PIVAS洁净区空气微生物动态变化的两种监测方法应用比较

Comparison of two monitoring methods for dynamic change of air microorganism in PIVAS clean zone

目的:评估沉降菌法和定量空气浮游菌采样法对PIVAS洁净区空气微生物动态变化的监测效果。方法:参照《医药工业洁净区(室)沉降菌的测试方法》(GB/T 16294—2010)、《医药工业洁净区(室)浮游菌的测试方法》(GB/T 16293-2010),对洁净区空气微生物进行动态监测,对数据进行统计学分析。结果:4个洁净区的空气微生物浓度均在合格范围内;两种方法对普通药/营养调配洁净区空气微生物的检出效果具有统计学差异(P<0.05),沉降菌法的检出率高于定量空气浮游菌采样法;抗生素/抗肿瘤药调配洁净区,两种方法的检出率无统计学差异(P>0.05)。结论:PIVAS洁净区空气微生物的动态监测,应同时采取沉降菌法和定量空气浮游菌采样法,两种方法相辅相成,互为补充。

OBJECTIVE To evaluate the monitoring effect of settling bacteria method and quantitative airborne microbe sampling method on the dynamic changes of airborne microorganisms in PIVAS clean area.METHODS The dynamic monitoring method of air microorganism in clean zone was based on the test method of GB/T 16294-2010and GB/T 16293-2010,and the data was statistically analyzed.RESULTS The airborne microorganism concentrations in the four clean areas were within the qualified range;there was statistical difference in the detection effect of airborne microorganism in the clean area prepared with common drugs/nutrition between the two methods(P<0.05),and the detection rate of sedimentation bacteria method was higher than that of quantitative airborne microbe sampling method;there was no statistical difference in the detection rate between the two methods in the clean area prepared with antibiotics/anti-tumor drugs(P>0.05).CONCLUSION The dynamic monitoring of air microorganism in PIVAS clean zone should adopt the methods of plate sedimentation method and quantitative airborne microbe sampling method at the same time,both of which could complement each other.