无菌检查时紊流型无菌隔离器内环境微生物监测方法研究  

Turbulence type aseptic isolator intra-environmental microbial monitoring method in sterility test

作　　者：史新昌[1] 范文红[1] 丁有学[1] 饶春明[1] 

机构地区：[1]中国食品药品检定研究院重组药物室,北京100050

出　　处：《药物分析杂志》2016年第4期685-690,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：重大专项(民口部分)十二五"生物技术药物质量标准和质量控制技术平台"课题(2012ZX09304010);国家863计划"基因治疗产品的质量控制研究"课题(2012AA020800)和国家863计划"抗体药物质量控制关键技术"课题(2012AA02A304)

摘　　要：目的:研究在紊流型无菌隔离器内进行无菌检查时的内环境微生物监测方法。方法:自制监测杯(Φ90 mm×50 mm)。应用沉降菌检测和侧向气流落菌检测对监测杯法与平皿法检测效果进行比较。并在实际监测中应用监测杯法进行监测。结果:沉降菌检测和侧向气流落菌检测结果显示监测杯法与平皿法检测效果之间的差别无统计学意义,P>0.05。空载实验证明监测杯可以通过无菌隔离器消毒程序进行消毒。监测杯应用实例证明监测杯可以对无菌隔离器内环境起到较好的监测作用,同时具有操作简单,使用方便等特点。结论:所建立的监测杯法可以替代平皿法对无菌隔离器内环境进行监测。Objective：To study the turbulence type aseptic isolator intra-environmental monitoring method in sterility test. Methods：Homemade intra-environmental monitoring cup（IMC,Φ90 mm×50 mm） was adopted for the study. The comparison between the effect of the IMC method and the plate method was carried out by the detection of the settlement bacteria and the detection of trapping becteria. In addition, the IMC was applied in the actual test. Results：Our results showed that the difference between the detection effect of IMC method and the plate method was not statistically significant, P〉0.05. No-load test data showed that the IMC could be disinfected by aseptic isolator disinfection procedures. The intra-environmental monitoring application example proved that the IMC could work effectively for isolator intra-environment monitoring. Moreover, the IMC method exhibits some advantages, such as simple operation and easy handling. Conclusion： The IMC method is able to replace the plate method for the monitoring of aseptic isolator intra-environmental.

关 键 词：无菌隔离器 替代方法 内环境监测 内环境监测杯 平皿法 沉降菌检测 侧向气流落菌检测 

分 类 号：R917[医药卫生—药物分析学]