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嘉峪检测网 2025-07-15 20:58
USP1231《制药用水》规定了水质检验样品存放时间和存放条件的相关要求,包括化学测试样品和微生物检验的样品。概述如下:
Sampling Hold Times for Chemical Tests
化学测试样品存放时间
Basically it is advisable to conduct chemical tests immediately after extracting samples, since impurities may dissolve in water once the sample has been bottled. These impurities may be caused by contamination from ambient air or by the walls of the sample container (“leach-out”). In both cases the longer the samples are stored, the greater the potential to be adversely impacted by containers or conditions, in the worst case creating a false positive result. The proper container should be one that does not contaminate the sample during storage/hold time, eliminating the possibility that leach-out impacts certain parameter, i.e. glass bottles for the TOC assessment, plastic bottles for the measuring of the conductivity. Irrespective of the material of the container, where possible the sample should be stored cool and only for a short time in order to obtain representative results.
基本上,在取完样之后立即进行化学检验是合适的,因为一旦样品装入瓶子里之后杂质可能会溶入水里。这些杂质可能来源于环境中的空气或者取样容器的内壁(浸出)。样品存放越长,受容器或条件不利影响的可能性越大,甚至导致假阳性结果。选择合适的容器使在存放过程中不污染样品,排除浸出影响某一参数可能性,如使用玻璃瓶进行TOC检验、使用塑料瓶进行电导率测试等。除了容器材质的影响,适当时,样品应被存放于阴凉条件下,并仅存放较短时间,以获取有代表性的结果。
Sampling Hold Times for Microbiology
微生物检验样品存放时间
As in the case of the chemical tests, the new guideline adds advice on hold times for the micro-biological examination of water (chapter 8.5.1). It points out that the results of incubation during a lengthy holding time may go either way, even unintentionally improving the sample or being detrimental to it. Germs found in very clean samples (and containers) will tend to decrease over time, whereas those in an impure sample are prone to increase. Thus, the risk of false positive/negative results increases during a lengthy holding time. Therefore, the sample should be cooled during a holding time of over two hours. Incubation should take place within 24 hours. In situations where even 24 h is not possible (such as when using off-site contract laboratories), it is particularly important to qualify the microbiological sample hold times and storage conditions to avoid significant changes in the microbial population during sample storage.
正如化学检验一样,该新指南提供了水质微生物检验保存时间的建议(章节8.5.1)。它指出样品保存期间培养的结果可能会变化,或,在非常干净的样品(或容器)中发现的细菌将会随着时间不断减少,而在一个不干净的样品中,则会不断增加。这样,在保存一段时间后得到假阳性/假阴性结果的风险将会增加。因此,样品保存时间超过2个小时的,应给放置于阴凉处。培养应在24小时内进行。当24小时内培养都没办法做到时(例如当使用工厂外的合同实验室时),微生物样品保存时间和保存条件应进行确认以避免样品保存期间微生物水平发现明显变化显得尤其重要。
Containers容器
When sampling water for off-line analysis, the selection and cleanliness of the container play a significant part in obtaining accurate data.在采集水样进行离线分析时,容器的选择和清洁度对获取准确数据起着重要作用。
For samples to be tested for chemical impurities according to 〈643〉 and 〈645〉, the proper container should be one that does not contaminate the sample during the storage/hold time.对于根据〈643〉和〈645〉进行化学杂质测试的样品,合适的容器应是在储存 / 放置期间不会污染样品的容器。
For example, the use and preparation of glass containers could be very acceptable for storing samples for TOC testing, but some glass containers do leach ions over time (hours and days), and they can adversely affect a conductivity test by creating a false positive result—if the storage time is too long.例如,玻璃容器的使用和准备对于储存 TOC 测试样品可能是非常合适的,但有些玻璃容器会随着时间(数小时和数天)浸出离子,如果储存时间过长,可能会导致电导率测试出现假阳性结果,从而产生不利影响。
Likewise, there are some polymer materials that can adversely affect the TOC chemical impurity in water.同样,有些聚合物材料可能会对水中的 TOC 化学杂质产生不利影响。
However, many polymer materials are very inert.然而,许多聚合物材料是非常惰性的。
In any case, cleanliness of the container is crucial because trace quantities of soaps and fingerprints will adversely affect the chemical purity of the water.在任何情况下,容器的清洁度都至关重要,因为微量的肥皂和指纹会对水的化学纯度产生不利影响。
Properly cleaned containers are acceptable because chemical impurities are easily rinsed away.经过适当清洁的容器是可以接受的,因为化学杂质很容易被冲洗掉。
Extensive chemical cleaning methods such as acid or caustic rinsing should never be needed.
无需采用诸如酸洗或碱洗之类的复杂化学清洗方法。
If they are needed, consider replacing the containers.如果需要这些方法,应考虑更换容器。
来源:GMP办公室