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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BCT Method 2(Process Modification)Determine & Document viability <strong>of</strong> B. diminutain Product under Process ConditionsDirect inoculation <strong>of</strong> B. diminutain product under process conditionsVIABLEIsB. diminutaviable in product underprocess conditions?NOT VIABLEModify process(adjust temperatures, etc.)Modify formulation(adjust pH, remove bactericidalcomponent or product surrogate)Change from B. diminutaUse bacteria isolated fromformulation or environmentUse product for time period that thechallenge organism is viablePrecondition filter with Product– followed by Microbial Challenge26
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