METHODS: the status quo of verification test in microbial test of drugs in an area, and the problems and their root causes were analyzed.
方法:剖析某地区药品微生物检查验证试验的现状以及存在的问题和根源。
The FTIR method was used to investigate the correlation of bacteria in the contaminated drug and the environmental microbes in the clean room for pharmaceutical microbial test.
应用FTIR法对药品检出菌与微生物检验洁净室环境菌进行相关性考察,通过临界匹配值法和聚类分析法比较药品检出菌与环境菌FTIR图谱的相似性;
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。
应用推荐