、工期控制和质量控制以及环保健康和安全管理等对于投资商的利益和发展都是至关重要。“朗脉”提供的专业化工程服务最大限度地避免了工程建设的风险,给投资方带来最大的经济效益。

 

For any project, the key to the benefit and development of investors are engineering design, installation and commissioning, investment control, project period control, quality control, environment protection, safety and security managemnt. Besides, GMP inspection consultation and validation services also play a special role in pharmaceutical factory project. Professional engineering services that offered by Macroprocess maximize the project risk avoidance and the benefit.

 

“朗脉”通过采用国际通用的工程总承包(EPC )模式,将“朗脉”自身的各子专业服务整合及与国际知名的工程公司合作,为您的药厂建设提供符合国际cGMP 规范的概念设计 、详细设计、工艺设备、洁净管道、暖通空调系统、洁净室系统、自动化系统、采购管理、施工管理、安装调试、验证等一体化整体解决方案。

 

Through adoption of EPC formula, integration of different specialties and cooperation with international famous engineering companies, Macroprocess can provide integrated total solution ,including conceptual design, detailed design, process equipments, sanitary piping , HVAC, cleanroom system, automation system , procurement management, construction management, installation, commissioning and validation etc. which are in conformity with international cGMP for pharmaceutical factory 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

 

 

2.2.3. 植物提取工艺优化Process optimization 

“朗脉”致力于植物提取工艺的优化及中药现代化。

we are committed to process optimization of plant extraction and TCM modernization

 

	
●  

	
植物提取工艺优化Optimization of Plant extraction 

我们提供植物提取生产线的工艺设计优化、工艺成套设备、管道安装及自动化集成等专业服务。 

 

We can provide process optimization for plant extraction production line, process equipment, piping installation and integration of automation control and etc.

 

	
●  

	
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节能、环保型干燥设备。彻底解决了其它干燥设备难以解决的高粘度、高脂、高糖、高热敏性等物料的干燥。 

 

Based on the introduction of foreign advanced technology ,

 

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

Macroprocess has developed this kind of new drying machine of high efficiency and ecological characteristics which can thoroughly solve the problem of drying substances of high vicosity, high fat, high sugar content and heat sensitivity etc. that other drying machines cannot overcome.

 

 

2.2.4. 自动化控制系统业务Automation Control system 

制药及相近行业自动化系统的设计、安装、调试及验证(中国GMP、欧盟EMEA 及美国FDA 的cGMP)的工程是上海朗脉科技有限公司主营业务之一。

 

Professional design, installation and validation (Chinese GMP,EU EMEA and USA FDA ) of automation systems for the pharmaceutical and relevant industry fields is one of Macroprocess Technology’s core business.

 

“朗脉科技”本着“以技术为核心”的原则,聘用多位国内外技术专家,经过长期发展,造就了一批经验丰富的设计、安装、调试及验证的专业团队。

 

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

In line with the principle “take the technology as the core”, we recruits lots of domestic and foreign technical experts. After the extensive experience we have cultivated and accomplished a group of specialized experts in design, installation and validation for domestic and foreign projects.

 

  2.2.5. 过程控制系统Process Flow 

 

在工业生产中,各单元操作集合而成的生产流程,例如:提取、发酵、合成、萃取、过滤、配料、浓缩、精馏、沉淀、结晶、干燥等,实现生产过程的自动化,并且可以大大提高生产效率,减少人为差错,保证产品质量,降低生产成本,提高生产质量管理水品,为企业现代化和信息化管理搭建数据平台。 

 

In pharmaceutical factory, the process flow integrated by each unit operation, i.e. extraction, fermentation, chemosynthesis, filtration, preparation, concentration, distillation, deposition, crystallization, drying and so on, and the process flow with automation could maximize production efficiency, reduce human error, ensure product quality, reduce production cost, advance the quality management level, set up the data platform for company modernization and informationization.

 

	

 

	
	
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

 

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

		
	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

 

上海朗脉科技有限公司拥有自己的洁净室项目实施管理团队,对制药厂房实 施项目实施。

 

Macroprocess has own team to manage clean room project, and to proceed the project for whole pharmaceutical facotory.

 

	 	

 

朗脉公司采用国际先进的板材保证洁净厂房的质量,采用先进的HVAC 系统,尤其对HVAC 系统进行自动化控制和门禁一卡通系统,实现EMS 管理和空气缓冲的互锁,符合FDA 的要求;对于空气质量要求高的厂房引入文丘里风阀系统保证压差。

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

 

 

朗脉公司认为一个好的洁净室项目的实施,离不开好的集成化的设计,公 司各个富有施工经验的专业人员利用三维设计对项目进行预演。

    We believe that to proceed a HVAC Automation system project without a integrated design, and we will preview the system via 3D software.

空调运行需要用大量的能源,系统在满足生产要求的前提下,实现能耗最 小化、运行效率最高化,可以提高设备运行安全可靠性和使用寿命。

HVAC’s operation needs lot of energy. BA system could minimize consumption, maximize operation efficiency, enhancing the reliability of operation and working life and achieving the process requirements.

系统具有数据记录、查询、报警、打印及趋势曲线图功能,利于管理。

 

	

 

	
	

[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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

BA System has the functions of data logging, search, alarm, printout and trend graph for easy operation.

 

2.2.7. 在线清洗系统Clean in place

 

全自动CIP 清洗是指设备(罐体、管道、泵等)及整个生产线在封闭的系 统中,无需人工拆卸便能进行有效的清洗和消毒。系统由酸、碱、热水、纯化 水、注射用水、酸碱配置罐和换热器组成,根据工艺特点设定酸碱浓度、清洗 流程、清洗液温度、清洗时间、保证产品质量,便于QA 工作的自动化和清洗 工作的规范化。

CIP means that the equipment and the whole production line could be efficiently cleaned and sanitized without disassembly in close system. A CIP system is composed by detergents, hot water, purified water, WFI, preparation tank and heat exchanger. Concentration of detergents, clean flow, water temperature and cleaning time can be set 

 

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

according to process specification, which could ensure the product quality, automation of QA affairs and standardization of cleaning. 

 

	
●

	
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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

2.3.1. 完善的工艺设计Perfect in process design 

 

对于我们承接的每一个项目,我们的设计团队在公司具有丰富管理施工经验的项目经理的领导下,并充分结合客户的URS 进行详细的优化设计,为客户做出具精确的P&ID 图、平面布局图、乃至施工图。这种优化设计是重要的,也是必须的,精确了材料数量,节省了施工时间,是为客户争取最大利益的保证。 

 

For each project in which we are participated, our project manager in construction; Our design team can provide fully integrated and optimized detailed design according to the URS of our clients, the precise P&ID chart, layout plans, as well as construction plans. This kind of optimized design is a must. The precise amount of material, the organization of time, guarantees to act in the best interests of customers. 

 

对于复杂的工艺管道系统,根据客户的需要和现场实际情况,我们的设计团队可以制作模拟现场的3D 效果图,从而保证了整个系统的精确定位和合理布置。3D 效果图可以衍生出相应的平面图,单管图及材料清单便于控制投资成本及施工周期,大大提高了施工效率和质量,是为提供给客户良好工程的重要 保证。 

 

Regarding complex piping systems, the needs of the customers and

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

the actual conditions, our design team can produce 3D simulation of the complete site, thus ensuring the accurate positioning and rational layout of the whole system. The corresponding plan can be developed from the 3D effect chart; singular pipeline plans can facilitate inventory control and materials costs and also the investment in the construction cycle, greatly increasing the efficiency and quality of construction.

2.3.2. 材料选型及采购Material Selection and Procurement

 

“质量和信誉是企业生存之本”,优质的材料供应商是高质量工程的基石。

Quality materials suppliers -- the cornerstone of high-quality works. 

 

采购部门,根据技术部门的提供的参数和要求,为客户选择可靠的供应商及高性价比的产品。通过对供应商的评估、采购数据、所购产品的认证并结合客户的URS 为我们良好的工程提供重要的保证。Procurement departments, according to provided technical parameters and requirements, purchase products from reliable suppliers with high performance. Through vendor evaluation, procurement data, certificate of products and integration with URS provide an important guarantee for our work. 

 

目前“朗脉科技”已经成为国内外许多知名公司的长期合作伙伴,如:After years of development, "Win Win" becomes the long-term partner of many well-known domestic and 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

瑞典:Alfa laval

德国:Gemu、Burker t、E+H、+GF+、Siemens 

瑞士:Mettler-Toledo 

丹麦:Grundfos 

台湾:Kinglai

 

优质的材料供应商,加上“朗脉科技”先进的优化设计理念、科学的工程管 理、丰富的国内外验证经验,以及科学严谨地规范每一个工作流程;确保您的整个自控系统工程准时、高质量地完成。

Good cooperative relations with suppliers and ensuring their quality plans to ensure that the project completed on time and according to the specified quality of the Client.

 

	 	 	 

 

2.3.3. 齐全的施工设备Construction facility 

我们齐全的施工设备能够承担任何作业。Our organization is fully equipped with hardware to undertake any task.

 

洁净管道专业切割设备Import cutting machinery specially for pipelines: 

	 	
●

	
 切割端面平整Flat 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 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

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

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

 

平口机完成专用切割机无法完成的其他任务,如特殊位置用的管件需要修整或对管道的端面进行平整等等。Tube square machine that can complete the mission that special cutting machine can not complete, e.g. special positions and surface in the pipeline which need trimming.

 

●  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

 

所有的焊接点都是经过专业处理,设备与材料具有可追溯型,手动焊接由受过培训的具有职业资格证书的人员操作。All welding joints are professionally treated; all materials and equipments are certified and traceable; Manual welding is accomplished by trained personnel with appropriate qualifications and certification.

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

 

 

	
2.3.4.

	
现场管理及现场施工Project management and construction

 

项目经理根据公司制定的良好工程规范组建项目组来进行质量管理、设计 变更控制、文件和数据的控制、采购控制、过程控制、检查和测试控制、检测 设备的控制、不合格品的控制、纠正和预防措施、安全防护控制、包装、运输、储存控制、培训以及验证等。

 

The project manager sets up the project team according to Clients Company for complete project quality management. Control in change of design, document and data control, procurement control, process control, inspection and control testing, testing of equipment control, control of defective products, corrective and preventive measures, security control, packaging, transport, storage control, training, testing and validation is also strictly monitored.

 

严谨规范的安装队伍是良好工程的保证。Installation team with stringent standards is our Guarantee for good work.

 

公司富有多年施工经验的施工人员将会按照公司制定的操作规范和客户要求进行施工操作。Our experienced construction staff are rich in experience and they will strictly follow the rules and regulations of operation, and customer 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 201100

T:021 54306717    F: 021 54306718

	
第44页/ 共47 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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

 

	 	 

 

2.3.5. 先进的检测设备Testing equipment 

 

先进的检测设备确保高质量的完成工程安装,公司拥有完善的焊接质量检测系统。Advanced testing equipment ensure the quality of the completed work.and Welding quality examination system as the follow aim: 

	
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 

为了确保每一个焊缝的焊接质量。公司结合科学的检测手段配备了先进的检测仪表,如X 光烫伤机、内窥镜、钝化检测仪等。To ensure the quality of welding, the company utilises the scientific detection means equipped with advanced instrumentation, such as the X-ray crack detection machine、Slope meter 、Passivation test and endoscope.

 

2.3.6. 系统调试和人员培训Training and system commission

根据包含的系统及其范围,我们将编制详细的调试计划。这个计划将包括范围内的每一个系统和设备的描述,包括自控系统;确定个系统进行调试顺利,

 

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	
第45页/ 共47 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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

 

 

及相关前后工序;与项目施工进度结合在一起。

 

According to the scope and contents of the system, we will establish the detailed commissioning plan. This plan will include descriptions of the scope for each system and equipment, including automatic control system and ensure all systems are commissioned in the correct order, and in their correlation to working procedures.

 

	 	 

 

我们确保所有人员的培训是有文件证明的。直到接受培训的人员能胜任他们各自的任务。

We ensure that all staff training is well documented with certification. Until those trained personnel are capable of performing their respective tasks.

 

所有人员的培训过程是必须可以被记录的。对于所有人员来说,都需要资格、经验和培训的记录。所有室内和室外的记录都将被保存。

All the training process must be documented for easy reference. For all the staffs they are required to acquire qualifications, experience and training records. All training records will be preserved.

 

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T: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

	
	

工艺配料系统

Process Formulation 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

 

2.3.7. 验证服务Validation service

 

作为药品生产过程中的关键系统。洁净管道在设计施工中面对的是严格的规范要求和质量标准。朗脉聘用的是曾经在跨国制药及工程公司服务多年的技术专家,按照国际GMP 规范进行洁净管道系统的验证。 

 

As one of the critical systems in pharmaceutical production facility, clean piping faces more and more stringent requirement on quality assurance and regulatory compliance. Macroprocess employs experts who have served at multinational pharmaceutical and engineering companies and provide qualification/validation services in accordance with international GMP guidelines.

 

我们在洁净管道系统方面的验证范围包括The scope of our qualification service include:

 

	
  

	
·

	
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 201100

T:021 54306717    F: 021 54306718

	
第47页/ 共47 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Techincal and control system proposal

 

 

第 3 部分

Part 3

 

技术及控制方案

 

Techincal and control system proposal

 

 

 

 

上海朗脉科技有限公司

 

ShangHai MacroProcess Technology Co.,Ltd

 

 

	
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      201100

T:021 54306717      F: 021 54306718

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

目 录

	
1. 技术方案Technical

	
2

	
  1.1. 项目背景Project Background

	
2

	
  1.2. 管道系统设计标准和规范Design Standards

	
4

	
  1.3. 施工规范和法规Construction Regulations and Guidance

	
8

	
   1.3.1. GMP 法规 GMP regulations

	
8

	
   1.3.2. ISPE 指南

	
9

	
   1.3.3. 工艺管道标准 Process pipe system standards

	
10

	
  1.4. 生产工艺描述Process Description

	
10

	
    1.4.1. 概要General

	
10

	
    1.4.2. 工艺配料系统Process Formulation System

	
11

	
2. 控制方案Technical

	
15

	
  2.1. 项目配置Project Configuration

	
15

	
    2.1.1. 系统拓扑结构Topological Structure of System

	
15

	
    2.1.2. 现场仪表层The Scene Instrument Layer

	
19

	
    2.1.3. 过程控制层Process Control Layer 

	
20

	
    2.1.4. 数据监控层Datamonitor Layer

	
22

	
  2.2. 技术方案Technical Solution

	
37

	
    2.2.1. 配液控制系统Liquid preparation control System

	
37

	
    2.2.2. CIP 在线清洗系统CIP control System

	
39

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第1页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

1. 技术方案Technical

 

1.1. 项目背景Project Background

沈阳三生制药有限责任公司是集生物药品的研发、生产和销售一体化的高新技术企业。公司的生产基地位于沈阳经济技术开发区,生产车间面积3000 平方米,通过了国家GMP 认证。公司计划建设新的厂房,提高生产能力,来满足日益增长的市场需求。

 

Shenyang Sunshine Pharmaceutical Company Limited (SUNSHINE) is an integrated biopharmaceutical company engaged in research/development, manufacture and marketing/sales of biopharmaceutical products in China. Its clinical and commercial manufacturing operations are based in Shenyang, China, where Chinese current Good Manufacturing Practice, or cGMP, certified, 3,000 square meters, and state-of-the-art facility resides. SUNSHINE plan to expand the plant in Shenyang to increase the manufacturing capacity and take further advantage of his favorable cost structure.

 

本次项目为沈阳三生制药有限责任公司的新建车间工艺配料系统的设计、材料、安装、检查和测试、调试、文件和交付。

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第2页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

This project is invited tender for design, supply & install of distribution loops for new workshop of SUNSHINE Company. And it is process formulation system including CIP system . this is a turnkey project.

 

上海朗脉科技有限公司被邀请参加本次洁净管路项目的招标,我们的系统方案以及设计完全按照业主2009 年1 月发布的招标要求以及系统设计要求。

 

Macroprocess was invited to provide a quotation for the clean piping/utilities systems of this facility. Our proposal is based on SUNSHINE’s tendering specification distributed in January 2009.

 

本次方案我们提供以下各系统的施工图设计,交货,安装,测试,调试和确认:

 

Our Scope of Work consists of final detail design, delivery, installation, testing, commissioning and qualification of following packages:

 

	 	
●

	
process formulation system 工艺配料系统

 

	 	
●

	
CIP 在线清洗系统

 

	 	
●

	
Related control system 相关的自控系统

 

	 	
●

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

 

各循环系统根据客户的要求进行详细设计,具体详见相关技术描述和

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第3页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

PID 图。我们按照GMP 的要求对贵公司的系统进行验证,此部分验证内容和报价可以参见报价清单说明。

 

All loop is designed to meet owner’s requirement and for details see technical description and PID.and we also provide the quotation on validtion to meet GMP requirement. And this part of validation scope and pricelist please refer to the related section.

 

公司聘认了国外专家专门从事FD A、WHO、欧盟、TGA 等法规的验证工作。“朗脉”的客户涵盖了许多国内外知名的制药企业,其中已有多家客户通过FDA 、EMEA 、TGA 等国外认证,并建立了良好的长期合作关系。

 

Macroprocess has accomplished an experienced professional team made up of experts on FDA ,WHO,EMEA,TGA validation by recuiting many technical experts both from home and abroad . Macroprocess has served many famous pharmaceutical enterprises both from home and abroad, of which many enterprises have passed foreign validation ( USA FDA, EU EMEA, Australian TGA and etc.) We are also maintaining excellent cooperative relationship with our clients.

 

1.2. 管道系统设计标准和规范Design Standards

	
  

	

·

	
According to related national and local government pipeline construction standards and stipulations

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第4页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

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 关于饮用水水质的指南

 

	
  

	
·

	
WHO about water treatment guide & aqueous system Examination guide 

WHO 关于水处理指南和水系统检测指南

 

	
  

	
·

	
Drugs production quality control in 1998 amended 药品生产质量管理规范1998 年修订

 

	
  

	
·

	
ASE BPE 2002 Edition 

ASE BPE 2002 年版

 

	
  

	
·

	
ICH Q7A GMP of Bulk Pharmaceutical Chemicals, November 2000 

ICH Q7A 原料药的GMP, 2000 年11 月

 

	
  

	
·

	
USP-29 2006 Edition 

USP-29 2006 年版

 

	
  

	
·

	
FDA federation laws & regulations related stipulation 

FDA 联邦法规有关规定

 

	
  

	
·

	
European pharmacopoeia 

欧洲药典

 

	
  

	
·

	
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》

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第5页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件 

Technical and control system

 

	
  

	
·

	
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》

 

	
  

	
·

	
According to Planning & Design Ordinance of Macroprocess Technology 

根据朗脉科技设计条例

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第6页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件 

Technical and control system

 

	
  

	
·

	
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

 

	
  

	
·

	
Laws and regulations for Electric appliance & installation 

电器设备和安装的法规

 

	
  

	
·

	
Laws & regulations for safety 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 201100

T:021 54306717    F: 021 54306718

	

第7页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件 

Technical and control system

 

安全标准、法典和规范

 

	 	
· 

	
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

 

1.3. 施工规范和法规Construction Regulations and Guidance

 

本洁净管道系统项目,将按照以下法规和指南进行设计、施工、调试和验证:This project for sanitary piping system will be assured that its design, construction, commissioning and qualification will be in accordance with the following regulations and guidance:

 

1.3.1. GMP 法规 GMP regulations

	 	
a)

	
(SFDA) 药品生产质量管理规范 1998 年修订版

Good Manufacturing Practice, revised in 1998

	 	
b)

	
(SFDA) 药品生产质量管理规范附录 1998 年

Annex of GMP, in 1998

	 	
c)

	
(FDA) 联邦法规第21 篇第210-211 部分,现行的成品药生产质量管理规范

21 CFR parts 210 and 211, Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals.

 

	 	
d)

	
(FDA) 联邦法规第21 篇第11 部分,电子记录和电子签名

21 CFR part 11, Electronic Records; Electronic Signatures

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第8页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件 

Technical and control system

 

	 	
e)

	
(FDA) 无菌工艺生产的无菌产品的GMP 的行业指南, 2004 年9 月

Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing- Current Good Manufacturing Practice, September 2004

 

	 	
f)

	
(FDA) 高纯水系统的检查指南,1993年7 月

Guide to Inspections of High Purity Water Systems, July 1993

 

	 	
g)

	
(Europe) 欧盟最新的

GMP European Current GMP

 

1.3.2. ISPE 指南

 

	
  

	
a)

	
ISPE 工程指南卷3:无菌生产厂房设施,2000年6 月

ISPE Baseline Guide Volume 3: Sterile Manufacturing Facilities, June 2000

 

	
  

	
b)

	
ISPE 工程指南卷4:水和蒸汽系统,2000年12 月

ISPE Baseline Guide Volume 4: Water and Steam System, December 2000

 

	
  

	
c)

	
ISPE 工程指南卷5:调试和确认,2000年6 月 

ISPE Baseline Guide Volume 5: Commissioning and Qualification, June 2000

 

	
  

	
d)

	
ISPE 工程指南卷6:生物制药,2003年1 月 

ISPE Baseline Guide Volume 6: Biopharmaceuticals, January 2003

 

	
  

	
e)

	
GAMP 5 : 制药生产中的自动化系统验证的良好规范 

Good Automated Manufacturing Practice for Validation of Automated Systems in Pharmaceutical Manufacture

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第9页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

1.3.3. 工艺管道标准 Process pipe system standards

 

	
  

	
a)

	
GB50235-97 工业金属管道工程施工及验收规范 

Code for construction and acceptance of industrial metallic piping.

 

	
  

	
b)

	
ASME BPE-2005 生物工艺设备 

Bioprocess equipment

 

1.4. 生产工艺描述Process Description

 

1.4.1. 概要General

 

以下技术描述基于UR S(用户需求规格)。我们提供各系统的详细设计包括设备,控制系统,以及各类仪表,并按照标准提供整个系统的设计、安装、交货、调试、验证、培训方案。我们的设计图纸(包括管路平面走向示意图、系统流程图和P&ID’s 等)将作为主要设计依据。另外,我们提供必要的条款,确保整个设计系统符合生产要求。

 

The following description is based on the URS. Upon award of the bid, we shall carry out detail design of the entire system including equipment, controls, and instrumentation, and use the approved design as guideline for the procurement, delivery, installation, commissioning and qualification of the system. Our design drawings, including Piping and Instrument Diagrams (P&ID's), piping layout drawing, piping isometric drawing and so on, will become the master documents to which and for which the Chengdu Institute’s documents will be modified. We shall provide necessary items to ensure that the overall system performs to meet the process requirements.

 

整个系统的符合中国、WHO、EU和FDA 的标准。

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第10页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

The sanitary aspects of the system will meet GMP requirements for China, WHO, EU and FDA.

 

  1.4.2. 工艺配料系统Process Formulation System

 

● 概述General

 

工艺配料系统:根据业主工艺流程要求,配合CIP/SIP 系统共同实现灭菌效果。CIP/SIP system will be designed as per client’s process requirements to sterilize Process Formulation System.

 

CIP 在位清洗站由注射水、纯水、碱液贮罐及动力罐、管道、分布器、出料泵、回流泵、气动控制阀、板式换热器、温度控制仪、电导率检测仪、称重模块、PLC 触摸屏及控制柜等部件组成。CIP system consists of storage tanks for WFI, PW and lye, power tank, piping, distributor, outfeed pump, return flow pump, pneumatic valves, plate exchanger, temperature controller, conductivity tester, weighing module, PLC touch screen and control cabinet.

 

贮罐用不锈钢316L 制作,具有保温层。出料泵入口与贮罐的底部放液口相连并用气动阀控制,其循环管道中设有板式换热器,清洗液经加热后送至各清洗点。回流泵入口与回流管道相连,其出口与贮罐上部的回流液入口相连,并用气动阀控制,每个贮液下部设有排污口,罐上设有温度计,顶部有孔盖,罐还设有呼吸器,以排放废气。阀门均由PLC 或PC 控制阀门的开关以实现各清洗程序。在管线上还设有各种在线检测元件以保证各项清洗参数。Storage tanks are made in AISI 316 stainless steel with heat insulation. The inlet of outfeed pump is connected with tank drains through pneumatic valves. Cleaning liquid will be heated by plate exchanger installed in the recirculation loop before reaching cleaning points. The inlet of return flow pump is connected with return flow

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第11页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

piping and outlet is connected with return flow inlet on the top of storage tanks through pneumatic valves. Each storage tank is equipped with drain, thermometer, lid and breathing ventilator. All valves are controlled by PLC or PC. Adequate online instruments are installed to monitor process parameters.

 

CIP 出料泵和回流泵选择离心泵。碱液从外部由蠕动泵输送到循环管道中。经纯化水或注射用水稀释后,由输送泵输送到需清洗的配液罐,清洗后的污水由回流泵返回CIP 罐或排放。Centrifugal pumps are used as outfeed pump and return flow pumps. Lye is pumped into recirculation loop by a dosing pump. After being diluted by PW or WFI, lye will be pumped into formulation tanks to be cleaned. Sewage will be drained or pumped into CIP tank by return flow pump.

 

所有的选型设备将满足不少于12 小时/天, 84 小时/周的工作强度要求。All the equipment will be guaranteed for 24 hours/day X 7 days/week per year operation. The major equipment within this system scope includes:

 

主要设备及工艺Main equipment and technical

 

	
  

	
Ø

	
阀门、仪表

 

自动化控制部分均选用进口气动操作阀组;现场仪表需采用隔膜式。CIP 管路管阀连接均采用快卡连接,其阀门采用卫生级隔膜阀。Import pneumatic opration valves configuration can be used in automatic control section; on-site instruments possess the characteristic of diaphragm-style. CIP ducts and valves are interconnected . All valves are hygienic diaphragm valves.

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第12页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

	
  

	
Ø

	
管道工程Pipelines Engineering

 

管道安装坡度不小于0.5%, 可重力全部排空;公司提供固定支架或滑动支架以便于现场安装。穿墙采用的是不锈钢套管,穿墙板或顶板采用不锈钢套管硅胶密封。

 

Pipeline installation slope won’t be less than 0.5%, for the total loss of gravity. Our company will provide both fixed frame and sliding frame for the pipeline bracket of on-site installation . Stainless steel pipe is used to pierce into the wall. Special seal on the joint of the penetration tube and inner pipe.

 

 

	
  

	
Ø

	
技术描述Technical Description

 

工作时,根据设置程序(程序可调)由CIP 清洗系统自动配制清洗液,首先检查清洗液的浓度是否按比例配制,如果浓度不够,泵入浓碱,直到罐内的浓度比例达到要求为止。经气动控制阀与增出料泵、回流泵来完成清洗液的输送及回流循环清洗、排放、回收的整个清洗过程。通过电导率、温度控制仪、酸碱计量及PLC 触摸屏组成的控制系统达到自动在线清洗功能。可以对每一道清洗程序时间、流量、电导率进行检测与记录,可打印输出,同时能确保清洗液温度和浓度在相应清洗过程中自动恒定,系统清洗结果由电导率仪自动检测显示,准确无误。

 

By setting up program to control CIP system , cleaning liquid can be automatically formulated. CIP system will firstly check whether the

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第13页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

density of cleaning liquid is formulated according to appropriate proportion or not. If not, alkali with high density will be pumped into the tank until the required density is achieved. The complete cleaning process ,including cleaning liquid transportation as well as the reflow liquid cleaning, discharging and recycling, is accomplished by pneumatic control valves , feeder pump and reflow pump. On-site cleaning function can be realized by utilizing electrical conductivity rate, temperature control meter , acid-alkali meter and PLC touch screen. Consequently, each cleaning program time ,flow and conductivity rate can be tested , recorded and printed out. Meanwhile, temperature and density can be assured consistently the same in different cleaning stages. System cleaning result can be automatically and precisely tested and displayed via conductivity rate meter.

 

循环泵根据瞬间用水量的大小实现自动变频控制,维持管道流速处于 0.6—1.5m/s 之间,以保证物料管道清洗效果。在系统循环泵出口设有在线隔膜式压力表,便于直观的看到泵的运行状况是否正常。所有水平管道均设计有1%的坡度,以便于排净管道中积水。Frequency of circulation pump would be automatically controlled as per instantaneous water current , so that water current velocity can be maintained between 0.6 to 1.5m/s. Thus a good cleaning result of the material pipelines can be assured. On-site diaphragm pressure meter beside the circulation pump exit can display the pump operation conditions. All pipelines are designed to own 1% slope , so that the water inside can be evacuated thoroughly.

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第14页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

主要清洗程序如下

注碱> > 碱循环> > 排空 > >碱回收 > > 纯化水冲洗碱 > >排空 > > 注射水清洗> > 排空> >压缩空气吹干 

配碱程序:水循环 > >补碱> > 碱加热 > > 配碱 > > 冲水 Main Cleaning Procedures as below 

Feeding Alkali> >Alkali circulation> > evacuation> >alkali recycling> >rinsing alkali with purified water> > evacuation> >rinsing with water for injection > >evacuation> >dying with compressed air

Alkali formulation procedure: water circulation> >feeding alkali> >heating alkali> >formulating alkali> >rinsing

 

2. 控制方案Technical

 

2.1. 项目配置Project Configuration

 

2.1.1. 系统拓扑结构Topological Structure of System 

 

两套工艺配料系统分别用两套PLC 系统控制。基本类似,控制层分为三层 , 总体结构如下图描述:

 

第一层为现埸仪表、执行器,即数据采集层和执行层;第二层为PLC 控制 器,即过程控制层,第三层为人机界面,通过彩色触摸屏的形式,实现对系统的监控,其中一线培养基配置罐1103/1109 设一台触摸屏,缓冲液配置罐1421 设一台触摸屏,缓冲液暂存罐1301 设一台触摸屏;二线培养基配置罐 2106/2109 设一台触摸屏,缓冲液配置罐2421 和缓冲液暂存罐2301 设一台触

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第15页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

摸屏,合计5 台触摸屏;系统实时状态、联动、报警、相关参数可以实现控制和记录,通常,至少实现三级密码保护。另外配置一台上位机,通过以太网(PN) 与纯化水和注射用水系统共用,实现打印、记录和存档等工作。

 

Two process ingredient systems are controlled by two PLC systems,the control layer is divided into three layers. The following diagram describes the overall structure:

 

The first layer is local instruments and actuators,just Data acquisition layer and implementation layer,PLC is the second layer,just process control layer.the third is a HMI device in the on the control cabniet.Through the in’touch ,the system is real-time monitored. Touch screens are used to First-line medium preparation tank 1103/1109, buffer preparation tank 1421, buffer tank 1301 for temporary save, Second-line medium preparation tank 2106/2109, buffer preparation tank 2421 and buffer tank 2301 for temporary save.there are five touch sreens.The system’s real-time data and status,interlock,alarms,general parameters can be controlled and recorded.Usually,it’s needed three grade password at least.Moreover,the system configured a computer as Engnieer Station. It is share with others system through Ethernet( PN ),to achieve print,record and store.

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第16页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

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 201100

T:021 54306717    F: 021 54306718

	

第17页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

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 201100

T:021 54306717    F: 021 54306718

	

第18页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

2.1.2. 现场仪表层The Scene Instrument Layer 

 

该层主要由电气执行设备和在线仪表组成,采集现场的参数信号,并执行PLC 下达的控制命令。 

 

The layer is mainly constituted by electrial devices and online instruments.It recives the scene’s parameters signals and actuates commands,which PLC sends. 

 

现场自动检测仪表对水处理和物料系统过程中的各个参数自动、连续地进行检测,通过变送器转换为4~20mA 标准信号,并将信号传送给PLC 控制站。 

 

The online instruments in the scene auotomatical and continuous detect parameters in water process and material systems,which are very importment to process control.And then these signals are transformed to 4~20mA standard signals by transmitters. These 4~20mA standard signals are transmitted to PLC,the control center. 

 

现场设备状态信号(如阀门的开关状态、泵的运行、故障状态)、报警信号直接传送到PLC 站,控制按钮、开关的动作信号等一般先经现场电控盘,以无源接点开关量信号的形式送至相应区域的PLC 站。 

 

The scene device’s status(for example valve’s O/C status,pump’s status,fault status) and alarms’ signals  are tranmittered to PLC plant.The actuator signals of buttons and switchs are through the electrial control panels ,which are installed in the scene,to PLC plant

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第19页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

with passive contact switch signal forms.

 

电气执行元件(如接触器、继电器、电磁阀线圈等)接收PLC 站开关量输出卡件送出的控制逻辑信号,用于改变现场设备的状态(如开关阀门、起停水泵)和信号屏指示灯的状态。

 

Electrial actuators(contactors),relays,solenoid valves) recives the logic signals which output cards send on PLC plant,so that changing the scene’s devices’status(open/close valves,run/stop pump) and signal lights’status.

 

执行系统一般具有现场手动/自动转换功能,功能便于设备的维护和调试,当某个设备切换到现场手动模式下,该设备就不受PLC 的控制,只接受现场的操作命令。

 

The actuator systems usually have manual/auto conversion function,so that these devices can be maintenanced and tested.When at manual mode,these devices are not controlled by PLC,instead of local operating commands.

 

2.1.3. 过程控制层Process Control Layer

 

● 主要功能Major Function

 

主要是完成控制联锁功能(PLC 控制站是本系统核心),系统的测控联锁功能主要是在这里完成的,包括:

 

This layer’s function is controlling the function of interlock(PLC

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第20页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

plant is the center of this system ).System’s function of measure and interlock are mainly finished in this layer.including:

 

	
  

	
v

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

 

	
  

	
v

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

 

	
  

	
v

	
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

 

根据工艺要求,完成对阀门,仪表,电机等控制;阀门的开关,仪表数据的采集,电机的启停;通过在程序中设计功能块,完成对这些阀门,电机等的控制;通过在上位机或者触摸屏上发命令,开启或者关闭阀门,启动或者停止电机,现场的阀门,电机收到信号动作,再反馈信号给PLC, 程序中采集到这些信号后,得出是否启动,是否动作,或者是否没有反馈,如果有反馈,在触摸屏上会显示一个运行状态,以颜色来区分。如果报警,又会以另外一种颜色来显示,提醒现场操作人员及时发现问题,解决问题;仪表反馈回来的信号,关键点都有工艺设定值,而一些不是很重要的点,只是在触摸屏中作为显示;象一些温度,流量,电导率,PH,压力等关键点通过PID 功能块来实现特定的控制功能。

 

According to the technical requirements, completion of the valves, meters, motor control, etc.Valves’ O/C, Instruments data acquisition,

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第21页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

motor start and stop. Through the process design function blocks to complete on these valves, electrical and machinery control. Through the PC or a touch screen, give an order to open/close the valve, start/stop the motor,then the scene of the valves,motors receive the electrical signals and act , and then feedback signals to PLC, PLC receives these signals ,and it is aware of status of these valves and motors, whether there is no feedback or not. If there is feedback ,on the touch screen,it will display a running status, to distinguish between colors. If alarm, with anothor color to show in the screen to remind the operator to detect and solve problems. Instrumentation feedback signal, the key point of both technology settings, and some not very important point, just display in a touch-screen.Such as temperature, flow, conductivity, PH, pressure , through the PID function blocks , achieve specific control functions.

 

2.1.4. 数据监控层Datamonitor Layer 

 

控制系统采用西门子人机界面,完成数据的采集、设定参数、处理和储存记录数据、实时时钟控制、监视、通讯等功能。 

 

Adopting PLC and touch screen control of Siemens as control system to gather, setup parameter,deal with and store data, to control real-time clock, to complete the display and communication etc.

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第22页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

● 显示功能Display Function

 

控制系统提供计算机图形化过程监控功能,操作人员可通过HMI 液晶屏观察生产线各自控设备单元的单元操作过程(例如生产品种、批号设备、所处的操作阶段,温度、压力、液位、时间等数据)。显示的画面种类如下:

 

The control system provides graphical process monitoring function. The operator can observe each unit control process of equipment of corrsponding production line (for example, the production of varieties, lot equipment, the operation phase, temperature, pressure, liquid level, time, etc. data)on computer screen. Displayed screen types as follows:

 

	
  

	
Ø

	
工艺流程图(Process Flow Diagram)

 

	
  

	
Ø

	
测量值显示(Measurement display)

 

	
  

	
Ø

	
趋势图显示(Trend display)

 

	
  

	
Ø

	
报警显示(Alarm display)

 

	
  

	
Ø

	
生产参数管理(Process parameters mangement)

不同产品在生产过程中,其工艺参数/控制参数可能各不相同,为了减轻工艺员烦琐的参数重复设定,减少参数输入出错率,保证系统非客观因素的正常运行,系统提供完善的生产参数管理功能;

 

Different products in the production process, the process parameters / control parameters may vary.In order to reduce cumbersome craft duplicate set of parameters, to reduce the error rate of

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第23页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

input parameters, and to ensure the system’s normal running of non-objective factors , System provides comprehensive management capabilities of production parameters. 

 

	 	
Ø

	
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. 

 

	 	
Ø

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

 

	 	
Ø

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

 

	 	
Ø

	
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. 

 

	 	
Ø

	
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. 

 

	 	
Ø

	
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

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第24页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

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.

 

	
  

	
Ø

	
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

 

	
  

	
控制系统提供即时报警和电子永久报警记录、查询功能,具体包括如下: Control system  provides real-time alarm and electronic permanent alarm records, the inquiry, including the following:

 

	
  

	
Ø

	
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.

 

	
  

	
Ø

	
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

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第25页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

distinction with different colors.

 

	
  

	
Ø

	
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.

 

	
  

	
Ø

	
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).

 

	
  

	
Ø

	
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.

 

	
  

	
Ø

	
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

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第26页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件 

Technical and control system

 

responsibility clearly.

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

操作人员可通过操作触摸屏编辑生产工艺,进行联动或单机启动/停止生产线的任一单元设备的单元操作过程和两个单元间的料液传输过程,还可暂停这些操作,进行人工干预。干预结束恢复正常控制,也可对各个控制环节和整个控制系统实施强制结束操作;

 

Operators can modify production process in in' touch sceen, so that carry out joint or signle start / stop any unit equipment ,unit operation process of production line and operate liquid transfer process  between  the two units, but also to suspend these operations, carry out human intervention. After interfere, the restoration of normal control, and also end each link or the entire control system in a mandtory operation. 

 

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

 

在授权允许的情况下,可通过操作触摸屏控制生产线的任何自控阀门开关、泵启停和电机启停、流量计清零操作,每次手动操作都会出现相应提示确认操作对话框,防止人为误操作。点动操作同样能够完成生产。

 

Authorization permission, through the operation of touch screen to control any self-control valve O/C, pump motor start or stop, flowmeter Clear operation of production line,.Each manual

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第27页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

operation,it will be prompted to confirm the operation with corresponding dialogue box, to prevent man-made misoperation.JOG operation can also complete the production.

 

	
●

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

 

计算机批量生产数据管理及报表功能如下Data management of mass production and print statements,function as follows:

 

	
  

	
Ø

	
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.

 

	
  

	
Ø

	
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.

 

	
  

	
Ø

	
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.

 

	
  

	
Ø

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

 

	
  

	
Ø

	
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

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第28页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

 

系统完善的操作记录及查询显示:

 

Perfect System operation records and inquiries show:

	
  

	
Ø

	
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.

 

	
  

	
Ø

	
记录操作内容、操作时间和操作者; 

Record on operational content, operation time and the operator.

 

	
  

	
Ø

	
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。 

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.

 

● 报警管理Alarm mangement

 

完善报警管理是系统安全操作控制保障。根据实践经验固化的报警管理系统已不再适应配液系统安全操作控制,报警管理控制系统提供全面的报警后台管理功能具体如下:

 

Perfect alarm management ensures the safe operation of system control. In accordance with practical experience in curing the alarm

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第29页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

management system,which is no longer equipped to adapt to the safe operation of hydraulic control systems.Alarm management control systems provide comprehensive background alarm management functions ,as follows:

 

	
  

	
Ø

	
报警值设定;Alarm set value

 

	
  

	
Ø

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

 

	
  

	
Ø

	
报警延迟时间设定;Alarm delay time settings

 

	
  

	
Ø

	
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

为了满足GAMP5 等规范的要求,本系统同时具有安全性及电子权限的设定、电子签名和电子记录功能。

 

In order to satisfy requirement of GMP5 etc, the System have security and electronic access settings, electronic signatures and electronic records functions.

 

系统采用封闭的系统管理,建立、修改、维保、或传送电子记录能够保持记录真实性、完整性和适当的机密性。电子签名和电子记录具有真实性,完整性,不可抵赖性,和不可篡改性。这样的程序和控制应包括如下:

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第30页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

The system uses a closed system management, to establish, modify, Maintenance, or send electronic records to maintain records of authenticity, integrity and appropriate confidentiality. Electronic signatures and electronic records have the functions of authenticity, integrity, non-repudiation, and not tamper with nature.

 

	
●

	
安全策略Security Policy

 

	
  

	
Ø

	
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.

 

	
  

	
Ø

	
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.

 

	
  

	
Ø

	
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

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第31页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

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.

 

	
  

	
Ø

	
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:

 

	
  

	
Ø

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

 

	
  

	
Ø

	
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.)

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第32页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

	
  

	
Ø

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

 

	
  

	
Ø

	
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.

 

	
  

	
Ø

	
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.

 

	
●

	
电子签名成分及管理 

Composition and management of electronic signatures 

 

	
  

	
Ø

	

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. 

 

	
  

	
Ø

	
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

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第33页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

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.

 

	
  

	
Ø

	
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.

 

	
●

	
识别代码和密码的管理

 

Identification code and password management. 

 

使用基于识别码和密码混合的电子签名应使用管理以保证他们的安全和完整,这种管理包括:

 

Using a mixture of electronic signatures based on ID and password ,people should study to manage it ,in order to ensure their safety and integrity, this management should include:

 

	
  

	
Ø

	
保持每一个的识别码和密码发布能定期被检查、收回或是修订; 

To ensure that each of the ID and password can be issued to regular inspection, to recover or to amend.

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第34页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

	
  

	
Ø

	
按照损失管理过程对丢失、被盗、找不到的用户和密码进行电子失效;

 

In accordance with loss management process ,these ID and password,such as thefting,losing and not finded should be conducted of electronic failure.

 

● 实施措施Implementing Measures

 

系统安全性由工艺的合理性、系统硬件、组态软件、二次开发软件操作安全性四部分组成,这里系统安全性是指二次开发软件操作安全性,为此本系统安全性由以下三部分组成:

 

System security is composed by the rationality of technology, system hardware, software configuration, the security of secondary development of software. System security here refers to the secondary development of software security, for it , the security of the system is composed by the following three parts:

 

	 	
Ø

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

 

	 	
Ø

	

电子权限管理Electronic Permissions management 

 

	 	
Ø

	

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. 

 

	 	
Ø

	

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

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第35页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

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).

 

Permission does not include inter-interoperability 。Any operation in the system has corresponding permission, only to log on and have the permissions to match their operation,and then operate it.

Permission of users to establish is  unified by the workshop manager in the management room. It has the

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第36页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

function to operate the registry and hasn’t the competence management capabilities in the operation room.When operators first use the user of workshop,operators are asked to mandatorily change their own passwords, so that it ensures a multi-level security and regulatory authority.

 

2.2. 技术方案Technical Solution

 

2.2.1. 配液控制系统Liquid preparation control System

配液控制系统功能描述如下(一、二线基本相同):

 

It’s the Function to Liquid preparation control System Description:

(The same of Line 1 & Line 2)

	
  

	
Ø

	
根据配液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 liquid preparation process requirement and URS.

 

	
  

	
Ø

	
控制系统用于配液系统的信号检测和过程控制;

This Monitor and Control System will be used for liquid preparation signal monitoring and process control 

 

	
  

	
Ø

	
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

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第37页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

Alarms.

 

	 	
Ø

	
现场控制系统带有密码权限功能,不同级别操作人员设不同操作权限

Different levels pass word are availably on control system, each operator will be assigned with different levels of access.

 

	 	
Ø

	
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.

 

	 	
Ø

	
在配液过程中,系统自动记录并保存过程中的温度、压力、流量、PH 参数以及每次操作人员资料,供以后查询追溯; 

During the liquid preparation, system will automatically record and store such important data like: Temperature, Pressure, Flow Rate, PH during the process and Operator’s Information for easy tracking in feature.

 

	
  

	
Ø

	
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.

 

	
  

	
Ø

	
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.

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第38页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

2.2.2. CIP 在线清洗系统CIP control System

 

	
●

	
CIP 的重要性(Importance of CIP)

GMP(Good Manufacturing Pra ctice)即药品良好的制作实施规范,目的是严格控制药品的制作过程,以保证药品的质量。在GMP 规范中,对于引起药品品种之间、药品批次之间的交叉污染要求严加排除,并实施在线的动态验证,以确保药品生产的万无一失。

 

GMP(Good Manufacturing Practice), the implementation norms of drugs production, in order to strictly control the drug production process to ensure the quality of medicines. In the GMP norms, Cross-contamination between drugs and batches is required strict exclusion. And implement a dynamic online verification, to ensure the safety of pharmaceutical production.

 

GMP 对制药设备有严格要求,设备除了要防止外界的微生物(杂菌)及其他杂菌混入反应物料之中外,还应具备原位清洗(Clean in place,简称 CIP) 的功能。在位清洗是指无需移动或拆卸设备即可进行有效清洗,以防止一批物料或其他杂质积存而影响后续批次的生产。

 

GMP for pharmaceutical equipment, there are strict requirements. Equipment has function of preventing micro-organisms (bacteria) and other bacteria of the outside world

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第39页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

into reaction of materials, but also has clean in place (Clean in place, referred to as CIP) function.CIP. Reign cleansing refers that it is not the need to move or demolition equipment to carry out effective cleaning to prevent a number of materials or other impurities affecting the accumulation of follow-up batches of production. 

 

● CIP 系统的组成(CIP System Composition)

 

在位清洗技术(Clean-in-place)是一种包括设备、管道、操作规程、自动控制和监控要求的一整套技术系统,能在不拆卸、不挪动设备、管线的情况下,利用清洗液的循环流动洗净污垢和滋生物。

 

Technology of CIP(Clean-in-place) is a kind of system which includes equipment, pipes, operation, automatic control and monitoring requirements technology.It can not be demolished, not to move equipment, and pipes, using of cleaning fluid circulation to wash dirt and Huizi biological. 

 

● CIP 的控制(Control of CIP)

 

a. CIP清洗程序(CIP Program)

 

	
  

	
v

	
碱洗(Alkaline clean)

 

	
  

	
v

	
酸洗(Acid clean)

 

	
  

	
v

	
饮用水洗(Drinking water to clean)

 

	
  

	
v

	
纯化水洗(Purification clean)

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第40页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

	
  

	
v

	
回水清洗(Return water clean)

 

	
  

	
v

	
压缩空气气吹(Compressed air blow)

b. 控制变量(Control variable)

	
  

	
v

	
时间(Time)

 

通过PLC 中的程序设定控制各工艺段的时间,根据验证设定时间。 The times of all procedures are controlled in accordance with settings in program of PLC.According verify,the time is setted.

 

	
  

	
v

	
温度(Temperture)

对于清洗是否成功CIP 温度是非常重要的,可以根据清洗对象和物料的清洗难度和粘度、生物度进行温度控制。在CIP 车间,温度传感器被装在不同的地方,每个CIP 罐上的传感器只是用来监测罐体的温度,在稳定性的监测中每条线都有一温度传感器 蒸汽的热度也有传感器。

 

在CIP 回路中的温度传感器监测回流介质温度,以确保设备清洗区域有足够高的温度。

 

The temperature of CIP is very important to sucessful CIP. In accordance with the cleaning objects ,cleaning difficulty ,viscosity,and bio-degree of materials,it can control temperature. In CIP workshop, temperature sensors are installed in different places.The temperature in each CIP tank is

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第41页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

used to monitor the temperature of the tank. In order to monitor the stability of each line,the pipe has also a temperature sensor. There is temperature sensor in steam pipe to monitor the Steam temperature.

 

In the CIP circuit pipe,temperature sensor is used to monitor the return of medium temperature to ensure that the temperature is enough to meet the seetings in cleaning devices.

 

	
  

	
v

	
压力,液位(Pressure,Level) 

为保证稳定性而控制和监测压力值,可在每条线上给定不同的CIP 清洗液的量和压力,这在所有的区域都是必须的。

 

In order to ensure stability,it must control and monitor the pressure values.Giving different CIP cleaning fluid volume and pressure in each pipe is necessary in all regions .

 

	
  

	
v

	
电导(Conductivity)

 

	
  

	
v

	
流量,流量开关(Flow,Flow Switch)

c. PL C程序 (PLC Program)

 

本系统的自动化控制,可实现自动清洗处理车间的各系统设备,从开始至最后的清洗工作,都由预先设定的清洗程序自动完成,操作人员只需要对所需清洗的设备选择和清洗过程的启停操作,即可快速、简单的洗净所有设

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第42页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

备。

 

The automatic control system can achieve self-cleaning the various workshop equipments. from the beginning to the final cleaning work, it is finished by the pre-set automatic washing program. Operators only need to choose the necessary cleaning equipment and start and stop of cleaning process,and all equipment are washed fast,simply.

 

	
  

	
v

	
CIP 各清洗罐自动液位检测和超限防护Automatical detecting the level of tank in CIP procedure and protection transfinite.

 

	
  

	
v

	
清水罐的自动补水(Automatic replenishment of water tank)

 

	
  

	
v

	
酸碱液的自动补加(Acid and lye solution automatically addtion)

 

	
  

	
v

	
温度的PID 控制(PID control of temperature)

 

	
  

	
v

	
阀门开关和泵的启停控制(Valve O/C and pump starting and stopping control)

 

	
  

	
v

	
运转状况实时显示(Real-time display of running status)

 

	
  

	
v

	
故障自动暂停及警示(Suspension and warning result of fault)

 

	
  

	
v

	
历史数据的记录和查询(Passed data records and inquirion)

 

	
  

	
v

	
在线电导率仪监测(Detection of online conductivity)

 

	
  

	
v

	
回水压力检测、判断是否断流(Detection pressure of return

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第43页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	
第3 部分公司介绍及资质文件

Technical and control system

 

water ,judging Devascularization)

 

	 	
v

	
自动回水判断、连续清洗工艺控制(Detection reutrn water, and continuous cleaning process control)

 

d. 具体控制流程 (Specific Control flow)

 

	
  

	
v

	
准备阶段(Preparation phase)

 

	
  

	
v

	
清洗液配置(Cleaning fluid configuration)

 

	
  

	
v

	
需清洗的设备设置(Cleaning equipment configuration)

 

	
  

	
v

	
自动清洗(Automatical cleaning)

 

	
  

	
v

	
清洁水或纯化水冲洗(Cleaning water or Purified water wash)

 

	
  

	
v

	
回水冲洗(Return water wash)

 

	
  

	
v

	
压缩空气反吹,压力检测,判断反吹是否完毕(Compressed air blowback,pressure detection,judging if the blowback finished or not)

 

	
  

	
v

	
清洗结束(CIP finish)

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第44页/共44 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation

 

第 4 部分

Part 4

验证方案

Validation

 

上海朗脉科技有限公司

 

ShangHai MacroProcess Technology Co.,Ltd

	
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      201100

T:021 54306717      F: 021 54306718

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

目 录 

 

Index

 

	
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

	
7

	
3.4. 设计确认Design Qualification

	
7

	
3.5. 工厂验收测试 Factory Acceptance Test

	
10

	
3.6. 现场验收测试 Site Acceptance Test

	
12

	
3.7. 校准Calibration

	
13

	
3.8. 安装确认Installation Qualification

	
15

	
3.9. 运行确认Operation Qualification

	
18

	
3.10. 控制系统的验证 Validation of Automatic Control System

	
19

	
3.11. 性能确认Performance Qualification

	
20

	
4. 质量项目计划Quality and Project Plan

	
21

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第1页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

 

验证服务范围

Work Scope of Validation Service

配料系统和CIP 站

Formulation system and CIP system

提供方:上海朗脉科技有限公司

Provided by: Shanghai Macroprocess Co., Ltd.

January 2009

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第2页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

1. 介绍Introduction

 

沈阳三生制药有限责任公司(“沈阳三生”) 将新建一个生物制药车间,现对工艺配料系统和CIP 站系统的详细设计、施工、调试和确认(验证)的工程服务项目进行招标。 

 

Shenyang Sunshine Pharmaceutical Co., Ltd. (3SBIO) will build one new biopharmaceutical plant, and now invite the bidding for the project of detailed design, construction, commissioning and qualification (validation) of preparation system and CIP system. 上海朗脉受邀参与投标,本文件将为本次的项目中验证范围进行做出说明,并给出最优的报价。 

Shanghai Macroprocess is invited to bid for this project. This document will define the work scope of validation activities and give a best quotation.

 

2. 验证范围Work scope of validation

我们提供的验证服务范围,见以下验证矩阵表。

We provide the validation services shown in Validation Matrix.

表T able 1-验证矩阵表Validation Matrix

	
系统System

	
RA

	
TM

	
DQ

	
FAT

	
SAT

	
IQ

	
OQ

	
PQ*

	
培养基配制系统 Media preparation 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 201100

T:021 54306717    F: 021 54306718

	

第3页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

	
缓冲液配制系统 Buffer solution preparation system

	
√

	
√

	
√

	
√

	
√

	
√

	
√

	
-

	
CIP 站 CIP system

	
√

	
√

	
√

	
√

	
√

	
√

	
√

	
-

备注Remark: 

 

	 	
1)

	
RA- 风险评估Risk Assessment ; TM- 追溯矩阵表Traceability Matrix; DQ- 设计确认Design Qualification; FAT -工厂验收测试Factory Acceptance Test; SAT- 现场验收测试Site Acceptance Test; IQ-安装确认Installation Qualification; OQ- 运行确认Operational Qualification; PQ- 性能确认 Performance Qualification

 

	 	
2)

	
PQ 方案和实施由客户负责。

PQ protocols are prepared and executed by client. 

详细的验证要求描述见后面章节。 

Detailed validation requirement description will be found in the following section. 

 

3. 验证方法Validation approach

 

3.1. 总要求General Requirement

我们将按照以下V 模型对关键系统开展验证工作。 

We will conduct the validation/qualification activities according to

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第4页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

the following V-Model.

 

在设计开始之时,验证工作也将同时开展。在详细设计完成的后期,进行设计确认,并对系统进行风险评估,编写追溯矩阵表。在采购和施工过程中,任何的关键性变更(影响产品质量或安全的变更) , 需要提交给验证人员进行审核。 

 

Validation activities should begin with design. In the end of detailed design stage, Design Qualification and Risk assessment will be conducted, and also Traceability matrix will be prepared. During purchase and construction, any significant change(impact product quality or safety) should be submitted to validation person for review. 系统施工结束后,进行调试,在合适的时候组织客户相关人员,进行FAT 或

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第5页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

SA T。然后,进行安装确认和运行确认。性能确认,由客户自己负责实施。 When the finish of construction and commissioning, we will invite related persons from client to conduct FAT or SAT. Then Installation and Operational qualification will be done by us with witness by client. Performance qualification will be done by client own.

 

	
3.2.

	
风险评估Risk Assessment 

风险评估的基本步骤Basic Steps of Risk Assessment:

 

	
  

	
-

	
了解系统或设备,以及工艺流程 

Identification of System/Equipment, Process

 

	
  

	
-

	
识别可能出现风险、产生的原因、带来的影响 

Identification of the risk event, cause and effects

 

	
  

	
-

	
评估该风险出现的可能性 

Evaluation of the probability that the event occurs

 

	
  

	
-

	
评估该风险带来的影响的严重程度 

Evaluation of the Impact of the Risk

 

	
  

	
-

	
评估该风险被发现的可能性 

Evaluation of the probability of detection of the event

 

	
  

	
-

	
建议采取的措施

	 	
  

	
Suggested actions

报告Reporting:

 

风险评估的结果将报告下列内容:

 

The results of the risk assessment will be reported with the following typical contents:

	
  

	
-

	
目的

	
  

	
Objective

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第6页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

	 	
-

	
风险评估的参与者

Participants in the risk analysis

	
  

	
-

	
工艺参数、功能、关键组件 

Process parameters, Function and Components

 

	
  

	
-

	
潜在的风险

	
  

	
Potential risk

	
  

	
-

	
GMP 关键性的判断

	
  

	
Identification if it is GMP critical

	
  

	
-

	
风险的原因和后果

	
  

	
Cause and consequences of risk

	
  

	
-

	
风险评估(出现的可能性、影响的程度、被发现的可能性)

Risk Assessment (probability of occur, Impact, probability of detection)

 

	
  

	
-

	
处理的措施(如测试要求、特别措施等)

Measures(e.g. Test requirement, specific measures etc.)

	
3.3. 

	
追溯矩阵表Traceability Matrix

 

追溯矩阵表对验证项目的质量关键及基本要求自用户需求标准到功能标准直至测试方案进行追溯。 

 

Traceability Matrix traces the quality critical and essential requirements from the User Requirements Specification (URS) to the functional specifications and onto the test protocols for this validation project.

 

	
3.4. 

	
设计确认 Design Qualification

 

DQ 是对系统的设计进行审核,以确认它们符合预定功能及运行要求,并符合GMP 要求。

DQ is the review for the design of system which ensures that these are according to advanced function and operation requirement as

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第7页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

well as GMP requirement. 

 

DQ 是贯穿于项目设计阶段的一个持续的过程,它保证与特定设备和系统相关的所有的设计文件符合现行GMP 的要求。我们将积极采取行动,保证项目的设计符合国际GMP 及客户的内控标准。 

 

DQ is a continuous progress throughout project design stage. DQ ensure the design documents related to specific equipment and system according to current GMP requirement. We will act for it and ensure the project design meet the international GMP and internal standard of Client. 

 

DQ 的关键工作是对系统的设计进行GMP 审查。该审查由朗脉验证专家主持,双方人员均参加。此审查将提供一个正式文件,证明设计按照GMP 各方面要求。会议的记录,完整的文件检查清单及变更清单将是DQ 的质量记录,被妥善保存。 

 

The critical work of DQ is GMP review to system design. This review is conducted by specialist from Macroprocess, both sides would join it. This review will provide an official document to prove the design meet the GMP requirement of each aspect. Meeting memo, complete document check list and change list will be quality record of DQ and will be preserved appropriately. 

 

设计确认(DQ )并非法规的恶强制要求。然而,从正式性和加强的设计审

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第8页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

核角度,我们推荐执行DQ。 

 

Design Qualification (DQ) is not a mandatory requirement of the regulations. However, in this formal format or through enhanced design reviews, it is recommended that it be carried out. 

 

DQ 通过对系统进行有组织的设计审查来进行。这种审查将在严格要求下进行,因为它在IQ、OQ之前能够更好地发现设计问题或不符合要求的方面,否则将对项目的工期和费用造成巨大影响。 

 

The DQ will be executed by applying a structured review of the design of the systems. The review should be rigorous as it is better to discover any design problems or non-conformance issues before reaching IQ or OQ, where remedial work may have a significant impact on the project schedule and cost. 

 

方案将用采用书面格式。详细的检查清单将确保设计和文件的所有方面均被涉及。方案被各方正式签署后执行。 

 

A protocol will be prepared with a written description of the format and approach for the reviews. Detailed checklists will be prepared to enable all aspects of the design and documentation to be interrogated. The requirements of the risk assessment and cGMP reviews will also be reviewed to ensure that their requirements are incorporated. The protocol will be formally signed off as approved

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第9页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

prior to execution and post execution by all parties.

DQ 文件的通常标准包括:

Typical criteria, which would be used to generate the DQ protocol are:

 

	
  

	
-

	
设计确保满足GMP 的要求 

Design satisfies GMPs and regulatory requirements

 

	
  

	
-

	
设计符合性能标准

	 	
  

	
Design meets performance criteria

	
  

	
-

	
材料材质

	 	
  

	
Materials of construction

	
  

	
-

	
清洗要求

	 	
  

	
Cleaning requirements

	
  

	
-

	
操作的可靠性和有效性 

Reliability and Efficiency of operation

 

	
  

	
-

	
设备安装

	 	
  

	
Equipment Installation

	
  

	
-

	
系统调试

	 	
  

	
System commissioning

	
  

	
-

	
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 

parameters of critical instruments, verify if the measuring range and accuracy satisfy the process and control requirement

 

	
  

	
-

	
关键组件的结构

	 	
  

	
Structure of critical components

	
  

	
-

	
文件要求

	 	
  

	
Documentation requirements

	
3.5.

	
工厂验收测试 Factory Acceptance Test

工厂验收测试应该关注设备关键的方面,包括进行测试活动。这些测试将在设备起运之前进行,以保证该设备已按照设计标准进行制造,并提供所需要 的文件。因此,FAT 可帮助避免可能影响现场测试的问题的产生。

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第10页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

Factory acceptance test could be applied to any critical aspect and includes test activity, that will be carried out before the shipment, to get assurance that a new critical equipment/ package has been built following the design specifications and it is provided with the required documentation; moreover the FAT will help to avoid problems that could affect the on site activities progress. 

 

FAT 可适用于所有关键的设备或设备包。 

 

FAT could be applied to any critical equipment or components. 

 

FAT 将包括IQ OQ 所包含的一些测试内容。任何不受运输或安装所影响的测试内容,如果其得到合适的执行、复核和记录,在以后的确认中,可以不需重复进行。下面是一些被认为可以作为确认目的的测试内容,但不仅限于此: 

 

FAT will already include some tests foreseen by the IQ and OQ; any test, which reliability will not be affected by the shipment and the installation could not be repeated for qualification purpose, if properly executed, witnessed and documented. Test activity that typically could be considered validated for qualification purpose, but not limited, are the following:

 

	
  

	
-

	
文件确认

  Documents 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 201100

T:021 54306717    F: 021 54306718

	

第11页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

	
  

	
-

	
图纸的确认(P&ID、布置图、电子和气路图)

Drawings verification (P&ID, Lay Out, electrical and pneumatic scheme)

 

	
  

	
-

	
材料和表面抛光的检查 

Materials and surfaces finishing verification

 

	
  

	
-

	
控制系统图形界面的检查 

Control system graphical pages check

 

	
  

	
-

	
报警和联锁

	
  

	
Alarms and interlocks

 

FAT 将要求进行记录;相关的测试报告或方案,将被提交给客户审核和批准。

 

FAT 将在客户批准后进行。 

 

FAT will be documented; the relevant test report or protocol, will be submitted to client for review, comments and approval; FAT execution will begin after client approval. 

 

本项目仅要求对储罐进行FA T。 

 

It is required to conduct FAT only for Tank.

 

	
3.6.

	
现场验收测试 Site Acceptance Test 

此工作适用于关键的系统或设备。 SAT 包含动态的和静态的测试活动,测试活动在现场由供应商在移交系统给客户之前进行。每一项SAT 工作将被文件记录下来。我们将提交测试文件(定义为SAT 报告或方案)给客户,以审核和批准。

 

Activity Applicable to critical system or equipment; SAT consists of

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第12页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

Dynamic and static testing activities performed on site by the vendor before hand over the system to the client. Each SAT activity will be documented. Macroprocess will submit the test document (defined as SAT report or protocol) to Client (for comments and approval). 

 

那些不会因为系统/设备的改变而影响可靠性的测试,如果已得到正确的执行、证明和文件记录,那么在验证过程中不必重复进行。 

 

All tests which reliability will not be affected by the system/equipment modification could not be repeated for qualification purpose, if properly executed (in conformity with Qualification Protocols), witnessed and documented.

 

	
3.7.

	
校准Calibration 

 

因为是新的安装, 所有的仪器仪表和变送器应被校准并产生校准证书。 

 

Since this is a new installation all transmitter instruments will be calibrated, and calibration certificate will be produced. 

 

所有不受安装影响的仪器仪表将经过校准后送到现场,并提供校准证书(溯源为NIST 或中国国家计量基准)。其它的仪器仪表将在现场使用计量标准进行校准。在任何情况下,应提供参考仪器的校准证书和校准程序。

 

All instruments not affected by the installation will be bench calibrated and then, supplied to the field, provided with NIST or

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第13页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

Chinese National measurement standards  traceable calibration certificate; the others will be calibrated in field using traceable standards references. In a case copy of the reference instrument calibration certificate and approved procedures will be provided. 

 

下列是对不同等级仪器仪表的处理方法。 

 

On the following different dedicated approach for class of instruments.

 

不受安装影响的仪表

 

Instruments not affected by the installation:

温度和压力变送器,需要校准证书(溯源为NIST 或中国国家计量基准)。确认工作,仅为确认安装情况(是否有合适的配置、范围、计量单位、信号)和带有相关显示器或相关监督和控制站的信号定位。 

 

Temperature and pressure transmitters; for which will be required (to the vendor) a bench calibration certificate (NIST or Chinese National measurement standards traceable) and during the qualification will only be verified the set up (if smart the relevant configuration, range, engineering unit, signals) and the signal alignment with the relevant indicator or the eventual supervision and control station.

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第14页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

会受安装影响的仪表

 

Instruments affected by the installation: 

 

流量和液位变送器,不需要实验室校准。校准将在现场使用可溯源为NIST 或中国国家计量标准的仪器进行校准。 

 

Flow rate and level transmitters; for which will not be required a bench calibration. The calibration will be performed after the installation in field using NIST or Chinese National measurement standards traceable reference instruments. 

 

电导仪和PH 计将在现场通过使用相关的指示器与标准溶液进行确认/校准。

 

conductivity and pH probe will be verified/calibrated in field reading the measurement using the relevant indicator in comparison with a reference standard solution. 

 

仪表的校准工作不属于验证工作。本项目的仪表校准工作由哪方负责,将由合同进行约定。 

 

Calibration is not included into Validation work. The responsible party for calibration work will be according to the contract.

 

	
3.8.

	
安装确认Installation Qualification

 

安装确认将检查每一个设备/系统的安装是否符合设计和相应的GMP 规范。IQ 将确认所有的需要用于设备/系统的管理和操作的文件的可用性。

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第15页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

The Installation Qualification will determine that each equipment/system has been installed in accordance with the design (if new or renovated) and the applicable current good manufacturing practice (either if new or existing). IQ will confirm the availability of all the required documentation useful to manage and operate with the equipment/system itself. 

 

在执行IQ 之前,系统的机械安装工作已完成。 

 

Prior to the IQ, systems will have to be mechanically completed.

 

IQ 方案编写 IQ Protocols Preparation:

 

在所有对产品质量有影响的系统上都要进行IQ。每个IQ 方案都是针对特定系统的,但是所有方案都基本包含以下内容:

 

For all of the system that affect product quality must undergo IQ. Each IQ protocol are targeted at specific system, but all protocols usually contain the following elements:

	
  

	
-

	
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 201100

T:021 54306717    F: 021 54306718

	

第16页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

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

 IQ 接受标准 IQ Acceptance Criteria:

 

	
  

	
-

	
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。 

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.

 

	
  

	
-

	
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。

All drawings (For example pipeline and measuringappliance flow chart, three dimensional pipelineschematic drawing, electrical chart, pneumatic operated chart and so on) and with the material quality proved and inspection file location will be recorded.

 

	
  

	
-

	
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 201100

T:021 54306717    F: 021 54306718

	

第17页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

	
3.9.

	
运行确认Operation Qualification 

 

运行确认是按照预设的操作范围和机械性能进行,通过记录的文件,证明系统和设备能正确运行。 

 

OQ could be executed and operated according to the pre-set operation arrange and mechanism performance through the recorded documentations prove that the system and equipment have been proper operated.

 

OQ 方案编写 OQ Protocols Preparation:

 

在所有对产品质量有影响的系统上都要进行OQ。我们会为每一个系统写一份OQ 方案。每个OQ 方案都是针对特定系统的,但是所有方案都包含以下内容: 

 

All systems which influence the product quality are needed to execute OQ. We will write a OQ protocol for each system. Each OQ protocol aims at specific system separately, but all protocols are including:

 

	
  

	
-

	
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

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第18页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

	
  

	
-

	
报警和联锁的检查Alarms and interlocks verification

 

	
  

	
-

	
人员的确认 Personnel identification

 

	
  

	
-

	
偏差报告Deivation report

 

	
  

	
-

	
实施结果批准 Execution review and approval

	
  

	
OQ 接受标准 OQ Acceptance Criteria:

 

	
  

	
-

	
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.

 

	
  

	
-

	
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).

	
3.10.

	
控制系统的验证 Validation of Automatic Control System

所有的跟产品生产、质量控制和分销有关的自控系统及其他数据采集,存储和处理系统都属于验证的范围。自控/计算机系统的验证将依据美国FDA (包括21CFR 第11 部分有关电子记录和电子签名的规定)、欧盟的GMP 指南和良好自控生产规范(GAMP)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 201100

T:021 54306717    F: 021 54306718

	

第19页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

All automatic control system and other data collection, storage and treatment system related to production, quality control and distribution are involved in the scope of validation. The validation of automatic system would be held according to the US FDA (21 CFR Part 11), GMP guideline of EU and GAMP.

 

	
3.11.

	
性能确认Performance Qualification 

 

OQ 的成功完成之后,将进行PQ 工作。PQ 将整合考虑规程、人员、物料、设备和工艺。 

 

Upon successful completion of the OQ, Performance Qualification will be carried out. The PQ will integrate procedures, personnel, material, equipment, and process. 

 

测试、规程和接受标准将在系统的挑战性实验之前确立,并在执行完PQ 之后进行审核。 

 

Tests, procedures and acceptance criteria will be defined before challenging the systems and review after PQ execution. 

 

PQ 将证明设备、工艺步骤和参数、公用设施、原料、中间体和标准操作程序可以生产出预先所建立的生产和质量要求。 

 

PQ will demonstrate that equipment, process phases and parameters, utilities, raw materials, intermediates and standard operating procedures allow to reach the pre-established manufacturing and

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第20页/共21 页

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第4 部分验证方案

Validation Service

 

quality requirements. 

 

测试可能包括化学的、物理的、微生物的分析。 

 

Testing may include analysis for chemical, physical, microbiological constituents.

 

任何显著变化的情况将被要求进行审核和调查,以最终决定适当的纠偏措施。 

 

Any outstanding condition will be identified for review and investigated to eventually determine the appropriate corrective action.

4. 质量项目计划Quality and Project Plan

参见附件See attachment.

 

	
上海市闵行区罗阳路168 号A 座101 室    201100 

1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717    F: 021 54306718

	

第21页/共21 页

  

  

  

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 1 of  19

 

Quality and Project Plan

质量项目计划

Preparation system and CIP system 

配料系统和CIP 站

 

	
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-03-QPP

	
Revision 版本:

	
 00

 

 

  

  

  

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 2 of  19

 

Review and Approval

审核和批准

	  	
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 History

版本历史

	
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

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 3 of  19

INDEX 目录

	
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

	
5

	
    3.2.1. References 参考文件

	
5

	
    3.2.2. Work Flow 工作流程

	
6

	
    3.2.3. Kick off meeting 项目启动

	
7

	
    3.2.4. Design Review and Design Qualification 设计审核和设计确认

	
7

	
    3.2.5. Receiving Inspection 收货检查

	
7

	
    3.2.6. Construction Control 施工控制

	
7

	
       3.2.6.1. Welding Documentation and Inspection 焊接文件和检查......

	
7

	
       3.2.6.2. Slope Inspection 坡度检查

	
9

	
       3.2.6.3. Hydraulic Testing 水压测试

	
9

	
       3.2.6.4. Cleaning and Passivation 清洗和钝化

	
10

	
    3.2.7. Acceptance Test 验收测试

	
11

	
       3.2.7.1. Factory Acceptance Test 工厂验收测试

	
11

	
       3.2.7.2. Site Acceptance Test 现场验收测试

	
12

	
    3.2.8. Installation Qualification 安装确认

	
12

	
    3.2.9. Documentation Management 文件管理

	
14

	
    3.2.10. Change Control 变更控制

	
15

	
    3.2.11. Deviation Handling 偏差处理

	
15

	
4. Project Plan 项目计划

	
16

	
    4.1. Project Organization 项目组织

	
16

	
    4.2. Deliverable Items 移交清单

	
17

	
    4.3. Project Schedule 项目进度表

	
18

	
5. Glossary 词汇

	
19

	
6. Attachment 附件

	
19

	
    6.1. Attach.1- Project Organization Chart 项目组织结构图

	
19

	
    6.2. Attach.2- Project Schedule 项目进度表

	
19

 

 

  

  

  

  

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 4 of  19

 

	
1.

	
Introduction

介绍

This Quality and Project Plan (QPP) is used for project management and quality control of new plant of Shenyang Sunshine pharmaceutical company limited. This document is written by Shanghai Macroprocess and is reviewed and approved by 3Sbio.

本质量项目计划是为了沈阳三生制药有限责任公司的新建车间的项目管理和质量控制而制定。本文件由上海朗脉科技有限公司编写完成,经三生审核和批准。

	
2.

	
Overview

概况

 

This project include the design, construction, commissioning and qualification for the following systems:

本项目包括了以下系统的设计、施工、调试和确认:

 

	
  

	
-

	
Media preparation system

培养基配制系统

 

	
  

	
-

	
Buffer solution preparation system

缓冲液配制系统

 

	
  

	
-

	
CIP system

	
  

	
CIP 系统

 

	
3.

	
Quality Plan

质量计划

 

	
3.1.

	
User Quality Requirements

用户质量要求

 

These systems of the project should be in accordance with Chinese GMP (1998) and FDA cGMP requirements.

本项目建设的系统,应该符合中国GMP(1998 年修订版)要求和美国cGMP 要求。

 

 

  

  

  

 

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 5 of  19

 

	
3.2.

	
QualitySystem

质量体系

3.2.1.  References

参考文件

The project will conduct the design, construction, commissioning and qualification according to the following regulations and guidance.

本项目将按照以下标准和法规进行设计、施工、调试和确认:

 

	
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

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 6 of  19

 

	
3.2.2.

	
Work Flow

工作流程

 

 

  

  

  

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 7 of  19

 

	
3.2.3. 

	
Kick off meeting

项目启动会

After the contract is signed and effective, our project manager will arrange the Kick-off meeting in order to confirm the project schedule, persons resource, detailed design and procurement etc.

合同签订生效之后,项目经理将召开项目启动会,进行技术交底,并讨论和确定项目进度、人员安排、详细设计和采购事项等等。

	
3.2.4. 

	
Design Review and Design Qualification

设计审核和设计确认

In the end of detailed design phase, the project manager will arrange our project team persons including validation person to do design review in order to the design is in accordance with user requirements and cGMP requirements. Finally, the reviewed design documents will be submitted to client for review and approval.

详细设计完成之后,项目经理将组织项目各专业人员,包括验证人员,对详细设计图纸进行设计审核,以确保设计能够符合用户需求和GMP 要求。最后,审核后的详细设计文件将提交给客户进行批准。

If the contract require that a formal DQ document should be provided, our validation engineer will write the DQ document and submit to client for review and approval. 

如果合同规定要提供正式的DQ 文件,那么我们的验证人员将编写一份DQ 文件,并提交给客户审核和批准。

	
3.2.5. 

	
Receiving Inspection

收货检查

When the material arrival at construction site, the receiving inspection will be done by our project engineer and a “material receiving inspection sheet” will be filled in.

材料到达现场时,项目人员将对材料进行检查,并填写“材料检查记录”。

 

As a minimum, the inspection items should at least include the following”

检查的项目,至少包括以下几项内容:

 

	
        

	
-

	
packaging inspection 外观检查,是否完好

 

	
        

	
-

	

check if the name, model and quantity of goods conform with purchase orders

与供货单进行对照,检查物品、型号规格、数量是否一致

 

	
        

	
-

	
documentation, such as material certificate 

文件资料是否完整,如材质证明。如没有随货一起,那么另外进行收集和检查

	
3.2.6.

	
Construction Control

施工控制

	
3.2.6.1. 

	
Welding Documentation and Inspection

焊接文件和检查

Prior to welding ,sample welds will be made to ensure highest quality of welding:

在正式焊接之前,要进行焊样焊接,以检查焊样是否合格。以下情况要进行焊样焊接和检查:

 

 

 

  

  

  

 

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 8 of  19

 

	 	
-

	
Daily at at the beginning and finishing of each work shift| 

每班开始和结束

 

	 	
-

	
when changing welding machine, pipe size or pipe lot. 

当更换焊机、管子规格或管子批号时

Each sample weld shall be given a subsequent number and welding parameters shall be noted on the “welding report of sample welds”. If contract requires that the report should be signed and approved by client representative, then the report shall be submitted to client for approval.

每个焊样都有一个独自的焊点编号,并编写“焊样焊接报告”。如果合同规定,焊样焊接报告由客户项目负责人或代表进行签字确认,则将此报告提交给客户签字。

Once the samples found satisfactory, the welding on the piping can begin.

焊样合格之后,才能进行正式焊接。

Welding type includes orbital welding and manual welding. After each welding, the visual inspection should be done for welding appearance, and fill result in the “welding report”, such as material, diameter, welding type, welding number, welder and welding date etc. Each weld will be consecutively numbered and marked on the isometric drawing.

焊接类型分为自动轨道氩弧焊和手工氩弧焊。每次焊接之后,要对焊点的外观进行检查,并填写“焊接报告”,包括焊接的物料、管径、焊接类型、焊点编号、焊接人和焊接日期等。每个焊接都有独自的焊点编号,并在管道轴测图上标注。

Generally, inspection for welding will be performed:

对焊点的检查,通常包括了以下项目:

 

	
  

	
-

	
Visual inspection of external surface on 100% of the welds

	
  

	
100%的焊点需进行外表面的外观检查

 

	
  

	
-

	
Borescopic Inspections of internal surface on 20% of the welds

	
  

	
20%的自动焊点需进行内表面的内窥镜检查

 

	
  

	
-

	
Borescopic Inspections of internal surface on 100% of the welds

	
  

	
100%的手工焊点需进行内表面的内窥镜检查

 

Borescopic inspection result is recorded on photograph or video.

内窥镜检查的结果以照片或录像的形式记录下来,并保存。

If contract requires that X-ray inspection should be done, X-ray inspection will be done after complete of pipe installation. Generally, the following inspection will be performed: (final sample quantity is according to contract) 

如果合同规定需进行焊点的X 光探伤检查,则安排进行X 光探伤检查,一般可对以下项目进行X光探伤检查(最终的取样量以合同约定为准):

 

	
  

	
-

	
100% of sample welds

	
  

	
100%的焊样

 

	
  

	
-

	
100% of manual welds

	
  

	
100%的手工焊点

 

X-ray inspection result is recorded on radiograph.

X 光探伤检查的结果以X 光片的形式记录下来,并保存。

 

Welding documents include:

 

 

 

  

  

  

 

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 9 of  19

 

焊接文件包括了以下:

 

	 	
-

	
Isometric drawing with welds marked and numbered 

带焊点的管道轴测图

 

	 	
-

	
Welding report for sample welds 

焊样的焊接报告

 

	 	
-

	
Welding report 

焊接报告

 

	 	
-

	
Welding machine print-out

机器打印报告

 

	 	
-

	
Borescopic inspection report and photograph or video 

内窥镜检查报告和照片或录像

 

	 	
-

	
X-ray inspection report and radiograph (if applicable)  

X 光探伤检查报告和X 光片(如果需要)

 

	 	
-

	
Welder’s certificates 

焊工资质文件

 

	
3.2.6.2.

	
Slope Inspection

坡度检查

In order to assure the complete drainability, it is required 0.5-1.0% of slope for horizontal line. 

为了使洁净管道系统能够实现完全排放,对于水平管道,要求有至少为0.5%-1%的坡度,以使管道残留水能够顺着管道排出。

During installation of pipe, the slope inspection will be done and recorded in the “slope inspection report”, if non-conformity, modification should be done.

在管道安装时,须对管道的坡度进行检查,并填写“坡度检查报告”, 如不符合要求,须进行调整。

Membrane valves on horizontal pipe should have a slope according to valve supplier and Diameter in order to completely drain.

水平管道上的隔膜阀的安装,须有一定的倾斜角度,以使管道的水能够完全排放。

	
3.2.6.3.

	
Hydraulic Testing

水压测试

Prior to hydraulic testing, the preliminary pneumatic testing shall be carried out with compressed air or nitrogen in order to check the networks tightness and no leakage.

在进行水压测试之前,先用压缩空气或氮气进行气压测试,以确保系统无泄漏。

Hydraulic Testing procedure and criteria: DI water or Purified water is used. The hydraulic test pressure is equal to 1.5 times the design pressure and not less than 0.6 MPa. The test time is not less than 2 hours. As criteria, there should be no leakage and pressure loss is not more than 0.03MPa. 

水压测试程序和标准:用去离子水或纯化水充满整个系统,用水压测试泵加压至设计压力的1.5 倍,且至少0.6 MPa 压力,保压至少2 小时,系统无泄漏,压力降低不大于0.03MPa。

 

 

  

  

  

 

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 10 of  19

 

	
3.2.6.4.

	
Cleaning and Passivation

清洗和钝化

The purpose of cleaning and passivation is to remove the grease, oxidation layer of welding and free iron etc. in the internal pipe and form a chromium oxide film.

清洗和钝化目的是为了去除管道系统内表面油脂、焊接氧化皮、游离铁离子等污物,并在管道内部形成一层铬保护膜。

The solution of cleaning and passivation should not contain chlorine. DI water (de-ionized water, purified water or more quality water should be used. In the document, DI water is in lieu of all others. 

清洗钝化过程使用不含氯的溶液,使用的水为去离子水,纯化水或更高水质的水,以下以去离子水统称。

Cleaning and passivation of sanitary pipe usually include the following stages:

洁净管道的清洗和钝化,大致分为以下步骤:

 

	
  

	
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

 

For loop system, such as purified water and WFI loops, the below procedure will be followed:

对于循环管路系统,如纯化水和注射用水分配系统,清洗和钝化程序如下:

Degreasing and cleaing 脱脂清洗

 

	
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

Passivation 钝化

 

	
Chemical 化学品 

	
 HNO3, HF 

	
Passivation solution 

钝化溶液

	
 20% HNO3 

 3% 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

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 11 of  19

 

For one way pipe system, such as pure steam distribution, the below procedure will be followed:

对于单路管路系统,如纯蒸汽分配系统,清洗和钝化程序如下:

 

Degreasing and cleaning 脱脂清洗

 

	
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

Passivation 钝化

 

	
Chemical 化学品

	
 HNO3, HF

	
Cleaning Solution 

清洗溶液

	
 20% HNO3 

 3% HF 

 77% DI water

	
Procedure 程序

	
 Completely filled 浸泡

	
Temperature 温度

	
 Ambient 室温

	
Time 时间

	
 45 min

After passivation, rinse with DI water until neutral pH is reached for each use point. 

钝化之后,进行去离子水冲洗,直至所有区域,包括每个使用点,用pH 试纸测试为中性为止。

For non-water pipe system such as compressed air, nitrogen, only cleaning is required and passivation is not required.

对于压缩空气、氮气等非水介质的管道系统,只需进行脱脂清洗,无需进行钝化。

	
3.2.7.

	
Acceptance Test

验收测试

	
3.2.7.1.

	
Factory Acceptance Test

    工厂验收测试

Factory acceptance test could be applied to any critical aspect and includes test activity, that will be carried out before the shipment, to get assurance that a new critical equipment/ package has been built following the design specifications and it is provided with the required documentation; moreover the FAT will help to avoid problems that could affect the on site activities progress.

工厂验收测试应该关注设备关键的方面,包括进行测试活动。这些测试将在设备起运之前进行,以保证该设备已按照设计标准进行制造,并提供所需要的文件。因此,FAT 可帮助避免可能影响现场测试的问题的产生。

FAT will be documented; the relevant test report or protocol, will be submitted to client for

 

 

 

  

  

  

 

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 12 of  19

review, comments and approval; FAT execution will begin after client approval. 

FAT 将要求进行记录;相关的测试报告或方案,将被提交给客户审核和批准。FAT 将在客户批准后进行。

 

It is required to conduct FAT only for Tank.

本项目仅要求对水系统储罐进行FAT 。

	
3.2.7.2.

	
Site Acceptance Test

现场验收测试

Activity Applicable to critical system or equipment; SAT consists of Dynamic and static testing activities performed on site by the vendor before hand over the system to the client. Each SAT activity will be documented. Macroprocess will submit the test document (defined as SAT report or protocol) to Client (for comments and approval). 

此工作适用于关键的系统或设备。 SAT 包含动态的和静态的测试活动,测试活动在现场由供应商在移交系统给客户之前进行。每一项SAT 工作将被文件记录下来。我们将提交测试文件(定义为SAT 报告或方案)给客户,以审核和批准。

All tests which reliability will not be affected by the system/equipment modification could not be repeated for qualification purpose, if properly executed (in conformity with Qualification Protocols), witnessed and documented. 

那些不会因为系统/设备的改变而影响可靠性的测试,如果已得到正确的执行、证明和文件记录,那么在验证过程中不必重复进行。

	
3.2.8.

	
Installation Qualification

安装确认

After SAT is finished, IQ and OQ will be conducted. In some case, IQOQ will be concurrent conducted with SAT .

在进行SAT 之后,进行安装确认(IQ)和运行确认(OQ)。有时,IQOQ 可与SAT 同时进行。

 

The Installation Qualification will determine that each equipment/system has been installed in accordance with the design (if new or renovated) and the applicable current good manufacturing practice (either if new or existing). IQ will confirm the availability of all the required documentation useful to manage and operate with the equipment/system itself.

安装确认将检查每一个设备/系统的安装是否符合设计和相应的GMP 规范。IQ 将确认所有的需要用于设备/系统的管理和操作的文件的可用性。

 

Prior to the IQ, systems will have to be mechanically completed.

在执行IQ 之前,系统的机械安装工作已完成。

 

IQ Acceptance Criteria IQ 接受标准:

	
     - 

	
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

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 13 of  19

 

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。

 

	
  

	
-

	
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.

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。

 

	
  

	
-

	
All equipment, instrument and accessory will be inspected and they are required to meet the pre-set standards

所有的设备,仪表和配套将被检查并须符合预设标准

 

	
  

	
-

	

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

 

OQ could be executed and operated according to the pre-set operation arrange and mechanism performance through the recorded documentations prove that the system and equipment have been proper operated.

运行确认是按照预设的操作范围和机械性能进行,通过记录的文件,证明系统和设备能正确运行。

OQ Acceptance Criteria:OQ 接受标准

 

	
  

	
-

	

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. 

所有的OQ 工作将按照已批准的方案执行

 

	
  

	
-

	

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. 

系统报警和联锁的情况应符合设计标准

 

	
  

	
-

	

The system’s function should operate in accordance with the design specification.

系统功能运行应符合设计标准

 

	
  

	
-

	

Utilities, used by the system, should be available at the battery limit within the specified range (temperature, pressure, flow-rate).

系统所用的公用设施应当在规定范围以内(温度、压力、流量)

 

For some simple system, such as pure steam distribution, because OQ tests are not much, usually IQ and OQ will be combined into one document. 

对于简单的系统,如纯蒸汽分配系统,因为OQ 测试项目较少,可将IQOQ 文件合二为一。

 

 

 

  

  

  

 

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 14 of  19

 

	
3.2.9.

	
Documentation Management

文件管理

The effective control of all documentation is vital to the Project Management System. This control is important to the technical documents that form the primary elements for the Project.

对所有文件的有效控制对项目管理是十分重要的。特别对于技术类文件的有效控制,是项目中的基本要素。

Documents controlled under this system include:

受控的文件,包括以下:

	 	
- 

	
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

其它与本项目的质量相关的文件

Document Control 文件控制

Design Specifications and Test Specifications will be reviewed and approved by Macroprocess and client. Documents within Design, Tests and Inspections are controlled as minimum by revision and document history, date, author’s initials and project information.

对于设计、测试和检查等的文件,应进行控制,起草之后,经过客户方授权的人审核和批准,并有版本、变更历史、日期和签名。

Modification of approved documents should be reviewed and approved by Macroprocess and Client and upgraded to next version.

批准后的文件的修改,需要经过朗脉和客户双方的审核和批准,版本进行更新。

Documentation and associated information should be stored safely and securely, They should be protected against accidental and malicious damage, and should be retrievable throughout the defined retention period.

文件档案应妥善保管,保证安全,避免遗失和损坏。

Document number and version 文件编号和版本

Every document should have a Document Number and Version. Document Number has the following structure:

每份文件应该有文件编号和版本。文件编号由以下几个部分组成:

	
      

	
-

	

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) 

Documents should be under version control and in draft form prior to formal issue. Their version number should clearly distinguish between draft and approved versions. Version numbers are assigned to each project document, ranging from 00, 01, 02, until 99. The project document has to be distributed as a new version, when any changes are made. If a new draft document is issued, the author assigns the version number 00 to it and distributes this under the “draft”

 

 

 

  

  

  

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 15 of  19

 

status to the review team. 

文件应进行版本控制,正式发布之前为草案。每个项目文件的版本号,从00、01、02 到99 进行一次编号。当文件有变更时,版本也进行更新。起草一份新的文件时,版本为00,意为“草案”, 经过审核和批准后,正式首次发布的版本为01。

	
3.2.10. 

	
Change Control

变更控制

All system changes that affect already approved documents and GMP Compliance have to be managed according to a change control procedure. All these changes are demonstrably planned, evaluated, approved, and GMP-conform executed and documented.

所有影响已经批准的文件和GMP 有关的变更,需要按照变更程序进行管理。所有这些变更需要进行书面提出,经过合适的评估和批准,然后实施,并进行记录。

	
3.2.11. 

	
Deviation Handling

偏差处理

A Deviation report will be generated during execution of tests. If a test result is not accepted according to the given acceptance criteria the report will be filled in. The deviation should be evaluated and documented and the action measures also should be evaluated, reviewed and approval before execution. Finally, follow-up should be done to check the action result.

如果在测试过程中,出现不符合要求的项目,需编写偏差报告。偏差情况需进行书面的评估、提出偏差处理意见,并经书面审核和批准,然后实施。而且,跟踪实施情况,记录实施的结果。

 

 

  

  

  

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 16 of  19

 

	
4.

	
Project Plan

项目计划

 

	
4.1. 

	
Project Organization

项目组织

For good management and control of whole project, one project team should be founded which include persons from Macroprocess and client. The project organization chart please see attachment 1. List of main project members is following:

为了对整个项目进行良好的管理和控制,成立一个项目组织团队,包括了朗脉的项目人员和客户的项目人员,项目组织结构图请见附件1。以下是主要项目人员的清单:

 

	
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

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 17 of  19

 

	
4.2. 

	
Deliverable Items

移交清单

 

	
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-03-QPP

	
Quality and Project Plan 

质量项目计划

	
W

	
A

	  	
标准和说明

	  	  
	
2

	
3SBIO-MPS-FS

	
Functional Specification of Media preparation system 

培养基配制系统的功能说明

	
W

	
A

	
3

	
3SBIO-BPS-FS

	
Functional Specification of Buffer solution preparation system 

缓存液配制系统的功能说明

	
W

	
A

	
4

	
3SBIO-CIP-FS

	
Functional Specification of CIP system 

CIP 站的功能说明

	
W

	
A

	  	
Design 设计-Mechanical Part 机械部分

	  	  
	
5

	
3SBIO-MPS-PID-01

	
P&ID of Media preparation system 

培养基配制系统的管道仪表流程图

	
W

	
A

	
6

	
3SBIO-BPS-PID-01

	
P&ID of Buffer solution preparation system 

缓存液配制系统的管道仪表流程图

	
W

	
A

	
7

	
3SBIO-CIP-PID-01

	
P&ID of CIP system 

CIP 站的管道仪表流程图

	
W

	
A

	  	
Construction Documents 施工文件

	  	  
	
8

	
QMS-SOP-SP-03-F01

	
Welding Report of sample welds 

焊样的焊接报告

	
W

	
A

	
9

	
QMS-SOP-SP-03-F02

	
Welding Report 

焊接报告

	
W

	
A

	
10

	
QMS-SOP-SP-03-F03

	
Borescopic Inspection Report 

内窥镜检查报告

	
W

	
A

	
11

	
QMS-SOP-SP-03-F04

	
X-Ray Inspection Report 

X 光探伤检查报告

	
W

	
A

	
12

	
QMS-SOP-SP-04-F01

	
Slope Test Report 

坡度测试报告

	
W

	
A

	
13

	
QMS-SOP-SP-05-F01

	
Hydraulic Test Report 

水压测试报告

	
W

	
A

	
14

	
QMS-SOP-SP-06-F01

	
Cleaning and Passivation Report 

清洗和钝化报告

	
W

	
A

	  	
Qualification Documents 确认文件

	  	  
	
15

	
3SBIO-MPS-DQ

	
DQ of Media preparation system 

培养基配制系统的DQ

	
W, E

	
A

 

 

 

 

 

 

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 18 of  19

 

	
No.

 序号

	
Document Number 

文件编号

	
Document Name 

文件名称

	
Macroprocess 

朗脉

	
3SBIO 

三生

	
16

	
3SBIO-BPS-DQ

	
DQ of Buffer solution preparation system 

缓存液配制系统的DQ

	
W, E

	
A

	
17

	
3SBIO-CIP-DQ

	
DQ of CIP system 

CIP 站的DQ

	
W, E

	
A

	
18

	
3SBIO-MPS-RA

	
RA of Media preparation system 

培养基配制系统的RA

	
W, E

	
A

	
19

	
3SBIO-BPS-RA

	
RA of Buffer solution preparation system 

缓存液配制系统的RA

	
W, E

	
A

	
20

	
3SBIO-CIP-RA

	
RA of CIP system 

CIP 站的RA

	
W, E

	
A

	
21

	
3SBIO-MPS-TM

	
TM of Media preparation system 

培养基配制系统的TM

	
W, E

	
A

	
22

	
3SBIO-BPS-TM

	
TM of Buffer solution preparation system 

缓存液配制系统的TM

	
W, E

	
A

	
23

	
3SBIO-CIP-TM

	
TM of CIP system 

CIP 站的TM

	
W, E

	
A

	
24

	
3SBIO-MPS-IQOQ

	
IQOQ of Media preparation system 

培养基配制系统的IQOQ

	
W, E

	
A

	
25

	
3SBIO-BPS-IQOQ

	
IQOQ of Buffer solution preparation system 

缓存液配制系统的IQOQ

	
W, E

	
A

	
26

	
3SBIO-CIP-IQOQ

	
IQOQ of CIP system 

CIP 站的IQOQ

	
W, E

	
A

	
27

	
3SBIO-MPS-PQ

	
PQ of Media preparation system 

培养基配制系统的PQ

	
/

	
W ,E, A

	
28

	
3SBIO-BPS-PQ

	
PQ of Buffer solution preparation system 

缓存液配制系统的PQ

	
/

	
W ,E, A

	
29

	
3SBIO-CIP-PQ

	
PQ of CIP system 

CIP 站的PQ

	
/

	
W ,E, A

Note 备注:

W-Writing 编写, R-Review 审核, A-Approval 批准, E-Execution 实施

 

4.3.         Project Schedule

项目进度表

The project will include the following activities:

本项目包括了以下活动:

 

	
        

	
-

	
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

 

 

 

 

  

  

  

 

	

Quality and Project Plan

	
 Preparation system and CIP system 配料系统和CIP 站

	
 Doc# 文件编号:  

	 3SBIO-03-QPP
	
 Revision 版本:  

	 00
	
质量项目计划

	
 Page 页码:  

	 19 of  19

 

The detailed Project Schedule is shown in attachment 2. (see bidding document) 

详细的项目进度表,请见附件2 (见标书其它部分)。

	
5.

	
Glossary

词汇

 

	
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

附件

	
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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

第 5 部分

Part 5

施工组织

Construction Scheme

 

 

上海朗脉科技有限公司

 

ShangHai MacroProcess Technology Co.,Ltd

 

 

	
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      201100

T:021 54306717      F: 021 54306718

  

  

  

 

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

目 录

Index

 

	
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

	
10

	
  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 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

  

1. 工程施工人员组织设计Staff organization

 

	
1.1.

	
人员组成结构图Organization Chart

 

目前拟定结构如下:At present,we study out the staff organization chart as the following:

 

 

	
1.2.

	
项目组成人员角色及职责team and responsibility

 

	 	

	
项目经理Project manager

 

项目负责人;协调和负责整个项目执行,确保项目执行达到各节点要求;安全第一负责人;是业主用户和上海朗脉科技有限公司的联系人;确认来往资料及传真,负责所有项目资料的归档。 

 

Take charge of the whole project , ensure the project proceed to the right requirement and conduct the construction staff. As the window between the owner and Macroprocess; clarify the letter

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

and fax and all document of the project.

 

	 	

	
项目组project team

 

负责监督完成系统的工艺设计、自动化控制系统设计、CAD 图纸制作等的设计,出图、资料准备、组态及实施监控,完成整个项目设计工作。 

 

Work together to take charge of all design, drawings of technical and control system. Also prepare the document, configration and inspection to achieve the design task.

 

	 	

	
施工经理 construction manager

 

负责项目系统的现场调度、实施、安装、检测和系统正常运行等现场技术支持服务,同时负责协调工程培训事宜,包括培训日程、地点、人员安排等。该职位作为项目实施过程中朗脉公司人员直接与业主沟通。 

 

Take charge of technical support for implement 、installation 、test and operation of whole project, and also response to training including the place、schedule。This position is used to communicate with owner directly.

 

	 	

	
品质管理和质量 quality manager

 

负责协调和监督工程实施过程中项目质量符合系统设计要求,满足客户需求,同时监控项目实施中的安全操作,确保人力物力的安全。 

 

Ensure the quality meet the owner’s requirement and comply with sepecification, and also control the operation in the construction work, ensure the safty of human resource and material resources.

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

	 	

	
采购经理 purchase manager

 

具体负责系统设备的预算、采购、物流等管理和支持工作,是项目正常实施的物流枢纽。

 

Take charge of project’s budget, purchase, logistic and other support. As a hinge of all project.

 

	 	

	
验证经理Validation manager

 

评估项目质量要求和提供项目实施验证方案确保符合顾客要求,验证与行业规范相符合。 

 

Evaluate the whole project quality requirement and provide the validation proposal to meet the client regulation requirement.

 

	 	

	
用户项目经理 owner project manager

 

为了使双方的共同渠道畅通,顾客需任命一名项目经理,该项目经理要保证用户的招标承诺实现。并且确认上海朗脉科技有限公司的项目经理定期与用户沟通。用户项目经理是用户与上海朗脉科技有限公司的交流窗口。 

 

In order to push the project smothly,client need to appoint one project manager to ensure promises of whole work. And also need to communicate with Macroprocess stablely.this postion is also a window between owner and client.

 

	 	

	
用户工程组 user team

 

用户工程组为上海朗脉科技有限公司提供实施项目质量保证的支持工作。作为设计、质量、验证、工程、安全卫生环保的沟通机构。 

 

This team shall provide support to Macroprocess to ensure

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

quality.

	 	

	
用户工程师代表 Engineer representation

 

工程的成功需要用户工程组的努力及配合,参与设计方案的准备有助于他们理解系统,而系统最终要由他们来维护。参与设计及以后的培训使他们能够更加彻底的了解系统。

 

Engineer representation of client need join with Macroprocess to understand the whole design and the proposal, and they will maintain the system by themselves. That to take part in the design is good for them to familiar with whole project.

	
1.3.

	
验证经理资质Validation manager qualification

 

验证是项目不可或缺的组成部分,验证的过程将直接确保项目的实施是否符合国际法规的要求,确认是否满足验证指定要求。上海朗脉科技有限公司的验证部门派出质量总监全权与其验证团队监督项目的执行。

 

Validation is one important part of the whole project, Macroprocess will delegate quality director with his team to monitor the project. And his qualification as the following:

 

他的履历情况如下: 

 

验证经理 Validtion manager 陈国笋 Chen Guosun

	 	

	
学历教育Education and Qualification: 

浙江大学药学院 药学专业本科 执业药师 

Bachelor in Pharmacy,

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

Pharmacy College of Zhejiang University

Licensed Pharmacist

 

	 	

	
专业技能 Professional Competence:

有8 年多的制药行业经验,尤其在验证和质量管理方面。Has over 8 years of professional experience in Pharmaceutical Industry, especially in Validation and Quality Management.

	 	
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.

	 	

	
主要项目Key Projects:

	 	

	
石家庄欧意药业  口服固体制剂 Shijiazhuang Ouyi Pharma.   Oral Solid Dosage Forms

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。对HVAC 系统和纯化水系统进行设计审核。编写HVAC 系统、洁净室和纯化水系统的IQOQ 方案,并实施。

Validation Manager 

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP. 

Design review of HVAC system and purified water system. 

IQOQ Protocols writing and execution of HVAC system, Clean room and purified water system. IQOQ protocols

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第6页/共18 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

writing and execution of HVAC computerized system. 

 

	 	

	
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      Sterile 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、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

Chengdu Institute of biological product      Vccine 

验证经理。负责按照中国GMP 和WHO GMP 的要求领导验证工作。 纯化水、注射用水、纯蒸汽和压缩空气的设计确认。 

Validation Manager 

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, WHO GMP. 

DQ of Purified water, WFI, Pure steam, compressed air.

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

	 	

	
浙江华海药业      口服固体制剂

Zhejiang Huahai Pharma.      Oral Solid Dosage Forms  

GMP 咨询师。按照中国GMP、FDA cGMP 和欧盟GMP 对概念设计进行GMP 审核。(已于2007 年通过FDA GMP 检查) 

GMP Consultant 

GMP review of conceptual design in accordance with the requirement of Chinese GMP, FDA cGMP and EU GMP. (Already passed FDA GMP Inspection in 2007) 

 

	 	

	
大连美罗制药厂      滴眼剂

Dalian Merro Pharma.      Eye Drops 

验证经理。负责按照中国GMP 和欧盟GMP 的要求领导验证工作。 

负责验证主计划的编写。编写HVAC 系统、洁净室、纯化水、注射用水系统的IQOQ 方案,并实施。

Validation manager 

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, EU GMP. 

Responsible for VMP writing. 

IQOQ protocols writing and execution of HVAC system, Clean room, PW/WFI system.

 

	 	

	
北京四环生物      疫苗

Beijing Four ring Bio-pharma      Vaccine

验证经理。负责按照中国GMP 和欧盟GMP 的要求领导验证工作。 

编写HVAC 系统、洁净室的IQOQ 方案,并实施。 

Validation manager 

Responsible for Design GMP review and VMP writing in accordance with the requirement of Chinese GMP, EU GMP. 

IQOQ protocols writing and execution of HVAC 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 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

and Clean room. 

 

	 	

	
石家庄恩必普药业      软胶囊 

Shijiazhuang NBP Pharma.      Soft capsule

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。 

负责验证主计划的编写。编写HVAC 系统、洁净室、纯化水系统的IQOQ 方案,并实施。工艺验证、清洗验证和分析方法验证的培训。 

工艺设备的计算机系统验证。 

Validation manager Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA GMP. Responsible for VMP writing. IQOQ protocols writing and execution of HVAC system, Clean room, PW system. Training of process validation, cleaning validation and analytical method validation. Computer validation of process equipments. 

 

	 	

	
北京费森尤斯卡比医药 片剂

Beijing Fresenius Kabi Pharma.     Tablet

验证工程师。HVAC 系统和洁净室的DQ/IQ/OQ 方案编写和实施。 

(已于2005 年通过EMEA 的GMP 检查) 

Validation engineer 

DQ/IQ/OQ protocols writing and execution of HVAC system and Clean room. 

(Already passed EMEA GMP Inspection in 2005) 

 

	 	

	
上海莱士 血制品

Shanghai RAAS 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 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

  

验证工程师。HVAC 系统、纯化水和注射用水系统的DQ/IQ/OQ 方案编写和实施。

Validation engineer 

DQ/IQ/OQ protocols writing and execution of HVAC system, Purified water and WFI systems.

 

	
1.4.

	
施工人员组织 Construction organize

 

为保质,按时完成贵公司的管道系统的施工,特组织人员如下:In order to guarantee the quality, & to complete the distribution loop on time, we especially organize our personnel as follows:

 

	
1.5.

	
项目经理负责人资质 project manager qualification

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

针对本次项目的情况,目前暂时确定选择经验丰富的程千振经理作为项目经理人负责整个项目的实施。他的履历情况如下:

Evaluating this project,we choose professional manager named Chen Qianzhen as project manager to take charge the technical of whole peoject. And the folloing is the qualification:

 

Cheng Qianzhen

程千振

 

Education and Qualifications 学历教育

	
•

	
Bachelor of Science,Mechanic Design (1992-1996) 

理学学士,机械设计(1992-1996)

Shandong University 

山东大学

Professional Experience 专业经验

Mr. Cheng has over 10 years of professional experience in project co-ordination, procurement and planning, facility design, generation of facility design drawings, commissioning in pharmaceutical engineering field.

 

程千振先生在制药工程领域内已有10 年以上专业的项目统筹经验,其中包括采购计划,设施设计,生产设备的设计图,设备调试等。

Key Projects 重点工程

MACROPROCESS TECHNOLOGY CO., LTD. 

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    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

  

	
Feb 2005 – 

2005 年2 月至今

	
CHENGDU INSTITUTE OF BIOLOGICAL PRODUCTS

成都生物制品研究所

Project Manager, responsible for engineering design, construction, commissioning and validation execution for clean utilities system which complies to WHO GMP 

项目经理,负责疫苗工厂按照WHO 的GMP 进行水系统设计,安装和验证执行。

 

NCPC NORTHBEST 

华北制药集团北元有限公司

Project Manager, responsible for complete a retrofitted Clean Piping system and validation execution which complies to FDA. Water for Injection distribution system, Purified Water distribution system, Pure Steam piping system and Clean Compressed air piping system are included. 

项目经理,制药厂按照美国FDA 的GMP 标准进行水系统的改造和验证执行。水系统包括注射用水分配系统,纯化水分配系统,纯蒸汽管道系统,洁净压缩空气管道系统等。

 

B.BRAUN MEDICAL (SUZHOU) CO., LTD. 

贝朗医疗(苏州)有限公司

Project Manager, responsible for complete a retrofitted material preparation system and validation execution which complies to EMEA. 

项目经理,制药厂按照欧盟的GMP 标准进行对大输液配料系统进行改造和验证执行。

SHANGHAI WISON BIOENGINEERING CO., LTD. 

上海惠生生物工程有限公司

Project Manager, responsible for complete a new clean piping system for a new vaccine plant and an antibody laboratory. Including WFI and PW distribution 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 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

项目经理,负责完成一个新的疫苗工厂和抗体实验室的洁净管道系统。包括注射用水系统和纯化水分配系统。

 

HANGZHOU TIANYUAN BIOPHARMA

杭州天元生物药业

Project Manager, responsible for engineering design, construction, commissioning and validation execution for clean utilities system which complies to WHO GMP 

项目经理,负责疫苗工厂按照WHO 的GMP 进行水系统设计,安装和验证执行。

 

POLIFARMA (NANJING) CO., LTD.

南京宝利化制药有限公司

Project Manager, responsible for complete a retrofitted Clean Piping system and validation execution which complies to TGA. Water for Injection distribution system, Purified Water distribution system are included. 

项目经理,制药厂按照澳大利亚TGA 的GMP 标准进行水系统的改造和验证执行。水系统包括注射用水分配系统,纯化水分配系统等。

GE HEALTHCARE (SHANGHAI) CO., LTD. 

通用电气(上海)药业有限公司

Project Manager, responsible for complete a retrofitted WFI piping and PS piping system which complies to FDA. This company has been certificated by FDA 

项目经理,制药厂按照美国FDA 的标准进行注射用水系统和纯蒸汽系统的改造。该厂的无菌大容量注射剂已通过美国FDA 的认证。

Project Manager, responsible for complete the clean piping system for their extension project which complies to FDA. WFI distribution system, PW distribution system, PS system and CA 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 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

项目经理,扩建项目按照美国FDA 的标准进行洁净管道系统的建设。包括注射用水分配系统,纯化水分配系统,纯蒸汽系统以及压缩空气系统。

 

SUZHOU DOWNRAYS 

苏州东瑞制药有限公司

Project Manager, responsible for process design, construction and commissioning for a clean piping for sterile API production. 

项目经理, 负责无菌原料药生产,洁净管道的工艺设计,安装和调试。

BAXTER HEALTHCARE (SHANGHAI) CO., LTD. 

百特医疗用品(上海)有限公司

Project Manager, responsible for complete a retrofitted material preparation system and validation execution which complies to EMEA. 

项目经理,制药厂按照欧盟的GMP 标准进行对大输液配料系统进行改造和验证执行。

QILU ANTIBIOTICOS PHARMACEUTICAL CO., LTD. 

齐鲁安替比奥制药有限公司

	
1996 – 2005

	
 

Project Engineer. Mr. Cheng, who has gotten rich engineering experience in this ten years, through organize and participate all the pharmaceutical project constructed by QILU Group. Such as sterile API project, sterile small volume injection dosage, lyo-product project and so on. 

And the sterile API project of Qilu Antibioticos has passed the qualification of EU GMP. Mr. Cheng organized and participate the whole duration. 

项目工程师,十年内,通过组织并参与了所有齐鲁集团建设的制药项目,有无菌原料药,无菌小容量液体制剂,冻干产品等

 

 

	
 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 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

 

一系列项目,他获得了丰富的工程经验。其中齐鲁安替比奥制药有限公司的无菌原料药通过了欧盟 GMP 的检查。他参与了全过程。

 

	
1.6.

	
质量控制组织图Quality 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 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

Construction Scheme

  

2. 施工设备材料投入计划Tools list

 

齐全的施工设备准备是一个项目能够顺利执行的前提条件,朗脉公司已经准备了设备随时按需入场,按照项目施工要求,公司拟定安排以下主要施工机械设备投入计划,清单参照如下(最终设备材料计划以项目经理实际安排为最终确认实施清单):

 

Our construction equipment is ready to undertake any task. And acoording to the requirement,we draw a draft plan to launch into project. The list as the following: (the finally plan is refer to project manager’s arrangement)

 

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

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 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第5 部分验证方案

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 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

  

第 6 部分

Part 6

施工工艺

Construction Technics

 

上海朗脉科技有限公司

 

ShangHai MacroProcess Technology Co.,Ltd

 

 

	
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      201100

T:021 54306717      F: 021 54306718

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

目  录 Index

 

	
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

	
15

	
1.5.1. 质量保证体系quality assurance system

	
15

	
1.5.2. 质量保证措施quality assurance measures

	
17

	  	  
	
1.6. 施工进度管理schedule manage

	
26

	
1.6.1. 进度管理及程序progress management and procedure

	
26

	
1.6.2. 全面资源保障Strategy for Deploying All Resources

	
26

	
1.6.3. 应急预案emergency preparation

	
27

	
1.6.4. 排除施工干扰之政策Strategy to Expel Interference

	
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 201100

 T:021 54306717    F: 021 54306718

	

第1页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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

	
1.1.

	
施工准备Construction preparations

施工准备按以下几个过程:Construction preparations refer to the following procedure:

 

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第2页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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 201100

 T:021 54306717    F: 021 54306718

	

第3页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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 201100

 T:021 54306717    F: 021 54306718

	

第4页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

Field welding include 现场焊接包括:

 

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第5页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

	
1.3.

	
配管质量检查流程 Pipline Quality Testing flow chart

 

	
1.4.

	
安全施工管理规范 Safety and Good Engineering Plan

 

	
1.4.1.

	
安全目标 safety target 

 

本项目的安全目标是“零事故”。 

 

The safety target for this project is Zero Accident.

 

	
1.4.2.

	
安全管理机构 management organization chart

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第6页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

项目经理是健康安全环保工作的第一责任人,对健康安全环保工作负全面的责任。 Project manager is the first responsible person for safety works. He is fully responsible for the safety work.

 

	 	

	
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.

	
1.4.3.

	
安全管理规范health and safety guidance

 

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第7页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

personnel. 

 

	 	

	
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,

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第8页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

dragging and throwing is allowed. 

 

	 	

	
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.

 

	 	

	
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,

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第9页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

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.

 

	 	

	
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

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第10页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

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.

 

	
1.4.4.

	
安全管理措施 safety management measures

 

	 	

	
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的有关法规。The general principle is to execute the owner’s safety plan, our company’s safety management system and relative official regulations.

	 	

	
安全教育 safety education

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第11页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

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)Safety education on field entrance * (*indicates tests will be held after education)

 

	 	

	
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

	 	

	
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:

 

	
  

	
n

	
进入设备作业许可证 Equipment entry operation license

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第12页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

		
■

	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.

 

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第13页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

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.

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第14页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

	
1.5.

	
施工质量管理Construction quality management

 

	
1.5.1.

	
质量保证体系quality assurance system

 

	
1.5.1.1.

	
公司质量方针guidance on quality

质量是永恒的追求,提供满足业主要求的工程和服务。

Quality is the goals to meet the requirement of owner on project and service.

	
1.5.1.2.

	
本项目质量目标target quality for this project

目标:保证我公司所提供的工程和服务,一次性通过相关认证。

Target: Ensure our engineering and services can pass relative certification only one time

	
1.5.1.3.

	
基本质量要求basic quality requirements

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第15页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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.

	
1.5.1.4.

	
现场质量保证体系construction field quality assurance system

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第16页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

quality control of the equipment and materials provided by the owner.

 

	 	

	
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

 

	
1.5.2.

	
质量保证措施quality assurance measures 

 

严格按公司质量体系要求进行,特别注意人员培训,资质审核,材料检验,焊接工艺评定,工机具、量器具检验,各质量控制点等方面严格把关。

 

Strictly operate according to the quality system. Pay special attentions to personnel training, qualification verification, material checking, welding verification, tools and instruments checking. Check all the quality control points.

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第17页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

	
1.5.2.1.

	
图纸资料管理drawings management

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.

	
1.5.2.2.

	
材料管理material management

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第18页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

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.

 

	 	

	
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.

 

	
1.5.2.3.

	
焊接管理 welding management

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第19页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第20页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

repair times should not be more than twice for stainless steel pipes. Do not forget to make repair records.

 

	 	

	
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.

	
1.5.2.4.

	
检验管理 checking management

 

	 	
 

	
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.

 

	
1.5.2.5.

	
质量控制

	 	

	
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

 

	 	

	
焊接工程 Welding

 

	 	

	
电气、仪表 Electricity and instruments

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第21页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

	 	

	
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 FDA、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 201100

 T:021 54306717    F: 021 54306718

	

第22页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

	
1.5.2.6.

	
针对性质量保证措施Pertinent quality assurance measures

	 	

	
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.

 

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第23页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

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 201100

 T:021 54306717    F: 021 54306718

	

第24页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

	
1.5.2.7.

	
资料管理

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第25页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

companies should also be available.

 

	

	

 

安装现场临时库房--分类存放

 

	

	

 

	
1.6.

	
施工进度管理schedule manage

 

	
1.6.1.

	
进度管理及程序progress management and procedure

	 	

	
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

 

	 	

	
进度管理程序图 Progress Management Process Chart

	
1.6.2.

	
全面资源保障 Strategy for Deploying All Resources

 

	 	

	
充分调动公司内部的资源 Sufficiently Deploy Resources in Our

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第26页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

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

	
1.6.3.

	
应急预案emergency preparation

 

	 	

	
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

 

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第27页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

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.

 

	 	

	
夏季施工工期保证措施Assuring Measures in Summer

 

	 	

	
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

 

	 	

	
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

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第28页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

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.

	
1.6.4.

	
排除施工干扰之政策Strategy to Expel Interference

 

	 	

	
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。Carry out checking month by month. Look out and guard against the attack of infection. If any patients are found, separate them from others.

 

	 	

	
管线及其它设施的加固措施 Solidifying Measures for Pipes and Other Devices

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第29页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第6 部分施工工艺

Construction Technics

 

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第30页/共30 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation for Piping System

 

 

第 7 部分

Part 7

管道系统施工规范

Construction Regulation for

Piping System

 

 

上海朗脉科技有限公司

 

ShangHai MacroProcess Technology Co.,Ltd

 

 

	
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      201100

T:021 54306717      F: 021 54306718

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

目 录

 

	
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

	
3

	
1.2.1. 总体要求 General requirements

	
3

	
1.2.2. 材料 Material

	
3

	
1.2.3. 焊接准备 Weld joint preparation and fit-up

	
3

	
1.2.4. 预热温度 Preheating temperature

	
3

	
1.2.5. 供电 Electrical characteristics

	
3

	
1.2.6. 焊接程序 Welding procedure

	
3

	
1.2.7. 焊接修补 Weld repair

	
3

	
1.2.8. 自动焊接程序Automatic welding program

	
3

	
1.2.9. 文档 Documentation

	
3

	
1.2.10. 非破坏性检查 Non destructive examination

	
3

	
1.2.11. 每日焊接样品 Weld daily samples

	
3

	  	  
	
1.3. 装配和安装 Fabrication and erection

	
3

	
1.3.1. 范围 Scope

	
3

	
1.3.2. 管件材料接收储存 Tubing materials receipt storage

	
3

	
1.3.3. 分类 Identification

	
3

	
1.3.4. 装配 Fabrication

	
3

	
1.3.5. 布管,切割和装备 Lay-out, cutting and fitting up

	
3

	
1.3.6. 焊接程序和资格 Welding procedure and qualifications

	
3

	
1.3.7. 安装 Erection

	
3

	
1.3.8. 焊接接口 Welded joints

	
3

	
1.3.9. 法兰接口 Flanged joints

	
3

	
1.3.10. 快装接口 Clamped joints

	
3

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第1页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

	
1.3.11. 支撑和穿管Support of tubing and penetrations

	
3

	  	  
	
1.4. 检查Inspection

	
3

	
1.4.1. 范围Scope

	
3

	
1.4.2. 配件和焊接编号Component & weld identification

	
3

	
1.4.3. 焊接准备Weld preparation

	
3

	
1.4.4. 焊接检验Weld inspection

	
3

	
1.4.5. 预装配件的保护Protection of prefabricated spools

	
3

	
1.4.6. 验收Acceptance

	
3

	
1.4.7. 其它要求Other requirements

	
3

	  	  
	
1.5. 水压测试与清洁water pressure test and cleaning

	
3

	
1.5.1. 压力测试Pressure testing

	
3

	
1.5.2. 测试报告Test reports

	
3

	
1.5.3. 水压压力测试Hydrostatic test pressure

	
3

	
1.5.4. 系统清洁和清洗System cleaning and flushing

	
3

	  	  
	
1.6. 管道系统脱脂、酸洗和钝化Chemical treatment

	
3

	
1.6.1. 安全Safty

	
3

	
1.6.2. 处理方法Method Treatment

	
3

	
1.6.3. 纯水和分配系统的化学处理treatment for PW and WFI

	
3

	
1.6.4. 蒸汽管道的化学处理solution for pure steam distribution loop

	
3

	  	  
	
1.7. 水压、酸洗以及焊接报告Report

	
3

	
1.7.1. 水压测试报告表Certificate hydraulic test

	
3

	
1.7.2. 管道系统脱脂、酸洗、钝化报告表 Report

	
3

	
1.7.3. 焊接报告表Welding inspection sheet

	
3

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第2页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

1. 管道系统施工规范Construction Regulation

 

	
1.1.

	
焊接总则 General

 

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第3页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

	 	

	
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.

 

	
1.2.

	
焊接规范 Welding regulation

本规范覆盖用自动轨迹焊接机或手动TIG 设备的气体钨电弧不锈钢焊接设备。

 

This specification covers the gas tungsten arc welding of austenitic stainless steel using automatic orbital tube welding machines or manual TIG equipments.

 

“管道”应包括所有需要焊接元件。 

 

The term TUBING shall include all components of the welding.

	
1.2.1.

	
总体要求 General requirements

 

	 	

	
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.

	 	

	
组件的定位点焊必须避免对完全焊接的不良影响。Tack welding of

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第4页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

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

	
1.2.2.

	
材料 Material

 

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第5页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

shall be 99.99% minimum purity.

	 	

	
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.

 

	
1.2.3.

	
焊接准备 Weld joint preparation and fit-up

 

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第6页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

abrasive wheel must be cleaned to remove the abrasive dust.

	 	

	
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

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第7页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

automatic welding machine.

 

	
1.2.4.

	
预热温度 Preheating temperature

 

	 	

	
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.

 

	
1.2.5.

	
供电 Electrical characteristics

 

	 	

	
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.

 

	
1.2.6.

	
焊接程序 Welding procedure

 

	 	

	
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 applicable welding schedule。

 

	
1.2.7.

	
焊接修补 Weld repair

 

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第8页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

	
1.2.8.

	
自动焊接程序 Automatic welding program

 

	 	

	
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.

 

	
1.2.9.

	
文档 Documentation

 

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第9页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

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.

	
1.2.10.

	
非破坏性检查Non destructive examination

 

	 	

	
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

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第10页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

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.

 

	
1.2.11.

	
每日焊接样品 Weld daily samples

 

	 	

	
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。

 

	
1.3.

	
装配和安装 Fabrication and erection

 

	
1.3.1.

	
范围 Scope

 

	 	

	
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.

 

	
1.3.2.

	
管件材料接收储存 Tubing materials receipt 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 201100

 T:021 54306717    F: 021 54306718

	

第11页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

管件材料接收储存和现场处理如下:Tubing materials receipt storage and handling at site:

 

	 	

	
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.

	
1.3.3.

	
分类 Identification

 

	 	

	
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

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第12页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

allow their proper identification.

 

	
1.3.4.

	
装配 Fabrication

 

	 	

	
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.

 

	
1.3.5.

	
布管,切割和装备 Lay-out, cutting and fitting up

 

	 	

	
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.

	 	

	
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.

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第13页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

	 	

	
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.

	
1.3.6.

	
焊接程序和资格 Welding procedure and qualifications

 

	 	

	
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.

 

	
1.3.7.

	
安装 Erection

 

	 	

	
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.

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第14页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

slope (0.3% max. 0.5%).

	
1.3.8.

	
焊接接口 Welded joints

 

	 	

	
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.

 

	
1.3.9.

	
法兰接口 Flanged joints

 

	 	

	
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.

 

	
1.3.10.

	
快装接口Clamped joints

 

	 	

	
不得使用螺纹接口。Threated joints shall not be used.

 

	
1.3.11.

	
支撑和穿管 Support of tubing and penetrations

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第15页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

	 	

	
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.

	
1.4.

	
检查 Inspection

 

	
1.4.1.

	
范围 Scope

 

	 	

	
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.

	 	

	
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,

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第16页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

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.

	
1.4.2.

	
配件和焊接编号 Component & weld identification

 

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第17页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

 

	
1.4.3.

	
焊接准备Weld preparation

 

焊接检查员决定是否进行下列检查/确认。

 

The following inspection/verification could be made at the welding inspector option.

 

	 	

	
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.

	 	

	
确认管道圆度公差。Verify tube roundness to tolerance.

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第18页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

	 	

	
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 join t。

	 	

	
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.

	 	

	
确认气源就位。Verify that purge bladder is in place.

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第19页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

	
1.4.4.

	
焊接检验 Weld inspection

 

每个焊接样品和所有装配焊都要目检管道内侧。如焊接有可修复的缺陷,

在焊接部件拆离焊机前进行第二次焊接以修复缺陷。如果重新焊接未修复缺陷,则此焊接视为不合格并不得装配。

 

Every sample weld and all production welds shall be visually inspected on the interior, If the weld has correctable defects, a second weld pass may be made to try to correct them before the spool is removed from the welding machine . If the rewelding does not remove the defect, the weld shall be rejected and not mounted. 

 

所有自动焊接按如下控制: 

 

All automatic welds will be controlled as follows:

 

	 	

	
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 automaticwelds, Rx will be carried out.

 

所有手工焊接要进行X 射线检验。All the manual weldings will be Rx inspected. 

 

如有表面缺陷,则本规格条目适用。For surface defects, the headlines of this specification are valid.

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第20页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

表1:Table 1

 

	  	  A	  	  B
	  	
须进行重新焊接的缺陷

Defects for which rewelding may be attempted

	  	
不合格的缺陷:须与受热区(棕色)一起切除:

Defects to be rejected : Cut out 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

点焊如有破裂、完全焊透、过烧、组件未对准,则视为不合格。Tack welds shall be rejected if : cracked, full penetrated, burned, components misalignment. 

 

焊件移离焊机后,对焊接外观进行目检。The outside of the weld is visually inspected after the spool is removed from the welding machine. 

 

	
1.4.5.

	
预装配件的保护 Protection of prefabricated spools

 

	 	

	
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.

 

	 	

	
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.

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第21页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

	 	

	
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.

	
1.4.6.

	
验收 Acceptance

 

	 	

	
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.

 

	
1.4.7.

	
其它要求 Other requirements

 

	 	

	
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.

 

	
1.5.

	
水压测试与清洁 water pressure test and cleaning

本规程包含在管道系统完成后,为测试系统性能和特性而进行的所有工作。This specification covers the activities to be carried out after 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 201100

 T:021 54306717    F: 021 54306718

	

第22页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

pipe construction, to test and improve his capability to perform the required characteristics.

	
1.5.1.

	
压力测试 Pressure testing

 

	 	

	
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.

 

	 	

	
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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第23页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

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.

	 	

	
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

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第24页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

	
1.5.2.

	
测试报告 Test reports 

 

承包商应为每个测试做相应记录,记录包含‘水压测试证书’和测试编号。The subcontractor shall make a record of the test as per specimen included “Hydraulic Test Certificate “, Certification Code “ CER-003 ”

 

	 	

	
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, pressureapplied and length of time at test pressure 。

 

	
1.5.3.

	
水压压力测试 Hydrostatic 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 for3.5 bar whichever is greater.  All test pressures shall be maintained a minimum of 15 minutes before visual examination of joints beings.

 

	 	

	
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.

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第25页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

	 	

	
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.

	
1.5.4.

	
系统清洁和清洗System cleaning and flushing

 

	 	

	
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”.

 

	
1.6.

	
管道系统脱脂、酸洗和钝化 Chemical treatment

本技术文件说明的是纯水,纯蒸汽,分配系统的化学处理操作。用于该分配系统的管道和管件是机械或电抛光的AISI316 L 不锈钢材料。This scope of this document is to describe the procedure for chemical conditioning of PW (purified water), PS (pure steam), WFI (water for injection) distribution loops. The pipes and fittings used for loops are in stainless steel (AISI 316L) and could be mechanically polished or electro polished.

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第26页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

系统的化学处理包括以下步骤:The chemical conditioning consists of the following steps: 

 

	 	

	
脱脂 DEGREASING

 

	 	

	
酸洗 PICKLING

 

	 	

	
钝化 PASSIVATION

脱脂是除去表面的油,油脂和微粒。

 

Degreasing removes from surfaces oil, grease and powders.

 

酸洗是除去焊接过程中产生的氧化物和机械抛光产生的沉淀层。

 

Pickling removes the oxides formed during welding and eventual deposits coming from mechanical polishing.

 

钝化是重新在表面镀上在机械和化学处理中除去的氧化防腐层。

 

Passivation restores on the surfaces the corrosion resistance layer of Cromo Oxides, that has been removed from previous mechanical and chemical operation

 

	
1.6.1.

	
安全 Safty

 

在化学处理中的安全防护措施 During the treatment observe the safety precautions listed here below: 

 

	 	

	
操作者需配戴透明面或眼镜 The operators shall wear a transparent face mask or suitable glasses.。

 

	 	

	
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

 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第27页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

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 c ase leakage。

 

参照化学品的安全说明。

 

Safety instructions for chemicals used are annexed.

 

	
1.6.2.

	
处理方法Method Treatment 根据参数用泵循环溶液处理管线。 Pipelines shall be treated by pumping and circulation solutionaccording to parameter indicated in sectio

 

	
1.6.3.

	
纯水和分配系统的化学处理treatment for PW and WFI 

 

	 	

	
脱脂 degtreasing

 

	
   化学品

	
无水酒精

	 
	
Necessary chemical components

	
- Absolute alcohol

	 
	
   溶液

	
去离子水 + 10% 酒精

	 
	
Solution :

	
- Demi water + 10% of alcohol

	 
	
   程序

	
泵压循环2-3bar

	 
	
Procedure :

	
- Recycle by a pump at 2/3 bar

	 
	
   温度

	
环境温度

	 
	
Temperature :

	
- Ambient

	 
	
   时间

	
30 分钟

	 
	
Time :

	
- 30 minutes

	 
	
   排放并用去离子水冲洗

	 	 
	
discharge and wash by demi water.

	 	 

 

	 	

	
酸洗

 

	
   化学品

	硝酸+ 氢氟酸	 

                  

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T:021 54306717    F: 021 54306718

	

第28页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

	
Necessary chemical components : 

	
- Nitric acid (HNO3) and Fluoridric acid (HF)

	 
	
   溶液

 

	
75% (重量)的硝酸和25%(重量)的氢氟酸组成的溶液,用50%体积的去离子水稀释

	 
	
Solution

	
- Prepare a solution composed of 75% in weight of HNO3 and 25% in weight of HF. Dilute the prepared volume at 50% with demi water

	 
	
   程序

	
泵压循环2-3bar

	 
	
Procedure :

	
- Recycle by a pump at 2/3 bar

	 
	
   温度

	
环境温度

	 
	
Temperature :

	
- Ambient

	 
	
   时间

	
1 小时

	 
	
Time :

	
- I hour

	 
	
   排放并用去离子水冲洗

	  	 
	
discharge and wash by demi water

	  	 

	

	
钝化 passivation

 

	
   化学品

Necessary chemical components :

	
硝酸

- Nitric acid (HNO3)

	  
	
   溶液

	
20% 的硝酸和80%的去离子水

	  
	
Solution

	
- Prepare a solution with 20% of HNO3 and 80% of demi water

	  
	
   程序

	
泵压循环2-3bar

	  
	
Procedure :

	
- Recycle by a pump at 2/3 bar

	  
	
   温度

	
环境温度

	  
	
Temperature :

	
- Ambient

	  
	
   时间

	
2 小时

	  
	
Time :

	
- 2 hour

	  
	
   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

	  	  

 

	
1.6.4.

	
蒸汽管道的化学处理 solution for pure steam distribution loop

 

	 	

	
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 201100

 T:021 54306717    F: 021 54306718

	

第29页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

	
   化学品

	
无水酒精

	  
	
Necessary chemical components :

	
- Absolute alcohol

	  
	
   溶液

	
去离子水 + 10% 酒精

	  
	
Solution :

	
- Demi water + 10% of alcohol

	  
	
   程序

	灌满整个系统静态保压	  
	
Procedure :

	- Static method. The whole distribution collector must be kept completely filled	  
	
   温度

	
环境温度

	  
	
Temperature :

	
- Ambient

	  
	
   时间

	
2 小时

	  
	
Time :

	
-2  hours

	  
	
   排放并用去离子水冲洗

	  	  
	
Discharge and wash by demi water

	  	  

 

备注:钝化检测仪

	 	

	
钝化 passivation

 

	
   化学品

	
双氧水

	  
	
Necessary chemical components :

	
-Hydrogen peroxide (H2O2)

	  
	
   溶液

	
25% 的双氧水和75%的去离子水

	  
	
Solution

	
- Prepare a solution with25% of H2O2 and 75% of demi water

	  
	
   程序

	
灌满整个系统静态保压

	  
	
Procedure :

	
Static method. The whole distribution collector must be kept completely filled

	  
	
   温度

	
环境温度

	  
	
Temperature :

	
-Ambient

	  
	
   时间

	
最少4 小时,最长72 小时

	  
	
Time :

	
-Min. 4 hours, Max. 72 hours

	  
	
   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 201100

 T:021 54306717    F: 021 54306718

	

第30页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

	
1.7.

	
水压、酸洗以及焊接报告 Report

 

	
1.7.1.

	
水压测试报告表 Certificate hydraulic test

	
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 3

THE PIPING LINE HAS BEEN HYDRAULICALLY TESTED UNDER THE CONDITIONS SPECIFIED BELOW. 

该管线已经在下列状况下进行水压测试。 

	
PRESSURE 

压力

	
TIME 

时间

	
MANOMETER 

压力表读数

	
RESULT 

结果

	
OPERATOR 

操作者

	  	  	  	  	  
	  	  	  	  	  

备注REMARKS : 

 

  

  

 

	
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 201100

 T:021 54306717    F: 021 54306718

	

第31页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

	
1.7.2.

	
管道系统脱脂、酸洗、钝化报告表 Report

	
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

THE DISTRIBUTION LOOP HAS BEEN DEGREASED, PICKLED AND PASSIVATED UNDER THE CONDITIONS SPECIFIED IN THE ATTACHED PROCEDURE 该管道分配系统已经在下列状况下进行脱脂、酸洗、钝化程序。 

 

	 	
1.

	
脱脂: 10%无水酒精用90%的纯化水稀释,用泵在2-3bar 压力下常温循环30 分钟后排放,并用纯化水冲洗干净。

 

	 	
2.

	
酸洗: 75% 硝酸和25% (重量)氢氟酸混合液用50%体积的纯化水稀释,用泵在2-3 bar 压力下常温循环,1小时后排放,并用纯化水冲洗至中性。

 

	 	
3.

	
钝化: 20%的硝酸用80%体积的纯化水稀释,用泵在2-3 bar 压力下常温循环2 小时后排放,并用纯化水冲洗至中性。

	
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 201100

 T:021 54306717    F: 021 54306718

	

第32页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

 

	
1.7.3.

	
焊接报告表Welding inspection sheet

 

	
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

	
自动

	
管道

	
ISO  2037

	
材质

	
AISI 316L

	
连接方式

	
管/管

	
直径

	
mm

	
壁厚

	
mm

	
焊机型号

	
COBRATIG 150

	
制造商

	
美国MK

	
焊头型号

	
5002

	
管道切割设备

	
G+F 切割机

	
端面清洁

	
乙醇

	
焊接时间

	
SEC

	
焊头氩气

	
lt/min

	
收弧氩气

	
lt/min

	
管内氩气

	
lt/min

	
电极缝隙

	
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 201100

 T:021 54306717    F: 021 54306718

	

第33页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

	  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 3

焊接报告单

 

	
 

 

 

 

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 201100

 T:021 54306717    F: 021 54306718

	

第34页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第7 部分管道系统施工规范

Construction Regulation

	
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

焊 接 报 告

	
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 201100

 T:021 54306717    F: 021 54306718

	

第35页/共35 页

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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

第 8 部分

Part 8

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

 

ShangHai MacroProcess Technology Co.,Ltd

 

 

	
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      201100

T:021 54306717      F: 021 54306718

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation 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

目 录

	
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 201100

 T: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

	
	

工艺配料系统

Process Formulation 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

1.1. 技术承诺Technical Promise

 

上海朗脉科技有限公司,拥有先进的焊接设备和质量检测设备,以及完全符合中国GMP 标准,FDA 认证以及其他国家标准的文件系统。工程中将使用验证过的全自动轨迹焊机进行焊接。所有的焊工都具有相关的上岗资格,至少要有2 年的实际工作经验或者经过工厂培训。上海朗脉科技有限公司承诺,我们承接的工程将完全按照GMP 标准进行施工。

 

工程质量保证期为1 年。

 

Macroprocess Technologies Co., Ltd. has advanced welding machine, quality-checking equipment and integrated files system according with Chinese GMP standard, FDA GMP standard and other country’s standards. Qualified automatic orbital welding machines will be used in our projects. All welders are qualified either by 2 year field experience or by factory training. The seller promises that the project we will do is completely according to GMP.

 

The Quality Guarantee Period of project will be 1 year.

 

1.2. 售后服务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

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation 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

 

 

	 	

	

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). 

	 	

	
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 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第9 部分偏离和图纸

Deviation and Drawings

第 9 部分

Part 9

偏离及图纸

 

 

Deviation and Drawings

 

上海朗脉科技有限公司

 

ShangHai MacroProcess Technology Co.,Ltd

 

 

	
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      201100

T:021 54306717      F: 021 54306718

 

  

  

  

 

		
沈阳三生制药有限责任公司

Shenyang Sunshine Pharmaceutical Company Limited

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第9 部分偏离和图纸

Deviation and Drawings

 

目 录

	
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 201100

 T: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

	
	

工艺配料系统

Process Formulation 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

 

9.1. 商务偏离表 Deviation Form for Commercial Terms

商务偏离表 

 

Deviation Form for Commercial Terms

 

	
项目名称

	
工艺配料系统 

Process Formulation 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。

投标人(公章): 上海朗脉科技有限公司

 

授权代表人(签字或盖章):

 

日期:

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第9 部分偏离和图纸

Deviation and Drawings

9.2. 技术偏离表 Deviation Form for Technical Specifications

 

技术偏离表 

 

Deviation Form for Technical Specifications

	
项目名称

	
工艺配料系统 

Process Formulation System

	
数 量

	
1 套

	
规格型号

	  
	
标 书要求

	
投标参数及其它

	
管件的外部抛光度Ra<0.8um,内部为R a<0.5um。 

 

CIP 回水管道BPE 抛光

	
管件外部Ra<1.0um 内部Ra<0.5um 

 

CIP 回水管道ISO2037

 

 

 

 

 

投标人(公章): 上海朗脉科技有限公司 

授权代表人(签字或盖章): 

日期: 

 

	
 上海市闵行区罗阳路168 号A 座101 室    201100 

 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100

 T: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

	
	

工艺配料系统

Process Formulation System

	
投标文件

Bidding Documents

	

第9 部分偏离和图纸

Deviation and Drawings

9.3. 图纸 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 201100

 T:021 54306717    F: 021 54306718

	

第4页/共4 页

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00195-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00195-of-00352.parquet"}]]