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

二OO三年

洁净区空气净化系统验证方案 第 2 页 共36页

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 10.生测室空气净化系统的验证 ········································································· 30 11．净化空调系统的运行管理 ·········································································· 34 五、验 证 报 告 ····························································································· 35

洁净区空气净化系统验证方案 第 3 页 共36页

一、空气净化系统验证方案的制订、

审核与批准

1、方案制定

签 名 2、方案审核

职 务 部 门 签 名 3、方案批准

职 务 部 门 审批意见： 审批人 4、方案执行

职务 批准日期 年 月 日 实施部门：工程部、质量部、生产部 执行日期： 年 月 日

洁净区空气净化系统验证方案 第 4 页 共36页

5、验证小组成员

组 长 签 名 成 员 职 务 部门