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洗手消毒效果验证方案
起 草 人:
审 核 人:
批 准 人:
起草部门:
起草日期:
审核日期:
批准日期:
执行日期:
验证小组会签
部门
岗位
签名
签名日期
颁发部门: [质量部]
Copy №: [ ]
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[ ]
变更记载:
修订号 批准日期 执行日期
00
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。
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4
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