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How to certify cleanrooms?

How to certify cleanrooms?

2023-06-17



How to Certify Cleanrooms Cleanrooms require regular testing and certification to ensure they maintain the appropriate levels of cleanliness for their intended purpose. The certification process ensures that a cleanroom is effectively controlling contaminants like particles, microbes, and moisture, allowing manufacturing operations to proceed safely and effectively. Here are the crucial steps to certify your cleanroom to comply with industry standards. Begin by developing a testing protocol based on the cleanroom's classification and use. Higher-grade cleanrooms require more rigorous testing at a more frequent interval. The protocol should specify things like:

 

• The tests that will be performed - typically particle counts, microbiology, and differential pressure.

• The frequency of testing - from yearly to continuously monitoring with sensors.

• The locations within the cleanroom to test - especially high-risk areas.

• The acceptable limits for each test based on the cleanroom's ISO class. Next, perform tests with calibrated equipment operated by trained personnel. Particle and viable particle counts require special equipment like particle counters and air samplers.

Statements that the cleanroom complies with its designated ISO class specifications Issue a certificate of conformance signed by the responsible party. This official document confirms that the cleanroom certification process has been completed. Continue monitoring with regular follow-up testing to confirm standards are maintained. Particle and microbiological sampling should occur at least yearly, while differential pressure should be checked quarterly. Consider installing permanent sensors for continuous monitoring of critical parameters like differential pressure. Recertify the cleanroom any time changes are made that could affect cleanliness levels, including alterations to HVAC systems, workflows, or room configuration. Changes often require recertifying more frequently until stable conditions are reestablished. Properly certifying your cleanroom gives you assurance that operations can proceed safely within designated contamination limits. Regular testing and corrective actions will help maintain those standards over the lifetime and use of the cleanroom. Following an organized certification protocol will demonstrate due diligence and compliance for regulators, customers, and internal stakeholders. With careful planning and execution, you can have confidence that your cleanroom is precisely as clean as it needs to be.

 

 

Suzhou Pharma Machinery Co.,Ltd.

2023/06/17

Mia

 


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