Microbiology.com

  Sterility test: As per USP 71 Sterility testing required for pharmaceutical products, medical devices, Cosmetics, and food items including liquids and water samples. Sterility testing is required during the sterilization validation process as well as for routine release testing.   Types of USP Sterility Methods There are three USP Sterility Methods: ·         Membrane Filtration ·         Direct Transfer (Product Immersion) ·         Product Flush/Extract/Rinsing Membrane Filtration Method for Sterility Testing The Membrane Filtration Sterility Test is the method of choice for many medical devices, food, cosmetics and pharmaceutical products. An appropriate use of this test is for devices that contain a preservative and are bacteriostatic and/or fungistatic under the direct transfer method. With membrane filtration, the concept is that the microorganisms w...

      Biological Indicators (BIs) are widely used to monitor the efficacy of sterilization processes. BIs provide a high level of sterility assurance and are ideal monitors of the sterilization process. The BI Sterility test is performed on exposed BIs after completion of a sterilization load through either a validation or routine lot release monitoring. The test is qualitative which yields results of either growth or no growth of the appropriate indicator organism. The test is performed on BIs subjected to different types of sterilization such as ethylene oxide, steam, dry heat, vapor phase hydrogen peroxide and ozone, as well as other novel processes. Both traditional BIs and self-contained BIs may be tested. This test is typically performed during validation as well as during routine production as a LOT release test. BI testing and sample requirements are in numerous standards including USP <55>, the ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 14161, and ANSI/AM...