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

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.

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