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消毒剂的消毒效果验证方案
目录
1.目的····································································································2·
2.范围····································································································2·
3.参考文件······························································································2·
4.职责····································································································2·
5.验证计划······························································································2·
6.验证内容······························································································2·
7.验证实施······························································································2·
8.验证周期······························································································4·
9.验证结论······························································································4·
1
1.目的
通过对消毒剂的选择及消毒效果进行验证，以确定消毒剂的消毒效果和更换
周期，使消毒效果始终保持有效性和稳定性。
2.范围
本方案适用于洁净车间、检验室无菌操作人员用于手部消毒的消毒剂型。
3.参考文件
3.1.GB15979-2002消毒与灭菌效果的评价方法与标准。
3.2.《中国药典》2020年版四部通则1105非无菌产品微生物限度检查：微生物计数
法。
4.职责
4.1.管理者代表：负责验证方案和报告的批准。
4.2.质量部负责人：负责验证方案的审核，协调验证过程，保证验证顺利完成，对验
证进行总结和评价。
4.3.生产员：负责方案的实施。
4.4.检验员：负责验证方案起草，质量控制和检测，出具相关记录和报告，验证用耗
材、试剂、表单等的准备工作。
5.验证计划
5.1.75%酒精溶液消毒效果确认，实施日期：XXXX年XX月XX日-XXXX年XX月XX日。
5.2.0.2%新洁尔灭溶液消毒效果确认，实施日期：XXXX年XX月XX日-XXXX年XX月
XX日。
6.验证内容
6.1.75%酒精溶液消毒后手部细菌数；
6.2.0.2%新洁尔灭溶液消毒后手部细菌数。
7.验证实施
7.1.验证前准备工作
操作人员按照洁净区7步洗手法将手洗干净，再将手烘干后取样；再使用喷壶喷出消
2
毒液，双手均匀搓开，晾干后再次取样。
7.1.1.检验器具、试剂：立式压力蒸汽灭菌器、生化培养箱、可调移液器、微生物
限度过滤系统、微孔过滤膜(0.45μm)、培养皿、培养基、PBS缓冲液。
7.1.2.实验用品准备
培养基的配制：见《培养基配制记录》
实验用品处理：将微生物限度仪泵头、移液枪头、镊子，放入不锈钢灭菌盒或用牛
皮纸包扎好。与洁净服一起放入灭
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