洗手消毒效果验证方案

洗手消毒效果验证方案 起 草 人： 起草日期： 审 核 人： 审核日期： 批 准 人： 批准日期： 验证小组会签 起草部门： 执行日期： 部门 颁发部门： [质量部] Copy №： [ ] 变更记载： 岗位 签名 签名日期 行政部[ ] 物供部[ ] 质量部QA[ ] 质量部QC[ ] 研发部[ ] 生技部[ ] 疫苗车间[ ] 分包装车间[ ] 工程部[ ] 保安部[ ] 营销部[ ] 财务部[ ] 变更原因及目的： 建立验证文件，并通过验证证明所验证对象有效、稳定、可靠。 修订号 批准日期 执行日期 00

目 录

验证方案·····································································································································3 1 概述·······································································································································3 2 目的·······································································································································3 3 职责·······································································································································3 4 验证方案及记录·····················································································································3 4.1 原理··································································································································3 4.2洗手效果试验·················································································································3 4.3形成的文件··················································································································4 5 验证周期·······························································································································4 附件 75%乙醇消毒剂消毒灭菌效果统计表

验证方案

1 概述

概述：我公司规定对手部进行浸泡时，将双手浸泡于盛有洗手液的洗手盆中，泡三分钟，或盛有75%乙醇消毒剂的手消毒器下（洗手所需消毒剂的量按400ml/人的量进行配制），洗手完毕后在烘手器下5～10cm烘干。

为了确认消毒效果，我们对其进行了验证，从而制订出《手部的清洗及消毒标准操作规程》。

2 验证目的

确认按照《手部的清洗及消毒标准操作规程》对手部进行消毒，能保证手部已被清洁消毒干净。

3 职责

验证实施小组：

（1）负责洗手消毒效果验证方案的起草； （2）负责洗手消毒效果验证方案的实施；

（3）负责洗手消毒效果验证过程记录的收集、整理； 验证领导小组：

（1）负责制订验证计划，并负责验证计划的组织与监督； （2）负责验证工作的协调；

（3）负责洗手消毒效果验证方案的审批； （4）负责洗手消毒效果验证数据及结果的审核； （5）负责洗手消毒效果验证报告的审批； （6）负责洗手消毒效果验证技术人员的培训； 4 方案内容 4.1 原理

利用化学试剂浸泡，使手部细菌蛋白质变性，从而达到灭菌的目的。 4.2 洗手效果试验

4.2.1 各选择三次按400ml/人的量进行配制的75％酒精，随机让车间的4个人分别洗手，洗手前、洗手后由QC分别对手指用蘸有生理盐水的棉签对手指进行擦拭取样。用10ml生理盐水洗涤棉签后，取1ml进行培养。可接受标准为：洗手后的生理盐水中

细菌数≤50个／ml。

4.3 形成的文件

《手部的清洗及消毒标准操作规程》 5 验证周期

正常情况下每年验证一次

时间： 次数 第一次 消毒后 结论 操作人 人员编号 消毒前 1 2 3 附件 75%乙醇消毒剂消毒灭菌效果统计表

4 复核人 时间： 次数 第二次 消毒后 结论 操作人 复核人 人员编号 消毒前 1 2 3 4 时间： 次数 第三次 消毒后 结论 操作人 复核人 人员编号 消毒前 1 2 3 4