关于分次灭菌取样

beiwei5du

各位蒲友：

关于过热灭菌的最终灭菌大容量注射剂，分多次灭菌柜灭菌，请问大家的取样的方式是什么？？？还有分次灭菌每个灭菌柜取样的取样是单独进行无菌检测，还是合并进行无菌 检测呢？？？
2. What are the sampling requirements for sterility testing when a finished product batch of a terminally sterilised medicinal product is made up of more than one steriliser load? H+V October 2008The sampling plan for sterility testing should take account of the definition of a batch as stated in the glossary of the GMP guideline together with the recommendations of annex 1 section 93 (section 127 in the February 2008 revision). Each steriliser load is considered to be an independent sub-batch. Consequently, one sterility test should be performed per sub-batch. The number of samples per steriliser load should conform to European Pharmacopoeia requirements, section 2.6.1.3.
Can there be any exceptions to this rule?For large-volume parenterals where the sterilisation cycle has been qualified with an overkill level, an alternative sampling plan in accordance with a specific internal procedure agreed with the supervisory authority can be accepted (unless already specified in the marketing authorisation).
This procedure should state the need to sample from each steriliser load including the coolest location identified during the steriliser qualification. The number of samples per load should be defined based on a risk-based approach and the overall number of samples per batch should conform to European Pharmacopoeia requirements, section 2.6.1.3. An alternative option, which would require a variation to relevant existing marketing authorisations, would be to introduce a system of parametric release, thereby avoiding the need to carry out the sterility test.

关于灭菌柜取样
https://www.ouryao.com/forum.php? ... E%FA%2B%C8%A1%D1%F9

jacob3263313

要是能把英文翻译一下就更好了

0长风烈马0

如能真正做到参数放行，少取那几瓶又何妨呢？

cnosema

你贴一份英文的，再贴一份中文的，是想进行比较吗？