新QC空调系验证方案.docVIP

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 Location 1189号酶标楼3楼 供 应 商 Manufacture 目录Content TOC \o 1-3 \h \z \u HYPERLINK \l _Toc236128080 1、目的 Purpose PAGEREF _Toc236128080 \h 3 HYPERLINK \l _Toc236128081 2、范围 Range PAGEREF _Toc236128081 \h 3 HYPERLINK \l _Toc236128082 3、设备描述 Description of System PAGEREF _Toc236128082 \h 3 HYPERLINK \l _Toc236128083 4、职责Responsibility PAGEREF _Toc236128083 \h 5 HYPERLINK \l _Toc236128084 5、参考文件Reference PAGEREF _Toc236128084 \h 5 HYPERLINK \l _Toc236128085 6、原理和测试总结Test principle and test conclusion PAGEREF _Toc236128085 \h 6 HYPERLINK \l _Toc236128086 6.1. 安装确认（IQ）Installation Qualification PAGEREF _Toc236128086 \h 6 HYPERLINK \l _Toc236128087 6.1.1. IQP的培训及文件资料确认 Qualification of IQP training and documents PAGEREF _Toc236128087 \h 6 HYPERLINK \l _Toc236128088 6.1.2. 主要部件确认Qualification of main parts PAGEREF _Toc236128088 \h 9 HYPERLINK \l _Toc236128089 6.1.3. 设备配套的关键仪表确认Qualification of assembled key instruments PAGEREF _Toc236128089 \h 11 HYPERLINK \l _Toc236128090 6.1.4. 检测用仪表确认Qualification of instrument for testing PAGEREF _Toc236128090 \h 12 HYPERLINK \l _Toc236128091 6.1.5. 公用、安全、环境等支持系统确认Qualification of support systems PAGEREF _Toc236128091 \h 13 HYPERLINK \l _Toc236128092 6.1.6. 风管和空调机组清洁确认Qualification of pipeline/air conditioner cleaning PAGEREF _Toc236128092 \h 15 HYPERLINK \l _Toc236128093 6.1.7. 高效过滤器检漏Qualification of HEPA test PAGEREF _Toc236128093 \h 16 HYPERLINK \l _Toc236128094 6.1.8. 安装确认（IQ）完成报告Installation qualification accomplish report PAGEREF _Toc236128094 \h 18 HYPERLINK \l _Toc236128112 7、可接受标准 Acceptable criterion PAGEREF _Toc236128112 \h 39 HYPERLINK \l _Toc236128113 8、偏差报告 Deviation report PAGEREF _Toc236128113 \h 39 HYPERLINK \l _Toc236128114 9、支持性文件 Supporting document P