消毒剂的消毒效果验证方案.pdfVIP

博学之，审问之，慎思之，明辨之，笃行之。——《礼记》

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

博学之，审问之，慎思之，明辨之，笃行之。——《礼记》

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.