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1、性能确认 Performance Qualification起草于 2015 年 04 月 Prepared April 2015名称Title脉动真空双扉灭菌柜-灭菌性能确认Pulsation Vacuum Autoclave Bacteria ChallengeTest房间号Room No：1283验证的仪器、设备或程序Instrument/Equipment/Procedure to be Validated设备供应商Supplied by:山东新华医疗器械股 份有限公司 SHINVA medical instrument Co., Ltd.设备序夕列号 Equipment Regist
2、er: 20132261设备编号 Equipment NumberMEO-09-01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王海洋 Haiyang Wang批准人 Approved By:主管 Supervisor王海洋 Haiyang WangQA
3、负责人 QA Manager刘振超 Zhenchao Liu机构负责人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 Prerequisite 31.1 目的 Objective 31.2 设备描述 Equipment Description 31.3术语和定义 32 责任 33 文件和标准操作规程 Documents and Standard Operating Procedures 43.1 完成本文件 Completion of this Document 4
4、3.2 文件列表 Qualification Documents 44 使用的仪器和标准品 Test Instrumentation and Standards Used in the Qualification 45 性能确认 Performance qualification 56 缺陷报告附件列表 Deficiency Report Attachments List 57 批准 Approvals 67.1 临时批准 Interim Approval 67.2 最终批准 Final Approval 61 通用说明和先决条件 General Instructions and Prereq
5、uisite1.1 目的 Objective这份方案描述脉动真空双扉灭菌柜，编号MEO-09-01的灭菌性能确认程序。这台设备 安置于房间号1283。将会确认设备在正常操作条件下，关键变量能在允许的公差范围 内持续稳定的重现。This protocol will define the procedure to be followed for the Performance Qualification of the Pulsation Vacuum Autoclave No: MEO-09-01. It is located in Room 1283. It will verify that t
6、he variables, critical to the operation, consistently operate within a specified tolerance range when operated under normal conditions.1.2 设备描述 Equipment Description这台设备的型号是XG1.DWF -1.5B,由山东新华医疗器械股份有限公司提供。其使用 目的是对进入SPF级动物房的物品进行灭菌。Model of this equipment is XG1.DWF - 1.5B, its supplied by SHINVA medi
7、cal instrument Co., Ltd. It is used to sterilize the items to be used in SPF area.1.3 术语和定义关键缺陷-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，可是继续使用没有被缺陷影响的项目。Non-Critical Deficiency Validation may be signed off and (co
8、ntinued) use of the item is not impacted by the deficiency.2 责任活动 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CTI BIOTECHNOLOGY (SUZHOU) Co., Ltd.协调验证活动Coordinate Validation Protocol Activities验证负责人VD-王海洋VD-Haiyang Wang提供使用仪器或设备的许可Provide access to item设备负责人-李永超Mainta
9、iner- Yongchao Li提供服务支持许可Provide contractor support and access山东新华医疗器械股份有限公司SHINVA medical instrument Co., Ltd.安排测试(如果需要)Arrange laboratory testing (as required)验证负责人VD-王海洋VD-Haiyang Wang执行方案和起草报告Execute Protocol and prepare report验证负责人VD-王海洋VD-Haiyang Wang 验证参与人员-李永超Participant-Yongchao Li 验证参与人员-王
10、雨蒙Participant-Yumeng Wang 验证参与人员-姜英Participant-Ying Jiang起草最终报告 Prepare final report验证负责人VD-王海洋VD-Haiyang Wang批准最终报告Approve final report验证负责人VD-王海洋VD-Haiyang Wang 机构负责人-夏玉叶TFM-Yuye xia3 文件和标准操作规程 Documents and Standard Operating Procedures3.1 完成本文件 Completion of this Document本文件不可复制。所有数据都必须在原始文件或附加表
11、格上完成。每份附加表格都必 须签名和署日期。This document is not to be copied. All results must be completed on the original document or on supplementary records attached to this document. Each attachment must be signed and dated.本文件提供的空格都必须填写，如果不需要填写或者不适用，应当在相应空格里说明。 如果某个数字或空格不需要，划对角线标明不适用，或填入 NA。 All spaces provided in
12、 the PQ document must be completed. If a result is not applicable or not required this should be stated in the space provided. If a number of spaces are not required, a diagonal line through all spaces with a Not Applicable sign may be used.本文件用黑色笔填写 This document must be completed in black pen only
13、.3.2 文件列表 Qualification Documents需要以下文件以完成 PQ The following documents are required for completion of the PQ文件 Document文件号和咸文件名Document # and/or Title确认人 Verified by:运行确认Operation Qualification需填入文件名或编号使用与维护规程Operationand maintenance SOPWI-BTC-EQU-011校验规程 Calibration SOPN/A培训记录 Training RecordBTC-MAN
14、-0305-1.2设备或仪器的使用日志Equipment /Instrument Log BooksBTC-EQU-0301-1.04 使用的仪器和标准品 Test Instrumentation and Standards Used in the Qualification 列举执行运行确认所需的测量仪器和标准品。List of test instruments and reference standards required for the execution of the PQ.仪器或标准品 Instrument or Standard序列号 Serial No.证书编号 Certifi
15、cate No.计量日期 Date Calibrated计量有效期至 CalibrationDue Date确认人Verified by:生化培养箱12070015NA嗜热脂肪芽胞 杆菌指示剂批号：NANANA5 性能确认 Performance qualification为系统关键参数的运行范围和可靠性提供可信根据。To provide confidence in the reliability and operating ranges critical operating variables of the system.列举所要进行的测试 List the tests to be completed here测试号Test #关键变量Critical Variable期望的运行范围Anticipated Operating Ranges责任分配Responsibility to Complete5.1灭菌性能确认Bacteria Challenge Test
