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Clean room change

Views:1     Author:Site Editor     Publish Time: 2021-08-05      Origin:Site

In various countriesCleanroomIn the standard, the number of experience ventilation in the same level is not the same. my country's \"Clean Plant Design Specification\" (GB 50073-2001) clearly stipulates the number of experiences required for different levels of different levels of freedom of clean and delivering air volume, see below:

Picture 3

Remark:

The number of ventilation is suitable for a clean room with a layer higher than 4.0m.

The room is small, and the lower limit is adopted.

Clean room with more than 100,000 level is not less than 12 times.

in addition:

Experimental animal environment and facility national standard GB14925-2001

Ordinary environment 8-10 times / h

Barrier environment 10-20

Isolation environment 20-50

Picture 2

First, temperature and relative humidity

The temperature and relative humidity of the clean room (region) should be adapted to the drug production process. When there is no special requirements, the temperature should be controlled at 18 to 26 ° C, and the relative temperature should be controlled at 45% to 65%.

Second, pressure difference

(1)CleanroomA certain positive pressure must be maintained, which can be achieved by maximizing the amount of air supply, and should have a device indicating a differential pressure.
(2) The static pressure difference between the adjacent rooms of the air cleanliness ratio should be greater than 5PA, and the static pressure difference of the clean room (region) and the outdoor atmosphere should be greater than 10 Pa, and there should be an apparatus for applying differential pressure.
(3) Process production produces a large amount of dust, harmful substances, alkene explosive substances and producing penicillin strongly sensitive drugs, some steroidal drugs, any microorganisms that believe in pathogenic effects, their operation rooms The neighboring room or region should remain relative negative pressure.

Third, fresh air volume
The amount of fresh air should be kept in the clean room, and the value should be removed in the lower value:
(1) Non-single-way streamlined room is 10% ~ 30%, one-way flow rate of 2% to 4%;
(2) Compensation for the amount of fresh air required for indoor exhaust and maintaining positive pressure values;
(3) Ensure that the amount of fresh air per person in the room is not less than 40 m3.

Other standard descriptions:
1. Sterile medical equipment management specifications (YY 0033-2000): 100,000 level clean zone ventilation:> 15 times / h thousand level clean zone ventilation:> 20 times / h.
2, in vitro diagnostic reagent Implementation Rules: There is no specific provision, only the pressure difference range is specified.
3. Pharmaceutical production quality management specification: no provisions, only specify the scope of the pressure difference.
4, clean factory design specifications (GB50073-2001): 100,000 level clean zone ventilation: 10 times / h-15 times / H 10,000 clean zone ventilation: 15 times / h-25 times / h.
5, GMP Verification Guide (2000 Edition) Suggestions: 100,000 Clean Areas Tourism:> 15 times / h 10 Clean Zone Time:> 25 times / h. Text
6, Biological Pollution Control (ISO14644) International Standard Chapter 1 Clean Level Division: 10,000 Clean Zone Tourism: 10 times / H-15 times / H 10 Clean Zone Tour: 15 times / h-25 times / h.
In other words, the problem of ventilation can be discussed.

Fourth, the general clean zone ventilation is explained:


serial number

Room name

tuyere

Long (m)

Width (m)

Room area M2

Room height M

Ticket wind speed (m / s)

Ventilation


1

Male one

1

0.484

0.484

6.9325

2.6

0.52

24.33


2

Male two

1

0.484

0.484

4.92

2.6


0.00


3

Female one more

1

0.484

0.484

6.9325

2.6


0.00


4

Female two

1

0.484

0.484

4.92

2.6


0.00


5

Buffer room

1

0.484

0.484

6.1425

2.6


0.00


6

aisle

1

0.484

0.484

31

2.6


0.00



2

0.484

0.484

2.6




3

0.484

0.484

2.6




4

0.484

0.484

2.6



7

Ten level laundry

1

0.63

0.63

11.6875

2.6


0.00


8

10,000 laundry sterilization

1

0.63

0.63

15.5125

2.6


0.00

9

Ten level whole clothes room

1

0.484

0.484

8.5

2.6


0.00

10

Roll room

1

0.484

0.484

34.72

2.6


0.00


2

0.484

0.484

2.6




3

0.484

0.484

2.6




4

0.484

0.484

2.6



11

Filling

1

0.985

0.525

3.458

2.6





2

0.985

0.525

2.6





3

1.235

0.72

2.6





4

1.235

0.72

2.6




12

Peel

1

0.32

0.32

1.581

2.6


0.00


13

Dressing

1

0.32

0.32

2.475

2.6


0.00


14

buffer

1

0.32

0.32

4.06

2.6


0.00


15

Pharmaceutical room

1

0.63

0.63

14

2.6


0.00



2

0.63

0.63

2.6



16

Container sterilization

1

0.484

0.484

15.8

2.6


0.00


17

Sanitary cleaning

1

0.484

0.484

8.2

2.6


0.00


18

Pharmaceutical assistant

1

0.484

0.484

7.8

2.6


0.00


19

10,000-level transmission room

1

0.484

0.484

4.675

2.6


0.00












serial number

Room name

tuyere

Long (m)

Width (m)

Room area M2

Room height M

Ticket wind speed (m / s)

Ventilation


1

Refined dress

1

0.484

0.484

2.475

2.6

0.34

44.56


2

Refining buffer

1

0.484

0.484

4.06

2.6

0.38

30.36


3

Filter room

1

0.484

0.484

16.95

2.6

0.38

17.80



2

0.484

0.484

2.6

0.55

4

Concentration

1

0.484

0.484

15.81

2.6

0.5

20.11


2

0.484

0.484

2.6

0.48


5

Overtimeter

1

0.484

0.484

13.6

2.6

0.48

21.46



2

0.484

0.484

2.6

0.42


6

Weighing

1

0.484

0.484

8.1

2.6


0.00



2

0.484

0.484

2.6



7

Container cleaning room

1

0.484

0.484

4.06

2.6


0.00












serial number

Room name

tuyere

Long (m)

Width (m)

Room area M2

Room height M

Ticket wind speed (m / s)

Ventilation


1

Wash bottle

1

0.484

0.484

6.29

2.6

0.32

16.50


2

Wash bottle buffer

1

0.484

0.484

4.255

2.6

0.3

22.87

3

Walkway in the bottle

1

0.484

0.484

6.3825

2.6

0.42

21.34

4

Washing room

1

0.484

0.484

52

2.6

0.7

17.47


2

0.484

0.484

2.6

0.7



3

0.484

0.484

2.6

0.7



4

0.484

0.484

2.6

0.7



5

0.484

0.484

2.6

0.7


5

Wash rubber

1

0.63

0.63

28

2.6

0.6

23.55



2

0.63

0.63

2.6

0.55



3

0.63

0.63

2.6

0.6


6

Sanitary cleaning

1

0.484

0.484

3.5

2.6


0.00












serial number

Room name

tuyere

Long (m)

Width (m)

Room area M2

Room height M

Ticket wind speed (m / s)

Ventilation


1

A dressroom

1

0.32

0.32

2.7

2.6

0.6

31.51


2

Two clothes room

1

0.32

0.32

2.45

2.6

0.6

34.72


3

Buffer room

1

0.32

0.32

2.45

2.6

0.57

32.99


4

aisle

1

0.484

0.484

20.54

2.6

1.1

33.16



2

0.484

0.484

2.6

1


5

Air gate 1

1

0.32

0.32

2.7

2.6

0.95

49.89


6

Air gate 2

1

0.32

0.32

2.4

2.6

0.4

23.63


7

Turnover room

1

0.32

0.32

16.64

2.6

1.1

17.89


2

0.32

0.32

2.6

1

8

Crush room

1

0.32

0.32

13.2

2.6

1

20.41


2

0.32

0.32

2.6

0.9

9

Dryer

1

0.32

0.32

18.18

2.6

1.05

18.33



2

0.32

0.32

2.6

1.3


10

Washole

1

0.484

0.484

23.76

2.6

1.2

31.40



2

0.484

0.484

2.6

1.1


11

front room

1

0.32

0.32

2.88

2.6

1.2

59.08


12

Purification room

1

0.63

0.63

43.35

3.5

1.1

29.19



2

0.63

0.63


2.6

1



3

0.63

0.63


2.6

1


13

Operation room

1

0.63

0.63

37.11

3

0.75

28.24



2

0.63

0.63


2.6

0.7



3

0.63

0.63


2.6

0.75


14

Weighing

1

0.32

0.32

8.36

2.6

1.2

20.35


15

Container cleaning room

1

0.484

0.484

11.98

2.6

0.95

25.72


16

Sewage storage room

1

0.32

0.32

3.3

2.6

0.7

30.08


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