HM-PR_03-5Sterility Testing

There are set guidelines for sterility testing of biologics in various pharmacopoeia and also section 21 of the CFR (Code of Federal Regulations) and Food and Drug Administration. Every biological product manufactured under GMP conditions requires sterility testing performed under GMP guidelines. HiMedia provides a complete set of sterility testing media and rinse solutions as per various pharmacopoeias. Two common types of sterility test methods widely described are Direct Inoculation or Immersion and Membrane Filtration. The Direct Inoculation or Immersion method involves the test article to be inoculated directly into specified media. While in the Membrane Filtration method the test article has to first pass through size exclusion membrane capable of retaining microorganisms and that filter is rinsed and transferred to the specified test medium. In both test methods the test article or membrane is incubated for 14 days in the test media. The majority of biological samples will be tested using the immersion method. But if it deals with large volumes then membrane filtration method may be required.
各種藥典中的生物製劑的無菌測試以及CFR（聯邦法規）和食品和藥品管理局的第21節都有一套指導方針。在GMP條件下生產的每種生物製品都需要根據GMP指南進行無菌測試。 HiMedia根據各種藥典提供一整套無菌測試介質和沖洗解決方案。廣泛描述的兩種常見類型的無菌測試方法是直接接種或浸入和膜過濾。直接接種或浸入法涉及將測試物品直接接種到指定的培養基中。在膜過濾方法中，測試物品必須首先通過能夠保留微生物的尺寸排阻膜，並且過濾器被沖洗並轉移到指定的測試介質中。在兩種測試方法中，將測試製品或膜在測試介質中溫育14天。大多數生物樣品將使用浸泡法進行測試。但如果它處理大量，則可能需要膜過濾方法。