hvac空调系统验证

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1、OPERATIONALQUALIFICATION运行确认HVACSYSTEMHVAC系统CODE/代码REVISION/修订PAGE/页码H3-VD-10495OQ0140of40OPERATIONALQUALIFICATIONPROTOCOL运行确认方案INSTALLATION:ZHEJIANGHISUNJIAOJIANGTAIZHOUCHINAASEPTICSTERILIZEINSTALLATIONPROJECT安装：中国xx药业椒江无菌灭菌设施安装项目SYSTEM:HVACSYSTEM系统：HVAC系统OPERATIONALQ

2、UALIFICATION运行确认HVACSYSTEMHVAC系统CODE/代码REVISION/修订PAGE/页码H3-VD-10495OQ0140of40PROTOCOLRESPONSIBILITYSIGNATURES方案职责签字PREPAREDBY编制POSITION/DEPARTAMENT职位/部门SIGNATURE签字DATE日期Validationengineer验证工程师REVIEWEDBY审核POSITION/DEPARTAMENT职位/部门SIGNATURE签字DATE日期QualityTechnician质量工程师

3、HISUN海正药业REVIEWEDBY审核POSITION/DEPARTAMENT职位/部门SIGNATURE签名DATE日期ValidationDepartment验证部BusinessDepartment事业部EngineeringDepartment工程部CenterOfMeasurment计量中心QualityAssuranceQAAPPROVEDBY批准POSITION/DEPARTAMENT职位/部门SIGNATURE签名DATE日期QualityDirector质量负责人OPERATIONALQUALIFICATION

4、运行确认HVACSYSTEMHVAC系统CODE/代码REVISION/修订PAGE/页码H3-VD-10495OQ0140of40REVISIONHISTORY修订记录RevisionNumber修订编号IssueDate发布日期ReasonforChange变更原因00Oct.26th.20112011年10月26日InitialDocument原始文件01March.10th.20122012年03月10日Splitbysystem按系统分开OPERATIONALQUALIFICATION运行确认HVACSYSTEMHVAC系

5、统CODE/代码REVISION/修订PAGE/页码H3-VD-10495OQ0140of40TABLEOFCONTENTS目录1PURPOSE目的62SCOPE范围63SYSTEMDESCRIPTION系统描述64RESPONSIBILITIES职责64.1TPRO/SVS64.2HISUN海正药业75REFERENCEDOCUMENTATION参考文件86QUALIFICATIONPROCEDURE确认程序86.1QUALIFICATIONSTRATEGY确认策略86.2TESTRESULTS测试结果97TESTS测试97.1P

6、RELIMINARYTEST初步测试107.2SYSTEMSTART-UP/SHUT-DOWNANDOPERATINGFUNCTIONSVERIFICATIONMATRIX系统开启关闭和运行功能确认矩阵127.3INSTALLEDFILTERSYSTEMLEAKAGETEST过滤器系统泄漏测试147.4SUPPLYAIRFLOWTESTANDAIRCHANGERATECALCULATION送风气流测试与换气率计算177.5AIRPRESSUREDIFFERENCETEST空气压差测试207.6AIRBORNEPARTICLECOUN

7、T空气颗粒计数227.7RECOVERYTEST恢复测试27THEREQUIREDTIMETORECOVERTHE‘ATREST’ROOMCLEANLINESSGRADEISNOTGREATERTHAN20MINUTES.恢复至‘静态’房间洁净度等级所需的时间不超过20分钟。287.8SOUNDLEVELDETERMINATION声级测定307.9TEMPERATUREANDHUMIDITYUNIFORMITYTESTS温度与湿度均匀性测试328QUALIFICATIONREPORT认证报告348.1INSTRUMENTS仪表348

8、.2PROTOCOLDEVIATIONS方案偏离358.3NONCONFORMITIESMANAGEMENT不合格项管理358.4QUALIFICATIONCONCLUSION确认结论389REFERENCEDOCUMENTATION