完整性测试1.ppt

密理博中国有限公司 生物制药工艺部 Content 讲座目录 What is filter integrity? 什么是滤膜完整性? Why Integrity Test? 为什么做完整性测试? Regulations about integrity test 法规中对完整性测试的规定 FDA Guideline指南 (2003) Whatever filter or combination of filters is used, validation should include microbiological challenges to simulate worst-case production conditions…”对于由一个或多个滤器组成的过滤系统，对它的验证都应该包括在最差条件下进行的微生物挑战试验。 Regulations about integrity test法规中对完整性测试的规定 Revision of annex 1 to EC Guide to GMP for sterile medicinal products (1997) 欧盟对于无菌药品GMP指南的附件一(1997版) “The integrity of the sterilized filter should be verified before use and should be confirmed immediately after use by an appropriate method such as a bubble point, diffusive flow or pressure hold test” 除菌过滤膜应该在使用前及使用后立即采取合适的方法确认其完整性,可以采用泡点,扩散流或压力保持的方法. FDA Guideline on Sterile Drug Products Produced by Aseptic Processing (1987) FDA对于无菌操作生产的无菌药品的要求(1987版) “Normally, integrity testing of the filter is performed after the filter unit is assembled and sterilized prior to use.” 完整性测试通常在过滤器安装,灭菌后使用前进行 PDA Technical Report # 26 PDA技术报告26版 “It generally is regarded as a cGMP requirement that filters or filter systems routinely be integrity tested both prior to and after use.” 现行的GMP要求过滤器及过滤系统在使用前及使用后均需要进行完整性测试 Where When Do We Integrity Test?何时和何地做完整性测试? WHEN TO DO IT? 什么时候做? Before sterilization 灭菌前 Before use 使用前 After use 使用后 What Are The Integrity Testing Choices? 完整性测试的选择? Destructive vs. Non-destructive Testing 破坏性和非破坏性测试 Integrity Testing Correlations 完整性测试关联 What Non-Destructive Integrity Tests are Available? 何种非破坏性测试合适? Bubble point is the pressure at which gas displaces liquid from the largest set of filter pores and flows rapidly through the filter 起泡点是气体从湿润的最大膜孔挤出液体快速流出时的压力 Bubble point indicates the magnitude of the forces holding liquid in the filter structure 起泡点显示过滤结构内保持液体的力的大小 The oldest non-destructive integrity test 最传统的非破坏性测试 Bubble point test 泡点测试 Bubble Point Test Applicability 起泡点测试适用性 Bubble Point Equation起泡点等式 Effect on bubb