性能确认Performance Qualification
广州美容网起草于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 Challenge Test |
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. 设备序列号Equipment Register: 20132261 |
设备编号Equipment Number | MEO-09-01 |
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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: 奇遇的意思 | | | |
主管Supervisor | 王海洋Haiyang Wang | | |
QA负责人QA Manager | 刘振超Zhenchao Liu | | |
机构负责人Test facility manager | 夏玉叶Yuye Xia | | |
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目录Table of Contents
1 通用说明和先决条件General Instructions and Prerequisite 3
1.1 目的Objective 3
1.2 设备描述Equipment Description 3
1.3 术语和定义 3
2 责任 3
3 文件和标准操作规程Documents and Standard Operating Procedures 4
3.1 完成本文件Completion of this Document 4
3.2 文件列表Qualification Documents 4
4 使用的仪器和标准品Test Instrumentation and Standards Ud in the Qualification 4
5 性能确认Performance qualification 5
6 缺陷报告附件列表Deficiency Report Attachments List 5
7开车基本步骤 批准Approvals 6
7.1 临时批准Interim Approval 6
7.2软件学习班 最终批准Final Approval 6
1 通用说明和先决条件General Instructions and Prerequisite
1.1 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 Qua
lification of the Pulsation Vacuum Autoclave No: MEO-09-01. It is located in Room 1283. It will verify that the 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, it’s supplied by SHINVA medical instrument Co., Ltd. It is ud to sterilize the items to be ud 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 clod 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 (continued) u 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 Maintainer- 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 xia |
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3 文件和标准操作规程Documents and Standard Operating Procedures
3.1 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 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 ud.
本文件用黑色笔填写This document must be completed in black pen only.
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
出厂价英语
文件Document | 文件号和/或文件名 Document # and/or Title | 确认人Verified by:英译汉在线翻译句子 |
运行确认 Operation Qualification | 奥普拉 温弗瑞需填入文件名或编号 | |
使用与维护规程Operation and maintenance SOP | WI-BTC-EQU-011 | |
校验规程Calibration SOP | N/A | |
培训记录Training Record | BTC-MAN-0305-1.2 | |
设备或仪器的使用日志Equipment /Instrument Log Books | BTC-EQU-0301-1.0 | |
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4 使用的仪器和标准品Test Instrumentation and Standards Ud 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Certificate No. | 计量日期Date Calibrated | 计量有效期至Calibration Due Date | 确认人Verified by: |
生化培养箱 | 12070015 | NA | | | raden |
嗜热脂肪芽胞杆菌指示剂 | 批号： padam padam | NA | NA | NA |
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5 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 Complete |
5.1 | 灭菌性能确认 Bacteria Challenge Test | 嗜热脂肪芽胞杆菌指示剂呈蓝紫色 Color of Bacillus stearothermophilus is Blue to Purple | 王雨蒙和姜英 Yumeng Wang& Ying Jiang |
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按照附件A的样式插入测试和结果记录表Inrt test sheets and result formats per attachment A.
