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Updated on May 10, 2024

› Forums › Quality Assurance (QA) › Clean Rooms and Clean Room controls › Particle count requirement for Clean Rooms › Reply To: Particle count requirement for Clean Rooms

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May 10, 2024 at 5:20 pm
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    May 10, 2024 at 5:20 pm

    Non viable Particle count (0.5u) should be <3520 in Grade A (ISO 5), <3520 in Grade B(ISO 6), <3,52,000 in Grade C (ISO 7) and <3,520,000 in Grade D (ISO 8) at rest. Particle (5u) should be < 20 in Grade A (ISO 5), <29 in Grade B(ISO 6), <2920 in Grade C (ISO 7) and <29,00 in Grade D (ISO 8) at rest. (Considering WHO, USFDA, EU GMP Annex 1 requirements) For Viable particles (CFU per ml) in:
    Grade A- Air Sample<1, Contact plate <1, Settle plate<1, Grade B – Air Sample<10, Contact plate<5, Settle plate<5, Grade C – Air Sample<100, Contact plate<25, Settle plate<50, Grade D – Air Sample<200, Contact plate<50, Settle plate<100