美国药典USP31 71 无菌检查法 双语版 下载本文

When using the technique of direct inoculation of media, use the quantities shown in Tables 2 and 3, unless otherwise justified and authorized. The tests for bacterial and fungal sterility are carried out on the same sample of the product to be examined. When the volume or the quantity in a single container is insufficient to carry out the tests, the contents of two or more containers are used to inoculate the different media.

当使用培养基直接接种法时,除非另有证据或授权,使用表2和3中显示的数量。用于检验细菌和霉菌的试验使用供试产品的同一个样品。当单一容器中的产品体积或数量不足以进行该试验时,适用2个或更多容器的内容物来接种不同的培养基。

1

In appropriate cases, periodic testing of the different batches prepared from the same lot of dehydrated medium is acceptable.

在适当的情况下,用同一个批次的脱水培养基配制的不同批次的定期试验是可以接受的