工业微生物2025，Vol.55Issue(6)：27-30,4.DOI:10.3969/j.issn.1001-6678.2025.06.009
快速无菌检查方法在药品无菌检验中的应用研究
Research on the Application of Rapid Sterility Examination Method in Pharmaceutical Sterility Testing
摘要
Abstract
This study proposes a validation study on the application of the BD BACTEC FX fully automatic bacterial culture system for sterility test of intermediate products that produce rabies vaccines and self-prepared liquid.In order to conduct operational identification,a temperature distribution test was conducted on the system.A total of 10 bacteria were selected,the sterility test of 11 samples under the system was analyzed,and the sensitivity limit inspection,the applicability inspection of the medium,and the method applicability inspection were conducted,along with the comparative assessment against the sterility test(film filtering method).The Results showes that the two have the same detection sensitivity and can be used for sterility test.However,there are still many restrictions on the fully automatic bacterial culture system.Therefore,its results cannot be used as a basis for the final release of products.But the system has the advantage of rapid testing,and can be used for the control of the intermediate process.The sterility test resluts(film filtering method)of finished products and intermediates shall be determined by the sterility test(film filtering method).关键词
全自动细菌培养系统/薄膜过滤法/方法验证/快速检验Key words
fully automatic bacterial culture system/film filtering method/method verification/rapid test引用本文复制引用
刘金凤,王英伟,赵文倩,郭岩,郭慧,李欢欢..快速无菌检查方法在药品无菌检验中的应用研究[J].工业微生物,2025,55(6):27-30,4.基金项目
冻干人用CPG佐剂狂犬病疫苗(Vero细胞)研究与开发(编号:20220204023YY). （Vero细胞）
