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002直接口服饮片车间HVAC系统验证方案含风险评估有报.doc
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002直接口服饮片车间HVAC系统验证方案含风险评估有报.doc
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编号:Q/MLK·SOP·YZsb·002
设备确认
页号:1/57
版本号:00
贵州苗立克
综合饮片车间 HVAC 系
统验证方案
生效日期:
年 月 日
颁发部门:质量管理部
分发部门:生产部、工程部、质量
管理部、综合饮片车间
制定人:梁昌遇 日期: 年 月
日
审核人:张荣勋 日期: 年 月
日
审核人:黄鸿 日期: 年 月
日
批准人:杨立志 日期: 年 月
日
目录
一、验证总览 .................................................................................................................................................6
1. 概述 .............................................................................................................................................................6
1.1 系统描述 ................................................................................................................................................6
1.1.1 场所位置 .............................................................................................................................................6
1.1.2 HVAC 系统的设计和布局................................................................................................................6
1.1.2.1 HVAC 系统的设计 .........................................................................................................................6
1.1.2.2 HVAC 系统的布局 .........................................................................................................................7
1.1.3 评估及验证内容 ...................................................................................................................................7
1.1.3.1 评估 .....................................................................................................................................................7
1.1.3.1.1 影响评估 .........................................................................................................................................7
1.1.3.1.2 风险评估 .........................................................................................................................................7
1.3 系统功能规格 ......................................................................................................................................10
1.4 硬件规格 ..............................................................................................................................................10
1.4.1 空调机组规格 ...................................................................................................................................10
1.4.2 滤器规格 ..........................................................................................................................................10
1.5 验证背景 .................................................................................................................................................10
2. 验证小组 ..................................................................................................................................................11
3. 验证计划 ..................................................................................................................................................11
![](https://csdnimg.cn/release/download_crawler_static/85984445/bg2.jpg)
编号:Q/MLK·SOP·YZsb·002
设备确认
页号:2/57
版本号:00
贵州苗立克
综合饮片车间 HVAC 系
统验证方案
生效日期:
年 月 日
4. 验证活动 ..................................................................................................................................................12
5. 再测试.......................................................................................................................................................12
6. 验收标准 ..................................................................................................................................................12
7. 偏差和不符合性 ......................................................................................................................................12
8. 数据处理 ..................................................................................................................................................12
8.1 HVAC 系统新回风比测试 .................................................................................................................12
8.2 换气次数的测试 ..................................................................................................................................13
8.3 洁净室静压差测试..............................................................................................................................13
8.4 洁净度测试 ..........................................................................................................................................13
8.5 微生物测试 ..........................................................................................................................................13
9. 验证报告 ..................................................................................................................................................13
二、安装确认 IQ .........................................................................................................................................13
1. 目的 ...........................................................................................................................................................13
2. 文件资料确认 ..........................................................................................................................................14
3.安装确认 ....................................................................................................................................................14
3.1 空气处理机组安装确认 ........................................................................................................................14
3.1.1 测试目的 ..............................................................................................................................................14
3.1.2 测试条件 .............................................................................................................................................14
3.1.3 测试程序 ..............................................................................................................................................14
3.1.4 验收标准 ..............................................................................................................................................15
3.2 排风机安装确认 ..................................................................................................................................15
3.2.1 测试目的 ............................................................................................................................................15
3.2.2 测试条件 .........................................................................................................................................15
3.2.3 测试程序 .........................................................................................................................................15
3.2.4 验收标准 ...........................................................................................................................................15
3.3 送/回/排风管安装确认..........................................................................................................................16
3.3.1 测试目的 ..............................................................................................................................................16
3.3.2 测试条件 ..............................................................................................................................................16
3.3.3 测试程序 ..............................................................................................................................................16
3.3.4 验收标准 ..............................................................................................................................................16
3.4 阀组附录安装确认..............................................................................................................................16
![](https://csdnimg.cn/release/download_crawler_static/85984445/bg3.jpg)
编号:Q/MLK·SOP·YZsb·002
设备确认
页号:3/57
版本号:00
贵州苗立克
综合饮片车间 HVAC 系
统验证方案
生效日期:
年 月 日
3.4.1 测试目的 ..............................................................................................................................................16
3.4.2 测试条件 ..............................................................................................................................................16
3.4.3 测试程序 ..............................................................................................................................................16
3.4.4 验收标准 ..............................................................................................................................................17
3.5 HEPA 安装确认...................................................................................................................................17
3.5.1 测试目的 ..............................................................................................................................................17
3.5.2 测试条件 ..............................................................................................................................................17
3.5.3 测试程序 ..............................................................................................................................................17
3.5.4 验收标准 ..............................................................................................................................................17
3.6 仪器仪表安装确认..............................................................................................................................17
3.6.1 测试目的 ..............................................................................................................................................17
3.6.2 测试条件 ..............................................................................................................................................17
3.6.3 测试程序 ..............................................................................................................................................17
3.6.4 验收标准 ..............................................................................................................................................18
三、运行确认 OQ ........................................................................................................................................18
1. 目的 ...........................................................................................................................................................18
2. 文件资料确认 ..........................................................................................................................................18
3. 验证用仪器、仪表清单 .........................................................................................................................18
4. 运行确认 OQ ...........................................................................................................................................18
4.1 风机转向确认 ......................................................................................................................................18
4.1.1 测试目的 ..............................................................................................................................................18
4.1.2 测试条件 ..............................................................................................................................................19
4.1.3 测试程序 ..............................................................................................................................................19
4.1.4 验收标准 ..............................................................................................................................................19
4.2.2 测试条件 ..............................................................................................................................................19
4.2.3 测试程序 ..............................................................................................................................................19
4.2.4 验收标准 ..............................................................................................................................................19
4.3 HVAC 系统风量测试 ............................................................................................................................19
4.3.1 测试目的 ..............................................................................................................................................19
4.3.2 测试条件 ..............................................................................................................................................19
4.3.3 测试程序 ..............................................................................................................................................19
![](https://csdnimg.cn/release/download_crawler_static/85984445/bg4.jpg)
编号:Q/MLK·SOP·YZsb·002
设备确认
页号:4/57
版本号:00
贵州苗立克
综合饮片车间 HVAC 系
统验证方案
生效日期:
年 月 日
4.3.4 验收标准 ..............................................................................................................................................20
4.4 换气次数测试.........................................................................................................................................20
4.4.1 测试目的 ..............................................................................................................................................20
4.4.2 测试条件 ..............................................................................................................................................20
4.4.3 测试程序 ..............................................................................................................................................20
4.4.4 验收标准 ..............................................................................................................................................20
4.5 洁净室静压差测试 ................................................................................................................................21
4.5.1 测试目的 ..............................................................................................................................................21
4.5.2 测试条件 ..............................................................................................................................................21
4.5.3 测试程序 ..............................................................................................................................................21
4.5.4 验收标准 ..............................................................................................................................................21
4.6 洁净室温湿度测试 ................................................................................................................................21
4.6.1 测试目的 ..............................................................................................................................................21
4.6.2 测试条件 ..............................................................................................................................................21
4.6.3 测试程序 ..............................................................................................................................................21
4.6.4 验收标准 ...........................................................................................................................................22
4.7 洁净室自净时间测试 .............................................................................................................................22
4.7.1 测试目的 .............................................................................................................................................22
4.7.2 测试条件 .............................................................................................................................................22
4.7.3 测试程序 .............................................................................................................................................22
4.7.4 验收标准 .............................................................................................................................................22
四、性能确认 PQ.........................................................................................................................................22
1. 目的 ...........................................................................................................................................................22
2. 文件资料确认 ..........................................................................................................................................23
3. 验证用仪器、仪表清单 .........................................................................................................................23
4. 性能确认 PQ ............................................................................................................................................23
4.1 洁净室洁净度测试..............................................................................................................................23
4.1.1 测试目的 ..............................................................................................................................................23
4.1.2 测试条件 ..............................................................................................................................................23
4.1.3 测试程序 ..............................................................................................................................................23
4.1.4 验收标准 ..............................................................................................................................................24
![](https://csdnimg.cn/release/download_crawler_static/85984445/bg5.jpg)
编号:Q/MLK·SOP·YZsb·002
设备确认
页号:5/57
版本号:00
贵州苗立克
综合饮片车间 HVAC 系
统验证方案
生效日期:
年 月 日
4.2 洁净室沉降菌测试..............................................................................................................................24
4.2.1 测试目的 ..............................................................................................................................................24
4.2.2 测试条件 ..............................................................................................................................................24
4.2.4 测试程序 ...........................................................................................................................................24
4.2.5 验收标准 ...........................................................................................................................................25
五、附录清单 ...............................................................................................................................................25
附录 10 文件资料确认 ...........................................................................................................................30
附录 11 空气处理机组安装确认 ..........................................................................................................31
附录 12 排风机安装确认 .......................................................................................................................32
附录 13 送/回/排风管安装确认 ...............................................................................................................33
附录 14 阀组附件安装确认......................................................................................................................34
附录 15 HEPA 安装确认...........................................................................................................................37
附录 16 仪器仪表安装确认......................................................................................................................40
附录 17 文件资料确认(OQ) ................................................................................................................42
附录 18 验证用仪器仪表清单..................................................................................................................43
附录 19 风机转向确认 ..............................................................................................................................44
附录 20 高效过滤器检漏测试 .....................................................................................................................45
附录 21 HVAC 系统新回风比测试 .........................................................................................................48
附录 22 洁净室换气次数测试..................................................................................................................49
附录 22-1 风速风量测试记录.......................................................................................................................52
附录 23 洁净室静压差测试........................................................................................................................55
附录 24 洁净室温湿度测试......................................................................................................................57
附录 25 洁净室自净时间测试 ...................................................................................................................60
附录 26 文件资料确认 ..............................................................................................................................61
附录 27 验证用仪器仪表清单..................................................................................................................62
附录 28 洁净室沉降菌测试布置图 .........................................................................................................63
附录 29 洁净室洁净度测试......................................................................................................................64
附录 30 洁净室沉降菌测试布置图 .........................................................................................................67
附录 31 洁净室沉降菌测试 ........................................................................................................................68
附录 32 补充记录.......................................................................................................................................72
附录 33 偏差和不符合性调查报告 .........................................................................................................73
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