3家制药企业臭氧消毒后洁净车间微生物群落分析  

Microbial community analysis of clean workshops after ozone disinfection in three pharmaceutical companies

作　　者：曲璐 程红杰 陈超杰 李鹏 赵新霞 QU Lu;CHENG Hongjie;CHEN Chaojie;LI Peng;ZHAO Xinxia(Anyang Food and Drug Inspection and Testing Center,Anyang 455000,Henan Province,China;Provincial Vaccine Batch Release Center,Henan Provincial Institute for Drug and Medical Device Inspection,Anyang 455000,Henan Province,China)

机构地区：[1]安阳市食品药品检验检测中心,河南安阳455000 [2]河南省药品医疗器械检验院/河南省疫苗批签中心,河南安阳455000

出　　处：《药学前沿》2025年第4期588-594,共7页China Pharmacist

基　　金：河南省市场监督管理局科技项目(2022sj124)。

摘　　要：目的研究制药企业洁净车间经臭氧消毒后微生物群落的组成及分布规律,分析臭氧消杀效果,为制药企业相同空间消毒方式提供数据参考。方法采用基质辅助激光解吸电离飞行时间质谱(MALDI-TOF MS)技术和全自动微生物分析系统(VITEK^(®)2 Compact)鉴定方法,对收集的浮游菌和沉降菌进行鉴定分析。结果776株菌均鉴定到属水平,消毒前427株菌,消毒后339株菌,A、B、C 3家企业减少比例分别为22%、19%和23%。消毒前后优势菌属均为葡萄球菌属、芽孢杆菌属、微球菌属,消毒效果最明显为微球菌属和考克菌属,消毒效果最差为芽孢杆菌属。其中人员更衣区污染菌量减少比例最少,企业B在消毒后的A级灌装区仍能采集到污染菌,说明臭氧消毒未完全覆盖可能出现的微生物污染风险。结论臭氧消毒是洁净车间空间消毒的常用方式,定期分析消毒后微生物种群,进一步提高消毒水平,保证药品生产有效性、安全性。Objective To study the composition and distribution rules of microbial community in clean workshops of pharmaceutical enterprises after ozone disinfection,analyze the effect of ozone disinfection and sterilization,and provide data reference for the same space disinfection method of pharmaceutical enterprises.Methods Using matrix-assisted laser desorption ionization time-of-flight mass spectrometry(MALDI-TOF MS)and VITEK^(®)2 Compact identification methods,the collected planktonic and sedimentary bacteria were identified and analyzed.Results 776 strains of bacteria were identified at the genus level,with 427 strains before disinfection and 339 strains after disinfection.The reduction rates of A,B and C enterprises were 22%,19%and 23%,respectively.Before and after disinfection,the dominant bacterial genera were Staphylococcus,Bacillus,and Micrococcus.Micrococcus and Clostridium showed the most obvious disinfection effect,while Bacillus had the worst disinfection effect.The proportion of reduced bacterial contamination in the personnel changing area was the lowest,and company B could still collect contaminated bacteria in the A-grade filling area after disinfection,indicating that ozone disinfection didn't fully cover the potential risk of microbial contamination.Conclusion Ozone disinfection is a common method for disinfecting clean workshop spaces.After disinfection,the microbial population is regularly analyzed,and the disinfection level is further improved to ensure the effectiveness and safety of drug production.

关 键 词：臭氧消毒 洁净车间 微生物群落 基质辅助激光解吸电离飞行时间质谱 自动化微生物识别系统 

分 类 号：Q93[生物学—微生物学]