培养时间的接受范围

惜君如常

培养时间若为：48h，接受的范围为多少？
若为5天，接受的范围为多少？
大家怎么在文件程序中规定？
谢谢

一片红云

问题没说清楚吧

惜君如常

一片红云 发表于 2017-3-7 15:39
问题没说清楚吧

也就是说，
具体到小时的培养时间，必须是整点正分来记录吗？
记录为天的培养时间，小时能有多大接受范围

一片红云

惜君如常 发表于 2017-3-7 16:47
也就是说，
具体到小时的培养时间，必须是整点正分来记录吗？
记录为天的培养时间，小时能有多大接受范 ...

应该具体到分钟，你只规定了一个点，不能有范围，除非你规定一个范围。gmp是很严格的，否则就是偏差

15206126084

最好是定一个范围，USP<1117>中建议超过72小时，以天为单位；小于3天的以小时计算。
"Incubation times for microbiological tests of less than 3 days’ duration should be expressed in hours (e.g. incubate at 30°C to 35°C for 18 to 72 hours).
Incubate for minimum specified time and exercise good microbiological judgment when exceeding the incubation time.

Tests longer than 72 hours’ duration should be expressed in days (e.g. incubate at 30°C to 35°C for 3 to 5 days).
Incubation started in the morning or afternoon should generally be concluded at that same time of day."

惜君如常

15206126084 发表于 2017-3-8 09:35
最好是定一个范围，USP中建议超过72小时，以天为单位；小于3天的以小时计算。
"Incubation times for micr ...

Tests longer than 72 hours’ duration should be expressed in days (e.g. incubate at 30°C to 35°C for 3 to 5 days).
Incubation started in the morning or afternoon should generally be concluded at that same time of day."
如果以天计算，开始培养时间为上午，那么结束时间也是上午；若开始培养时间为下午，结束时间也为下午，这么理解吗？

15206126084

惜君如常 发表于 2017-3-11 09:40
Tests longer than 72 hours’ duration should be expressed in days (e.g. incubate at 30°C to 35°C ...

是的，至少我是这么理解的。