Clean Room Standards

Clean room test criteria

To prove that the clean room works satisfactorily, it must be proved that it meets the requirements of the following criteria:

1. The air supply volume of the clean room is sufficient to dilute or eliminate indoor pollution.

2. The air in the clean room flows from the clean area to the area with low cleanliness,the flow of polluted air reaches the minimum, and the flow direction of air at the entrance and in the indoor building is correct.

3. The air supply in the clean room will not significantly increase indoor pollution.

4. The movement state of indoor air can ensure that there is no high concentration gathering area in the secret room.

If the clean room meets the requirements of these criteria, its particle concentration or microbial concentration (if necessary) can be measured to determine that it meets the specified clean room standards.

Clean room test:

1. Supply air volume and exhaust air volume: if it is a turbulent clean room, it is necessary to measure its supply air volume and exhaust air volume. If it is a one-way flow clean room, its wind speed shall be measured.

2. Air flow control between zones: in order to prove that the air flow direction between zones is correct, that is, from the clean zone to the area with poor cleanliness, it is necessary to detect: (1) the pressure difference between zones is correct; (2) The air flow direction at the door or at the opening of the wall and floor is correct, that is, from the clean area to the area with poor cleanliness.

3. Filter leakage detection: the high-efficiency filter and its outer frame shall be inspected to ensure that the suspended pollutants will not pass through: (1) the damaged filter; (2) The gap between the filter and its outer frame; (3) Other parts of the filter device.

4. Isolation and leak detection: This test is to prove that suspended pollutants do not penetrate the building materials into the clean room.

5. Indoor air flow control: The type of air flow control test depends on the air flow mode of the clean room - turbulent flow or one-way flow. If the air flow in the clean room is turbulent, it must be verified that there is no area with insufficient air flow in the room. If it is a one-way flow clean room, it must be verified that the wind speed and direction of the whole room meet the design requirements.

6. Suspended particle concentration and microbial concentration: if the above tests meet the requirements, the particle concentration and microbial concentration (if necessary) shall be measured finally to verify that they meet the technical conditions of the cleaning room design.

7. Other tests: In addition to the above pollution control tests, sometimes one or more of the following tests must be carried out: Temperature,Relative humidity,Indoor heating and cooling capacity, Noise value, Light intensity, Vibration value

                 

                 

Suzhou Pharma Machinery Co.,Ltd.

2023/03/06

Spencer