无菌检查用隔离系统致假阴性检验结果风险的评估

Risk Assessment of False Negative in Sterility-testing Isolator System

为研究无菌检查隔离系统微生物灭菌过程对无菌试验可能造成的不利影响,本研究尝试建立对无菌隔离系统应用中假阴性风险的评估方法,包括灭菌过程对包装完整性的影响,以及考察无菌检查过程中杀孢子剂残留对内容物暴露的影响。结果表明,试验材料在经过连续2轮灭菌程序处理后,包装完整性通过挑战;在较高杀孢子剂残留浓度下暴露的无菌检查操作也未受到影响,假阴性风险可控。本研究建立的方法可用于评估灭菌方法与物料包装和无菌检查暴露过程的兼容性。

In order to investigate the potential negative effects of decontamination cycle on the sterility test, methods were established to evaluate the possibility of getting false negative results when sterility-testing isolator system was used. The potential risks included the effect of decontamination cycle on the package integrity, and the effect of residual sporicide on the exposed materials when sterility test was performed. The experimental results indicated that the package integrity was not damaged by two rounds of decontamination cycle, moreover, the sterility test was not interfered when the materials were exposed to residual sporicide in relative higher amount. As such, risks of false negative results could be controlled. The established methods could be used to assess the compatibility of decontamination cycle with either the material package integrity or the exposure process in sterility test.