脉动真空灭菌柜验证方案模板.pdfVIP

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脉动真空灭菌器（器具）验证方案

（模板）

目录

1基本情况·······························································3

1.1概述··································································3

1.2基本情况······························································3

1.3脉动真空灭菌器流程概述··············································3

1.4设备主要技术参数····················································3

1.5记录填写、偏差分析及变更控制········································4

2确认目的································································4

3确认范围································································4

4确认小组成员及职责····················································4

4.1职责··································································5

4.2培训··································································5

5风险评估·······························································6

6确认内容·······························································8

6.1验证前的准备工作····················································8

6.2设计确认·····························································9

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6.3安装确认10

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6.4运行确认11

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6.5性能确认12

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7拟订日常监测程序及再确认周期15

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8确认结果评定与结论