培养基模拟灌装的培养过程

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大家做培养基模拟灌装的培养过程都是怎样的呢？

絮絮冰子

为什么时间要定在7天和14天

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絮絮冰子 发表于 2013-7-19 14:28
为什么时间要定在7天和14天

有GMP指南这么指导的

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@cheng9gong  说下你们怎么培养呀

wj1914

FDA和PIC上要求先低温开始。20-25 7天   30-35  7天

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wj1914 发表于 2013-7-19 14:52
FDA和PIC上要求先低温开始。20-25 7天   30-35  7天

It is generally accepted to incubate at 20-25°C for a minimum of 7 days followed
immediately, or after a first reading, by incubation at 30-35°C for a total minimum
incubation time of 14 days. Other incubation schedules should be based on
supporting validation data.这是pic/s的，低温7天或者第一次读数后，高温14天还是高低温累计14天呢

情非得已

wj1914 发表于 2013-7-19 14:52
FDA和PIC上要求先低温开始。20-25 7天   30-35  7天

usp35的Typically, for general microbiological growth media such as SCDM, incubation temperatures in the ranges of 22.5 ± 2.5 and 32.5 ± 2.5 have been used with an incubation time of not less than 72 hours. Longer incubation times may be considered when contaminants are known to be slow growing. The temperature ranges given above are by no means absolute. Mesophilic bacteria and mold common to the typical facility environment are generally capable of growing over a wide range of temperatures. For many mesophilic organisms, recovery is possible over a range of approximately 20 . In the absence of confirmatory evidence, microbiologists may incubate a single plate at both a low and a higher temperature. Incubating at the lower temperature first may compromise the recovery of Gram-positive cocci that are important because they are often associated with humans.又该怎么理解呢？

lunmulunmu

先低温7，后高温7；
先高温7，后低温7.
二者有什么区别吗？我们始终执行的是先低温7，后高温7；

絮絮冰子

情非得已 发表于 2013-7-19 14:39
有GMP指南这么指导的

是哪本书，我看的那本好像只是写到要这样做，但是具体的没有写

残伤

我们执行的是先低温7，后高温7

wj1914

情非得已 发表于 2013-7-19 15:04
It is generally accepted to incubate at 20-25°C for a minimum of 7 days followed
immediately, or ...

高低温累积14天

wj1914

情非得已 发表于 2013-7-19 15:06
usp35的Typically, for general microbiological growth media such as SCDM, incubation temperatures i ...

“then the vials are incubated at 20 to 25 or at 30 to 35 for a minimum of 14 days. If two temperatures are used for incubation of media-filled samples, then these filled containers should be incubated for at least 7 days at each temperature (see Microbiological Evaluation of Clean Rooms and Other Controlled Environments 1116). Inspect for microbial growth over 14 days as described in Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices and Cleaning/Disinfection Procedures. ”

“Following the aseptic processing of the medium, the filled containers are incubated at 22.5 ± 2.5 or at 32.5 ± 2.5. All media
filled containers should be incubated for a minimum of 14 days. If two temperatures are used for incubation of media filled
samples, then these filled containers should be incubated for at least 7 days at each temperature”等等。。。

FDA:20-35，目标值+—2.5，不少于14天。选择2个温度的话，每个温度至少培养7天，从低温开始。我不太清楚从高温开始培养的依据从哪儿来的，不知道是否指点下

情非得已

lunmulunmu 发表于 2013-7-19 15:07
先低温7，后高温7；
先高温7，后低温7.
二者有什么区别吗？我们始终执行的是先低温7，后高温7；

有区别吧，usp的解释是先低温再高温有可能减少革兰氏阳性菌的复苏

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絮絮冰子 发表于 2013-7-19 15:13
是哪本书，我看的那本好像只是写到要这样做，但是具体的没有写

gmp指南（无菌药品）

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wj1914 发表于 2013-7-19 15:34
“then the vials are incubated at 20 to 25 or at 30 to 35 for a minimum of 14 days. If two tempera ...

usp35有相关描述

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残伤 发表于 2013-7-19 15:25
我们执行的是先低温7，后高温7

培养前倒置或反转么？还是培养期间翻转呢？

lunmulunmu

情非得已 发表于 2013-7-19 16:15
培养前倒置或反转么？还是培养期间翻转呢？

每天检查时翻转一次

四叶花

选1和3应该说没多大关系吧，总共14天，刚好没那多培养箱，二者互换

zhouyuyy

哈 学习了

絮絮冰子

情非得已 发表于 2013-7-19 16:00
gmp指南（无菌药品）

哦，这本我还没有看