洁净区空气净化系统验证方案.docx

洁净区空气净化系统验证方案
洁净区空气净化系统验证方案
洁净区空气净化系统验证方案
力邦制药 方案编号：
洁净区空气净化系统
验证方案
西安力邦制药有限公司
OO 三年
洁净区空气净化系统验证方案
洁净区空气净化系统验证方案
洁净区空气净化系统验证方案
验证目录
一、空气净化系统验证方案的制订、审核与批准 ··························3 1、方案制定 ·················································3 2、方案审核 ·················································3 3、方案批准 ·················································3 4、方案执行 ·················································3 5、验证小组成员 ···············································3
二、精烘包洁净区空气净化系统验证概述 ·······························5 1、设计要求 ·················································5 2、工艺要求 ·················································6 3、空气净化系统的构成（设计） ···································6
4、空调净化系统构成示意图 ······································7
5、精、烘、包工艺流程及环境区域划分示意图 ·························7
6、洁净室布局图 : ··············································7
7、人流物流示意图： ··········································7
三、安装确认（ Installation Qualification ） ································8 1、文件确认 ·················································8 2．空调系统安装确认 ··········································9
四、运行性能确认（ Operation Qualification ） ····························12
1、精、烘、包净化空调系统的验证 ·································12
2．测量器具一览表 ···········································13
3．精、烘、包各洁净室换气次数验证 ································15
4．精、烘、包洁净室尘埃粒子的验证 ································17
5．精、烘、包洁净室照度的验证 ···································19
6. 精、烘、包净化室空气压力验证 ································21
7. 精、烘、包各洁净室温湿度验证 ································23
8. 精、烘、包洁净室沉降菌验证 ·····································25
9．精、烘、包洁净室空调送风系统消毒验证 ····························28
······································30
11．净化空调系统的运行管理 ·······