Monitoring standards and related rules for clean room clean room after completion_Company News_News_sz-pharma

Clean room testing reference standards: 1 'Code for Design of pharmaceutical cleanroom' GB50073-20012 'Code for Construction of Clean Operating Department of Hospital' GB 50333-20023 'Code for Construction of Biosafety Laboratory' GB 50346-20044 'Code for Construction and Acceptance of Clean Room' GB 50591-20105 'Test method for suspended particles in clean room (area) of pharmaceutical industry' GB/T 16292-20106 'Test method for planktonic bacteria in clean room (area) of pharmaceutical industry' GB/T 16293-20107 'Clean room (area) of pharmaceutical industry) District) Test Methods for Sedimentation Bacteria' GB/T 16294-2010 Clean room testing refers to the relevant rules: In order to prove that the clean room works satisfactorily, the clean room must prove that it meets the requirements of the following guidelines: 1. The delivery of the clean room The air volume is sufficient to dilute or eliminate the pollution generated indoors. 2. The air in the clean room flows from the clean area to the area with poor cleanliness, the flow of polluted air reaches the lowest level, and the flow direction of the air at the door and in the indoor building is correct. 3. The air supply of the clean room will not significantly increase the indoor pollution. 4. The movement state of indoor air can ensure that there is no high-concentration gathering area in the closed room. If the cleanroom meets these guidelines, its particle concentration or microbial concentration (if necessary) can be measured to determine that it meets the specified pharma clean room standards. 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 pharma clean room. 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 cleanroom 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 pharma clean room 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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