Page 71 - Assurance of Sterility for Sensitive Combination Products and Materials

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Assurance of sterility for sensitive combination products and materials
Japan (Aseptic
Clean room standards—airborne particulate limits (particles/m 3 )
USP <1116> Processing JP XVI Guidance) EU Annex 1 and WHO Grade A Grade B Grade A Grade Grade A Grade B ISO 5/Class (at rest) B (at rest) (at rest) 100 3520 3520 3500 3520 Not specified 20 c 1 d Not specified NA NA NA ISO 6/Class 1000 NA NA NA 35,200 NA NA NA Not specified Grade B Grade B
Comparison of clean room designations [15]. US FDA (Aseptic Processing Guidance) ISO 14644 ISO 5/Class 100 a,b 3520 c Not specified ISO 6/Class 1000 35,200 Not specified ISO 7/Class 10,000 352,000 Not specified Class 100,000 3520,000 3520,000 Not specified a Class 100 and Grade A are defined as requiring unidir

Table 4.2 Particle size ISO 5 3520 ≥0.5 μm 29 ≥5 μm ISO 6 35,200 ≥0.5 μm 290 ≥5 μm ISO 7 352,000 ≥0.5 μm 2900 ≥5 μm ISO 8 ≥0.5 μm 29,000 ≥5 μm