超净工作台-IQ.doc

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 No
1410
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 Register: 2013-82096
设备编号Equipment Number
MEC-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

机构负责人Test facility manager
夏玉叶Yuye Xia

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

1 通用说明和先决条件General Instructions and Prerequisite

1.1 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 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 the Laminar flow cabinet, No.: MEC-06-02. It is located in the 1410.

1.2 设备或仪器描述Equipment/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

1.3 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 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

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，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) 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:_______________________

3 文件Documentation

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 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.
3.2 文件列表Qualification Documents List

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

功能规格
Functional Specification
是
Yes

图纸
Drawings
否
No

装配审计报告
Fabrication Audit Report
否
No

工厂可接受测试报告
Factory Acceptance Testing Report (FAT)
否
No

供应商手册
Suppliers Manual
是
Yes

维护手册
Procedures for Maintenance
是
Yes

装配和使用程序
Procedures for Set-up and Use
是
Yes

其他SOP列表Other SOPs(list)
否
No

确认人Verified by:__________________ 日期Date:__________________

4 公用设施要求Utilities Requirements
4.1 公用设施列表Utilities List

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

确认人Verified by:__________________ 日期Date:__________________
5 列举需要计量的项目Calibration Items

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:__________________

6 安装、接线、安全和外观检查Installation, Hookup, Safety and Physical Inspection

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:__________________

7 预防性维护和安全评估Preventive Maintenance and Safety Assessments

7.1 预防性维护Preventative Maintenance

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: ________________
7.2 安全评估Safety Assessment
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: ________________

8 缺陷报告附件列表Deficiency Report Attachments List

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

□关键Critical
□非关键Non – Critical

9 批准 Approvals

9.1 临时批准Interim Approval
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

QA负责人QA Manager
刘振超Zhenchao Liu

机构负责人TFM
夏玉叶Yuye Xia

9.2 最终批准Final Approval

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

QA负责人QA Manager
刘振超Zhenchao Liu

机构负责人TFM
夏玉叶Yuye Xia

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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