Standard Reference Of The Air Change Rate In A Cleanroom

1. In the cleanroom standards of various countries, the air exchange rate in a non-unidirectional flow cleanroom of the same level are not the same. 

Our country’s “Code for Design of Clean Workshops”(GB 50073-2001) clearly stipulates the air change rate required for the calculation of clean air supply in non-unidirectional flow cleanrooms of the different levels. In addition, International standard for laboratory animal environment and facilities (GB14925-2001) stipulates 8~10 times/h in ordinary enironment; 10~20 times/h in barrier environment; 20~50 times/h in isolated environment.

2. Temperature and relative humidity

The temperature and relative humidity in the cleanroom (area) should be compatible with the pharmaceutical production process. If there are no special requirements, the temperature should be controlled at 18~26℃, and the relative temperature should be controlled at 45%~65%.

3. Differential pressure

(1) The cleanroom must maintain a certain postive pressure, which can be achieved by enabling air supply volume greater than the exhaust air volume, and there should be a device to indicate the pressure difference.

(2) The static pressure difference between adjacent rooms in differenct air cleanliness levels should be greater than 5Pa, the static pressure between the cleanroom (area) and the outdoor atmosphere should be greater than 10Pa, and there should be a device to indicate the pressure difference.

(3) A large amount of dust, harmful substances, olefinic and explosive substances as well as penicillin-type strong allergenic drugs and some steroid drugs produced in the production process. The operation room or area with the mocroorganisms production process that are thought to have any pathogenic effects, should maintain a relatively negative pressure from the afjacent room.

4. Fresh air volume

A certain amount of fresh air should be maintained in the cleanroom, and its value should take the maximum of the following:

(1) 10%~30% of the total air supply volume in the non-unidirectional flow clean room, or 2% to 4% of the total air supply volume of the one-way flow cleanroom.

(2) Comepensate The amount of fresh air required for indoor exhaust and maintain positive pressure.

(3) Ensure the amount of fresh air for per person per hour in the room is no less than 40 m3.