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Cleanroom Classifications

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. While ISO 1 is the purist class and ISO 9 is the least pure class. Even if it’s classified as the “least pure” class, the ISO 9 clean room environment is cleaner than a regular room.

The most common ISO clean room classes are ISO 7 and ISO 8. The Federal Standard 209 ( FS 209E ) equivalent for these ISO classes are Class 10,000 and Class 100 000.

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. This standard was replaced in 1999 by ISO-14644-1. It was withdrawn in 2001, however the standard is still widely used.

Clean rooms are obligated also follow industry-specific and international standards. For example, EU GMP (A-B-C-D), applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies.