Views:1 Author:Site Editor Publish Time: 2021-09-26 Origin:Site
(1) In various countriesCleanroomIn the standard, the number of air changes in the non-unidirectional flow clean room of the same level is not the same.
my country's \"Code for Design of Clean Workshops\" (GB 50073-2001) clearly stipulates the number of experience air changes required for calculation of clean air supply for different levels of non-unidirectional flow clean rooms, as shown in the following table:
① The number of air changes is suitable for clean rooms with a floor height of less than 4.0m.
② When the number of people indoors is small and the heat source is small, the lower limit should be adopted.
③ The number of air changes in a clean room greater than class 100,000 shall not be less than 12.
In addition: the international standard GB14925-2001 for laboratory animal environment and facilities
Normal environment 8~10 times/h
Barrier environment 10~20
Isolated environment 20~50
(2) Temperature and relative humidity
CleanroomThe temperature and relative humidity of the (zone) should be compatible with the pharmaceutical production process.When there is no special requirement, the temperature should be controlled at 18~26℃, and the relative temperature should be controlled at 45%~65%.
(3) Differential pressure
(1) The clean room must maintain a certain positive pressure, which can be achieved by making the air supply volume greater than the exhaust air volume, and there should be a device that indicates the pressure difference.
(2) The static pressure difference between adjacent rooms with different air cleanliness levels should be greater than 2Pa, the static pressure difference between the clean room (area) and the outdoor atmosphere should be greater than 10Pa, and there should be a device for indicating the pressure difference.
(3) The production process of producing a large amount of dust, harmful substances, easily ene and explosive substances and producing penicillin-like highly allergenic drugs, certain steroid drugs, and any microorganisms that are considered to have pathogenic effects, the operation room is similar to the production process. Adjacent rooms or areas should maintain a relatively negative pressure.
(4) Fresh air volume
CleanroomA certain amount of fresh air should be maintained inside, and its value should be the largest of the following air volumes:
(1) 10%~30% of the total air supply volume of the non-unidirectional flow clean room, 2%~4% of the total air supply volume of the one-way flow clean room;
(2) Compensate the amount of fresh air required for indoor exhaust and maintain positive pressure;
(3) Ensure that the amount of fresh air per person per hour in the room is not less than 40 m3.
(5) Description of the number of air changes in the general clean area
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