摘要
本文提出的阳性对照方案可使污染的供试品错误通过无菌检查的可能率比现行方法大大降低，提出的无菌结果判断方案可避免误判。
An improved positive contrast design, which could reduce the possibility of microbiologically contaminated drug products passing the sterility test,and the observation and interpretation of sterility test results including validation of these processes were discussed.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
1994年第9期411-412,共2页
Chinese Journal of Pharmaceuticals
关键词
无菌检查
阳性对照
药品检定
test for sterility, Positive contrast.interpretation
