药品洁净实验室物体表面微生物采集方法研究  

Collection Methods for Surface Microorganisms on Objects in Drug Cleanliness Laboratory

作　　者：佘凡 刘刚 崔亚宁 闵红 张健宇 SHE Fan;LIU Gang;CUI Yaning;MIN Hong;ZHANG Jianyu(Drug Testing Monitoring and Evaluation Center of Yangling Agricultural High-Tech Industrial Demonstration Zone,Xianyang,Shaanxi,China 712100;Shaanxi Institute for Food and Drug Control,Xi'an,Shaanxi,China 710065)

机构地区：[1]陕西省杨凌示范区药品检验监测评价中心,陕西咸阳712100 [2]陕西省食品药品检验研究院,陕西西安710065

出　　处：《中国药业》2024年第13期81-84,共4页China Pharmaceuticals

基　　金：陕西省重点研发计划项目[S2023-YF-YBSF-0265]。

摘　　要：目的为药品洁净实验室物体表面微生物采集方法的选择提供参考。方法以金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、大肠埃希菌、白色念珠菌、黑曲霉为代表菌株,对生物安全柜操作台面、集菌仪、非织布无菌服、无菌手套表面进行人工染菌制备负载样品,分别采用擦拭法和接触碟法采集同一物体表面的微生物,并比较回收率。分别采用接触碟法、擦拭法对实验室各洁净级别环境(A-D级)物体进行表面微生物采集,并比较单位面积表面微生物数量。结果负载样品接触碟法的回收率均大于80%,显著高于擦拭法的(51.3±2.5)%~(67.7±3.1)%(P<0.05)。实验室各级别环境(B-D级)物体表面微生物菌落计数中,接触碟法检出率均显著高于擦拭法(P<0.05)。结论药品洁净实验室平整光滑的物体表面的微生物采集适宜采用接触碟法,可提高检出率,能较好地反映物体表面微生物的污染状况。Objective To provide a reference for the selection of collection methods for surface microorganisms on objects in the drug cleanliness laboratory.Methods Representative strains of Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Escherichia coli,Candida albicans,and Aspergillus niger were used to artificially stain and prepare loaded samples on the laboratory operating surfaces of biosafety cabinets,bacterial collectors,non-woven sterile clothing,and sterile glove surfaces.The surface microorganisms of the same object was collected by the wiping and contact plate methods,and the recovery rates were compared.For each cleanliness level environment(A-D levels)in the laboratory,the surface microorganisms of objects were collected by contact disc method and wiping method,and the number of surface microorganisms per unit area was compared.Results The recovery rate of the contact disc method for loaded samples was over 80%,which was significantly higher than(51.3±2.5)%to(67.7±3.1)%of the wiping method(P<0.05).The results of microbial sampling on the surface of environmental objects at different levels(B-D levels)in the laboratory showed that the detection rate of the contact disc method was significantly higher than that of the wiping method(P<0.05).Conclusion The contact disc method is suitable for collecting microorganisms on the flat and smooth surface of objects in the drug cleanliness laboratory to improve the detection rate and truly reflect the surface microbial contamination status.

关 键 词：表面微生物 药品洁净实验室 擦拭法 接触碟法 

分 类 号：R917[医药卫生—药物分析学] R954[医药卫生—药学]