疫苗生产环境用消毒剂的效果验证

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.

Validation for disinfection effect of disinfectants on vaccine production environment

Objective To validate the disinfection effect of AIERSHI,Chlorhexidine,peracetic acid,and 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 considered 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 was ≥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,and Baidusha meet the validation requirements of disinfection effect.They can be used for disinfection in vaccine production environment.