关于QC的烘箱验证问题

kakaowen1234

目前QC的烘箱功能主要：干燥失重、装量检测、基准物质等烘干的的作用，
每个烘干的温度有好多种，是不是每一个温度点都需要做验证，还是只要验证
最大最小温度点呢？其实这些对温度精度要求并不是很高。

七-月

问仪器供应商，他们还会卖验证方案的……

wjcking123

加上一些评估，进行最高最低的验证

hongwei2000

如果标准是一致的
例如都是正负1或正负2度
可以只做最低和最高的
如果限度不一样则分别做

kakaowen1234

hongwei2000 发表于 2014-7-9 08:53
如果标准是一致的
例如都是正负1或正负2度
可以只做最低和最高的

这种温度点貌似药典里都没有正负要求的

hongwei2000

kakaowen1234 发表于 2014-7-9 08:54
这种温度点貌似药典里都没有正负要求的

你检验方法中没有要求吗

沁人绿茶.

我们是根据需要的温度点范围做的。

咕咕

可参照温度湿度校准规范校准

结果

常用温度是需要的。然后就是极限温度。

yjjjuichin

用到的每个点都做，比如60度，105度

kakaowen1234

hongwei2000 发表于 2014-7-9 08:58
你检验方法中没有要求吗

没有，我们公司SOP就是写着105度干燥多少小时，无他。我是认为这些东西最后还是要恒重的，只是时间长短罢了，对检验的结果影响很小。

hongwei2000

以下是USP的要求
LOSS ON DRYING



The procedure set forth in this chapter determines the amount of volatile matter of any kind that is driven off under the conditions specified. For substances appearing to contain water as the only volatile constituent, the procedure given in the chapter, Water Determination 921, is appropriate, and is specified in the individual monograph.


Unless otherwise directed in the individual monograph, conduct the determination on a 1 to 2 g test specimen. Mix the substance to be tested and, if it is in the form of large particles, reduce the particle size to about 2 mm by quickly crushing before weighing out the test specimen. Tare an appropriate glass-stoppered, shallow weighing bottle that has been dried for about 30 minutes under the same conditions to be employed in the determination and cooled to room temperature in a desiccator. Put the test specimen in the bottle, replace the cover, and accurately weigh the bottle and the contents. By gentle, sidewise shaking, distribute the test specimen as evenly as practicable to a depth of about 5 mm generally, and not more than 10 mm in the case of bulky materials. Place the loaded bottle in the drying chamber, removing the stopper and leaving it also in the chamber. Dry the test specimen at the temperature and for the time specified in the monograph. [Note—The temperature specified in the monograph is to be regarded as being within the range of ±2 of the stated figure. ]  Upon opening the chamber, close the bottle promptly, and allow it to come to room temperature in a desiccator before weighing.

windows

有同感，对于这个问题还真不清楚到底拿什么标准判定。
事实上，任何一台烘箱，都存在有温度差异的情况，只是大小的问题，也就是温度分布不均匀，但到底温度差异多少可以认为符合要求，没有一个明确的标准，检验条件也仅是规定一个温度，比如60、105或者其它温度，保持多少时间，但在具体的一个温度点，箱体不同点的温差在什么范围没有标准，还有一个问题就是比如温度要求60，若箱体温度高于60，是不是就不行。

lug1314520

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