【讨论】请大家讨论冻干粉针验证中过滤除菌前药注微生物限度验证
这个帖子发布于 15 年零 305 天前，其中的信息可能已发生改变或有所发展。
请问各位，我做冻干产品的工艺验证，想做除菌过滤前微生物污染水平测定，就是想验证药液配制后存放时间期限，具体做法是配制后、开始除菌过滤前取样放置几个时间段，然后测微生物！我想知道怎么控制冻干产品药液过滤前药液带菌量的标准？GMP中没有明确规定，但欧洲一些国家根据自己生产经验得到一个数值：最终灭菌前微生物污染程度限度为10CFU/100ml，我是否可借用此标准，检测规定不超10CFU/瓶？
参考文件：
Note for Guidance on Manufacture of the Finished Dosage Form (CPMP/QWP/486/95)
－－－相关章节及描述：
7. Special Items
For sterilisation by filtration the maximum acceptable bioburden prior to the
filtration must be stated in the application.
In most situations NMT 10 CFU’s/100 ml will be acceptable, depending on the
volume to be filtered in relation to the diameter of the filter. (I.e. total
load)
If this requirement is not met, it is necessary to use a pre-filtration through
a bacteria-retaining filter to obtain a sufficiently low bioburden.
参考文件：
Note for Guidance on Manufacture of the Finished Dosage Form (CPMP/QWP/486/95)
－－－相关章节及描述：
7. Special Items
For sterilisation by filtration the maximum acceptable bioburden prior to the
filtration must be stated in the application.
In most situations NMT 10 CFU’s/100 ml will be acceptable, depending on the
volume to be filtered in relation to the diameter of the filter. (I.e. total
load)
If this requirement is not met, it is necessary to use a pre-filtration through
a bacteria-retaining filter to obtain a sufficiently low bioburden.
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