完整性测试原理方法及应用.docxVIP

sartorius stedim biotech Principle and Application of Integrity Test 完整性测试原理方法及应用 赛多利斯中国 潘俊华 sartorius Why is Integrity Testing so important?为什么完整性测试? stedim biotech . To prevent damage to the product by the use of defective filters 避免使用有缺陷的滤器对产品造成损害 ·To determine the presence of oversized pores within the membrane · 确保选择正确的过滤器孔径 · To detect system leaks (housings, o-rings, etc.) 检测是否存在系统泄漏 . To fulfill the regulatory requirement To get reliable sterility assurance! 满足法规要求 获得可靠的无菌保障! biotechsartorius stedim biotech Definition of a Sterilizing Grade Filter 无菌滤器定义 Bacterial retention: FDA Gu