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1、 编号No：IQP-XXXX安装确认Installation Qualification起草于2015年 04月Prepared April 2015名称Title超净工作台-安装确认Laminar flow cabinet-Installation Qualification 房间号Room No1410验证的仪器、设备或程序Instrument/Equipment/Procedure to be Validated设备供应商Supplied by:上海汇析精密仪器有限公司Shanghai Huixi Precision Instrument Co., Ltd.设备序列号Equipment
2、Register: 2013-82096设备编号Equipment NumberMEC-06-02验证方案的批准Approval of the Validation Protocol审核和批准了相关SOP、标准和日程表之后在下表签字Sign here after reviewing and approving the SOPs, standards and schedules头衔Title姓名Name签名Signature日期Date起草人Written By:验证负责人VD王雨蒙Yumeng Wang批准人Approved By:QA负责人QA Manager刘振超Zhenchao Liu机
3、构负责人Test facility manager夏玉叶Yuye Xia目录Table of Contents1通用说明和先决条件GENERAL INSTRUCTIONS AND PREREQUISITE31.1目的和范围Objective and Scope31.2设备或仪器描述Equipment/Instrument Description31.3主要组件列表Major Components List31.4术语和定义Terms and Definitions42责任RESPONSIBILITIES43文件DOCUMENTATION53.1完成本文件Completion of this D
4、ocument53.2文件列表Qualification Documents List54公用设施要求UTILITIES REQUIREMENTS64.1公用设施列表Utilities List65列举需要检定的项目CALIBRATION ITEMS66安装、接线、安全和外观检查INSTALLATION, HOOKUP, SAFETY AND PHYSICAL INSPECTION77预防性维护和安全评估PREVENTIVE MAINTENANCE AND SAFETY ASSESSMENTS77.1预防性维护Preventative Maintenance77.2安全评估Safety Ass
5、essment78缺陷报告附件列表DEFICIENCY REPORT ATTACHMENTS LIST79批准 APPROVALS89.1临时批准Interim Approval89.2最终批准Final Approval81 通用说明和先决条件General Instructions and Prerequisite1.1 目的和范围Objective and Scope通常一份方案包含以下方面The different aspects that a normal protocol would address are:I. 主要组件列表 Major Component ListII. 所需文
6、件Required Documents III. 公用系统需求Utility RequirementsIV. 检定CalibrationV. 安装、接线、安全和外观检查Installation, Hookup, Safety and Physical InspectionVI. 预防性维护需要Preventive Maintenance RequirementsVII. 缺陷报告附件列表：一份显示安装确认过程中产生的缺陷报告和缺陷报告状态的列表Deficiency Report Attachment List: a list of the deficiency reports produced
7、 during the Installation Qualification and their status.VIII. 证明Certification这份方案描述超净工作台，编号MEC-06-02的安装确认程序。这台设备安置于1410。This protocol will define the procedure to be followed for the installation qualification of the Laminar flow cabinet, No.: MEC-06-02. It is located in the 1410.1.2 设备或仪器描述Equipmen
8、t/Instrument Description此设备或仪器放置在细胞培养间，房间号1410。The Equipment/Instrument located in room No 1410 of cell culture lab.所需信息Required Information实际上As Found生产商ManufacturerEsco Micro Pte. Ltd.订单号Purchase Order #N/A 型号Model #ACB-6A1设备编号Equipment Identification #MEC-06-02位置Location1410图纸号Drawing NumberN/A1.
9、3 主要组件列表Major Components List组件名称# Item描述Item Description型号/序列号Model/ Serial #生产商Manufacturer手册Manual #工作台箱体The worktable box主体框架The main body frameN/AESCOUser manual玻璃防护窗Front glass screen调节操作口的高度Change the width of its mouthN/AESCOUser manual底架Chassis支撑工作台Supporting tableN/AESCOUser manual台面Stainl
10、ess platform供操作时使用For operation useN/AESCOUser manual初效过滤器 Pre-filter过滤空气中的大颗粒Trap large particles in the airN/AESCOUser manualULPA高效过滤器ULPA Filter捕集0.3m及以下的颗粒灰尘及各种悬浮物Trap 0.3 m and dust particles following and various suspensionN/AESCOUser manual鼓风机Blower将空气压入工作台内部Press air into the table inside N/
11、AESCOUser manual控制面板Control panel控制面板上的按键控制超净工作台的运行The keys on the control panel to control the operation of the super clean working tableN/AESCOUser manual照明灯Fluorescent lamp用于照明Used for lightingN/AESCOUser manual紫外灯Optional UV light用于紫外消毒Used for ultraviolet disinfectionN/AESCOUser manual插座Optiona
12、l electrical outlet可外接小型仪器Can be connected with the small instrumentN/AESCOUser manual万向轮Universal wheel便于移动Easy to moveN/AESCOUser manual 1.4 术语和定义Terms and Definitions关键缺陷-在关键缺陷项目被（解决）完成之前，验证工作不能签署通过。Critical Deficiency Validation may not be signed off until the item is closed out.非关键缺陷-验证工作可以签署通过
13、，可是继续使用没有被缺陷影响的项目。NonCritical Deficiency Validation may be signed off and (continued) use of the item is not impacted by the deficiency.2 责任RESPONSIBILITIES活动Activity责任方Responsible Party起草和批准方案Prepare and approve protocol苏州华测生物技术有限公司CTIBIOTECHNOLOGY（SUZHOU）CO., Ltd.协调验证活动Coordinate Validation Protoc
14、ol Activities验证负责人- 王雨蒙VD-Yumeng Wang提供使用仪器或设备的许可Provide access to item设备负责人- 王雨蒙Maintainer-Yumeng Wang提供服务支持许可Provide contractor support and access上海汇析精密仪器有限公司Shanghai Huixi Precision Instrument Co., Ltd.安排测试（如果需要）Arrange laboratory testing (as required)N/A执行方案和起草报告Execute Protocol and prepare report验证负责人- 王雨蒙VD-Yumeng Wang起草最终报告Prepare final report验证负责人- 王雨蒙VD-Yumeng Wang批准最终报告Approve final report验证负责人- 王雨蒙
