1 总则······7
2 术语······8
3 生产区域的环境参数······11
3.1 一般规定······11
3.2 环境参数的设计要求······11
4 厂址选择和总平面布置······13
4.1 厂址选择······13
4.2 总平面布置······13
5 工艺设计······15
5.1 工艺布局······15
5.2 人员净化······18
5.3 物料净化······20
5.4 工艺用水······20
6 工艺管道······22
6.1 一般规定······22
6.2 管道材料、阀门和附件······22
6.3 管道的安装、保温······23
6.4 安全技术······24
7 设备······25
7.1 一般规定······25
7.2 设计和选用······26
8 建筑······28
8.1 一般规定······28
8.2 防火和疏散······28
8.3 室内装修······30
9 空气净化······32
9.1 一般规定······32
9.2 净化空气调节系统······32
9.3 气流流型和送风量······37
9.4 风管和附件······39
9.5 监测与控制······40
9.6 青霉素等药品生产洁净室的特殊要求······41
10 给水排水······42
10.1 一般规定······42
10.2 给水······42
10.3 排水······43
10.4 消防设施······43
11 电气······45
11.1 配电······45
11.2 照明······46
11.3 通信······46
11.4 静电防护及接地······47
附录A 药品生产环境的空气洁净度等级举例······49
附录B 医药洁净室(区)的维护管理······52
附录C 医药洁净室(区)的验证······54
本规范用词说明······56
