Clean room test procedures, reference basis, industry specifications_Company News_News_sz-pharma
Clean room test: 1. Supply and exhaust air volume: If it is a turbulent clean room, then measure its supply and exhaust air volume. If it is a one-way flow clean room, its wind speed should be measured. 2. Airflow control between zones: In order to prove that the direction of airflow between zones is correct, that is, from the clean zone to the zone with poor cleanliness, it is necessary to check: (1) The pressure difference in each zone is correct; (2) At the door or on the wall The direction of airflow movement is correct at the openings in the floor, etc., that is, from the clean area to the area with poor cleanliness. 3. Filter leak detection: The high-efficiency filter and its outer frame should be inspected to ensure that suspended pollutants will not pass through: (1) damaged filter; (2) the gap between the filter and its outer frame; (3) ) other parts of the filter device and intrude into the room. 4. Isolation Leak Detection: This test is to prove that suspended contaminants do not penetrate the building material and enter the cleanroom. 5. Room airflow control: The type of airflow control test depends on the airflow pattern in the cleanroom—whether it is turbulent or unidirectional. If the pharma clean room airflow is turbulent, it must be verified that there are no areas of the room where airflow is insufficient. If it is a one-way flow clean room, it must be verified that the wind speed and direction of the entire room meet the design requirements. 6. Suspended Particle Concentration and Microbial Concentration: If these tests above meet the requirements, the particle concentration and microbial concentration (if required) are finally measured in order to verify compliance with cleanroom design specifications. 7. Other tests: In addition to the above-mentioned 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, illuminance, vibration value, etc.
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