Microbiology.com

  BET TEST: Endotoxin Testing (LAL) Lipopolysaccharides (LPS) are bacterial endotoxins and present in Gram-negative bacterial cell walls known to cause fevers and diseases. Endotoxin testing of medical devices manufactured, and pharmaceuticals produced is necessary to ensure that the product is endotoxin free. It required on various stages of product life cycle: Bulk Lot Release Testing Final Product Release Testing Raw Material Testing Limulous amoebocyte lysate (LAL)  is a test performed as this is based in the biology of the horseshoe crab which produces LAL enzymes in blood cells to bind and inactivate endotoxin from invading bacteria. This method is accepted worldwide. USP <85> requires testing of a production lot for the presence of bacterial endotoxin. LAL - endotoxin tests with a variety of assay options including: Quantitative and qualitative testing Gel-clot method (LAL test) Chromogenic methods (USP Chromogenic) The Gel-clot met

  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 will collect onto the surface of a 0.45-micron pore size filter. This filter is segmented and transferred to approp