XXX区域HVAC及洁净室安装与运行确认验证方案IOQP（最全）.docVIP

文件名称FileName

XXX区域HVAC及洁净室安装与运行确认方案

InstallationandOperationalQualificationProtocol

forCleanHVACandCleanroomontheXXX

文件编号Doc.No.

版本Rev.

XXX000048

A

XXX区域HVAC及洁净室安装与运行确认方案

InstallationandOperationalQualificationProtocolfor

ClenaHVACandCleanroomontheXXX

（验证发起的原因是：初始验证）

（TriggeredBy:InitialValidation）

姓名PrintedName签名Signature日期

姓名

PrintedName

签名

Signature

日期(Date)(Y-M-D)

Department

起草人Author

审核人Reviewer

审核人Reviewer

审核人Reviewer

批准人Approver

注意：签字意味着方案的内容经过审阅并符XXX的要求。

Note：SignaturemeansthatthevalidationprotocolisreviewedandconformtorequirementsofXXX

文件名称FileName

XXX区域HVAC及洁净室安装与运行确认方案

InstallationandOperationalQualificationProtocol

forCleanHVACandCleanroomontheXXX

文件编号Doc.No.

版本Rev.

XXX000048

A

目录

TABLEOFCONTENT

1.0目的PURPOSE 3

2.0简述DESCRIPTION 3

3.0范围SCOPE 5

4.0职责RESPONSIBILITIES 8

4.1XXX职责ZhuorunMedical(Suzhou)Responsibilities 8

4缩写ABBREVITION 10

5参考资料REFERENCE 11

6培训TRAINING 12

7实施EXECUTION 12

8.1.先决条件确认PrerequisitesVerification 14

8.2.文件确认DocumentationVerification 16

8.3.测试用仪器仪表校准确认TestEquipmentCalibrationVerification 20

8.4.关键仪表确认InstrumentofEquipmentVerification 24

8.5.空调机组及其主要部件安装确认AHUMainComponentsandPrimaryMedium

FilterInstallationVerification 27

8.6.洁净房间安装检查CleanroomInstallationCheck 38

8.7.材质确认MaterialProofVerification 46

8.8.运行确认前提OQPrerequisites 48

8.9.送风口风量和换气次数测试AirVolumeandAirExchangeRatesVerification 50

8.10.房间压力测试RelativeRoomPressureDifferentialVerification 57

8.11.高效过滤器安装及完整性确认HEPAInstallationandFilterIntegrityVerification

62

8.12.房间温度和相对湿度测试TemperatureandRelativeHumidityTest 76

8.13.照度确认LightingLevelVerification 82

8.14.噪声测试NoiseLevelVerification 87

8.15.洁净室悬浮粒子测试Air