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ISO14644-1 clean room air change rate standard

Popularity:5 Release time:2022-05-01 09:11:01

(1) In the iso14644-1 clean room standards of various countries, the experience ventilation times of the same level of non-unidirectional flow iso14644-1 clean rooms are not the same. my country's "Code for Design of Clean Workshops" (GB50073-2001) clearly stipulates the number of empirical air changes required for the calculation of clean air supply for different levels of non-unidirectional flow iso14644-1 clean rooms.

See the table below:

Remark:

①. The number of air changes is suitable for iso14644-1 clean rooms with floor height less than 4.0m.

② The lower limit should be adopted if the number of people in the room is small and the heat source is small.

③. The number of air changes in the iso14644-1 clean room with class greater than 100,000 is not less than 12 times.

in addition:

Laboratory animal environment and facilities

National standard GB14925-2001

Regulation

Normal environment 8-10 times/h

Barrier environment 10-20/h

Isolated environment 20-50/h

(2) Temperature and relative humidity?

The temperature and relative humidity of the iso14644-1 clean room (area) should be compatible with the pharmaceutical production process. Without special requirements, the temperature should be controlled at 18~26℃, and the relative temperature should be controlled at 45%~65%.

(3) Differential pressure

①, iso14644-1 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 indicating the pressure difference.

②. The static pressure difference between adjacent rooms with different air cleanliness levels should be greater than 5Pa, the static pressure difference between the iso14644-1 clean room (area) and the outdoor atmosphere should be greater than 10Pa, and there should be a device to indicate the pressure difference.

3. The production process of producing a large amount of dust, harmful substances, olefinic and explosive substances, and the production of penicillin-type strong allergenic drugs, some steroid drugs, and any microorganisms that are considered to have pathogenic effects, its operating room is adjacent to it The room or area should maintain a relatively negative pressure.

(4) Fresh air volume

A certain amount of fresh air should be maintained in the iso14644-1 clean room, and its value should take the maximum value of the following air volumes:

①, 10%-30% of the total air supply volume of the non-unidirectional flow iso14644-1 clean room, and 2%-4% of the total air supply volume of the one-way flow iso14644-1 clean room.

②. Compensate the amount of fresh air required for indoor exhaust air and maintaining positive pressure.

③. Ensure that the amount of fresh air per person in the room is not less than 40m3 per hour.

(5) Other standard descriptions:

①. Management Standard for Sterile Medical Devices (YY? 0033-2000): The number of air changes in the 100,000-level clean area: ㄒ15 times/h The number of air changes in the 10,000-level clean area: T20 times/h.

②Implementation rules for in vitro diagnostic reagents: There is no specific regulation, only the pressure difference range is specified.

③Good Manufacturing Practice for Pharmaceuticals: There is no regulation, only the pressure difference range is specified.

④、⑤⑥ Design specification for clean workshop (GB50073-2001): The number of air changes in the 100,000-level clean area: 10 times/h-15 times/h The number of air changes in the 10,000-level clean area: 15 times/h-25 times/h.

⑤. The GMP verification guide recommends: the number of air changes in the 100,000-level clean area: T15 times/h in the 10,000-level clean area: T25 times/h.

⑥, Biological pollution control (ISO14**4) specific standards Chapter 1 cleanliness classification: 100,000-level clean area ventilation times: 10 times/h-15 times/h 10,000-level clean area ventilation times: 15 times/h -25 times/h.

That is to say, the number of air changes can be negotiated.


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