无菌第15天张菌

qq540202

    培养至第15天的时候涨菌，第14天都未涨菌。第十五天准备清理的时候发现涨菌。这是什么问题？

凉白开水

那也算没涨菌

near

漂亮，逼疯质量的事件

Zzzno8

最后一天，估计要疯了吧。。。

死库水

要么你方法没经过确认，要么培养基自身有问题或后面几天引入了污染（毕竟你培养箱里也不是无菌）

Odxkx4jdd

--开盖了?

qq540202

Odxkx4jdd 发表于 2023-7-27 08:53
--开盖了?

没有，就是不知道什么情况

wenzhao10

相当的头疼

胡汉三12

按照第14天算，药典只是要求在14天 后面的可以自己内部找寻原因；
如果第16天或者20天长菌了，难道也要算不合格

因果律-一人

只管14天                    

651906014

集中培养还是分开培养的，分开培养的话，长菌的比例如何

火舞精灵

14+7，这种情况可以再培养7天

hd4861

是不是14天观察的时候污染了

七-月

逼死人         

栗子7

看你们质量部的衡量了
这个真的太讨厌了

逸清草堂

千年难得一遇的行情，但是你敢算合格放行吗，受权人胆子没有这么肥吧哈哈哈

ejckuo

USP <71> STERILITY TESTS
Incubate portions of the media for 14 days. No growth of microorganisms occurs.
If the material being tested renders the medium turbid so that the presence or absence of microbial growth cannot be readily determined by visual examination, 14 days after the beginning of incubation transfer portions (each not less than 1 mL) of the medium to fresh vessels of the same medium, and then incubate the original and transfer vessels for not less than 4 days.
The test may be considered invalid only if one or more of the following conditions are fulfilled:
1. The data of the microbiological monitoring of the sterility testing facility show a fault.
2. A review of the testing procedure used during the test in question reveals a fault.
3. Microbial growth is found in the negative controls.
4. After determination of the identity of the microorganisms isolated from the test, the growth of this species (or these species) may be ascribed unequivocally to faults with respect to the material and or the technique used in conducting the sterility test procedure.
If the test is declared to be invalid, it is repeated with the same number of units as in the original test. If no evidence of microbial growth is found in the repeat test, the product examined complies with the test for sterility. If microbial growth is found in the repeat test, the product examined does not comply with the test for sterility.

ejckuo

火舞精灵 发表于 2023-7-27 09:16
14+7，这种情况可以再培养7天

14+4         

lunmulunmu

看药典的要求，取一部分在培养看看结果。

Qiang.T

已经超出法规，公司内部评估可以做内部调查，分析。不在作为质量事件