如果小容量注射剂在无菌检测项目中出现细菌或者真菌，原因会有哪些？

歪打正着

zc3205 发表于 2013-9-10 08:51
素质决定高度！！！！！！！！！！1

读死书的，没见过车间怎么灭菌吧，明显素质有问题啊。

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294747568

百里冰 发表于 2014-3-23 17:43
初来乍到，请多多关照。

相互学习，相互进步

pharm1234

这么复杂的问题，大家还不要讨论了！
楼主都没说清最终灭菌or 非最终灭菌产品，大家讨论有益吗！！！！！！！？？？
严谨些吧！包括楼主

白云的云

如果车间所有的环境监测是合格的，无菌检查浑浊的培养物与车间的污染菌形态不一致时，实验室的污染就是最主要的原因了。

qzai

玻璃杯 发表于 2013-9-3 13:25
感谢指导，提供鉴定方法，我学习下

可以送到微生物检验所鉴定的。

yhdaizy@163.com

无菌被破坏，原因很多，看物料情况、灭菌情况、灭菌后暂存条件、 人员操作、无菌环境等等

无损检测技术

包装密封不合适，有泄漏

294747568

无损检测技术 发表于 2015-6-12 16:31
包装密封不合适，有泄漏

安瓿瓶密封着呢，不漏气

木木方

楼主的产品是最终灭菌还是非最终灭菌？无菌检查异常是个很头疼的事情，因为结果出来的晚，你很难对当批的生产情况进行追溯。如果当批生产有异常，首先考虑异常造成的影响。鱼骨图分析也好人机料法环也好都是推理，没有证据都还是站不住脚的。菌种鉴别可以证明微生物是水源还是气源的有利于你的调查，如果你们车间有做过车间常见菌、人员常见菌的话就更利于调查了。说了这么多怕被喷，我读书少工作资历也浅公司也没有很强的微生物方面的技术支持，在这里只是想和大家做个交流，和谐和谐

木木方

歪打正着 发表于 2013-9-10 12:15
读死书的，没见过车间怎么灭菌吧，明显素质有问题啊。

每家公司的情况不一样，可能你家做不了人家能做，车间灭菌我见过一些，可是针对楼主的问题，我没看出是最终灭菌还是非最终灭菌，指不定人家不灭菌呢

木木方

zc3205 发表于 2013-9-9 09:06
@歪打正着  别把自己办不到的事情就认为是理所当然的。无菌检测不合格，要么证明你实验操作失误，重新进行 ...

说的很完整，支持你一下

294747568

木木方 发表于 2016-1-28 10:00
楼主的产品是最终灭菌还是非最终灭菌？无菌检查异常是个很头疼的事情，因为结果出来的晚，你很难对当批的生 ...

多谢大侠，非最终灭菌产品

小金库

感谢分享