安装确认和运行确认方案 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL

设备名称 Equipment Name 层流车 设备编码 Equipment ID 生产线 Production line 建筑楼 Building No Prepared by 起草 Title 职务 Name 姓名 Signature 签字 Date

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生产 Production

Reviewed by 审核 Title 职务 Name 姓名 Signature 签字 Date

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工程 Engineering 生产 Manufacturing 验证 Validation 质量 QA

Approved by 批准 Title 职务 Name 姓名 Signature 签字 Date

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质量管理负责人 QP 修订历史纪录 Revision History

Revision 版本 Revision Date 修订日期 Reason for Revision/Change Request 修订/更改要求的原因 Revised By 修订人

01 TABLE OF CONTENTS 目录

1. 目的OBJECTIVE ............................................................................................................................ 6 2. 确认范围QUALIFICATION SCOPE ................................................................................................ 6 3. 系统描述SYSTEM DESCRIPTION ................................................................................................ 6 4. 部门职责DEPARTMENTAL RESPONSIBILITIES.......................................................................... 7 4.1验证VALIDATION ...................................................................................................................... 7 4.2工程ENGINEERING .................................................................................................................. 7 4.3生产PRODUCTION ................................................................................................................... 7 4.4质量保证 QUALITY ASSURANCES (QA) ................................................................................ 7 4.5质量管理负责人QUALIFIED PERSON （QP）......................................................................... 8 5. 接受标准ACCEPTANCE CRITERIA .............................................................................................. 8 6. 总结报告SUMMARY REPORT RESULTS ..................................................................................... 8 7. 实施和文件要求IMPLEMENT AND DOCUMENTATION REQUIREMENTS ................................. 8 8. 培训确认/签名表PRE-QUALIFICATION TRAINING VERIFICATION/SIGNATURE LOG ............. 8 9. 检测仪器校准情况确认TEST INSTRUMENT CALIBRATION VERIFICATION ............................ 10 10. 安装确认INSTALLATION QUALIFICATION ................................................................................. 10 10.1标牌及各部件安装确认NAME PLATE DATA AND INSTALLATION QUALIFICATION ........ 11 10.2 推荐润滑油确认RECOMMENDED LUBRICANTS VERIFICATION ..................................... 13 10.3 预防性维护程序确认PREVENTATIVE MAINTENANCE PROGRAM VERIFICATION ........ 14 10.4设备/系统文件SYSTEM DOCUMENTATION ........................................................................ 15 11. OQ许可审批APPROVAL TO PROCEED WITH OQ .................................................................... 16 12. 运行确认OPERATIONAL QUALIFICATION ................................................................................. 17 12.1 标准操作程序确认STANDARD OPERATING PROCEDURE VERIFICATION .................... 17 12.2培训确认TRAINING VERIFICATION ..................................................................................... 18 12.3关键仪器校准确认CRITICAL INSTRUMENTATION CALIBRATION VERIFICATION .......... 19 12.4系统功能测试SYSTEM FUNCTIONAL TESTING ................................................................. 20 12.4.1 功能测试 - UPS续航能力确认 FUNCTIONAL TESTING –UPS ENDURANCE ABILITY CONFIRMATION 21

12.4.2 功能测试-层流风机无级调速确认 FUNCTIONAL TESTING –CHECK OF LAMINAR FLOW FAN SPEED REGULATION 22

12.4.3功能测试-层流风速检测 FUNCTIONAL TESTING – LAMINAR AIR FLOW VELOCITY TEST .... 23 12.4.4功能测试--压差检查FUNCTIONAL TESTING –CHECK OF DIFFERENTIAL PRESSURE ............ 25 12.4.5 功能测试-层流高效过滤器完整性测试 FUNCTIONAL TESTING –LAMINAR FLOW HIGH EFFICIENCY FILTER INTEGRITY TEST ........................................................................................................................ 26

12.4.6功能测试-静态层流流型测试 FUNCTIONAL TESTING –STATIC LAMINAR FLOW PATTERN TEST 27

12.4.7 功能测试-静态尘埃粒子测试 FUNCTIONAL TESTING –STATIC STATE PARTICLES TEST .... 28 13. 确认接受标准总结QUALIFICATION ACCEPTANCE CRITERIA SUMMARY .............................. 29 14. 方案修改PROTOCOL MODIFICATIONS ..................................................................................... 30 15. 方案偏差PROTOCOL DEVIATIONS ............................................................................................ 30 16. 参考文件REFERENCES .............................................................................................................. 30 17. 附件ATTACHMENTS ................................................................................................................... 31