Clean room frequency standard
(1) In the dust-free workshop standards of various countries, the experience of non-unidirectional flow clean room of the same level is not the same. China's "Code for Design of Clean Plants" (GB 50073-2001) clearly specifies the number of experience ventilation required for the calculation of clean air supply volume of non-unidirectional flow clean rooms of different grades, as shown in the following table:
Air cleanliness level | GB 50073-2001 | ISO/DIS 14644-4 | Medical clean room design specification |
Level 6 (1000 level) | 50 to 60 times | 25 to 56 times | -- |
Level 7 (10000 level) | 15 to 25 times | 11 to 25 times | ≥25 times |
Level 8 (100000 level) | 10 to 15 times | 3.5 to 7 times | ≥15 times |
Level 9 (1000000 level) | 10 to 15 times | 3.5 to 7 times | ≥12 times |
Remarks:
1 The number of air changes is suitable for dust-free workshops with a floor height of less than 4.0m.
2 If the number of people in the room is small and the heat source is small, the lower limit should be adopted.
3 The number of air changes in the dust-free workshop of more than 100000 is not less than 12 times.
In addition:
National standard for laboratory animal environment and facilities GB 14925-2001
Specify the general environment 8 to 10 times / h
Barrier environment 10~20
Isolation environment 20~50
(2) Temperature and relative humidity The temperature and relative humidity of the dust-free workshop (area) should be compatible with the pharmaceutical production process. When there is no special requirement, the temperature should be controlled at 18~26°C, and the relative temperature should be controlled at 45%~65%.
(3) Pressure difference (1) The dust-free workshop must maintain a certain positive pressure, which can be achieved by making the air supply volume larger than the exhaust air volume, and should have a device indicating the pressure difference.
(2) The static pressure difference between adjacent rooms with different air cleanliness levels should be greater than 5 Pa, and the static pressure difference between the clean room (zone) and the outdoor atmosphere should be greater than 10 Pa, and there should be a device for indicating the differential pressure.
(3) The process produces a large amount of dust, harmful substances, enamel explosive substances and the production of penicillin-type strong allergenic drugs, some steroid drugs, any production process of microorganisms considered to have pathogenic effects, the operation room and its phase Adjacent rooms or areas should maintain a relatively negative pressure.
(4) Fresh air volume
The amount of fresh air should be kept in the clean room, and the value should be taken as the large value of the following air volume:
(1) 10%~30% of the total air supply volume of the non-unidirectional flow clean room, and 2%~4% of the total air supply volume of the one-way flow clean room;
(2) Compensating for the amount of fresh air required for indoor exhaust and maintaining a positive pressure value;
(3) Ensure that the amount of fresh air per person per hour is not less than 40 m3.
(5) Description of other standards:
1, sterile medical device management practices (YY 0033-2000): 100,000-level clean area air exchange times: ã„’ 15 times / h million-level clean area air exchange times: ã„’ 20 times / h.
2. In vitro diagnostic reagent implementation rules: There is no specific regulation, only the pressure difference range is specified.
3, pharmaceutical production quality management practices: no regulations, only the pressure difference range.
4, clean factory design specifications (GB50073-2001): 100,000-level clean area air exchange times: 10 times / h - 15 times / h million-level clean area air exchange times: 15 times / h - 25 times / h.
5, GMP verification guide (2000 version) recommended: 100,000-level clean area air exchange times: ã„’ 15 times / h 10,000-level clean area air exchange times: ã„’ 25 times / h. Text 6, biological pollution control (ISO14644) international standard * Chapter cleanliness classification: 100,000-level clean area air exchange times: 10 times / h - 15 times / h million-level clean area air exchange times: 15 times / h - 25 times / h.
In other words, the number of air changes can be discussed.
(6) Description of the number of air changes in general clean areas:
Numbering | Room name | tuyere | Long (m) | Width (m) | Room size M2 | Room height m | Tuyere wind speed (m/s) | Air exchange times | |
1 | Male one more | 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 | 1 | 0.484 | 0.484 | 6.9325 | 2.6 | 0.00 | ||
4 | Female second | 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 | Million laundry | 1 | 0.63 | 0.63 | 11.6875 | 2.6 | 0.00 | ||
8 | Million laundry sterilization | 1 | 0.63 | 0.63 | 15.5125 | 2.6 | 0.00 | ||
Ten thousand | 9 | Classroom dressing room | 1 | 0.484 | 0.484 | 8.5 | 2.6 | 0.00 | |
level | 10 | Rolling room | 1 | 0.484 | 0.484 | 34.72 | 2.6 | 0.00 | |
Area | 2 | 0.484 | 0.484 | 2.6 | |||||
3 | 0.484 | 0.484 | 2.6 | ||||||
4 | 0.484 | 0.484 | 2.6 | ||||||
11 | Filling pass | 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 | Peeling | 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 | Dispensing room | 1 | 0.63 | 0.63 | 14 | 2.6 | 0.00 | ||
2 | 0.63 | 0.63 | 2.6 | ||||||
16 | Container sterilization room | 1 | 0.484 | 0.484 | 15.8 | 2.6 | 0.00 | ||
17 | Sanitary ware cleaning room | 1 | 0.484 | 0.484 | 8.2 | 2.6 | 0.00 | ||
18 | Pharmaceutical auxiliary room | 1 | 0.484 | 0.484 | 7.8 | 2.6 | 0.00 | ||
19 | Class transfer room | 1 | 0.484 | 0.484 | 4.675 | 2.6 | 0.00 | ||
Numbering | Room name | tuyere | Long (m) | Width (m) | Room size m2 | Room height m | Tuyere wind speed |
Fingerprint Safe,Biometric Fingerprint Safe,Portable Fingerprint Safe,Fingerprint Lock Safe Box
Ningbo Reliance Security Technology CO.,Ltd , https://www.reliancesafes.com