摘要
文章对BD BACTEC FX全自动细菌培养系统在生产狂犬疫苗的中间产品及自配液体无菌检验中的应用展开验证研究。为进行操作鉴定,对该系统开展温度分布测试。共选取10种菌,分析11种样品在该系统下的无菌检验,并组织灵敏度限值检查、培养基适用性检查、方法适用性检查,同时与无菌检查(薄膜过滤法)比对。结果显示,二者具有同样的检出灵敏度,可用于无菌检验。然而,由于全自动细菌培养系统存在很多限制,其结果不能作为最终放行产品的依据。但是,该系统具备快速检验的优势,可用于中间过程控制。产品及中间产品的无菌检验结果要以无菌检验(薄膜过滤法)为准。
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 11samples 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).
作者
刘金凤
王英伟
赵文倩
郭岩
郭慧
李欢欢
LIU Jinfeng;WANG Yingwei;ZHAO Wenqian;GUO Yan;GUO Hui;LI Huanhuan(Changchun Zhuoyi Biological Co.,Ltd.,Changchun 130600,China)
出处
《工业微生物》
2025年第6期27-30,共4页
Industrial Microbiology
基金
冻干人用CPG佐剂狂犬病疫苗(Vero细胞)研究与开发(编号:20220204023YY)。
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
fully automatic bacterial culture system
film filtering method
method verification
rapid test
