Validation of Sterilizing Grade Filters - ASQ Long Island Section
Validation of Sterilizing Grade Filters - ASQ Long Island Section
Validation of Sterilizing Grade Filters - ASQ Long Island Section
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Filter Qualification TestsBrevundimonas diminuta (ATCC 19146)Until the late 1960’s, 0.45 μm-rated membraneswere considered “sterilizing grade” filters, and wereused successfully in the sterilizing filtration <strong>of</strong> parenterals.In the mid-1960’s Dr. Frances Bowman observed a 0.45 μm“sterile-filtered” culture medium to be contaminated with amicro-organism, subsequently shown to penetrate 0.45 μm-ratedmembranes repeatedly in small numbers.6
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