05制药工业实验室培养基控制方法-陈影影.pdf

培养基质量控制方法 Dr. Andreas Bubert, MERCK KGaA , Darmstadt , Germany ISO 11133 ISO 11133-1 (2000-06-01) ISO 11133-2 (2003-12-15) Microbiology of food and Microbiology of food and animal feeding stuffs食品和动物 animal feeding stuffs食品和动 饲料微生物学— 物饲料微生物学– Guidelines on preparation andGuidelines on preparation and Practical guidelines onPractical guidelines on production of culture media performance testing of culture 验室培养基制备的质量保证一般导 media培养基性能测试实用指南- 则- Part 1: Part 2 : This new standard describe for the first time in history of Microbiology the definition of quality control for commercial culture media. 第一次规定了商业培养基的质量控制标准。 Quantitative testing and reporting of results ( CoA ) 质检报告包含量化数据 Requirements规定 Culture media must meet established or minimal performance criteria which are a prerequisite for any microbiological work培养基必须符合已建立或 最低性能测试标准，微生物检测的先决条件: Sufficient testing should be carried out to demonstrate需要充分的实验证明: • Acceptability of each batch of medium每批培养基的接受性 •• The medium is “fit for purpose“The medium is “fit for purpose“培养基适合检测目标培养基适合检测目标 • The medium can produce consistent results 培养基稳定性 These requirements are valid for users as well as for manufacturers of culture media and are valid for规定对于用户和生产商同样有效: • Commercially manufactured ready-to use media商业预制成品培养基 • Media prepared from commercially available dehydrated formulations干 粉培养基 • Media prepared from it‘s individual components培养基独立组分 IMPORTANT GOOD CULTURE MEDIA PREPARATION PARAMETERS acc to ISO 11133-1 and 2培养基配置重要参数 Water l Preferred is fresh distilled water / if chlorinated then neutralise chlorine prior to distillation现处理蒸馏水/ 中和氯 l Store distilled water in inert material containers (glass, polyethlyene) 储存于惰性容器玻璃聚乙烯材质 pHpH l Measure at 25 oC