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Product Sterility

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This test evaluates samples for sterility by placing them in the appropriate growth promotion media, incubating them for a minimum of 14 days, and checking them for evidence of microbial growth.  Samples may be tested using either direct transfer or membrane filtration.  Product sterility testing is performed according to the recommendations in USP General Chapter <71> and ANSI/AAMI/ISO 11737-2.  Product sterility test methods are validated by performing a Method Suitability (Bacteriostasis/ Fungistasis) test.