制剂线设计原理.pptxVIP

;制剂流程;Mixing Tank;如何设计合适的一次性搅拌混匀袋？;Serial Filtration;Redundant Filtration 冗余过滤 An additional sterilizing-grade filter is placed in the filter train to ensure against loss of product 过滤组件加一个额外的除菌过滤器以确保防止产品损失 Applies if integrity failure of primary sterilizing grade filter 若主要除菌过滤器完整性失效，才使用冗余过滤器 The additional filter does not require post-use integrity testing unless the primary filter fails 额外的除菌过滤器不需要通过完整性测试除非主要除菌过滤器失败 Batch can be released as sterile if the second (redundant) filter passes integrity test post-use 如果第二（冗余）过滤器通过使用后完整性测试，产品批就可以称为无菌而释放 ;生物负荷检测控制点;Guidelines Summary for IT Require