超净工作台安装确认书
目录Table of Contents
1 通用说明和先决条件GENERAL INSTRUCTIONS AND PREREQUISITE 3
1.1 目的和范围OBJECTIVE AND SCOPE 3
1.2 设备或仪器描述EQUIPMENT/INSTRUMENT DESCRIPTION 3
1.3 主要组件列表MAJOR COMPONENTS LIST 3
1.4 术语和定义TERMS AND DEFINITIONS 4
2 责任RESPONSIBILITIES 4
3 文件DOCUMENTATION 5
3.1 完成本文件COMPLETION OF THIS DOCUMENT 5
3.2 文件列表QUALIFICATION DOCUMENTS LIST 5
4 公用设施要求UTILITIES REQUIREMENTS 6
4.1 公用设施列表UTILITIES LIST 6
5 列举需要检定的项目CALIBRATION ITEMS 6
6 安装、接线、安全和外观检查INSTALLATION, HOOKUP, SAFETY AND PHYSICAL INSPECTION 7
7 预防性维护和安全评估PREVENTIVE MAINTENANCE AND SAFETY ASSESSMENTS 7
7.1 预防性维护PREVENTATIVE MAINTENANCE 7
7.2 安全评估SAFETY ASSESSMENT 7
8 缺陷报告附件列表DEFICIENCY REPORT ATTACHMENTS LIST 7
9 批准 APPROVALS 8
9.1 临时批准INTERIM APPROVAL 8
9.2 最终批准FINAL APPROVAL 8
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 List
II. 所需文件Required Documents
III. 公用系统需求Utility Requirements
IV. 检定Calibration
V. 安装、接线、安全和外观检查Installation, Hookup, Safety and Physical Inspection
VI. 预防性维护需要Preventive Maintenance Requirements
VII. 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 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 theLaminar flow cabinet, No.:MEC-06-02. It is located in the1410.
此设备或仪器放置在细胞培养间,房间号1410。
The Equipment/Instrument located in room No1410ofcell culturelab.
所需信息Required Information |
实际上As Found |
生产商Manufacturer |
Esco 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Location |
1410 |
图纸号Drawing Number |
N/A |
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 frame |
N/A |
ESCO |
User manual |
|
玻璃防护窗 Front glass screen |
调节操作口的高度 Change the width of its mouth |
N/A |
ESCO |
User manual |
|
底架 Chassis |
支撑工作台 Supporting table |
N/A |
ESCO |
User manual |
|
台面 Stainless platform |
供操作时使用 For operation use |
N/A |
ESCO |
User manual |
|
初效过滤器 Pre-filter |
过滤空气中的大颗粒 Trap large particles in the air |
N/A |
ESCO |
User manual |
|
ULPA高效过滤器 ULPA Filter |
捕集0.3μm及以下的颗粒灰尘及各种悬浮物 Trap 0.3 μm and dust particles following and various suspension |
N/A |
ESCO |
User manual |
|
鼓风机 Blower |
将空气压入工作台内部 Press air into the table inside |
N/A |
ESCO |
User 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 table |
N/A |
ESCO |
User manual |
|
照明灯Fluorescent lamp |
用于照明 Used for lighting |
N/A |
ESCO |
User manual |
|
紫外灯 Optional UV light |
用于紫外消毒 Used for ultraviolet disinfection |
N/A |
ESCO |
User manual |
|
插座 Optional electrical outlet |
可外接小型仪器 Can be connected with the small instrument |
N/A |
ESCO |
User manual |
|
万向轮 Universal wheel |
便于移动 Easy to move |
N/A |
ESCO |
User manual |
|
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。
NonCritical Deficiency ? Validation may be signed off and (continued) use of the item is not impacted by the deficiency.
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-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 VD-Yumeng Wang 机构负责人-夏玉叶 TFM-Yuye Xia |
批准执行方案Approval to Commence Execution of Protocol
验证负责人VD : _____________________ 日期Date:_______________________
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 IQ 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.
文件类型Document Type |
需要(是/否)Required? (Yes/No) |
可用(是/否)Available? (Yes/No) |
参照文件号Reference # |
用户需求规格 User requirement specification |
否 No |
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功能规格 Functional Specification |
是 Yes |
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图纸 Drawings |
否 No |
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装配审计报告 Fabrication Audit Report |
否 No |
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工厂可接受测试报告 Factory Acceptance Testing Report (FAT) |
否 No |
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供应商手册 Suppliers Manual |
是 Yes |
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维护手册 Procedures for Maintenance |
是 Yes |
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装配和使用程序 Procedures for Set-up and Use |
是 Yes |
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其他SOP列表Other SOPs(list) |
否 No |
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确认人Verified by:__________________ 日期Date:__________________
公用设施Utility |
要求Requirements |
实际As Measured |
可接受(是/否)Acceptable? (Yes/No) |
电Electricity |
220-240V/50Hz, AC |
|
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确认人Verified by:__________________ 日期Date:__________________
列举所有的需要检定的项目-分类为关键(需要校验)和非关键(仅列出)List all instrument and measuring devices ? categories into critical (under calibration) or not critical for indication only)
项目号Item # |
项目描述 Item Description |
是否关键(是/否)Critical (Yes/No) |
运行范围Operating Range |
公差Tolerance |
再计量日期Recalibration Period |
1 |
平均气流速率 The average flow rate |
是Yes |
0.4 m/s-0.6 m/s |
±20% |
|
确认人Verified by:__________________ 日期Date:__________________
条目Item |
要求Requirements |
满意? Satisfactory? |
检查人Checked by |
设备和设计规格一致吗Equipment supplied as per design specification? |
仪器或设备与图纸一致Drawings of equipment matched that of the machine |
£Yes £No £N/A |
|
安全检查Safety Inspections |
接地线已接地Verified that the item has been earthed |
£Yes £No £N/A |
|
没有裸露的电线No bare wire |
£Yes £No £N/A |
||
外观检查Physical Inspections |
没有可见的裂缝或损坏No visible leak or damage on the equipment or glass mask |
£Yes £No £N/A |
确认人Verified by:__________________ 日期Date:__________________
确认是否有预防性维护方案和程序。
Verify that the Preventive Maintenance program and procedures are available.
□有Available □没有Not Available
确认人Verified by: ________________ 日期Date: ________________
确认是否需要安全评估,如果需要是否已经执行。
Verify that a Safety assessment is required and if so has been conducted
□需要Required □不需要Not required
□完成(如果需要)Completed (if required) □有报告Report Available
确认人Verified by: _____________________ 日期Date: ________________
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。
List deficiency reports produced during the Installation Qualification and their status. Refer to attached detailed reports.
缺陷报告号Deficiency Report # |
缺陷概要描述Deficiency Description Summary |
分类Classification |
完成Close out |
|
检查人Checked by |
日期Date |
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□关键Critical □非关键Non ? Critical |
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如果没有关键验证缺陷调查,就直接进行最终批准。如果有关键缺陷就暂停批准。如果有非关键缺陷存在就执行临时批准,但不能执行最终批准。
If there are no outstanding Critical Validation Deficiency Investigations go to final approval. If there are critical deficiencies withhold approvals. If the deficiencies are non-critical provide interim approval but not final approval.
头衔Title |
姓名Name |
签名Signature |
日期Date |
验证负责人VD |
王雨蒙Yumeng Wang |
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QA负责人QA Manager |
刘振超Zhenchao Liu |
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机构负责人TFM |
夏玉叶Yuye Xia |
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执行最终批准,当所有的缺陷都已经解决和完成。Provide final approval when ALL deficiencies are resolved and closed out.
头衔Title |
姓名Name |
签名Signature |
日期Date |
验证负责人VD |
王雨蒙Yumeng Wang |
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QA负责人QA Manager |
刘振超Zhenchao Liu |
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机构负责人TFM |
夏玉叶Yuye Xia |
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参与验证的人在签名记录表签名Include Sheet of signatures of those involved with the validation activity
签名记录表Signature Record
所有参与验证的人员在下表中签名以表明身份。All personnel involved in this qualification must complete the table below to provide identification of all the signatures/initials used in this document.
公司Company |
头衔Title |
签名Signature |
日期Date |
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原文来源:http://www.icleanbench.com/