5、过滤工艺验证_顿昕答案.pptVIP

Operator training过滤操作者培训 Filtration equipment assembly and use 过滤设备的管理 Documentation文件建立与管理 Control of filter devices 过滤器管理 Process control and environmental Monitoring过滤过程控制与环境监控（包括人员和物料） Sterilization of filters 过滤芯及过滤装置的灭菌 Water systems filtration水纯化及其中过滤系统管理 Validation of filters过滤器验证 Risk assessment in Filtration Process 过滤工艺中的风险分析 Filter application and Qualification 过滤器的应用与确认 Filter Integrity testing 过滤器完整性测试 Filtration process Validation 过滤工艺验证 Filtration process review 过滤工艺审核 过滤前料液的生物负荷 过滤器的选择风险与验证困难 过滤工艺的操作与控制 过滤系统的设计与灭菌验证 Risk analysis in Filtration Process 过滤工艺中的风险分析 Filter application and Qualification 过滤器的应用与确认 Filter Integrity testing 过滤器完整性测试 Filtration process Validation 过滤工艺验证 Filtration process review Risk analysis in Filtration Process 过滤工艺中的风险分析 Filter application and Qualification 过滤器的应用与确认 Filter Integrity testing 过滤器完整性测试 Filtration process Validation 过滤工艺验证 Filtration process review 讲座目录 为什么要进行完整性测试? 法规中认可的两类完整性测试方法 什么可以用起泡点来代替挑战试验？ FDA对无菌过滤工艺的指南 “Normally, integrity testing of the filter is performed prior to processing, after the filter apparatus has already been assembled and sterilized.” 正常情况下, 滤器应在过滤前，即组装好后，且灭菌后执行完整性检测. “It is important that the integrity testing be conducted after filtration to detect any filter leaks or perforations that might have occurred during the filtration.”非常重要的是:在过滤后对滤器进行完整性检测,从而查看滤器是否泄漏和膜已破损. PDA Technical Report n° 26 PDA技术报告26号 “... It generally is regarded as a cGMP requirement that filters or filter systems routinely be integrity tested both prior to and after use.“ 一般认为过滤前后的常规性完整性检测是现行GMP的要求. EU GMP “The integrity of the sterilised filter should be verified before use and should be confirmed immediately after use by an appropriate method such as bubble point, diffusive flow or pressure hold test.”对于已灭菌的滤器的完整性检测应该在使用前和使用后立即执行,例如泡点,扩散流及压力保持试验. 起泡点是气体从湿润的最大膜孔快速流出的压力 起泡点显示过滤结构内保持液体的力的大小 最传统的非破坏性测试 起泡点等式 不同孔径标准不同 CVVL PVDF 0.1um 23摄氏度 水 =