Limitations of Sterility Test 无菌检查的局限性
Objective To discuss the current situation of drug sterility test in our country.
目的讨论目前我国药品无菌试验的实际情况。
If the membrane filtration technique is unsuitable, use the Direct Inoculation of the Culture Medium method under Test for Sterility of the Product to be Examined.
如果膜过滤技术是不适合的，则使用在供试产品无菌检查法项下的培养基直接接种法。
If no evidence of microbial growth is found in the repeat test, the product examined complies with the test for sterility.
如果在复检中未发现微生物生长的证据，则该供试产品符合无菌试验的要求。
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