首页|药品微生物检验洁净室中常见环境菌的消毒效果研究

药品微生物检验洁净室中常见环境菌的消毒效果研究

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通过对药品检验洁净室中常用的消毒剂进行效能验证,进而控制潜在的微生物污染风险.本研究采用悬液定量杀灭试验法,利用已知的标准菌株及从洁净区采集的已鉴定环境菌,对甲酚皂、新洁尔灭、75%乙醇和杀孢子剂等4种常见消毒剂的杀菌效果进行快速评估.结果显示,在各种消毒剂对菌株的杀灭效果中,当作用时间不同时,会呈现出显著的差异.75%乙醇和甲酚皂在作用时间较短时,对大多数细菌营养体杀灭对数值小于5,在延长作用时间后,效果有显著提高.新洁尔灭及杀孢子剂的杀菌效果在短时间内效果较好,尤其是对于葡萄球菌属和微球菌属,而芽孢对于各类消毒的敏感性均较低.在最长作用时间下,各消毒剂对营养体、芽孢及霉菌孢子的杀灭对数值均大于5.多种类的环境菌株更能全面反映洁净环境中真实的微生物污染状况,更有利于筛选合适消毒剂,进而为药品微生物检验机构及企业制定合理且有效的消毒程序提供依据.
Study on the disinfection effect of common environmental bacteria in drug microbiology examination cleanroom
The potential risk of microbial contamination is controlled by verifying the efficacy of disinfectants commonly used in drug testing clean rooms.Suspension quantitative germicidal test was used to quickly evaluate the germicidal efficacy of cresol soap,bromogeramine,75%ethanol and sporicides by using known standard strains and identified environmental bacteria collected from clean areas.The results showed that the germicidal efficacy of different disinfectants on strains was significantly different with different action time.The killing logarithm value of 75%ethanol and cresol soap on most bacterial nutrients was less than 5 when the action time was short,and the effect was significantly improved after prolonging the action time.The bactericidal effect of bromo geramine and sporicide is better in a short time,especially for Staphylococcus and micrococcus,while spores have low sensitivity to all kinds of disinfection.Under the longest action time,the killing value of each disinfectant on nutrients,spores and mold spores was greater than 5.A variety of environmental strains can more fully reflect the real microbial pollution situation in the clean environment,and is more conducive to the screening of appropriate disinfectants and then provide a basis for drug microbial inspection institutions and enterprises to develop reasonable and effective disinfection procedures.

DisinfectantSuspension quantitative germicidal testEnvironmental isolated bacteriaEfficacy verification

刘蓉、赵晓冬、王丹、袁昕蓉、徐美丽

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沈阳市食品药品检验所 辽宁沈阳 110122

消毒剂 悬液定量杀灭试验 环境分离菌 效能验证

2024

质量安全与检验检测
中国检验检疫科学研究院

质量安全与检验检测

影响因子:0.399
ISSN:2096-8876
年,卷(期):2024.34(6)