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。
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.