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STPYZSWCJF型净化工作台验证方案
SW-CJ-1F净化工作台验证方案
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: 颁发部门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···································································································································2 目的···································································································································
3 职责···································································································································
4 内容···································································································································3
4.1 预确认·······················································································································4.2 安装确认·······························································································3
4.3 运行确认···················································································································
4.4 性能确认···················································································································4.4.1 目的·······················································································································4
4.4.2 可接受标准···········································································································4
4.4.3 静态尘埃粒子检测·······························································································4
4.4.4 静态沉降菌检测···································································································4
5 日常监控···············································
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