ISPE Good Practice Guide 供暖、通 风和 空调(HVAC)
目录
序言 ............................................................................4
致谢. ...........................................................................5
1 导言 ...................................................................... . 7
1.1 背景 ...................................................................................... 7
1.2 目的 ...................................................................................... 7
1.3 范围 ...................................................................................... 7
1.4 优势 ...................................................................................... 8
1.5 目标 ...................................................................................... 9
1.6 关键概念 .................................................................................. 9
1.7 结构 ..................................................................................... 17
2 设计过程 ................................................................... 19
2.1 一.导言 ................................................................................ . 19
2.2 开发用户需求 ............................................................................. 23
2.3 HVAC系统风险评估.......................................................................... 35
2.4 详细设计 ......................................................................... 程序设计40
3 设计注意事项 ............................................................... 45
3.1 导言. .................................................................................... 45
3.2 一般设计考虑因素.......................................................................... 45
3.3 按设施类型划分.................................................................... 的气流图50
3.4 活性药物成分（API）-（湿部）.............................................................. 50
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3.5 活性药物成分（API）-（干端）51..............................................................
3.6 生物制品 ................................................................................. 52
3.7 口服固体制剂（非强效化合物）.............................................................. 54
3.8 口服固体制剂（有效化合物）................................................................ 57
3.9 无菌处理设施 ............................................................................. 60
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页面2 ISPE良好实践指南：供
暖、通风和空调
3.10 包装/标签................................................................................. 65
3.11 实验室 ................................................................................... 66
3.12 取样/分发................................................................................. 70
3.13 行政及总务大楼............................................................................ 72
3.14 72号仓库....................................................................................
3.15 过程设备集成.............................................................................. 73
3.16 医疗器械 ................................................................................. 77
4 设计审查 ................................................................... 79
4.1 设计评审（设计鉴定）...................................................................... 79
4.2 设计审查过程 ............................................................................. 81
5 设备规范、鉴定、安装和操作 ....................................................87
5.1 设备规格 ................................................................................. 87
5.2 空气过滤 ................................................................................ 104
5.3 设备安装和启动 .......................................................................... 115
5.4 调试和鉴定 .............................................................................. 123
5.5 培训 .................................................................................... 125
5.6 设备操作与维护 .......................................................................... 126
5.7 备件 .................................................................................... 133
6 文件要求 .................................................................. 135
6.1 导言 .................................................................................. . 135
6.2 工程文档生命周期......................................................................... 135
6.3 维护和操作文件（非GMP）.................................................................. 136
6.4 主/记录文件 ............................................................................. 137
6.5 GMPHVAC文件 ............................................................................. 137
7 附录1-HVAC ........................................................ 基础知识141
7.1 导言 .................................................................................. . 142
7.2 什么是供暖、通风和空调？................................................................. 142
7.3 空气质量基础知识......................................................................... 147
7.4 Psychrometrics湿度计..................................................................... 154
8 附录2-HVAC应用和设备 ....................................................... 157
8.1 设备 .................................................................................... 158
8.2 HVAC系统配置 ............................................................................ 163
8.3 压力控制策略 ............................................................................ 169
8.4 通风策略176
8.5 HVAC控制和监控 .......................................................................... 180
9 附录3-温湿度计 ............................................................ 197
9.1 导言 .................................................................................. . 198
9.2 干球温度 ................................................................................ 199
9.3 湿球温度199
9.4 露点温度计 .............................................................................. 200
9.5 相对湿度（饱和度百分比）................................................................. 201
9.6 气压或总压力 ............................................................................ 201
9.7 比焓 .................................................................................... 202
9.8 第202卷.....................................................................................
9.9 湿度比或特定湿度......................................................................... 203
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ISPE良好实践指南：
供暖、通风和空调
页面3
9.10 蒸汽压力204
9.11 八个基本向量............................................................................. 204
9.12 系统映射 ................................................................................ 205