Industry classification standards for clean rooms and clean workshops_Industry Specifications_News_sz-pharma1

classes are based on the number and size of airborne particles. The primary authority in the United States and Canada is the ISO classification system ISO 14644-1. This ISO standard includes the following pharma clean room categories: ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. ISO 1 is the 'cleanest' category and ISO 9 is the 'dirtiest' category. Air Particle Cleaning Class (in cubic meters): Class Particles per cubic meter by micrometer size 0.1 microns 0.2 microns 0.3 microns 0.5 microns 1 microns 5 microns 237000102,000352008,320293ISO 7352,000832002930ISO 83520,000832,00029,300ISO 935,200,0008320,000293000 Even though it is classified as the 'dirtiest' category, an ISO 9 clean room environment is cleaner than a normal room. The most common ISO pharma clean room categories are ISO 7 and ISO 8. Federal Standard 209 (FS 209E) is equivalent to Class 10,000 and Class 100,000 of these ISO classes. The old Federal Standard 209E (FS 209E) included these cleanroom categories: 100,000; 10,000; 1000; 100; 10; 1. This standard was superseded by ISO-14644-1 in 1999. It was withdrawn in 2001 but is still widely used. Cleanrooms must also follow industry-specific international standards. For example, EU GMP (A-B-C-D) applies to pharmaceuticals and USP (795, 797 and 800) applies to compounding pharmacies.

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