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疫苗生产环境用消毒剂的效果验证

  • 王石全 严东珍 江莉
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  • 610023 成都生物制品研究所有限责任公司质量检定室

网络出版日期: 2025-08-16

Validation for disinfection effect of disinfectants on vaccine production environment

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  • Quality Control Department, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China

Online published: 2025-08-16

摘要

 目的   对疫苗生产环境中使用的4种消毒剂的消毒效果进行验证。方法   配制0.5%硫代硫酸钠+2.0%吐温80+0.2%卵磷脂复方中和剂,并对其进行鉴定。用爱尔施、洗必泰、过氧乙酸、百毒杀对金黄色葡萄球菌、大肠埃希菌、枯草杆菌黑色变种芽胞和白念珠菌4种标准菌株进行定量悬液杀灭试验,细菌和霉菌的杀灭对数值分别≥5.00和≥4.00判为有效。结合环境监测所获得的菌型,选取环境中的常见菌进行不锈钢板载体菌杀灭试验,细菌杀灭对数值≥3.00判为有效。 结果   复方中和剂能有效中和消毒剂的杀菌作用。4种消毒剂对标准菌株的定量悬液杀灭试验均达到可接受标准,细菌杀灭对数值为5.11~8.32,霉菌杀灭对数值为4.05~7.32。环境监测所获得的环境菌主要为莱拉/藤黄微球菌、蜡样芽孢杆菌、人葡萄球菌和沃氏葡萄球菌。4种消毒剂对环境常见菌能起到很好的杀灭作用,杀灭对数值为4.89~6.37。 结论   爱尔施、洗必泰、过氧乙酸、百毒杀4种消毒剂的消毒效果达到了验证要求,能用于疫苗生产环境消毒。

本文引用格式

王石全 严东珍 江莉 . 疫苗生产环境用消毒剂的效果验证[J]. 国际生物制品学杂志, 2016 , 39(6) : 285 -288 . DOI: 10.3760/cma.j.issn.1673-4211.2016.06.006

Abstract

Objective  To validate disinfection effect of AIERSHI, Chlorhexidine, Peracetic acid, Baidusha used in vaccine production environment.  Methods   Neutralizer containing 0.5% sodium thiosulfate solution, 2.0% Tween 80 and 0.2% lecithin was prepared and  identified. Suspension quantitative germicidal test of the 4 disinfectants was performed against Staphylococcus aureus, Escherichia coli, Bacillus subtilis var. niger and Candida albicans. The disinfectants were consided effective when killing logarithm values of bacteria and fungi were ≥5.00 and ≥4.00, respectively. The common microorganisms in the manufacturing process were chosen and smeared on stainless steel plate. The disinfectants were effective when the killing logarithm value ≥3.00.   Results   The compound neutralizer effectively neutralized killing effect of the disinfectants. Suspension quantitative germicidal test showed that 4 disinfectants reached the acceptable standards. Killing logarithm values of bacteria and fungi were 5.11- 8.32 and 4.05-7.32, respectively. Micrococcus luteus/lylae, Bacillus cereus, Staphylococcus hominis, and Staphylococcus warneri were the environment microorganisms. Four disinfectants effectively killed the microorganisms. Killing logarithm value was 4.89-6.37.   Conclusions    AIERSHI, Chlorhexidine, Peracetic acid, Baidusha meet the validation requirements of disinfection effect. They can be used for disinfection in vaccine production environment.
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