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    Particle count requirement for Clean Rooms

    0
    Q
    Queries Qvents
    2026-03-30 12:06:45

    What are the non viable and viable particle count requirements for Pharma clean rooms (ISO 5,6,7,8) areas


    0
    I
    InfoQvents
    2026-03-30 12:54:40

    EUGMP Annex 1 (as well as WHO) classifies Clean Rooms as Grade A, Grade B, Grade C and Grade D and defines clean room requirements for typical operations, particulate (non-viable) and microbial (viable) count requirements:

    • Aseptic Filling etc / GMP Grade A / ISO 5 (at rest and operations) / Non-viable (count/m3) 3,520 (at rest and operations) / Viable (cfu/m3) <1
    • Background to Grade A / GMP Grade B / ISO 5 (at rest) & ISO 7 (operations) / Non-viable (count/m3) 3,520 (at rest) & 352,000 (operations) / Viable (cfu/m3) <1 (at rest) & <10 (operations)
    • Solution Prep etc / GMP Grade C / ISO 7 (at rest) & ISO 8 (operations) / Non-viable (count/m3) 352,000 (at rest) & 3,520,000 (operations) / Viable (cfu/m3) <100 (at rest) & <200 (operations)
    • Staging / Entry points etc / GMP Grade D / ISO 8 (at rest) / Non-viable (count/m3) 3,520,000 (at rest) / Viable (cfu/m3) <200 (at rest)

    USFDA requirements are similar

    Also refer: 📎 Clean Room Requirements.pdf