.
目 的
1 验证目的..........................................................................................4
2 适用围.............................................................................................4
3 编写依据..........................................................................................4
4 简述................................................................................................ 4
4.1 纯化水系统工艺流程设计..............................................................................4
4.2 纯化水的使用点..........................................................................................5
4.3 系统流程简图................................................................................ 6
5 验证职责与小组成员..........................................................................8
6 验证计划..........................................................................................8
7 培训确认..........................................................................................8
8 设计确认..........................................................................................9
8.1 目的..........................................................................................................9
8.2 检查记录....................................................................................................9
9 安装确认和运行确认........................................................................10
9.1 开箱检查和资料附件的确认........................................................................10
9.2公用工程安装确认......................................................................................10
9.3 纯化水系统各设备单元安装确认和运行确认..................................................10
10 纯化水系统性能确认......................................................................24
10.1 性能确认目的............................................................................24
10.2 纯化水验证计划......................................................................................24
10.2.1 取样方法.......................................................................................24
10.2.2 纯化水合格标准..............................................................................24
10.2.3 纯化水系统取样时间计划与频率.......................................................25
10.3 纯化水系统性能确认各阶段水质检验结果统计.............................................26
10.4 样品异常情况处理...................................................................................26
10.5 系统运行警戒指标...................................................................................26
10.6 系统运行指标趋势分析.............................................................................27
11 验证结果评价与建议......................................................................27
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