方案批准Protocol approval签名Signature日期Date起 草 人Written by工程审核Reviewed by EN QA 审 核Reviewed by QA QA经理批准Approved by QA manager 设备信息Equipment information设备名称Equipment name 空调净化系统HVAC system 型号 Model 无菌室阳性对照室微生物限度室安装地点Location1189 号酶标楼 3 楼供 应 商 Manufacture目录 Content 1、目的Purpose .......................................................................................................................... 32、范围Range ............................................................................................................................. 33、设备描述Description of System ............................................................................................. 34、职责 Responsibility .................................................................................................................. 75、参考文件Reference ................................................................................................................ 86、原理和测试总结Test principle and test conclusion ................................................................. 96.1. 安装确认（ IQ）Installation Qualification ................................................................ 96.1.1. IQP 的培训及文件资料确认Qualification of IQP training and documents9 6.1.2. 主要部件确认Qualification of main parts ...................................................... 11 6.1.3. 设备配套的关键仪表确认Qualification of assembled key instruments ......... 12 6.1.4. 检测用仪表确认Qualification of instrument for testing ................................. 13 6.1.5. 公用、安全、环境等支持系统确认Qualification of support systems ............ 14 6.1.6. 风 管 和 空 调 机 组 清 洁 确 认Qualification of pipeline/air conditioner cleaning 16 6.1.7. 高效过滤器检漏Qualification of HEPA test ................................................... ...
