2021 054LTc IQ V1.0 2021.11.19

INSTALLATION QUALIFICATION
安装确认
CUSTOMER NAME/客户名称:
VACSERA
SUPPLIER NAME/供应商:
Tofflon Science and Technology NO./编号:

Group Co.,Ltd. 2021-054LTc
东富龙科技集团股份有限公司
MODEL/型号:
FT0140
INSTALLATION QUALIFICATION FOR

STERILIZING DEPYROGENATING TUNNEL
灭菌去热原烘箱安装确认
EXPERTISE IN PHARMACEUTICAL INDUSTRY
ADD: 139, DUHUI RD.,SHANGHAI -201108 CHINA

TEL: +86 21 64909996
FAX: +86 21 64908881
www.tofflon.com
Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Installation Qualification for
Version V 1.0
Tofflon Science
Sterilizing Depyrogenating Tunnel 版本号
and Technology Group Co.,Ltd.
灭菌去热原烘箱安装确认 Page
东富龙科技集团股份有限公司 1 of 53-1
页码

Sterilizing Depyrogenating Tunnel
灭菌去热原烘箱安装确认
The signatures below indicate the approval of this protocol and it is ready for execution. Any changes or
modification of this protocol requires the approval and generation of an amendment, which must be
approved prior to execution.
下面的签名表示批准本文件，且表明已经为执行作好了准备。在批准后，任何对本文件进行的改变或
修正都必须提供补充文件，并在执行以前必须取得批准。
Document Approval 文件批准
Department Name Signature Date

部门姓名签名日期
Xiaoqing
Packaging Machine Department
Prepared by 起草 Huang
分装机事业部
黄晓晴
Packaging Machine Department Alice Liu
Reviewed by 审核
分装机事业部刘桂江
Packaging Machine Department Carol Ning

Approved by 批准
分装机事业部宁晓丹
Document Approval(Customer)文件批准(客户)
Department Signature Date
部门签名日期
Reviewed by 审核
Reviewed by 审核
Reviewed by 审核
Reviewed by 审核
Approved by 批准

专业技术服务于制药工业
Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Version History 版本历史
Version 版本 Issued Date 颁布日期 Reason for Issue 颁布原因
V 1.0 Initial Issue 首次发布

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Index 目录
1. Purpose 目的...............................................................................................................................................4
2. Scope 范围..................................................................................................................................................4
3. Abbreviations 缩略语..................................................................................................................................4
4. Responsibilities 职责...................................................................................................................................5
5. References 参考文件..................................................................................................................................6
6. System Description 系统描述.....................................................................................................................6
7. Documentation Control Specification 文件管理规范.................................................................................7
8. Test List 测试列表......................................................................................................................................9
9. Personnel Identification 人员确认............................................................................................................10
10. Qualification Procedure 确认程序..........................................................................................................11
10.1. Prerequisites 先决条件.................................................................................................................11
10.2. SAT Punch List Closeout Qualification SAT 遗留清单关闭确认...............................................14
10.3. Test Leveraging 测试引用............................................................................................................17
10.4. Test Instruments Calibration Qualification 测试用仪器仪表校准确认......................................20
10.5. Documentation Qualification 文件确认.......................................................................................23
10.6. Installation Check 安装检查........................................................................................................26
10.7. Critical Materials Certificate Qualification 关键材料材质证明确认..........................................29
10.8. Main Components Check 主要部件检查.....................................................................................32
10.9. Instruments Calibration Qualification 仪器仪表校准确认..........................................................35
10.10. Utilities Check 公用设施检查....................................................................................................39
11. Deviation Handling 偏差处理.................................................................................................................43
12. Change Control 变更控制.......................................................................................................................45
13. Punch List 遗留清单...............................................................................................................................47
14. Attachment List 附件清单......................................................................................................................49
15. IQ Summary IQ 总结..............................................................................................................................51
15.1. Test Result Summary 测试结果汇总...........................................................................................51
15.2. IQ Conclusion IQ 结论.................................................................................................................52

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
1. Purpose 目的
The purpose of Installation Qualification (IQ) is to establish that the critical components are installed
correctly and in accordance with design documentation requirements. Supporting documentation should be
in place and of suitable quality. IQ is an activity that is regulated by the Current Good Manufacturing
Practice, and is a part of final qualification activities before process validation begins.
安装确认的目的是保证关键的部件得到了正确的安装，并符合设计文件的要求。支持文件保存在合
适的地方，并符合质量部门的要求。安装确认是 cGMP 规定进行的活动，它是在工艺验证开始之前
确认活动的一部分。
2. Scope 范围
This document is applicable to the vials Sterilizing Depyrogenating Tunnel, model FT0140 for VACSERA.
本文件适用于安装在 VACSERA 的 FT0140 型灭菌去热原烘箱。
3. Abbreviations 缩略语
Abbreviations Definition
缩略语定义
Attachment
Att.
附件
Commissioning and Qualification
C&Q
调试与确认
National Medical Products Administration
NMPA
国家药品监督管理局
Current Good Manufacturing Practice
cGMP
现行药品生产质量管理规范
Central Processing Unit
CPU
中央处理器
Deviation
Dev.
偏差
Design Qualification
DQ
设计确认
High Efficiency Particulate Air
HEPA
高效空气过滤器
International Society for Pharmaceutical Engineering
ISPE
国际制药工程协会
Identification
ID
身份
Installation Qualification
IQ
安装确认
Installation Manual
IM
安装手册

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Abbreviations Definition
缩略语定义
Leveraging
Lev.
引用
Length × Width × Height
L×W×H
长×宽×高
Maintenance Manual
MM
维护手册
Not Applicable
N/A
不适用
Number
No.
序号
Operation Manual
OM
操作手册
Piping and Instrumentation Diagram
P&ID
管道和仪表工艺图
Punch List
PL.
遗留项目清单
Programmable Logic Controller
PLC
可编程控制器
Quantity
Qty.
数量
Stainless Steel
SS
不锈钢
Tofflon Science and Technology Group Co.,Ltd.
Tofflon
东富龙科技集团股份有限公司
User Requirements Specifications
URS
用户需求说明
Vials Per Minute
VPM
瓶/分
4. Responsibilities 职责
The Responsibilities of Tofflon include but not limited to:
东富龙的职责包括但不仅限于：
Prepare, review and pre-approval of IQ protocol;
IQ 方案编制、审核及预批准；
Execution of IQ;
IQ 执行；
Gather raw data and fill in the test form;
收集原始数据并填写在测试表格中；

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Record and handle deviation/change which occur during the execution of IQ;
记录及处理 IQ 过程中发生的偏差/变更；
Submit the IQ documentation for customer to review and approval.
提交 IQ 记录，以供用户进行审核和批准。
Responsibilities of customer include but not limited to
客户的职责包括但不仅限于
The review and approval of IQ protocol;
IQ 方案审核及批准；
Assistant to record and handle the deviation/change occurred during the execution of IQ;
协同记录和处理 IQ 过程中发生的偏差/变更；
Assistant to collect raw data and fill in relevant check table;
协同收集原始数据并填写相关表格；
Provide the provision of necessary human resource and equipment;
提供为此次执行本方案所必要的资源（包括人力资源、设备运行资源）；
Review and approve the final conclusion.
审核和批准最终结论。
5. References 参考文件
(NMPA) Good Manufacturing Practice（2010）
(NMPA) 药品生产质量管理规范（2010）
EudraLex Volume 4 - EU Guidelines for Good Manufacturing Practice for Medicinal Products for
Human and Veterinary Use
EudraLex 第 4 卷 – 欧盟人用药品和兽用药品 GMP 指南
Chinese Pharmacopoeia
中国药典
China current Industry standards and norms
中国现行相关行业标准及规范
ISPE Baseline Guide Volume 5: Commissioning and Qualification
ISPE 基准指南第 5 卷：调试和确认
6. System Description 系统描述
The vials Sterilizing Depyrogenating Tunnel shall sterilize and depyrogenate pharmaceutical glass vials
with the following functions:
灭菌去热原烘箱应依靠以下功能对药用西林瓶进行灭菌和去热原：
- Vials are transferred at constant speed into the process chambers.
瓶子匀速送入工艺箱体
- Preconditioning the vials for the depyrogenation process in the pre-heating zone.
在预热段中对瓶子进行去热原预处理
- Vial sterilization and depyrogenation in the heating zone which is heated up to the temperature of 300
-340 °C.
瓶子在温度达到 300- 340 °C 的高温段中进行灭菌和去热原
- Vials cooling after the sterilization and depyrogenation process in the outfeed cooling zone.
在出料冷却段中对经过灭菌和去热原过程后的瓶子进行冷却
Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
 Continuous differential pressure regulation of the outfeed cooling zone to assure the correct air flow
from the sterile area.
对出料冷却段的压差进行连续控制以确保与无菌室之间的空气流向正确
7. Documentation Control Specification 文件管理规范
Recording Pens 记录用笔：

 Choose nonfading ink pens or marker pens. Blue pens are recommended.
使用不消褪的墨水笔或记号笔，推荐使用蓝色笔记录
Signature 签名：
 Only authorized persons can sign on any documents.
被授权的人员才能签署文件
 Unless otherwise specified, the full name shall be used as the signature.
应签全名，除非文件另有规定
 The signature shall be legible.
签名应该是可辨认的
 The signatures shall be consistent.
签名应始终一致
Column Filling 填写栏目：
 All the columns shall be filled.
所有栏目必须填写
 The full text shall be filled if it is the same as that in the field above.
填写内容与上面栏目相同应重新填写
 If there is nothing to be filled in to an individual field, N/A (abbreviation for not applicable)
shall be written in this field.
若有单个栏目不需要填入内容，则在空白处填写英文字母“不适用”的简写“N/A”，
以表示无此项内容。
 If there is nothing to be filled in more than one neighboring fields, such fields shall be
crossed with a diagonal line, with “N/A” noted above the line and the signature and the date
noted below the line. The signature and the date shall be written along the line on the same
side as much as possible.
填写记录时，若有多个栏目不需要填入内容，应用斜线划掉，斜线上方填写“N/A”，
下方签名和注明日期。签名及日期应尽量沿斜线同侧填写。
Correction of Mistakes 更改错误：

 When any mistakes are to be corrected immediately after the document has been complete,
Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
the correct record shall be entered and signed and dated. The original information shall be
left clearly readable.
文件刚完成，立即更改的在错误处划线，填入正确的，签名和注明更改日期，确保原
先信息仍清晰可识别
For example: January 1, 2016, signature and date
如：2016.01.01 签字，日期
 When any mistakes are to be corrected afterwards, besides conforming to the above
requirements, the reasons for the correction must be noted indicating the possible influences.
The same shall also be assessed and noted with signature and current date.
事后更改的，除非立即更改的要求外，还应注明更改的原因，检查和注释可能的影响。
Date Recording Format 记录日期：
 Four digits shall be used for the indication of the year, two digits for the month and another
two for the date.
年用 4 位数表示，日和月用 2 位数表示
For example: 2016.01.01
如：2016.01.01
Use of Abbreviations 使用缩略语：
 An abbreviation shall be noted in brackets immediately after the full name before it can be
used in the rest of the document.
在术语全称后的括号内注明缩写，然后才可以使用缩写。
Written Words and Names 书面语及名称：
 Standard written words and names shall be used.
使用规范的书面语及名称
 The names shall be consistent all through the document.
文件前后名称要一致

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
8. Test List 测试列表

Tests that shall be performed in this protocol are listed in the following form.
在下面的表格列出了本方案将要执行的测试。
Test No. Test Name

测试编号测试名称
Prerequisites
10.1
先决条件
SAT Punch List Closeout Qualification

10.2
SAT 遗留清单关闭确认
Test Leveraging
10.3
测试引用
Test Instruments Calibration Qualification

10.4
测试用仪器仪表校准确认
Documentation Qualification
10.5
文件确认
Installation Check
10.6
安装检查
Critical Materials Certificate Qualification

10.7
关键材料材质证明确认
Main Components Check

10.8
主要部件检查
Instruments Calibration Qualification

10.9
仪器仪表校准确认
Utilities Check
10.10
公用设施检查

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
9. Personnel Identification 人员确认
All persons involving in this protocol must sign in the following form before IQ execution. All persons
must be trained to ensure that they are competent for IQ work.
在开始执行 IQ 前，本方案涉及的所有人员必须在下表签字。参加确认的人员必须经过培训，以保
证胜任 IQ 工作。
Name Signature Company Title Date

姓名签名公司职务日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10. Qualification Procedure 确认程序

10.1. Prerequisites 先决条件
Purpose 目的
Verify all prerequisites for this protocol execution have been satisfied.
确认所有进行本方案的先决条件已经得到满足。
Verify all persons involved in this protocol are trained.
确认参与此方案的人员都已经过培训。
Acceptance Criteria 可接受标准
All prerequisites must be satisfied before this protocol execution.
开始执行本方案之前，所有的先决条件必须得到满足。
All persons involved in this protocol must be trained.
参与此方案的人员都必需经过培训。
Procedure 程序
This protocol has been approved.
本方案已经得到批准。
There should be a documented training for all persons involved in the tests before the initiation of
this protocol.
在本方案执行前，对所有参与测试的人员进行培训，培训应该有记录。
Note: if there is any additional person, the additional person shall be provided with supplementary
training. The training record shall be attached to this test item, and the executive and the auditor
shall add signature and date.
注：后续若出现新增人员，则对新增人员进行补充培训，培训记录作为附件附在本测试项
后，需对执行人和审核人进行补充签名及日期。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Prerequisites
先决条件
Prerequisites Yes/No
先决条件是否符合要求
The protocol for Sterilizing Depyrogenating Tunnel:

The protocol has been
灭菌去热原烘箱方案：
approved.
Yes ( ) No ( )
本方案已经得到批 Document No.文件号：________________________
准。
Version No.版本号：___________________________
All persons involved in the tests have been trained and recorded.
所有参与测试的人员已经过培训并有记录。 Yes ( ) No ( )
Att. ID 附件编号：_______________________

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Conclusion/Remarks 结论/备注
Conclusion
结论
Remarks 备注：
Conformity
符合性
Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10.2. SAT Punch List Closeout Qualification SAT 遗留清单关闭确认

Purpose 目的
Verify the issue which were documented during the SAT, and required to be verified during IQ had
been addressed.
确认执行 SAT 过程中记录的需要遗留到 IQ 阶段进行确认的遗留项目及其他事项已经得到解
决。
The issues identified during SAT and which should be verified during IQ had been appropriately
addressed as per the resolution listed next to each issue.
在 SAT 活动中确定的需要在 IQ 阶段进行确认的遗留项目已经按照每一遗留项目旁边的应对
措施进行了解决。
Procedure 程序
Obtain a copy of SAT Punch List.
取得 SAT 测试的遗留清单的复印件。
Review and remark each item which shall be verified during IQ and verify it had been
appropriately “closed” as per the resolution listed in Punch List.
在 IQ 期间逐一审核，确认每一项遗留到 IQ 的项目均已得到合适的解决并关闭，在该遗留
清单中进行标注。
Some issues which are required to be verified in the following work, such as the OQ, shall be not
as the veto items for this test and they shall be documented in the Punch List of IQ and verified in
following work.
某些遗留项目需要遗留到后续的工作，例如 OQ 中进行确认，可以不作为本项测试否决项，
但这些项目将遗留到 IQ 的遗留清单中，然后在后续的工作中进行确认。
And some issues shall be closed upon successful test execution as part of IQ. In that case, the
issues should be closed after these tests are completed.
某些遗留项目需要在成功完成 IQ 的某些测试之后才能被关闭，必须等待这些测试完成之后
再关闭该遗留项目。
Attach the copy of SAT punch list to this test.
附上此项测试的 SAT 遗留清单复印件。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
SAT Punch List Closeout Qualification

SAT 遗留清单关闭确认
Description Yes/No
描述是否符合要求
The issues identified during SAT and which should be verified during IQ had been
appropriately addressed as per the resolution listed next to each issue.
Yes ( ) No ( )
在 SAT 活动中确定的需要在 IQ 阶段进行确认的遗留项目已经按照每一遗留项
目旁边的应对措施进行了解决。
Attach the copy of SAT Punch List.

附上 SAT 遗留清单复印件。
Att. ID 附件编号：______________________________________________

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Conclusion
结论
Remarks 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10.3. Test Leveraging 测试引用

Purpose 目的
Summary the leveraging test items that are required in IQ document, but had been performed in
FAT and SAT, and verify these test items had been released.
汇总需要在 IQ 阶段执行，但实际已经在 FAT 及 SAT 执行过的测试项目，确认这些项目已
经成功执行。
All the leveraging test items had been executed in FAT or SAT successfully, and the test condition
can present the final condition of equipment delivery. And the copy of test documents and records
had been attached to this protocol.
所有通过“测试引用”的方式执行的项目的已经在 FAT 或 SAT 阶段成功被执行，测试通过，
且执行条件能够反映设备最终交付的状态，相关的测试文件和记录的复印件也已经被附到
本方案之后。
Procedure 程序
According to the approved IQ document and review the test items required by IQ, and verify
whether them had been performed in SAT or FAT.
根据已批准的 IQ 文件中执行的测试项目，确认其是否在 FAT 或 SAT 中已经被执行过。
If a test item had been executed in FAT or SAT successfully, and this test item had been defined in
this protocol also, review the test condition of FAT and SAT, to verify whether are same or similar
with the test requirements described in this protocol and can present the final delivery condition of
equipment:
如果某个测试项目在 FAT 或 SAT 已经被成功执行过，且该项目也被定义到本方案中，确认
在 FAT 或 SAT 阶段执行本项目时的测试条件与本方案描述的测试条件是否相同或相近，能
够代表设备最终的交付状态：
 If yes, handle the test form of this protocol as per the requirements of section 7.0 and obtain a
copy of the test section and test documents of FAT or SAT and attach to this protocol and
note the attachment number, and fill the information in the form of this section.
如果是，则将本方案中该项目的测试表格按 7.0 中定义的要求划掉。然后将 FAT 或
SAT 所对应的该章节及测试记录复印，附到本方案后，注明引用的附件编号，并将相
关信息登记在本章节表格中。
 If no, perform this item again as per the procedure defined in this protocol.
如果测试条件不同，则按本方案规定的程序重新进行测试。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Test Leveraging
测试引用
Lev. Item Title Lev. For Lev. From Lev. Reason Att. ID
引用项目引用章节引用自引用理由附件编号

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Conclusion
结论
Remarks 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10.4. Test Instruments Calibration Qualification 测试用仪器仪表校准确认

Purpose 目的
Verify that each test instruments that will be used during the execution of the protocol has been
calibrated.
确认执行本方案需使用的所有仪器仪表都经过校准。
The testing instruments for this protocol have been calibrated and are within the calibration due
date.
本方案测试使用的仪器仪表均经过校准，且在有效期内。
Measurement standard for calibration can be traced back to National Standards of Measurement.
用于校准的计量标准能够追溯到国家计量基准。
Procedure 程序
Record the name, serial number, model, the calibration certificate number, calibration dates, and
the next calibration dates of instruments used for the protocol test, and attach copy of calibration
certificate. Check whether it can be traced back to National Standards of Measurement.
记录本方案测试用仪器仪表名称、序列号、型号、校准证书编号、校准日期以及有效期至，
并附上仪器校准证明复印件。检查是否能够追溯到国家计量基准。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Test Instruments Calibration Qualification

测试用仪器仪表校准确认
Calibration Calibration 校准
Instruments Name Manufacture Serial No. Model
Certificate No. Cal. Date Due Date
仪器仪表名称生产厂家系列号型号
校准证书编号校准日期有效期至
Att. ID 附件编号：____________________________________________

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Conclusion
结论
Remarks 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10.5. Documentation Qualification 文件确认

Purpose 目的
Verify all documents which should be supplied to user are applicable and conform to the user
requirements.
确认此项目需要提供给用户的所有文件都可用并符合用户需求。
All documents have been approved, which include document name, document number, version and
issuing date.
所有的文件都已被批准，同时文件中应有文件名称、文件编号、版本、颁布日期。
Procedure 程序
Check documents one by one, record the document number, version, issuing date and relevant
approval status.
对现有的文件进行逐个确认，记录文件编号、版本、颁布日期和相关的批准状态。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Documentation Qualification
文件确认
Document Name Document No. Version Issuing Date Applicable and Approved
文件名称文件编号版本颁布日期是否适用的和被批准的
Layout Drawing
Yes ( ) No ( )
平面布局图
P & ID
Yes ( ) No ( )
管道和仪表工艺图
Wiring Drawing
2021-054LTc-WD Yes ( ) No ( )
电气图
Design Qualification
2021-054LTc -DQ Yes ( ) No ( )
设计确认
Site Acceptance Test

2021-054LTc-SAT Yes ( ) No ( )
客户现场验收测试
Installation
Qualification 2021-054LTc-IQ Yes ( ) No ( )
安装确认
Installation Manual
LT-IM Yes ( ) No ( )
安装手册
Operation Manual
LT-OM Yes ( ) No ( )
操作手册
Maintenance Manual
LT-MM Yes ( ) No ( )
维护手册
Main Components
List 2021-054LTc-MCL Yes ( ) No ( )
主要部件清单
Spare Parts List

2021-054LTc-SPL Yes ( ) No ( )
备品备件清单
Material of
Certificate 2021-054LTc-MOC Yes ( ) No ( )
材质证明
Main Components
Instructions List
2021-054LTc-MCI Yes ( ) No ( )
主要部件说明书清
单

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Conclusion
结论
Remarks 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10.6. Installation Check 安装检查

Purpose 目的
Verify that the installation of the machine conforms to the latest approved drawings.
确认设备的安装与已批准的最新版的图纸相符。
Detail acceptance criteria refer to the following table.
详细接受标准参见下表。
Procedure 程序
Copy the relevant drawings (see the following table), and record the Drawing No. and Version in
the table.
复印相关图纸(参见下表)，在表格中记录图号和修订版本。
Compare the drawing against the installation and highlight the drawing in green when field
observed condition matches drawing.
比较图纸和现场安装。如果现场安装与图纸一致，用绿色荧光笔在图纸上标识。
Compare the drawing against the installation and highlight the drawing in RED when field
observed condition doesn’t match drawing. Correct with RED ink.
比较图纸和现场安装。如果现场安装与图纸不一致，用红色荧光笔在图纸上标识，并用红
色水笔纠正。
Attach all the checked drawings to this test.
此项测试附上检查的所有图纸。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Installation Check
安装检查
Relevant Drawing Information Acceptance Criteria Yes/No

相关图纸信息接受标准是否符合要求
No components missing.
Yes ( ) No ( )
没有部件缺失。
P&ID The type, installation and specification of

管道和仪表工艺图 component are consistent with the P&ID without
apparent damage condition. Yes ( ) No ( )
Drawing No.图号：部件的类型、安装方式、规格与 P& ID 一致，
无明显的损坏。
Version：版本： The indicator of the machine, parts, instruments

(including the nameplate, ID etc.) are complete
and clear. Yes ( ) No ( )
设备、部件、仪表的标示（铭牌、编号等）完
整、清晰。
The relative position, shape and external

dimensions are in accordance with those marked
on the approved layout drawing (the tolerance
Layout Drawing range: length and width within ±20mm, height can
Yes ( ) No ( )
平面布局图 be adjusted within 950±20mm).
设备的相对位置、外型和外部尺寸与批准的平
Drawing No.图号：面布局图上所标注的相符(公差范围：长和宽在
±20mm，高度 950±20mm 内可调节)。
Version：版本： Position and connection of all utility are in

accordance with the approved layout drawing.
Yes ( ) No ( )
公用设施的位置和接口与批准的平面布局图相
符。
Wiring Drawing The layout of all the components in the control

cabinet is in accordance with the wiring drawing.
电气图 Yes ( ) No ( )
电器柜内所有元器件布置均与电气图纸相一
Drawing No.图号：致。
The wiring is in accordance with the wiring

Version：版本： drawing. Yes ( ) No ( )
实际接线与电气图线图相符合。
Att. ID 附件编号：_______________________________________

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Conclusion
结论
Remarks 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10.7. Critical Materials Certificate Qualification 关键材料材质证明确认

Purpose 目的
Verify whether materials of surface that direct or indirect contacting with product conform to GMP
or user requirements.
确认与产品直接或间接接触的材料是否符合 GMP 或用户的要求。
All metal material in contact with products or cleaning medium should be 316 (L) or 304 stainless
steel or other material required by user.
所有与产品或清洗介质接触的金属材料必须使用 SS316(L)或 SS304 不锈钢或其它用户要求的
材料。
All non- metallic material in contact with products or cleaning medium should be POM, silicone or
other material required by user or GMP.
所有与产品或清洗介质接触的非金属材料必须使用聚甲醛、硅胶等符合 GMP 或用户要求的材
料。
Procedure 程序
Obtain the copy of the material of certificate list, and record the document number and version
number in the result table.
复印材质证明清单，记录文件编号、版本在表格中。
According to the list, check the supplied certificates one by one and verify that the critical material is
in accordance with GMP or user requirements.
根据清单，逐一核对所提供的材质证明，确认关键材质符合 GMP 或用户要求。
Fill "OK" in remark of the list when the material of certificate matches the requirements. Fill in the
result in remark of the list when the material of certificate doesn’t match the list requirements.
如果材质证明与要求一致，在清单的备注一列中填“OK”；如果材质证明与要求不一致, 在清
单的备注一列中填写结果。
Attach the material of certificate list for this test.
此项测试附上检查的材质证明清单。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Critical Materials Certificate Qualification

关键材料材质证明确认
Document Name Document No. Version
文件名称文件编号版本
Material of Certificate List
材质证明清单
No. Description Yes/No

序号描述是否符合要求
All certificates informations match with the requirements.

1. Yes ( ) No ( )
所有提供的证书证明材料与要求相符。
Att. ID 附件编号：________________________________________________________________

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Conclusion
结论
Remarks 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10.8. Main Components Check 主要部件检查

Purpose 目的
Verify that the critical components of the machine comply with approved main components list。
确认设备的关键部件与已批准的主要部件清单一致。
The installed components are in accordance with the main components list.
实际安装部件与主要部件清单一致。
Procedure 程序
Obtain the copy of the main components list.
取得主要部件清单复印件。
Compare the main components list against the installation, and fill "OK" in remark of the main
components list when the observed condition matches the main components list. Fill out the actual
result in remark of the main components list when the observed condition doesn’t match the main
components list.
比较主要部件清单和现场安装。如果现场安装与主要部件清单一致，在清单的备注一列中
填“OK”；如果现场安装与主要部件清单不一致, 在清单的备注一列中填写实际结果。
Attach the checked main components list to this test.
此项测试附上检查的主要部件清单。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Main Components Check

主要部件检查
Document Name Document No. Version
文件名称文件编号版本
Main components list
主要部件清单
Verified Item and Acceptance Criteria Yes/No

检查项目和可接受标准是否符合要求
The installed components are in accordance with the main components list. Yes ( ) No ( )
实际安装部件与主要部件清单一致。
Att. ID 附件编号: _____________________________________

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Conclusion
结论
Remarks 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10.9. Instruments Calibration Qualification 仪器仪表校准确认

Purpose 目的
Verify that all instruments are calibrated and are within the calibration due date.
确认所有仪器仪表均被校验且在有效期内。
All the instruments had been calibrated and are within the validity and the calibration report are
exist and readable.
所有仪器仪表均已校准，且在有效期内，校准文件存在、可读。
Measurement standard for calibration can be traced back to National Standards of Measurement.
用于校准的计量标准能够追溯到国家计量基准。
Procedure 程序
Check whether the calibration certificates provided are consistent with the installed instrument
according to the calibration certificates list.
根据校准证书清单检查提供的校准证书与现场安装的仪器仪表是否相符。
After execution, the executor signs and dates on the calibration certificates list.
确认后，确认者在校准证书清单上签名及注明日期。
Check whether the calibration certificate of the instrument is valid and can be traced back to
National Standards of Measurement. Record the calibration certificate number, calibration date and
due date of instrument.
检查仪器仪表的校准证书是否在有效期内并能够追溯到国家计量基准，记录校准准证书编
号、校准日期以及有效期至。
Attach the checked calibration certificates list to this test.
此项测试附上检查的校准证书清单。
Notes 备注：
Tofflon is responsible for the calibration of instruments, Tofflon is only responsible for the first
calibration.
仪器仪表由东富龙负责校验，东富龙只负责首次校验。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Instruments Calibration Qualification

仪器仪表校准确认
Calibration Certificate Calibration 校准

No. Instruments Name Yes/No
No. Cal. Date Due Date
序号仪器仪表名称是否符合要求
Yes ( )
1.
No ( )
Yes ( )
2.
No ( )
Yes ( )
3.
No ( )
Yes ( )
4.
No ( )
Yes ( )
5.
No ( )
Yes ( )
6.
No ( )
Yes ( )
7.
No ( )
Yes ( )
8.
No ( )
Yes ( )
9.
No ( )
Yes ( )
10.
No ( )
Yes ( )
11.
No ( )
Yes ( )
12.
No ( )
Yes ( )
13.
No ( )
Yes ( )
14.
No ( )
Yes ( )
15.
No ( )
Yes ( )
16.
No ( )

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Calibration Certificate Calibration 校准

No. Instruments Name Yes/No
No. Cal. Date Due Date
序号仪器仪表名称是否符合要求
Yes ( )
17.
No ( )
Yes ( )
18.
No ( )
Yes ( )
19.
No ( )
Yes ( )
20.
No ( )
Yes ( )
21.
No ( )
Yes ( )
22.
No ( )
Yes ( )
23.
No ( )
Yes ( )
24.
No ( )
Yes ( )
25.
No ( )
Yes ( )
26.
No ( )
The calibration certificates provided are in conformity with the installed instruments. Yes ( )
提供的校准证书与现场安装的仪器仪表相符。 No ( )
Att. ID 附件编号：_______________________________________________________________________

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Conclusion
结论
Remarks 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10.10. Utilities Check 公用设施检查

Purpose 目的
Verify the utilities required for operation have been correctly connected.
确认设备运行需要的公用设施已经正确连接。
Verify the utility parameters for operation are conforming to the use requirements.
确认设备运行需要的公用设施参数满足使用要求。
All the utilities are correctly connected and their operative parameters are in accordance with the
design.
所有的公用设施已经正确连接，公用设施的操作参数符合设计要求。
Procedure 程序
Verify all the utilities necessary to equipment are correctly connected.
确认与设备有关的所有的公用设施已经正确连接。
List all the utilities and fill the following table.
列出所有的公用设施，完成以下表格。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Utilities Check
公用设施检查
No. Item Requirements Actual Results Yes/No

序号项目要求实际结果是否符合要求
Electrical
电源
Power Supply 3Phase 5Wires Yes ( ) No ( )
电源类型
Voltage [V]
380±10% Yes ( ) No ( )
电压 [V]
1
Frequency [Hz] 50 Yes ( ) No ( )
频率 [Hz]
Total Power [kW] ≈125 Yes ( ) No ( )
总功率 [kW]
Cleaning Compressed Air
洁净压缩空气
Connected load of
cleaning compressed
air in [bar] 6~7 Yes ( ) No ( )
洁净压缩空气负荷
[bar]
2
Cleaning compressed
air inlet [mm]
φ8 Yes ( ) No ( )
洁净压缩空气进口
[mm]
Cooling Water
冷却水
Connected load of
cooling water in [bar] 3~6 Yes ( ) No ( )
冷却水负荷[bar]
Supply temperature of
cooling water min/max
3 in (℃) 7~12℃ Yes ( ) No ( )
冷却水最低/最高温度
(℃)
Cooling water inlet

TRI-Clamp2＂
/outlet Yes ( ) No ( )
2＂卡箍式接头
冷却水进口/出口
Purified Water
纯化水

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
No. Item Requirements Actual Results Yes/No

序号项目要求实际结果是否符合要求
Connected load of
purified water in [bar] 2~3 Yes ( ) No ( )
纯化水负荷[bar]
4
Connection type TRI-Clamp1.5＂
Yes ( ) No ( )
接口类型 1.5＂卡箍式接头
Air Volume
风量
Air outlet connection of
pre-heating zone[mm] 140mm x325mm Yes ( ) No ( )
预热段排风口[mm]
5
Air outlet connection of
cooling zone[mm] 140mm x325mm Yes ( ) No ( )
冷却段排风口[mm]

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Conclusion
结论
Remarks 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
11. Deviation Handling 偏差处理
If the qualification result is not conformity with acceptance criteria, it shall be filled in deviation record
and determine the comments. If there are many deviation records, they should be marked number in the
deviation forms.
如果确认结果与验收标准不符，应当填写偏差记录，明确处理意见，如果有多份偏差记录，则在
偏差表上必须填好编号。
An independent ID is necessary for each deviation. Numbering for deviation shall be as per: D + section
number-sequence number, such as the D10.1-01, means the first deviation of 10.1 section.
每个偏差需要一个独立的编号。编号原则为：D+章节编号-顺序号，例如 D10.1-01，代表 10.1 章
节的第一个偏差。
Collect all found deviations during the IQ and record.
收集 IQ 中发生的所有偏差并记录。
For all the found deviations during IQ, Tofflon need to provide solutions to close these deviations and the
customer has responsible for reviewing and approving the solutions.
IQ 中发现的偏差，东富龙需提出解决方法，由客户审核、批准解决方案。
If there are too many deviation points and deviation list is not enough to record, the blank deviation list
can be copied.
如果偏差项太多，偏差清单不够用，可复印空白的偏差清单。
Indicate page number in upper right corner.
在右上角注明页码。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Deviation List
偏差清单
(Page of )
Deviation Other
Deviation Description Deviation Correction Attachments Conclusion
ID Description
偏差描述偏差整改附件结论
偏差编号其他说明
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
12. Change Control 变更控制
Any change for this protocol, it shall be filled in change report and determine the comments.
如果需要对本文件变更，应填写变更报告，明确处理意见。
An independent ID is necessary for each Changing. Numbering for Changing shall be as per: C + section
number-sequence number, such as the C10.1-01, means the first changing of 10.1 section.
每个变更需要一个独立的编号。编号原则为：C+章节编号-顺序号，例如 C10.1-01，代表 10.1 章
节的第一个变更。
Collect all found changes during the IQ and record.
收集 IQ 中发生的所有变更并记录。
For all the found changes during IQ, Tofflon need to provide solutions to close these deviations and the
customer has responsible for reviewing and approving the solutions.
IQ 中发现的变更，东富龙需提出解决方法，由客户审核、批准解决方案。
If there are too many change points and change list is not enough to record, the blank change list can be
copied.
如果变更项太多，变更清单不够用，可复印空白的变更清单。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Change List
变更清单
(Page of )
Change Other
Change Description Change Correction Attachments Conclusion
ID Description
变更描述变更整改附件结论
变更编号其他说明
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
13. Punch List 遗留清单
If there are any issues which need to be verified in following work and a punch list shall be drafted as per
the requirements.
如果尚有未决事项需要遗留到后续工作，则需要按照遗留项目要求起草遗留工作清单。
An independent ID is necessary for each pending item. Numbering for pending item shall be as per: P +
section number-sequence number, such as the P10.1-01, means the first pending item of 10.1 section.
每个遗留项目需要一个独立的编号。编号原则为：P+章节编号-顺序号，例如 P10.1-01，代表 10.1
章节的第一个遗留项目。
Collect and record all punch points during the IQ execution.
收集 IQ 中的所有遗留项并记录。
If there are too many punch points and punch list is not enough to record, the blank punch list can be
copied.
如果遗留项目太多，遗留清单不够用，可复印空白的遗留清单。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Punch List
遗留清单
(Page of )
Punch
Other
List ID Pending Item Description Pending Item Correction Attachments Conclusion
Description
遗留清单遗留项目描述遗留项目整改附件结论
其他说明
编号
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
N/A ( ) Yes ( )
Att. ID: No ( )
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
14. Attachment List 附件清单
Record all documents attached to this protocol.

记录所有附在本报告中的文件。
An independent ID is required for each attachment. Numbering principle: A+section number-sequence
number, such as the A10.1-01, means the first attachment of 10.1 section.
每个附件需要一个独立的编号。编号原则为：A+章节编号-顺序号，例如 A10.1-01，代表 10.1 章
节的第一个附件。
The executor should sign and date on the first and last page, indicate page number on each page as per
X/X, such as the 1/10, means the first page of a ten page attachment.
执行人员应在附件的首末页签字，并在每页上注明页码：X/X，例如：1/10，代表一个共有 10 页
的附件的第一页。
If there are too many attachments and attachment list is not enough to record, the blank attachment list
can be copied.
如果附件太多，附件清单不够用，可复印空白的附件清单。

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Attachment List
附件清单
(Page of )
Attachment ID Attachment Description Pages
附件编号附件描述页数

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
15. IQ Summary IQ 总结
15.1. Test Result Summary 测试结果汇总
Test No. Test Name Conclusion Deviation ID Punch List ID

测试编号测试名称结论偏差编号遗留清单编号
Prerequisites N/A ( ) N/A ( )

10.1 Yes ( ) No ( )
先决条件 Dev. ID: PL. ID:
SAT Punch List Closeout N/A ( ) N/A ( )

10.2 Qualification Yes ( ) No ( )
SAT 遗留清单关闭确认 Dev. ID: PL. ID:
Test Leveraging N/A ( ) N/A ( )

10.3 Yes ( ) No ( )
测试引用 Dev. ID: PL. ID:
Test Instruments Calibration N/A ( ) N/A ( )

测试用仪器仪表校准确认 Dev. ID: PL. ID:
Documentation Qualification N/A ( ) N/A ( )

10.5 Yes ( ) No ( )
文件确认 Dev. ID: PL. ID:
Installation Check N/A ( ) N/A ( )

10.6 Yes ( ) No ( )
安装检查 Dev. ID: PL. ID:
Critical Materials Certificate N/A ( ) N/A ( )

关键材料材质证明确认 Dev. ID: PL. ID:
Main Components Check N/A ( ) N/A ( )

10.8 Yes ( ) No ( )
主要部件检查 Dev. ID: PL. ID:
Instruments Calibration N/A ( ) N/A ( )

仪器仪表校准确认 Dev. ID: PL. ID:
Utilities Check N/A ( ) N/A ( )

10.10 Yes ( ) No ( )
公用设施检查 Dev. ID: PL. ID:
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

Doc. No.
2021-054LTc-IQ
文件编号
IQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
15.2. IQ Conclusion IQ 结论
Review the test result and data, and give a final conclusion for IQ of Sterilizing Depyrogenating
Tunnel.
对测试结果和数据进行审核，得出灭菌去热原烘箱安装确认的最终结论。
IQ Review and Approval:

IQ 审核与批准：
Department or Company Result Signature/Date

部门或公司结果签名/日期
CHECKED BY:
(by Supplier) Yes ( ) No ( )
核查（供应商）
REVIEWED BY:
(by Customer) Yes ( ) No ( )
审核（用户）
REVIEWED BY:
审核（用户）
REVIEWED BY:
审核（用户）
REVIEWED BY:
审核（用户）
APPROVED BY:
批准（用户）


2021 054LTc IQ V1.0 2021.11.19

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

2021 054LTc IQ V1.0 2021.11.19

Uploaded by

Copyright:

Available Formats

INSTALLATION QUALIFICATION

Tofflon Science and Technology NO./编号:

INSTALLATION QUALIFICATION FOR

EXPERTISE IN PHARMACEUTICAL INDUSTRY

ADD: 139, DUHUI RD.,SHANGHAI -201108 CHINA

Installation Qualification for

Document Approval 文件批准

Department Name Signature Date

Packaging Machine Department Carol Ning

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Version History 版本历史

Version 版本 Issued Date 颁布日期 Reason for Issue 颁布原因

V 1.0 Initial Issue 首次发布

EXPERTISE IN PHARMACEUTICAL INDUSTRY

EXPERTISE IN PHARMACEUTICAL INDUSTRY

EXPERTISE IN PHARMACEUTICAL INDUSTRY

EXPERTISE IN PHARMACEUTICAL INDUSTRY

7. Documentation Control Specification 文件管理规范

Recording Pens 记录用笔：

Correction of Mistakes 更改错误：

EXPERTISE IN PHARMACEUTICAL INDUSTRY

8. Test List 测试列表

Test No. Test Name

SAT Punch List Closeout Qualification

Test Instruments Calibration Qualification

Critical Materials Certificate Qualification

Main Components Check

Instruments Calibration Qualification

EXPERTISE IN PHARMACEUTICAL INDUSTRY

9. Personnel Identification 人员确认

Name Signature Company Title Date

EXPERTISE IN PHARMACEUTICAL INDUSTRY

10. Qualification Procedure 确认程序

EXPERTISE IN PHARMACEUTICAL INDUSTRY

The protocol for Sterilizing Depyrogenating Tunnel:

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

EXPERTISE IN PHARMACEUTICAL INDUSTRY

10.2. SAT Punch List Closeout Qualification SAT 遗留清单关闭确认

EXPERTISE IN PHARMACEUTICAL INDUSTRY

SAT Punch List Closeout Qualification

Attach the copy of SAT Punch List.

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

EXPERTISE IN PHARMACEUTICAL INDUSTRY

10.3. Test Leveraging 测试引用

EXPERTISE IN PHARMACEUTICAL INDUSTRY

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

EXPERTISE IN PHARMACEUTICAL INDUSTRY

10.4. Test Instruments Calibration Qualification 测试用仪器仪表校准确认

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Test Instruments Calibration Qualification

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

EXPERTISE IN PHARMACEUTICAL INDUSTRY

10.5. Documentation Qualification 文件确认

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Site Acceptance Test

Spare Parts List

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________