Document:

Unassociated Document

Exhibit 4.8.68 -Design Drawings -Summary

 

	
Room No.

	 	
Room Name

	 	
L/W/H

	 	
Telephone

	 	
Network

	
1-D-1-01

	 	
People Air Brake

	 	
3.5/2.0/2.8

	 	
N

	 	
N

	
1-D-1-02

	 	
Material Air Brake

	 	
3.5/2.0/2.8

	 	
N

	 	
N

	
1-C-1-03

	 	
People Air Brake

	 	
3.5/2.0/2.8

	 	  	 	  
	
1-C-1-04

	 	
Material Air Brake

	 	
3.5/2.0/2.8

	 	  	 	  
	
1-C-1-05

	 	
Clean Walkway

	 	
/2.8

	 	
2

	 	  
	
1-C-1-06

	 	
Storage after Sterilization

	 	
7.0/3.8/2.8

	 	  	 	  
	
1-C-1-07

	 	
Sterilization

	 	
7.0/5.0/2.8

	 	
1

	 	  
	
1-C-1-08

	 	
Storage

	 	
7.0/5.3/2.8

	 	
1

	 	  
	
1-D-1-09

	 	
Washing

	 	
7.0/8.0/3.5

	 	
1

	 	  
	
1-E-1-10

	 	
Material Purifying

	 	
2.4/3.0/2.8

	 	  	 	  
	
1-C-1-11

	 	
Exit Air Brake

	 	
2.7/2.0/2.8

	 	  	 	  
	
1-C-1-12

	 	
Preparation of Buffer Solution

	 	
5.4/6.2/3.5

	 	
1

	 	  
	
1-C-1-13

	 	
Control Room

	 	
5.4/3.3.2.8

	 	
1

	 	
1

	
1-C-1-14

	 	
Preparation of Culture Medium

	 	
5.4/10.9/4.0

	 	
1

	 	  
	  	 	  	 	  	 	  	 	  
	
2-C-1-01

	 	
Material Air Brake

	 	
5.4/2.0/2.8

	 	  	 	  
	
2-C-1-02

	 	
People Air Brake

	 	
5.4/2.2/2.8

	 	  	 	  
	
2-C-1-03

	 	
Cell Culture Room

	 	
11.6/25.2/2.8

	 	
1

	 	  
	
2-C-1-04

	 	
Cold Room

	 	
4.9/19.0/2.8

	 	  	 	  
	
2-C-1-05

	 	
Exit Air Brake

	 	
2.2/2.2/2.8

	 	  	 	  
	  	 	  	 	  	 	  	 	  
	
3-B-1-01

	 	
People Air Brake

	 	
2.0/2.2/2.8

	 	  	 	  
	
3-B-1-02

	 	
Material Air Brake

	 	
2.0/2.4/2.8

	 	  	 	  
	
3-B-1-03

	 	
Seed Proliferation

	 	
17.3/4.6/2.8

	 	
1

	 	  
	
3-B-1-04

	 	
Exit Air Brake

	 	
1.7/2.8/2.8

	 	  	 	  
	
3-C-1-05

	 	
Exit Air Brake

	 	
1.7/2.8/2.9

	 	  	 	  
	  	 	  	 	  	 	  	 	  
	
4-C-1-01

	 	
People Air Brake

	 	
2.4/1.8/2.8

	 	  	 	  
	
4-C-1-02

	 	
Material Air Brake

	 	
3.4/2.0/2.8

	 	  	 	  
	
4-C-1-03

	 	
Ultrafiltration

	 	
6.6/7.4/2.8

	 	
1

	 	  
	
4-C-1-04

	 	
Material Air Brake

	 	
2.9/2.0/2.8

	 	  	 	  
	
4-C-1-05

	 	
People Air Brake

	 	
2.4/2.0/2.8

	 	  	 	  
	
4-C-1-06

	 	
Purification

	 	
11.8/3.5/2.8

	 	
1

	 	
1

	
4-B-1-07

	 	
People Air Brake

	 	
2.4/2.0/2.8

	 	  	 	  
	
4-B-1-08

	 	
Original Solution

	 	
3.6/3.8/2.8

	 	
1

	 	  
	
4-B-1-09

	 	
Exit Air Brake

	 	
1.8/1.8/2.8

	 	  	 	  
	
4-C-1-10

	 	
Exit Air Brake

	 	
1.8/1.8/2.8

	 	  	 	  
	
4-D-1-11

	 	
Exit Walkway

	 	
/2.4/2.8

	 	  	 	  
	
4-D-1-12

	 	
Air Brake

	 	
2.4/2.4/2.8

	 	  	 	  
	
4-E-1-13

	 	
Hygiene Instruments Washing

	 	
2.4/2.0/2.8

	 	  	 	  
	
4-E-1-14

	 	
Hygiene Instruments Storage

	 	
2.4/2.0/2.8

	 	  	 	  

 

  

  

 

 

	
Room No.

	 	
Room Name

	 	
L/W/H

	 	
Telephone

	 	
Network

	
5-D-1-01

	 	
People Air Brake

	 	
3.5/2.0/2.8

	 	  	 	  
	
5-D-1-02

	 	
Material Air Brake

	 	
3.5/2.0/2.8

	 	  	 	  
	
5-C-1-03

	 	
People Air Brake

	 	
3.5/2.0/2.8

	 	  	 	  
	
5-C-1-04

	 	
Material Air Brake

	 	
3.5/2.0/2.8

	 	  	 	  
	
5-C-1-05

	 	
Clean Walkway

	 	
/2.8

	 	
2

	 	  
	
5-C-1-06

	 	
Storage after Sterilization

	 	
7.0/3.8/2.8

	 	  	 	  
	
5-C-1-07

	 	
Sterilization

	 	
7.0/5.0/2.8

	 	
1

	 	  
	
5-C-1-08

	 	
Storage

	 	
7.0/5.3/2.8

	 	
1

	 	  
	
5-D-1-09

	 	
Washing

	 	
7.0/8.0/3.5

	 	
1

	 	  
	
5-E-1-10

	 	
Material Purifying

	 	
2.4/3.0/2.8

	 	  	 	  
	
5-C-1-11

	 	
Exit Air Brake

	 	
2.7/2.0/2.8

	 	  	 	  
	
5-C-1-12

	 	
Preparation of Buffer Solution

	 	
5.4/7.3/3.5

	 	
1

	 	  
	
5-D-1-13

	 	
Control Room

	 	
5.4/3.6.2.8

	 	
1

	 	
1

	
5-C-1-14

	 	
Preparation of Culture Medium

	 	
5.4/10.9/4.0

	 	
1

	 	  
	  	 	  	 	  	 	  	 	  
	
6-C-1-01

	 	
Material Air Brake

	 	
5.4/2.0/2.8

	 	  	 	  
	
6-C-1-02

	 	
People Air Brake

	 	
5.4/2.2/2.8

	 	  	 	  
	
6-C-1-03

	 	
Cell Culture Room

	 	
11.6/25.2/2.8

	 	
1

	 	  
	
6-C-1-04

	 	
Cold Room

	 	
4.9/19.0/2.8

	 	  	 	  
	
6-C-1-05

	 	
Exit Air Brake

	 	
2.2/2.2/2.8

	 	  	 	  
	  	 	  	 	  	 	  	 	  
	
7-B-1-01

	 	
People Air Brake

	 	
2.4/2.1/2.8

	 	  	 	  
	
7-B-1-02

	 	
Material Air Brake

	 	
2.4/2.1/2.8

	 	  	 	  
	
7-B-1-03

	 	
Seed Proliferation

	 	
/2.8

	 	
1

	 	  
	
7-B-1-04

	 	
Exit Air Brake

	 	
1.7/2.8/2.8

	 	  	 	  
	
7-C-1-05

	 	
Exit Air Brake

	 	
1.7/2.8/2.9

	 	  	 	  
	  	 	  	 	  	 	  	 	  
	
8-C-1-01

	 	
People Air Brake

	 	
2.4/1.8/2.8

	 	  	 	  
	
8-C-1-02

	 	
Material Air Brake

	 	
3.4/2.0/2.8

	 	  	 	  
	
8-C-1-03

	 	
Ultrafiltration

	 	
6.6/7.4/2.8

	 	
1

	 	  
	
8-C-1-04

	 	
Material Air Brake

	 	
2.9/2.0/2.8

	 	  	 	  
	
8-C-1-05

	 	
People Air Brake

	 	
2.4/2.0/2.8

	 	  	 	  
	
8-C-1-06

	 	
Purification

	 	
11.8/3.5/2.8

	 	
1

	 	
1

	
8-B-1-07

	 	
People Air Brake

	 	
2.4/2.0/2.8

	 	  	 	  
	
8-B-1-08

	 	
Original Solution

	 	
3.6/3.8/2.8

	 	
1

	 	  
	
8-B-1-09

	 	
Exit Air Brake

	 	
1.8/1.8/2.8

	 	  	 	  
	
8-C-1-10

	 	
Exit Air Brake

	 	
1.8/1.8/2.8

	 	  	 	  
	
8-D-1-11

	 	
Exit Walkway

	 	
/2.4/2.8

	 	  	 	  
	
8-D-1-12

	 	
Air Brake

	 	
2.4/2.4/2.8

	 	  	 	  
	
8-E-1-13

	 	
Hygiene Instruments Washing

	 	
2.4/2.0/2.8

	 	  	 	  
	
8-E-1-14

	 	
Hygiene Instruments Storage

	 	
2.4/2.0/2.8

	 	  	 	  

 

  

  

 

 

	
Room No.

	 	
Room Name

	 	
L/W/H

	 	
Telephone

	 	
Network

	
9-D-1-01

	 	
Material Air Brake

	 	
2.3/1.9/2.8

	 	  	 	  
	
9-C-1-02

	 	
Material Air Brake

	 	
2.5/1.9/2.8

	 	  	 	  
	
9-D-1-03

	 	
People Air Brake

	 	
2.4/1.8/2.8

	 	  	 	  
	
9-C-1-04

	 	
People Air Brake

	 	
2.4/1.8/2.8

	 	  	 	  
	
9-B-1-05

	 	
Material Air Brake

	 	
2.4/1.8/2.8

	 	  	 	  
	
9-B-1-06

	 	
People Air Brake

	 	
2.1/2.7/2.8

	 	  	 	  
	
9-B-1-07

	 	
Storage

	 	
2.8/2.6/2.8

	 	  	 	  
	
9-B-1-08

	 	
Solution Dosing

	 	
3.0/3.7/2.8

	 	
1

	 	  
	
9-B-1-09

	 	
Exit Air Brake

	 	
2.4/1.8/2.8

	 	  	 	  
	
9-C-1-10

	 	
Exit Air Brake

	 	
2.4/1.8/2.8

	 	  	 	  
	
9-D-1-11

	 	
Exit Air Brake

	 	
2.4/1.8/2.8

	 	  	 	  
	
9-B-1-12

	 	
Filling and Capping of Vials

	 	
7.9/5.0/2.8

	 	
1

	 	  
	
9-B-1-13

	 	
Exit Air Brake

	 	
1.9/1.6/2.8

	 	  	 	  
	
9-C-1-14

	 	
Exit Air Brake

	 	
1.6/1.6/2.8

	 	  	 	  
	
9-D-1-15

	 	
Walkway

	 	
/2.8

	 	  	 	  
	
9-D-1-16

	 	
Air Brake

	 	
1.9/1.8/2.8

	 	  	 	  
	
9-E-1-17

	 	
Light Testing, Labeling

	 	
10.2/4.4/2.8

	 	
1

	 	  
	
9-C-1-18

	 	
Cleaning and Sterilization of Vials

	 	
6.2/5.4/2.8

	 	
1

	 	
1

	
9-C-1-19

	 	
People Air Brake

	 	
1.8/2.7/2.8

	 	  	 	  
	
9-C-1-20

	 	
Material Air Brake

	 	
1.8/2.7/2.8

	 	  	 	  
	
9-C-1-21

	 	
Clean Instruments Storage

	 	
5.1/2.7/2.8

	 	  	 	  
	
9-C-1-22

	 	
Exit Air Brake

	 	
1.8/1.8/2.8

	 	  	 	  
	
9-D-1-23

	 	
Washing

	 	
5.2/3.6/2.8

	 	
1

	 	  
	
9-C-1-24

	 	
Exit Air Brake

	 	
5.2/1.7/2.8

	 	  	 	  
	
9-C-1-25

	 	
Clean Walkway

	 	
/2.8

	 	
1

	 	  
	
9-C-1-26

	 	
Temporary Storage of Inner Packing Materials

	 	
10.7/1.9/2.8

	 	
1

	 	
1

	
9-E-1-27

	 	
Aluminum-Plastic Packing

	 	
10.2/6.0/2.8

	 	
1

	 	  
	
9-C-1-28

	 	
Labeling, Light Testing

	 	
8.0/5.5/2.8

	 	
1

	 	  
	
9-C-1-29

	 	
Exit Air Brake

	 	
2.4/1.8/2.8

	 	  	 	  
	
9-B-1-30

	 	
People Air Brake

	 	
1.9/1.9/2.8

	 	  	 	  
	
9-B-1-31

	 	
Storage

	 	
2.2/1.9/2.8

	 	  	 	  
	
9-B-1-32

	 	
Pre-filling Syringe Filling

	 	
4.2/5.5/2.8

	 	
1

	 	  
	
9-B-1-33

	 	
Material Air Brake

	 	
1.9/1.9/2.8

	 	  	 	  
	
9-B-1-34

	 	
People Air Brake

	 	
1.9/1.9/2.8

	 	  	 	  
	
9-B-1-35

	 	
Solution Dosing

	 	
3.9/4.0/2.8

	 	
1

	 	  
	
9-B-1-36

	 	
Exit Air Brake

	 	
3.9/1.8/2.8

	 	  	 	  
	
9-C-1-37

	 	
Exit Air Brake

	 	
3.0/1.8/2.8

	 	  	 	  
	
9-C-1-38

	 	
Preparation of Buffer Solution

	 	
2.9/6.0/2.8

	 	
1

	 	  
	
9-C-1-39

	 	
Enter Air Brake

	 	
2.6/1.9/2.8

	 	  	 	  
	
9-D-1-40

	 	
Air Brake

	 	
2.4/1.7/2.8

	 	  	 	  

 

  

  

 

 

	
Room No.

	 	
Room Name

	 	
L/W/H

	 	
Telephone

	 	
Network

	
11-F-1-01

	 	
Lobby

	 	
6.0/9.5/

	 	  	 	  
	
11-F-1-02

	 	
Stair

	 	  	 	  	 	  
	
11-F-1-03

	 	
Lavatory

	 	  	 	  	 	  
	
11-F-1-04

	 	
Lavatory

	 	  	 	  	 	  
	
11-F-1-05

	 	
Ante-room

	 	  	 	  	 	  
	
11-F-1-06

	 	
Steam Decompression

	 	
7.4/2.4

	 	  	 	  
	
11-F-1-07

	 	
Control Room

	 	
4.5/2.4

	 	
1

	 	
1

	
11-F-1-08

	 	
PW/WFI

	 	  	 	  	 	  
	
11-F-1-09

	 	
Stair

	 	  	 	  	 	  
	
11-F-1-10

	 	
Chilled Circulating Water

	 	  	 	  	 	  
	
11-F-1-11

	 	
Safe Walkway

	 	  	 	  	 	  
	
11-F-1-12

	 	
Air Cylinder Room

	 	  	 	  	 	  
	
11-F-1-13

	 	
Central Control Room

	 	
4.4/3.8

	 	
1

	 	
1

	
11-F-1-14

	 	
Changing Shoes

	 	  	 	  	 	  
	
11-F-1-15

	 	
Changing Clothes

	 	  	 	  	 	  
	
11-F-1-16

	 	
Changing Clothes

	 	  	 	  	 	  
	
11-F-1-17

	 	
Changing Clothes

	 	  	 	  	 	  
	
11-F-1-18

	 	
Changing Clothes

	 	  	 	  	 	  
	
11-F-1-19

	 	
Buffering

	 	  	 	  	 	  
	
11-D-1-20

	 	
People Air Brake

	 	
2.7/1.8/2.8

	 	  	 	  
	
11-C-1-21

	 	
People Air Brake

	 	
2.7/1.8/2.8

	 	  	 	  
	
11-C-1-22

	 	
Work Clothes Storage in Clean Area

	 	
3.0/6.0/2.8

	 	
1

	 	  
	
11-C-1-23

	 	
Exit Air Brake

	 	
1.5/1.7/2.8

	 	  	 	  
	
11-D-1-24

	 	
Exit Air Brake

	 	
1.5/1.7/2.8

	 	  	 	  
	
11-D-1-25

	 	
Work Clothes Cleaning in Clean Area

	 	
5.4/5.9/2.8

	 	  	 	  
	
11-E-1-26

	 	
Hygiene Instruments Cleaning

	 	  	 	  	 	  
	
11-E-1-27

	 	
Hygiene Instruments Storage

	 	  	 	  	 	  
	
11-E-1-28

	 	
Work Clothes Cleaning in General Area

	 	  	 	
1

	 	  
	
11-E-1-29

	 	
Maintanence Room

	 	
8.2/2.8

	 	
1

	 	
1

 

  

  

 

 

	
Room No.

	 	
Room Name

	 	
L/W/H

	 	
Telephone

	 	
Network

	  	 	
Training Room

	 	
303sq.m.

	 	  	 	  
	  	 	
Middle-Size Meeting Room

	 	
36sq.m.

	 	  	 	  
	  	 	
Big-Size Meeting Room

	 	
45sq.m.

	 	  	 	  
	  	 	
QA Reference Room

	 	
50sq.m.

	 	  	 	  
	  	 	
Factory Director's Office1

	 	
14sq.m.

	 	  	 	  
	  	 	
Factory Director's Office2

	 	
14sq.m.

	 	  	 	  
	  	 	
Factory Director's Office3

	 	
14sq.m.

	 	  	 	  
	  	 	
Factory Director's Office4

	 	
14sq.m.

	 	  	 	  
	  	 	
Factory Director's Office5

	 	
14sq.m.

	 	  	 	  
	  	 	
Opening Office Area

	 	
376sq.m.

	 	  	 	  
	  	 	
Reception Room

	 	
9sq.m.

	 	  	 	  
	  	 	
Parlor

	 	
10sq.m.

	 	  	 	  
	  	 	  	 	  	 	  	 	  
	  	 	  	 	  	 	  	 	  
	
13-F-2-01

	 	
HVAC

	 	
50.5/66.5

	 	
1

	 	
1

	
13-F-2-02

	 	
Maintenance

	 	
7.0/9.7

	 	
1

	 	
1

	
13-F-2-03

	 	
Power Distribution

	 	
7.0/9.7

	 	
1

	 	
1

	
13-F-2-04

	 	
Hall for Machine Room

	 	  	 	  	 	  
	  	 	  	 	  	 	  	 	  
	
14-F-2-01

	 	
Changing Clothes

	 	  	 	  	 	  
	
14-F-2-02

	 	
Changing Clothes

	 	  	 	  	 	  
	
14-F-2-03

	 	
Process Technology Room

	 	
3.6/6.8

	 	
1

	 	
1

	
14-F-2-04

	 	
Samples Keeping Room of Raw and Complementary Materials

	 	
3.5/6.8

	 	  	 	  
	
14-F-2-05

	 	
Balance Room

	 	
4.8/5.1

	 	  	 	  
	
14-F-2-06

	 	
Reagent Room

	 	
4.8/4.2

	 	  	 	  
	
14-F-2-07

	 	
Samples Keeping Room of Products

	 	
5.0/6.8

	 	  	 	  
	
14-F-2-08

	 	
Walkway

	 	  	 	  	 	  
	
14-F-2-09

	 	
Laboratory

	 	
7.4/10.2

	 	
1

	 	
1

	
14-F-2-10

	 	
Protein Analysis Room

	 	
7.2/10.2

	 	
1

	 	
4

	
14-F-2-11

	 	
Storage Room

	 	
4.6/6.5

	 	  	 	  
	
14-F-2-12

	 	
Gas Chromatography Room

	 	
4.6/3.6

	 	  	 	
1

	
14-F-2-13

	 	
Physical and Chemical Analysis Room

	 	
7.6/10.2

	 	
1

	 	
4

	
14-F-2-14

	 	
Activity Detection Room

	 	
7.2/10.2

	 	
1

	 	
4

	
14-F-2-15

	 	
Preparation

	 	
3.4/10.2

	 	  	 	  
	
14-F-2-16

	 	
Sterilization

	 	
7.8/4.2

	 	  	 	  
	
14-F-2-17

	 	
Washing and Brushing

	 	
7.8/6.1

	 	  	 	  
	
14-B-2-18

	 	
Cleanroom for Sterile Examination

	 	
5.1/4.0/2.8

	 	  	 	  
	
14-C-2-19

	 	
Walkway

	 	
9.8/2.0/2.8

	 	
1

	 	  
	
14-C-2-20

	 	
Material Air Brake

	 	
2.6/2.1/2.8

	 	  	 	  
	
14-D-2-21

	 	
Material Air Brake

	 	
2.3/2.1/2.8

	 	  	 	  
	
14-C-2-22

	 	
People Air Brake

	 	
2.3/2.1/2.8

	 	  	 	  
	
14-D-2-23

	 	
People Air Brake

	 	
2.3/2.1/2.8

	 	  	 	  
	
14-E-2-24

	 	
Culture Room

	 	
5.2/6.0

	 	  	 	  
	
14-E-2-25

	 	
Activity Detection Room

	 	
3.7/10.2

	 	  	 	  
	
14-C-2-26

	 	
Instrument Storage

	 	
3.2/4.1/2.8

	 	  	 	  
	
14-C-2-27

	 	
Microbial Limits Testing

	 	
3.6/3.7/2.8

	 	  	 	  
	
14-C-2-28

	 	
Enter Air Brake

	 	
1.7/2.0/2.8

	 	  	 	  
	
14-B-2-29

	 	
Enter Air Brake

	 	
1.7/1.9/2.8

	 	  	 	  
	
14-B-2-30

	 	
Exit Air Brake

	 	
1.8/1.3/2.8

	 	  	 	  
	
14-C-2-31

	 	
Exit Air Brake

	 	
2.0/1.9/2.8

	 	  	 	  
	
14-D-2-32

	 	
Exit Air Brake

	 	
1.8/1.8/2.8

	 	  	 	  

 

  

  

 

 

	
Room No.

	 	
Room Name

	 	
L/W/H

	 	
Telephone

	 	
Network

	
10-E-1-01

	 	
Liquid Nitrogen

	 	
1.8/2.8

	 	  	 	  
	
10-E-1-02

	 	
Seed Bank

	 	
2.2/2.8

	 	  	 	  
	
10-F-1-03

	 	
Normal Temperature Storehouse

	 	
21.2/28.4

	 	
1

	 	
1

	
10-D-1-04

	 	
People Air Brake

	 	
1.7/2.7/2.8

	 	  	 	  
	
10-D-1-05

	 	
Material Purifying

	 	
3.6/2.2/2.8

	 	  	 	  
	
10-C-1-06

	 	
People Air Brake

	 	
4.0/1.8/2.8

	 	  	 	  
	
10-C-1-07

	 	
Weighting and Sampling Room

	 	
3.4/4.0/2.8

	 	
1

	 	
1

	
10-F-1-08

	 	
Original Solution Storehouse

	 	
7.6/3.6

	 	  	 	  
	
10-F-1-09

	 	
Refrigerator for Bulk Products

	 	  	 	  	 	  
	
10-F-1-10

	 	
Refrigerator for Raw Materials

	 	  	 	  	 	  
	
10-F-1-11

	 	
Buffering

	 	  	 	  	 	  
	
10-F-1-12

	 	
Warehouse Management

	 	
7.6/3.4

	 	
1

	 	
1

	
10-F-1-13

	 	
Relay

	 	
11.4/5.9

	 	  	 	  
	
10-F-1-14

	 	
Outer Packing Removal Area

	 	  	 	  	 	  
	
10-F-1-15

	 	
Buffering

	 	  	 	  	 	  
	
10-F-1-16

	 	
Hygiene Instruments

	 	  	 	  	 	  
	
10-F-1-17

	 	
Lavatory

	 	  	 	  	 	  
	
10-F-1-18

	 	
Dangerous Cargo Warehouse

	 	  	 	  	 	  
	
10-F-1-19

	 	
Stair

	 	  	 	  	 	  
	
10-F-1-20

	 	
Elevator Hoistway

	 	  	 	  	 	  
	
10-F-1-21

	 	
Ante-room for Elevator

	 	  	 	  	 	  
	
10-F-1-23

	 	
Shipping Area

	 	
8.4/10.2

	 	
1

	 	
1

	
10-F-1-24

	 	
Buffering

	 	  	 	  	 	  
	
10-F-1-25

	 	
Refrigerator

	 	  	 	  	 	  
	
10-F-1-26

	 	
Auxiliary Machine

	 	  	 	  	 	  
	
10-F-1-27

	 	
Refrigerator for Finished Prodcuts

	 	  	 	  	 	  
	
10-F-1-28

	 	
Refrigerator for Finished Prodcuts

	 	  	 	  	 	  
	
10-E-1-29

	 	
Packing

	 	
16.6/10.2

	 	
1

	 	
1

	
10-E-1-30

	 	
Coding Room

	 	
4.2/10.2

	 	  	 	  
	
10-E-1-32

	 	
Walkway in Control AreaUnassociated Document

 

Exhibit 4.8.69 - Pipeline - Design and Construction Specification

 

	

	
 

 Design and Construction 

Specification

 

Shenyang Sunshine Pharmaceutical Company Limited

New Factory Engineering Project

 

Design of Construction Drawing

 

Pipeline Specialty

 

	
 

	
 

	
 

	
Eng. No.

	
p-558

	
7 Pages

	
Prepared by

	
Checked by

	
Approved by

	
Drawing No.

	
  D文-558-2-PP-1/1

  

  

  

	
 

	
Shenyang Sunshine Pharmaceutical Company Limited New Factory Engineering Project

	
Eng. No.

	
P-558

	
Drawing No.

	
D文-558-2-PP-1/1

	
Page 1

	
Of 10

Design and Construction Specification

Table of Contents

	
1. Design Basis

	  2
	  	  
	
2. Standard, Specification and Regulation in Design

	  2
	  	  
	
3. Installation Instructions for Equipment

	  2
	  	  
	
4. Installation Instructions for Pipelines

	  3
	  	  
	
5. Pressure Testing Instructions for Pipeline System

	  8
	  	  
	
6. Blow Wash Instructions for Equipment and Pipeline System

	  9
	  	  
	
7. Installation Notes

	  10

  

  

  

 

	
 

	
Shenyang Sunshine Pharmaceutical Company Limited New Factory Engineering Project

	
Eng. No.

	
P-558

	
Drawing No.

	
D文-558-2-PP-1/1

	
Page 2

	
Of 10

Design and Construction Specification

	
1.

	
Design Basis

	
  

	
1.1

	
Drawings and relevant specifications from Wuhan Pharmaceutical Industry Design Institute

	
  

	
1.2

	
Adjustment according to the requirements of Owner

	
  

	
1.3

	
Relevant national laws and regulations

	
2.

	
Standard, Specification and Regulation in Design and Construction

	
  

	
2.1

	
Code for Quality Control of Pharmaceutical Production and appendices (1998, revised) by State Drug Administration

	
  

	
2.2

	
National Standard of the People's Republic of China Code of Design on Building Fire Protection and Prevention (GB50016—2006)

	
  

	
2.3

	
National Standard of the People's Republic of China Code for Construction and Acceptance of Water and Sewerage Pipeline Works (GB50268-2008)

	
  

	
2.4

	
National Standard of the People's Republic of China Design Code for Industrial Metallic Piping 2008 Edition (GB50316-2000)

	
  

	
2.5

	
National Standard of the People's Republic of China Code for Construction and Acceptance of Industrial Metallic Piping (GB50235-97)

	
  

	
2.6

	
National Standard of the People's Republic of China Code for Design of Clean Room (GB50073-2001)

	
  

	
2.7

	
Industrial Standard of the People's Republic of China Standard Drawing of Pipe Rack (HG/T21629-1999)

	
3.

	
Installation Instructions for Equipment (Production equipment provided by Owner, except Water Preparation Room)

	 	
3.1

	
Relevant technical information prior to equipment installation

3.1.1 Certificate of Compliance

3.1.2 Record of Out-of-Box Audit

3.1.3 Instructions for Equipment Installation and Usage

3.1.4 Assembly Drawing of Equipment

  

  

  

 

	
 

	
Shenyang Sunshine Pharmaceutical Company Limited New Factory Engineering Project

	
Eng. No.

	
P-558

	
Drawing No.

	
D文-558-2-PP-1/1

	
Page 3

	
Of 10

Design and Construction Specification

	 	
3.2 

	
Equipment installation procedure and requirement of civil construction

3.2.1 Civil construction of equipment foundation shall be carried out after confirming the consistency between physical equipment/purchase order documents of equipment and installation base of equipment.

3.2.2 Installation of large-scale equipment and construction sequence of civil work shall be applied according to requirements of installation specialties. Site Person in Charge shall do dispatch and coordination to installation of large-scale equipment and construction sequence of civil work.

	 	
3.3 

	
Equipment Installation Requirements

3.3.1 Equipment installers and builders shall do construction and installation according to technological equipment list, layout drawing of technological equipment installation, structural drawing of equipment, anchor bolt list for equipment, installation instructions for approved equipment, and construction drawing for non-approved equipment. This also shall be carried out after confirming the consistency between drawings and physical equipment, so as to ensure location dimensions and mounting height of equipment as well as orifice orientation of pipe in their right place.

3.3.2 All equipment in Class A and Class B production areas of the project shall be anti-static earthing to the nearest point, see drawings of electrical specialty and Standard Drawing of Static Earthing Installation for Chemical Industry for details.

	
4.

	
Installation Instructions for Pipelines

4.1 Basic installation condition for process pipelines

4.1.1 Basic engineering condition for pipeline installations on buildings and structures has been approved; embedded parts for pipeline installations have been ready.

4.1.2 The equipment connected with pipelines has been in position and meet design requirements through inspection.

4.1.3 Pipelines, fittings and valves have been approved.

4.1.4 Installation instructions for special pipe fittings and valves.

4.1.5 Civil works of pipe racks have been completed and meet design requirements through inspection.

  

  

  

 

	
 

	
Shenyang Sunshine Pharmaceutical Company Limited New Factory Engineering Project

	
Eng. No.

	
P-558

	
Drawing No.

	
D文-558-2-PP-1/1

	
Page 4

	
Of 10

Design and Construction Specification

4.2 Specification of pipeline materials and usage instructions for valves

	
Fluid Name

	
Pipe Material

	
Valve

	
System

Working Pressure

	
Insulation Notes

	
process chilled water

	
304 Stainless steel

	
Butterfly valve/ stop valve

	
≤6Kg

	
SeeD文-558-2-hv-11/12

	
A.C. circulated cooling water

	
Seamless steel pipe

	
Butterfly valve

	
≤6Kg

	
SeeD文-558-2-hv-11/12

	
A.C. circulated chilled water

	
Seamless/ galvanized pipe

	
Butterfly valve/ stop valve

	
≤6Kg

	
SeeD文-558-2-hv-11/12

	
Steam pipeline

	
Seamless steel pipe

	
Stop valve

	
≤16Kg

	
SeeD文-558-2-hv-11/12

	
Drain pipe of condenser water

	
Galvanized steel pipe

	
Stop valve

	
N/A

	
SeeD文-558-2-hv-11/12

	
Running water pipe

	
304 Stainless

steel

	
Globe valve

	
≤4Kg

	  
	
Fire fighting pipeline

	
Galvanized steel pipe

	  	
≤12Kg

	
N/A

4.2.1 Selection of valves: the materials shall be according to pipeline materials

4.2.2 Cooling water system and chilled water system: butterfly valve (D71X-10) for nominal diameter>DN50; screw thread stop valve (J11H-10) for nominal diameter≤DN50

4.2.3 Seamless steel pipe: if dimensions are big or no specification, spiral welded pipe shall be applied.

4.2.4 Steam system: flange stop valve (J41H-16) for nominal diameter>DN50; screw thread stop valve (J11H-16) for nominal diameter≤DN50

4.2.5 Drainage system of condenser water: valves shall be selected according to types of steam pipes

4.2.6 Running water system: pipelines shall be argon arc welding; valves shall be fast assembled with hoops

4.2.7 Galvanized pipeline system: pipes and valves shall be connected by screw thread

  

  

  

 

	
 

	
Shenyang Sunshine Pharmaceutical Company Limited New Factory Engineering Project

	
Eng. No.

	
P-558

	
Drawing No.

	
D文-558-2-PP-1/1

	
Page 5

	
Of 10

Design and Construction Specification

4.2.8 Screw thread drain valves apply to the places where need arrangement of empty points

4.2.9 Stainless steel pipes for process cooling water shall be according to GB/T12770-2002 and SCH10S of GB/T18705-2002.

	 	
4.3

	
Pipeline elevation

Elevations shown on the drawing shall be measured from floor or ground where pipelines have been installed as punch mark of ±0.00. Generally, pipeline elevation means elevation from bottom of pipeline. Where arrangement of pipe racks, it means elevation from surface of pipe rack.

	 	
4.4

	
Notation of pipeline connection

Flange Connection    Screw Thread Connection   Sock Connection

Union              Pagoda-Shape Connector

 

	 	
4.5

	
Selection instruction for pipe racks

4.5.1 The pipe racks for process pipelines of the project shall be selected according to Industrial Standard of the People's Republic of China Standard Drawing of Pipe Rack (HG/T21629-1999). Some non-standard pipe racks shall be treated according to detail drawings attached to Pipe Rack Table or practical site conditions.

4.5.2 Roots of pipe racks fixed to beams and columns of buildings shall leave embedded parts corresponding to structural drawings of civil works. Wall shelves shall be embedded according to civil drawings during construction. All parts not embedded shall be installed by expansion bolts or other ways according to specific conditions during site operation. The mounting heights shall be determined by pipeline elevations.

4.5.3 Orientation of pipe racks shall be determined by positions shown on the drawing and site conditions. The amount of pipe racks can increase/decrease, as appropriate.

  

  

  

 

	
 

	
Shenyang Sunshine Pharmaceutical Company Limited New Factory Engineering Project

	
Eng. No.

	
P-558

	
Drawing No.

	
D文-558-2-PP-1/1

	
Page 6

	
Of 10

Design and Construction Specification

Reference Table for Space between Pipe Racks

	
Norminal Diameter

	
20

	
25

	
40

	
50

	
65

	
80

	
100

	
125

	
150

	
200

	
250

	
Space

 m

	
Non-Insulating Pipe

	
4

	
4

	
5

	
5.5

	
6.5

	
7

	
8

	
9

	
10

	
12

	
14

	
Insulating Pipe

	
3

	
3

	
3

	
3.5

	
4

	
4

	
5

	
5.5

	
6.5

	
9

	
11

4.5.4 Selection principle for pipe clamp/bracket

4.5.4.1 When steam pipelines are laid horizontally above pipe racks, welded slide or fixed pipe brackets shall be used; when laid vertically, pipe brackets with clamps shall be applied.

4.5.4.2 Cold insulation low temperature pipe brackets applies to fluid pipelines in which temperature is below -10°C.

4.5.4.3 In addition to pipelines above mentioned and specially noted, the other pipelines on pipe racks shall be fixed to pipe racks by clamps.

4.5.4.4 Rubber washers or stainless steel plates shall be inserted between stainless steel pipe clamps and pipe racks.

4.5.4.5 Pipe brackets with clamps apply to non-metallic pipelines.

	 	
4.6

	
Requirement of pipeline installation

4.6.1 Process metallic pipelines shall be installed according to Code for Construction and Acceptance of Industrial Metallic Piping (GB50235-97).

4.6.2 It is noted that “air pocket” or “pocket” phenomenon shall be avoid, excavation manhole, where appropriate, shall be set in main pipeline.

4.6.3 Pipeline welds shall not be within support or hanging bracket. Generally, space between weld and edge of support shall be no less than 100mm; the point of weld is not suitable for pore or pipe branch.

4.6.4 Space between pipelines shall be settled on basis of convenience of installation and maintenance, refer to the valves as follows (midway space in the table is center distance of pipe).

  

  

  

 

	
 

	
Shenyang Sunshine Pharmaceutical Company Limited New Factory Engineering Project

	
Eng. No.

	
P-558

	
Drawing No.

	
D文-558-2-PP-1/1

	
Page 7

	
Of 10

Design and Construction Specification

Space between Pipelines (when pipelines are laid side-by-side, flanges in staggered form) in mm

	
DN

	
25

	
40

	
50

	
70

	
80

	
100

	
125

	
150

	
200

	
250

	
300

	
d

	
A

	
B

	
A

	
B

	
A

	
B

	
A

	
B

	
A

	
B

	
A

	
B

	
A

	
B

	
A

	
B

	
A

	
B

	
A

	
B

	
A

	
B

	
A

	
B

	
25

	
120

	
200

	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	
110

	
130

	
40

	
140

	
210

	
150

	
230

	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	
120

	
140

	
50

	
150

	
220

	
150

	
230

	
60

	
240

	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	
150

	
150

	
70

	
160

	
230

	
160

	
240

	
170

	
250

	
180

	
260

	  	  	  	  	  	  	  	  	  	  	  	  	  	  	
140

	
170

	
80

	
170

	
240

	
170

	
250

	
180

	
260

	
190

	
270

	
200

	
280

	  	  	  	  	  	  	  	  	  	  	  	  	
150

	
170

	
100

	
180

	
250

	
180

	
260

	
190

	
270

	
200

	
280

	
210

	
310

	
220

	
300

	  	  	  	  	  	  	  	  	  	  	
160

	
190

	
125

	
190

	
260

	
200

	
280

	
210

	
290

	
220

	
300

	
230

	
310

	
240

	
320

	
250

	
330

	  	  	  	  	  	  	  	  	
170

	
210

	
150

	
210

	
280

	
210

	
300

	
220

	
300

	
230

	
300

	
240

	
320

	
250

	
330

	
260

	
340

	
280

	
360

	  	  	  	  	  	  	
190

	
230

	
200

	
230

	
310

	
240

	
320

	
250

	
330

	
260

	
340

	
270

	
350

	
280

	
360

	
290

	
370

	
300

	
390

	
300

	
420

	  	  	  	  	
220

	
260

	
250

	
270

	
340

	
270

	
350

	
280

	
360

	
290

	
370

	
300

	
380

	
310

	
390

	
320

	
410

	
340

	
420

	
360

	
450

	
390

	
480

	  	  	
250

	
290

	
300

	
290

	
370

	
300

	
380

	
310

	
390

	
320

	
400

	
330

	
410

	
340

	
420

	
350

	
440

	
360

	
450

	
390

	
480

	
410

	
510

	
400

	
540

	
280

	
320

	
350

	
290

	
400

	
330

	
410

	
340

	
420

	
350

	
430

	
360

	
440

	
370

	
450

	
380

	
470

	
390

	
480

	
420

	
510

	
450

	
540

	
470

	
570

	
310

	
350

Note: 1) When laying non-insulating pipes next to insulating pipes, space between pipelines = (space between non-insulating pipes + space between insulating pipes)/2.

2) If threaded connection is applied, space between pipelines shall minus 20mm on the basis of the above table.

3) Clear distance between pipe walls is 160mm~180mm in pipe trench, distance between pipe wall and trench wall is around 200mm.

4) In the table, A is non-insulating pipe, B is insulating pipe, and “d” is distance of pipeline axis from wall surface.

Space between Pipelines (when pipelines are laid side-by-side, flanges in alignment) in mm

	
DN

	
25

	
40

	
50

	
80

	
100

	
150

	
200

	
250

	
25

	
250

	  	  	  	  	  	  	  
	
40

	
270

	
280

	  	  	  	  	  	  
	
50

	
280

	
290

	
300

	  	  	  	  	  
	
80

	
300

	
320

	
330

	
350

	  	  	  	  
	
100

	
320

	
330

	
340

	
360

	
375

	  	  	  
	
150

	
350

	
370

	
380

	
400

	
410

	
450

	  	  
	
200

	
400

	
420

	
430

	
450

	
460

	
500

	
550

	  
	
250

	
430

	
440

	
450

	
480

	
490

	
530

	
580

	
600

4.6.5 When pipelines go through walls and floors in explosion-proof areas, the clearances between pipelines and holes shall be filled with cement mortar or other sealing materials satisfactory to the requirements of fire resistance limit.

4.6.6 The sections, within sleeves, that go through walls and floors shall not have welds.

4.6.7 Pipelines going through walls and ceilings in clean areas shall be installed with sleeves and sealed with silica gel.

4.6.8 When slopes of pipelines are not marked, the slopes shall be built as follows:

  

  

  

 

	
 

	
Shenyang Sunshine Pharmaceutical Company Limited New Factory Engineering Project

	
Eng. No.

	
P-558

	
Drawing No.

	
D文-558-2-PP-1/1

	
Page 8

	
Of 10

Design and Construction Specification

	
Steam 2~5‰

	
Chilled Brine 5‰

	 	 
	
Vacuum 3‰

	
Production Waste 1‰

	 	 
	
Water Supply 2~5‰

	
Condenser Water 3‰

	 	 
	
Compressed Air 4‰

	
Clean Drainage Water 5‰

	 	 
	
General Gas 5‰

	
High Viscosity Fluid <10‰

 

4.6.9 Formed seamless pipe fittings (elbows and reducers etc.) shall not be suitable to be welded with slip-on welding flanges directly.

4.6.10 Anti-static earthing of pipeline system

1) All pipelines in Class A and Class B production areas of the project shall be anti-static earthing to the nearest point, see drawings of electrical specialty and Standard Drawing of Static Earthing Installation for Chemical Industry (CD90B4-88) for details.

2) Outer pipes in the factory shall be earthing before entering into Class A and Class B production areas.

4.6.11 Mounting height of valve member

Valve members that frequently operated shall be installed in a height of 1.2~1.5m from ground, net clearance of hand wheel >50~80mm.

	
5.

	
Pressure Testing Instructions for Pipeline System

5.1 Appearance quality of pipeline welds shall be according to current national standard Code for Construction and Acceptance of Field Equipment, Industrial Pipe Welding Engineering (GB50236-98).

5.2 When finding deficiencies on the surfaces of welds, it shall timely remove deficiencies, after then retesting shall be applied till qualified requirements.

5.3 When find welds are out of specifications, it must do repair, after then repaired pipelines shall be tested in original method.

5.4 Testing pressure of metallic pipelines shall be 1.5 higher than design pressure, and be no less than 0.4Mpa.

5.5 Lifting pressure slowly during hydraulic testing, keep the pressure for 10min when reaching testing pressure; reduce to design pressure, and then hold the pressure again. If pressure is unchanged and has no leakage, the pipeline will be deemed qualified.

5.6 Pressure testing and leakage testing of process pipelines and system shall comply with provisions specified in Code for Construction and Acceptance of Industrial Metallic Piping (GB50235-97).

  

  

  

 

	
 

	
Shenyang Sunshine Pharmaceutical Company Limited New Factory Engineering Project

	
Eng. No.

	
P-558

	
Drawing No.

	
D文-558-2-PP-1/1

	
Page 9

	
Of 10

Design and Construction Specification

	
6.

	
Blow Wash Instructions for Equipment and Pipeline System

6.1 All process pipelines of the project shall do blow wash after completion of installation and approval by pressure testing.

6.1.1 The method of blow wash shall be determined according to working medium used by equipment and pipelines, and contamination degree of inner surface.

6.1.2 The equipment and pipelines not allowed for blow wash shall be kept separate from blow wash system.

6.2 All pipelines of the project shall use following methods of blow wash:

6.2.1 The method of water flush applies to pipelines which transfer fluid, and flow velocity is no less than 1.5m/s.

6.2.2 The method of steam blow applies to steam pipelines, and flow velocity is no less than 30m/s.

6.3 Requirements of blow wash for pipelines in clean areas

6.3.1 After approval by strength testing, clean fluid pipeline system must be washed with purified water or injection water before system operation, and the consistency between water quality of outlet and that of let shall be considered as qualified.

6.3.2 After approval by various testing, clean gas pipelines must be blown with clean compressed air or nitrogen at flow velocity more than 20m/s. When no smoke/dust by visual inspection, a wooden target plate with white cloth or white paint on its surface shall be put at air vent, if there is no iron rust, dust, water and miscellaneous in a period of 5min, the gas pipelines shall be considered as qualified.

6.4 The method of blow wash and test standard of pipelines shall conform to provisions specified in Code for Construction and Acceptance of Industrial Metallic Piping (GB50235-97).

 

  

  

  

 

	
 

	
Shenyang Sunshine Pharmaceutical Company Limited New Factory Engineering Project

	
Eng. No.

	
P-558

	
Drawing No.

	
D文-558-2-PP-1/1

	
Page 10

	
Of 10

Design and Construction Specification

	
7.

	
Installation Notes

7.1 All process pipelines and fittings can be used after approval by Code for Construction and Acceptance of Industrial Metallic Piping (GB50235-97).

7.2 Superfluous pipe orifices shall be sealed with blind plates or pipe plugs after completing installation of equipment and pipelines.

7.3 If pipe racks are installed on anticorrosive lining of steel equipment, pipe racks will be made prior to lining of equipment.

7.4 After approval by pressure testing, pipeline systems and pipelines shall do thermal insulation works.

7.5 For convenience of maintenance, unions and flanges shall be added to pipelines of public engineering system.

7.6 An emptying valve for fluid transport pipes shall be settled at the lowest point of piping system, in case of maintenance.

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