臭氧消毒.压缩空气.空调净化三个系统的验证方案

臭氧消毒.压缩空气.空调净化三个系统的验证方案,请大家参考

臭氧消毒系统

目 录
1.系统基本情况.................................................... 4
1.1 概述..........................................................4
1.2 基本情况......................................................4
1.3 维修服务......................................................4
2.验证目的........................................................ 4
3.验证范围........................................................ 5
4.验证机构组成.................................................... 5
4.1 验证委员会组成................................................5
4.2 验证小组成员..................................................5
5.职责............................................................ 6
5.1 验证委员会....................................................6
5.2 验证小组......................................................6
5.3 生产部........................................................6
5.4 工程部........................................................6
5.5 品质部........................................................7
6.验证方案的起草与审批............................................ 7
6.1 验证方案的起草................................................7
6.2 验证方案的审批................................................7
7.进度计划........................................................ 7
8.验证............................................................ 8
8.1安装确认..................................................... 8
8.1.1 安装确认的目的..............................................8
8.1.2 安装确认的原理..............................................8
8.1.3 文件资料....................................................8
8.1.4 风管清洁的确认..............................................9
8.1.5 风管漏风检测................................................9
8.1.6 安装确认的内容..............................................9
8.1.7 安装确认的方法..............................................9
8.1.8 可接受标准..................................................9
8.1.9 异常情况的处理..............................................9
8.1.10 起草标准操作程序..........................................10
8.1.11 结果与评定................................................10
8.2运行确认.................................................... 10
8.2.1 运行确认的目的.............................................10
8.2.2 运行确认的原理.............................................10
8.2.3 验证所需的仪器仪表.........................................11
广东##公司验证文件
臭氧消毒系统验证方案
第 3 页 共 30 页
8.2.4 运行确认的内容.............................................11
8.2.5 运行确认的方法.............................................11
8.2.6 可接受标准.................................................11
8.2.7 异常情况的处理.............................................11
8.2.8 结果与评定.................................................12
8.3性能确认.................................................... 12
8.3.1 性能确认的目的.............................................12
8.3.2 性能确认的原理.............................................12
8.3.3 性能确认的内容.............................................12
8.3.4 性能验证的周期.............................................12
8.3.5 监测方法...................................................12
8.3.6 性能确认的方法.............................................13
8.3.7 可接受标准.................................................13
8.3.8 异常情况的处理.............................................13
8.3.9 拟订日常监测程序及验证周期.................................13
8.3.10 结果与评定................................................13
9.验证结果及分析................................................. 14
10.附件.......................................................... 14
附件1: ..........................................................15
附件2： .........................................................16
附件3： .........................................................17
附件4: ..........................................................18
附件5: ..........................................................19
附件6: ..........................................................20
附件7： .........................................................21
附件8： .........................................................24
附件9： .........................................................26
附件10： ........................................................30

系 统 验 证 方 案目 录
1.设备基本情况.................................................... 4
2.验证目的........................................................ 4
3.验证范围........................................................ 4
4.验证机构组成.................................................... 4
4.1 验证委员会组成................................................4
4.2 验证小组成员..................................................5
5.职责............................................................ 5
5.1 验证委员会....................................................5
5.2 验证小组......................................................5
5.3 生产部........................................................5
5.4 工程部........................................................6
5.5 品质部........................................................6
6.验证方案的起草与审批............................................ 6
6.1 验证方案的起草................................................6
6.2 验证方案的审批................................................6
7.进度计划........................................................ 7
8.验证............................................................ 7
8.1安装确认..................................................... 7
8.1.1 安装确认的目的..............................................7
8.1.2 安装确认的原理..............................................7
8.1.3 文件资料....................................................8
8.1.4 关键性仪表..................................................8
8.1.5 过滤器完整性确认............................................8
8.1.6 管路试压....................................................8
8.1.7 管路的吹扫..................................................9
8.1.8 安装确认的内容..............................................9
8.1.9 安装确认的方法..............................................9
8.1.10 可接受标准.................................................9
8.1.11 异常情况的处理.............................................9
8.1.12 起草标准操作程序...........................................9
8.1.13 结果与评定................................................10
8.2 运行确认.....................................................10
8.2.1 运行确认的目的.............................................10
8.2.2 运行确认的原理.............................................10
8.2.3 验证所需的仪器仪表.........................................10
广东##公司验证文件
压缩空气系统验证方案
第 3 页 共 40 页
8.2.4 运行确认的内容.............................................11
8.2.5 运行确认的方法.............................................11
8.2.6 可接受标准.................................................11
8.2.7 异常情况的处理.............................................11
8.2.8 结果与评定.................................................11
8.3性能确认.................................................... 12
8.3.1 性能确认的目的.............................................12
8.3.2 性能确认的原理.............................................12
8.3.3 性能确认的内容.............................................12
8.3.4 性能验证的周期.............................................12
8.3.5 监测方法...................................................12
8.3.6 性能确认的方法.............................................12
8.3.7 可接受标准.................................................12
8.3.8 异常情况的处理.............................................13
8.3.9 拟订日常监测程序及验证周期.................................13
8.3.10 结果与评定................................................13
9.验证结果及分析................................................. 13
10.附件.......................................................... 14
附件1: ..........................................................15
附件2： .........................................................16
附件3： .........................................................17
附件4： .........................................................19
附件5： .........................................................20
附件6： .........................................................22
附件7: ..........................................................23
附件8： .........................................................24
附件9： .........................................................25
附件10： ........................................................26
附件11： ........................................................28
附件12： ........................................................37
附件13： ........................................................38
附件14： ........................................................40