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发表于 2021-5-26 11:15:48
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USP 1231 Water for Pharmaceutical Purposes
8.5.1 Microbial Enumeration Consideration
▲Consideration should also be given to the timeliness of microbial testing after sample collection. The number of detectable organisms in a sample collected in a sterile, scrupulously clean sample container will usually decrease as time passes. The organisms within the sample may die or adhere to the container walls, reducing the number that can be withdrawn from the sample for testing. The opposite effect can also occur if the sample container is not scrupulously clean and contains a low concentration of nutrients that could promote microbial growth. Because the number of organisms in the water can change over time after sample collection, it is best to test the samples as soon as possible. If it is not possible to test the sample within 2 h of collection, the sample should be held at refrigerated temperatures (2 ℃ – 8 ℃) and tested within 24 h. 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.▲ 1S (USP41) |
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