摘要
对无菌隔离舱在药品无菌检查中是否适用进行验证。验证实验采用运行确认和性能确认的方法。结果表明无菌隔离舱为药品无菌检查提供了一种可靠的实验环境。
The applicability of isolator system in sterility testin g for drugs was validated. The validation study was performed in phases of opera tion qualification and performance qualification. Isolator system was validated to be credible equipment in sterility testing for drugs.
出处
《中国药事》
CAS
2005年第2期79-81,共3页
Chinese Pharmaceutical Affairs
关键词
无菌隔离舱
无菌检查
验证
isolator system
sterility testing
validation
