This is critical not just for the clean zone, but also for the airlocks/gowning room which prevent the migration of particles from outside into the clean space. Want to learn more about Clean Rooms? -> What is a Clean room?ĭepending on the class of clean room system you would like to reach, it is important to allow for enough square footage. You might also like this article -> How Classification Impacts your Cleanroom Design For example, EU GMP (A-B-C-D), applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies. It was withdrawn in 2001, but it is still widely used.Ĭlean rooms must also follow industry-specific and international standards. This standard was replaced in 1999 by ISO-14644-1. The old Federal Standard 209E ( FS 209E ) includes these clean room classes : Class 100,000 Class 10,000 Class 1,000 Class 100 Class 10 Class 1. The Federal Standard 209 ( FS 209E ) equivalent for these ISO classes are Class 10,000 and Class 100 000.
The most common ISO clean room classes are ISO 7 and ISO 8. Even if it’s classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room. ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. The primary authority in the US and Canada is the ISO classification system ISO 14644-1. The clean room class is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic meters of air. Clean rooms are classified according to the cleanliness level of the air inside the controlled environment.
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