过滤技术及应用解析.pptVIP

Example of Changed Diffusional Flow 举例 Example of Changed Diffusional Flow 举例 Example of Changed Diffusional Flow 举例 “Diffusion Testing” Summary 扩散测试总结 疏水滤膜采用有机溶剂进行完整性测试的问题 HydroCorr Testing Hydrocorr测试 HydroCorr Test Resistance to water intrusion 水浸入法测试 HydroCorr Test Results测试结果 HydroCorr Test Considerations测试的注意点 ?? Must have a leak-free system必须在一密闭系统内进行 ?? Filters must be dry and clean过滤芯必须干燥且干净 ?? It is relatively easy to Hydrocorr test “very hydrophobic” membranes such as PTFE ?? 对于疏水性很强的滤芯,例PTFE材质的膜,水浸入法是相当容易 ?? Successfully testing “less hydrophobic” membranes such as PVDF requires ideal conditions that can be difficult to achieve in actual biopharmaceutical processes ?? 在实际的生物制药工艺中,测试一些疏水性不强的滤膜,例PVDF膜是比较困难的 ?? Temperature changes should be minimized ?? 尽量减少温度的变化 ?? Reference testing is important ?? 相关的参考比较重要 ?? Must have a complete validation package ?? 必须有一完整的验证文本 ?? Values must be comprehensively correlated to microorganism challenge ?? 数据必须与细菌挑战相关 完整性测试失败处理措施 润湿建议 Summary总结 ?? Bubble point and Diffusion or “Forward flow” are BOTH valid integrity tests as per regulatory agencies. 起泡点, 扩散流（或前向流）和HydroCorr是法规认可 的完整性测试方法 ?? The choice of an integrity test depends on the testing equipment, the filter manufacturer, the company‘s philosophy and the testing environment 完整性测试的选择倚赖测试装置，过滤器制造商，公司体系和 测试环境 ?? Bubble point provides a direct correlation to bacterial retention, the critical performance characteristic 起泡点提供与细菌截留的直接关联，重要的性能特性 ?? Diffusion testing provides a sensitive way to determine integrity for larger area filters扩散测试提供一个敏感方法来测试大面积过滤器 Automated Integrity Testers 自动完整性测试仪 Why Do People Use Automatic Testers 为何用户会选用自动测试仪 Post SIP Integrity Testing SIP后的完整性测试 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 pr