完整性测试的原理.ppt

疏水性空气滤芯的完整性测试方法 以前: 异丙醇测试 由于疏水性的多孔滤膜不能被水相溶液润湿， 必须使用异丙醇/水的混合溶液来润湿滤膜： e.g. 标准润湿剂 60/40-异丙醇/水混合液 异丙醇测试的缺点: 过滤时疏水性是空气滤芯的特点但在测试时却 需要将滤芯亲水化 通常滤芯必须从过滤滤壳中取出并在另一个独立的滤壳中测试，同时要求设备的防爆性能。 异丙醇测试只能在灭菌前进行 4. 异丙醇作为气体污染物必须被彻底去除 5. 无法检测滤芯的疏水性 6. 无法检测滤芯安装的正确性 疏水性空气滤芯的完整性测试方法 现在: 由Sartorius首创的水侵入法 疏水性空气滤芯的完整性测试方法 W I T Water intrusion test Product Management Process Filtration Biotechnology Division 完整性测试原理 to confirm the integrity of the filter prior to (out of box, after SIP/autoclaving) and after use (release requirement) to detect system leaks (housings, tubes, o-rings, etc.) as a SOP and auditing requirement as a regulatory requirement Integrity testing of filter is necessary... 在使用前（开包装、在线蒸汽灭菌/高压灭菌） 和使用后（产品放行要求）验证过滤器的完整性。 监测系统泄漏（钢壳、管道、O形圈等） SOP和审计要求 相关法规的要求 过滤器的完整性测试是必要的 “Normally, integrity testing of the filter is performed after the filter unit is assembled and sterilized prior to use. More importantly, however, such testing should be conducted after the filter is used in order to detect any filter leaks or perforations that may have occurred during the filtration. Forward flow, bubble point and pressure hold tests are acceptable integrity tests.“ FDA Guideline on sterile drug products produced by aseptic processing, 1987 Regulations for Integrity Testing 法规要求（1） FDA无菌工艺生产无菌药品指南，1987 通常完整性测试是在过滤器安装和灭菌之后、正式使用 前进行的。另外，使用后进行完整性测试在发现过滤 过程中的意外泄漏或穿透现象显得尤为重要。 可接受的完整性测试方法如扩散流、气泡点测试、稳压测 试。 完整性测试的相关法规 EC GMP (Annex 1, Filtration of medicinal products which cannot be sterilised in their final container, (June 2001)) 85. ?The integrity of the sterilised 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... The integrity of critical gas and air vent filters should be confirmed after use. The integrity of other filters should be confirmed at appropriate intervals.“ Regulations for Integrity Testing Critical gas