空调系统安装运行确认报告.docVIP

设备安装运行确认报告 Qualification Report 设备名称Equipment 空调净化系统 Heating Ventilation and Air Condition（HVAC） 设备编号Code M208 安装地点Location 212车间 报告编号Report № PD-VR 21211 版本Version B 报告日期Report Date 2009-2-11 签名程序Procedure部门Dept. 姓名Name 签名Signature/Date 起草Prepared by 工程部 Reviewed by Dept. 计量科 生产车间 QA 生产技术部 工程部 Approved by 生产副总经理 Jiuzhou Pharma 目 录contents 报告总结 Summary Report 目的Purpose 系统描述System Description 接受标准Acceptance Criteria 责任者Person Responsibility 预确认Design Qualification(DQ) 设备的性能要求Requirement of Equipment Performance 供应商的选择Select Supplier 资料档案Document 预确认结论Conclusion of DQ 安装确认Installation Qualification(IQ) 设备概况Equipment Description 设备安装Equipment Installation 设备部件检查Parts of Equipment Examination 设备附带仪表检查Instrument of Equipment Examination 安装确认结论Conclusion of IQ 运行确认/性能确认Operation/Performance Qualification (OQ/PQ) 运行/性能确认OQ and PQ 运行/性能确认结论Conclusion of OQ and PQ 预防性维修项目和周期Preventative Maintenance Items and Schedule 附录Appendix 操作规程SOP 报告总结 按批准的方案，对212车间的空调系统（M208）设备安装运行确认，结果如下： 设备型号符合使用要求，设备档案和数据齐全，售后维修服务联系正常。 设备安装公用管线和环境符合使用条件，安装确认的所有设备被完成并通过了确认，符合安装运行确认方案要求。 设备进行试运转，符合设备运转要求，可投入使用。 Summary Report The qualification is performed according to the approved protocol for HVAC（M208）of 212 plant. Results are shown as below： Machine form is suitable for the usage requirements. Equipment archives and data are in their place. Post maintenance service is committed to be done. Connection of public medium and installation environment meets the conditions for the use of the apparatus. All kinds of instrument are qualified. Installation conforms to the protocol requirements. Test running under the conditions of unload and load meet with the acceptance criteria. The validation meets the requirements, and the equipment is approved to be used. 目的Purpose 保证空调净化系统的安装和运行质量符合制造厂的设计制造要求和212车间使用的要求，特安排本安装确认。规定了空调净化系统的验证范围、方法和有关资料，验证结果用于确认空调净化系统的安装和运行质量以及有关附件的连接是否达到设计标准和符合cGMP要求。 适用于212车间空调净化系统的安装和运行确认。安装确认包括对设备及部件安装和电气连接检查确认，运行验证是在设备运行状态下，对空调净化系统的电机、风机、箱体与工艺、动力管道连接的检查。 系统描述Sy