2021 054LTc OQ V1.0 2022.1.18

OPERATIONAL QUALIFICATION
运行确认
CUSTOMER NAME/客户名称:
VACSERA
SUPPLIER NAME/供应商:
Tofflon Science and NO./编号:

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

STERILIZING DEPYROGENATING TUNNEL
灭菌去热原烘箱运行确认
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-OQ
文件编号
OQ
Model
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型号
Operational Qualification for
Version V 1.0
Tofflon Science
Sterilizing Depyrogenating Tunnel 版本号
and Technology Group Co.,Ltd.
灭菌去热原烘箱运行确认 Page
东富龙科技集团股份有限公司 1 of 87-1
页码

Sterilizing Depyrogenating Tunnel
灭菌去热原烘箱运行确认
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
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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

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Index 目录
1. Purpose 目的...............................................................................................................................................5
2. Scope 范围..................................................................................................................................................5
3. Abbreviations 缩略语..................................................................................................................................5
4. Responsibilities 职责...................................................................................................................................6
5. References 参考文件..................................................................................................................................7
6. System Description 系统描述.....................................................................................................................7
7. Documentation Control Specification 文件管理规范.................................................................................8
8. Test List 测试列表....................................................................................................................................10
9. Personnel Identification 人员确认............................................................................................................12
10. Qualification Procedure 确认程序..........................................................................................................13
10.1. Prerequisites 先决条件.................................................................................................................13
10.2. IQ Punch List Closeout Qualification IQ 遗留清单关闭确认.....................................................16
10.3. Test Leveraging 测试引用............................................................................................................19
10.4. Test Instruments Calibration Qualification 测试用仪器仪表校准确认......................................22
10.5. SOP Qualification SOP 确认.......................................................................................................25
10.6. HMI Navigation Test HMI 导航测试...........................................................................................28
10.7. System Access Test 系统访问测试..............................................................................................31
10.8. Alarm Test 报警测试...................................................................................................................34
10.9. Power Recovery Test 断电恢复测试...........................................................................................37
10.10. Recipe Function Qualification 配方功能确认............................................................................40
10.11. Audit Trail Test 审计追溯测试..................................................................................................43
10.12. Data Back-Up and Recovery Qualification 数据备份和还原确认............................................46
10.13. Entry Field Boundary Test 输入字段边界测试.........................................................................49
10.14. Air Velocity Test 风速测试........................................................................................................52
10.15. HEPA Filter Integrity Test 高效过滤器完整性测试.................................................................57
10.16. Non-Viable Particle Test 悬浮粒子测试....................................................................................63
10.17. Differential Pressure Test 压差测试...........................................................................................68
10.18. Empty Chamber Temperature Distribution Test 空载温度分布测试........................................71
10.19. Operational Process Test 运行程序测试....................................................................................76
10.20. System Operational Test 系统运行测试....................................................................................79
10.21. Full Load Temperature Penetration Test 满载热穿透测试........................................................82
10.22. Surface Temperature Test 箱体表面温度测试..........................................................................89

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11. Deviation Handling 偏差处理.................................................................................................................92

12. Change Control 变更控制.......................................................................................................................94
13. Punch List 遗留清单...............................................................................................................................96
14. Attachment List 附件清单......................................................................................................................98
15. OQ Summary OQ 总结.........................................................................................................................100
15.1. Test Result Summary 测试结果汇总.........................................................................................100
15.2. OQ Conclusion OQ 结论............................................................................................................102

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1. Purpose 目的
The purpose of Operational Qualification (OQ) is to establish, through documented testing, that all critical
components are capable of operating within established limits and tolerances. It is the process of testing to
ensure that individual components and systems operate as specified, and how that information is recorded.
OQ is an activity that is regulated by the Current Good Manufacturing Practice, and is a part of final
qualification activities before process validation begins.
运行确认的目的是通过测试证明所有关键部件能够在已制定的界限及承受能力下运行。这是一个测
试的过程，来确保独立部件和系统能够按照规定运行，并记录信息。运行确认是 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
Deviation
Dev.
偏差
Design Qualification
DQ
设计确认
Good Manufacturing Practice
GMP
药品生产质量管理规范
Human Machine Interface
HMI
人机界面
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
Laminar Air Flow
LAF
层流

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Abbreviations Definition
缩略语定义
Leveraging
Lev.
引用
Not Applicable
N/A
不适用
Number
No.
序号
Operational Qualification
OQ
运行确认
Piping and Instrumentation Diagram
P&ID
管道和仪表工艺图
Punch List
PL.
遗留项目清单
Site Acceptance Test
SAT
现场验收测试
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 OQ protocol;
OQ 方案的起草、审核及预批准；
 Execution of OQ;
OQ 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；
 Record and handling deviation/change which occurred during OQ;
记录及处理 OQ 过程中发生的偏差/变更；
 Submit the OQ documentation for customer to review and approve.
提交 OQ 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 OQ protocol;
OQ 方案审核及批准；
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 Assistant to record and handle the deviation/change occurred during the execution of OQ;
协同记录和处理 OQ 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
 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.
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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,
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.

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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

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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
IQ Punch List Closeout Qualification
10.2
IQ 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
SOP Qualification
10.5
SOP 确认
HMI Navigation Test
10.6
HMI 导航测试
System Access Test
10.7
系统访问测试
Alarm Test
10.8
报警测试
Power Recovery Test
10.9
断电恢复测试
Recipe Function Qualification
10.10
配方功能确认
Audit Trail Test
10.11
审计追溯测试
Data Back-Up and Recovery Qualification
10.12
数据备份和还原确认
Entry Field Boundary Test
10.13
输入字段边界测试
Differential Pressure Test
10.14
压差测试
Empty Chamber Temperature Distribution Test
10.15
空载温度分布测试
Operational Process Test
10.16
运行程序测试
System Operational Test
10.17
系统运行测试
Full Load Temperature Penetration Test
10.18
满载热穿透测试
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Test No. Test Name

测试编号测试名称
Surface Temperature Test
10.19
箱体表面温度测试

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9. Personnel Identification 人员确认
All persons involving in this protocol must sign in the following form before OQ execution. All persons
must be trained to ensure that they are competent for OQ work.
在开始执行 OQ 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 OQ 工作。
Name Signature Company Title Date

姓名签名公司职务日期

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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。

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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：_______________________

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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

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

Purpose 目的
Verify the issue which were documented during the IQ, and required to be verified during OQ had
been addressed.
确认执行 IQ 过程中记录的需要遗留到 OQ 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 IQ and which should be verified during OQ had been appropriately
addressed as per the resolution listed next to each issue.
在 IQ 活动中确定的需要在 OQ 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 Punch List of IQ.
取得 IQ 测试的遗留清单的复印件。
Review and remark each item which shall be verified during OQ and verify it had been
appropriately “closed” as per the resolution listed in Punch List.
在 OQ 期间逐一审核，确认每一项遗留到 OQ 的项目均已得到合适的解决并关闭，并在该遗
留清单中进行标注。
And some issues which are required to be closed upon successful test execution as part of OQ. 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 OQ 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 IQ punch list to this test.
附上此项测试的 IQ 遗留清单复印件。

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IQ Punch List Closeout Qualification

IQ 遗留清单关闭确认
Description Yes/No
描述是否符合要求
The issues identified during IQ and which should be verified during OQ had been
appropriately addressed as per the resolution listed next to each issue.
Yes ( ) No ( )
在 IQ 活动中确定的需要在 OQ 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 IQ Punch List.

附上 IQ 遗留清单复印件。
Att. ID 附件编号：__________________________________________________________

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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

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10.3. Test Leveraging 测试引用

Purpose 目的
Summary the leveraging test items that are required in OQ document, but had been performed in
FAT, SAT and IQ, and verify these test items had been released.
汇总需要在 OQ 阶段执行，但实际已经在 FAT、SAT 及 IQ 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, SAT or IQ 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、SAT 或 IQ 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 OQ document and review the test items required by OQ, and verify
whether them had been performed in FAT, SAT or IQ.
根据已批准的 OQ 文件中执行的测试项目，确认其是否在 FAT、SAT 或 IQ 中已经被执行过。
If a test item had been executed in FAT, SAT or IQ successfully, and this test item had been defined
in this protocol also, review the test condition of FAT, SAT and IQ, 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、SAT 或 IQ 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、SAT 或 IQ 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, SAT or IQ 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、SAT
或 IQ 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。

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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

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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

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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。

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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：____________________________________________

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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

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10.5. SOP Qualification SOP 确认

Purpose 目的
Verify the documents for operational and maintenance of the equipment.
确认设备运行及维护所需的 SOP 文件状态。
The documents for operational and maintenance of the equipment had been prepared or approved.
设备运行及维护所需的文件已起草或批准。
Procedure 程序
Check that the SOPs needed for operational and maintenance of the equipment are available and
they have been approved or have been drafted.
检查设备运行和维护所需要的 SOP 是否都存在，并确认其处于已批准或草稿状态。
Record the document information in the table, here including the Doc. Name, No. and Version No.,
and Review & Approval Status.
将文件信息记录在表格中，包括文件名称、编号、版本号及签批状态。
Customer is responsible for SOP documents.
SOP 文件由客户负责。

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SOP Qualification
SOP 确认
Doc. Name Doc. No. Ver. No. Status

文件名称文件编号版本号状态
Approved 已批准 ( )
Draft 草稿 (
)
Draft 草稿 (
)
Draft 草稿 (
)
Draft 草稿 (
)
Draft 草稿 (
)

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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

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10.6. HMI Navigation Test HMI 导航测试

Purpose 目的
Confirm HMI Custom Displays and Navigation are correctly setup.
确认 HMI 常规显示和导航被正确设定。
All the interfaces are present and the displays operation and navigation are correctly and meet the
user requirements.
所有界面存在，且画面显示、操作及导航切换均正确，并符合用户需求。
Procedure 程序
Perform the test referring the test table and check in site.
参见测试表格, 进行现场核查。
Record the check result and mark the non-conformities.
记录检查结果并标注出不符合项。

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HMI Navigation Test

HMI 导航测试
Execution Items Expected Result Yes/No

执行动作预期结果是否符合要求
Control System Menu Verification

控制系统菜单确认
Click the menu to be verified The menu is opened Yes ( )
点击菜单菜单打开 No ( )
Close the menu to be verified The menu is closed Yes ( )
关闭菜单菜单关闭 No ( )
The navigation is permitted in the all existing
Navigate in the menu Yes ( )
menu
在菜单中导航 No ( )
能够在所有可见菜单中进行导航
Click the sub menu to be verified All the existing sub menu are properly working Yes ( )
点击下级菜单所有可见下级菜单均正确工作 No ( )
Control System Graphic Pages Navigation Verification

控制系统画面导航确认
Open the graphic page The graphic page is opened Yes ( )
打开画面画面打开 No ( )
Close the graphic page The graphic page is closed Yes ( )
关闭画面画面关闭 No ( )
Activate and deactivate, one at a time, all
The devices in the synoptic graphic page
the devices showed in the synoptic graphic
shown the real state of the activated
page one by one (only if applicable for this Yes ( )
/deactivated devices
page) No ( )
主画面上的能够显示装置激活/复位的实际
将主画面上的装置逐一激活和复位（只
状态
在本页面存在的情况下）

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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

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10.7. System Access Test 系统访问测试

Purpose 目的
Verify that the access to the control system is only allowed with pre-defined access password.
确认只有输入预先授权的口令才可以进入控制系统相应的界面。
The use of correct password must allow the access to each specified functions.
使用正确的密码能有权使用所指定的功能。
Verify that the access to the control system need electronic signature.
确认进入控制系统相应的界面需要电子签名。
Access to the control system is allowed only after entering the relevant correct access key
(password). The access is automatically denied if a wrong password is entered.
只有在输入相应正确的口令可以进入控制系统，错误的口令将自动拒绝。
The use of correct password must allow the access to each specified functions.
使用正确的密码能有权使用所指定的功能。
Execute the corresponding functions are required to electronic sign as the system access list.
如系统访问清单，执行对应功能时需要电子签名。
Procedure 程序
Obtain the copy of the system access list, and record the document number and version number in
the result table.
复印系统访问清单，记录文件编号、版本在表格中。
For each human interface to the control system and for each access level enter the corresponding
password and verify the allowed control system functions, repeat the procedure entering a wrong
password, verify the denied access.
对每个控制系统的人机界面和进入等级，输入相应的口令，确认允许进入控制系统的相应
功能，使用相同步骤输入错误的口令，确认拒绝进入。
Log in at different levels of users and check whether the relevant operations can be performed and
be electronic signature.
以各级用户登录，测试是否可以进行相应的操作及是否需要电子签名。
Fill "OK" in remark of the list when the system access matches the requirements. Fill in the result
in remark of the list when the system access doesn’t match the list requirements.
如果系统访问与要求一致，在清单的备注一列中填“OK”；如果系统访问与要求不一致, 在
清单的备注一列中填写结果。
Attach the system access list for this test.
此项测试附上检查的系统访问清单。

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System Access Test

系统访问测试
Document Name Document No. Version

文件名称文件编号版本
System Access List

系统访问清单
Verified Item and Acceptance Criteria Yes/No

检查项目和可接受标准是否符合要求
The system access and electronic signature are in accordance with the system
access list. Yes ( ) No ( )
实际系统访问权限和电子签名与系统访问清单一致。
Att. ID 附件编号: _____________________________________

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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

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10.8. Alarm Test 报警测试

Purpose 目的
Verify that alarm will be activated properly and can be reset properly.
确认报警能被正确触发和复位。
Alarm is correctly generated, expected results and action due to alarm triggering is in accordance
with alarm list.
报警正确地产生预计的结果和行动，与报警清单一致。
Procedure 程序
The alarm list will be used as test scheme. The alarm tests are performed in operational mode.
将报警清单作为测试方案。报警测试要在正常操作模式下进行。
For key alarm, generate an alarm condition using one of the following methods:
对关键报警，使用下面所列的方法之一来产生报警：
 Modify the alarm threshold.
改变报警限。
 Use a proper signal generator.
使用适当的信号发生器。
 Disconnecting the device (sensor, photocell, instruments).
断开设备（传感器、光电管、仪器仪表）。
 Disconnecting or shorting the signal cable (only applicable for digital signals).
断开或短接信号线（仅对数字信号）。
 Simulating ‘real condition’ (e.g.: putting the element in the warm bath to simulate the high
temperature).
模拟“真实的条件”（例如将元件放入水浴中模拟高温）。
Make sure that all the alarm work properly.
确认报警功能正常。
Note: No alarm shall be triggered in a way that could damage the unit.
注：不能以有可能损坏系统的方式触发报警。
Print alarm record.
打印报警记录。
Attach the checked alarm record and alarm list to this test.
此项测试附上检查的报警记录及报警清单。

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Alarm Test
报警测试
Document Name Document No. Version

文件名称文件编号版本
Alarm List
报警清单
Alarm Test Yes/No

报警测试是否符合要求
Alarm is correctly generated, expected results and action due to alarm triggering is in
accordance with alarm list. Yes ( ) No ( )
报警正确地产生预计的结果和行动，与报警清单一致。
Att. ID 附件编号：____________________________________________

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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

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10.9. Power Recovery Test 断电恢复测试

Purpose 目的
Verify the machine will halt when the power is cut off during the normal operation.
确认设备正常运行时如果断电设备将停止运行。
Verify the machine enter the standby model when the power is restored.
确认设备恢复电源后，系统处于待机状态。
Verify there is no data loss.
确认设备没有数据丢失。
If the power supply is cut when the machine is in normal operation, all the programs that are
running before the power supply is cut would stop and there are no abnormal responses from the
machine and the operating parameters are not lost.
如果设备在正常运行时突然断电，所有断电前运行的程序将停止运行，设备无异常响应，
运行参数不会丢失。
Procedure 程序
Turn on the machine and run the machine at 50% speed（base on main size），to reduce the
machine damage.
首先启动设备，降速 50%运行设备(基于主规格)，以减少设备损伤。
When the program is running, cut off the power supply.
在程序运行过程时，切断设备电源，使设备断电。
Then restore the power supply 2 minutes later.
断电时间超过两分钟后，再重新给设备上电。
Visually inspect the operation of the machine.
目测设备运行情况。

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Power Recovery Test

断电恢复测试
Step Acceptance Criteria Result Yes/No

步骤接受标准实际结果是否符合要求
The system is running
Turn on the machine
normally Yes ( ) No ( )
启动设备
系统运转正常
Cut off the main power supply.
断开主电源 The running procedure
Power off time: stop. Yes ( ) No ( )
断电时间：运行的程序停止。
：～：；
The system enter the
standby model Yes ( ) No ( )
Restore the power 系统进入待机状态
恢复电源 The saved data is not
lost. Yes ( ) No ( )
保存的数据不会丢失

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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

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10.10. Recipe Function Qualification 配方功能确认

Purpose 目的
Confirm the validity and accuracy of the recipe and maintenance of the recipe;
确认提供的配方建立和维护的程序有效且准确；
Able to establish and maintain the equipment recipe (create, delete, storage, etc.) based on the
system file.
能够依据系统文件建立和维护设备配方（新建/创建、删除和存储等）。
Provide the recipe and maintenance of the program to effectively and accurately;
提供的配方建立和维护的程序有效且准确；
Able to establish and maintain the equipment recipe (create, delete, storage, etc.) based on the
system file.
能够依据系统文件建立和维护设备配方（新建/创建、删除和存储等）。
Procedure 程序
Start the system and perform the operation according to the following table.
启动系统，按照下表执行操作。

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Recipe Function Qualification

配方功能确认
Yes/No
No. Item
序号项目是否符合要求
Create recipe
1. Yes ( ) No ( )
新建/创建配方
View Recipe
2. Yes ( ) No ( )
查看配方
Modify Recipe
3. Yes ( ) No ( )
修改配方
Download Recipe
4. Yes ( ) No ( )
下载配方
Delete Recipe
5. Yes ( ) No ( )
删除配方

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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

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10.11. Audit Trail Test 审计追溯测试

Purpose 目的
Confirm whether the system's audit trail function meets the user requirements.
确认系统的审计追溯功能符合用户需求。
All the login, operation, setting and modification activities carried out in the system can be
recorded.
在系统上进行的所有登录、操作、设置和修改活动均可被记录。
Procedure 程序
Check the alarm and operational record through table personal computer and verify that the audit
trail information is correctly saved.
通过平板电脑检查操作记录及报警记录，审计追溯信息被正确储存。
Perform the activities on the touch screen such as: login and logout, set or change parameters,
change safety etc. And verify the activities of operator can be correctly traced, including time &
date, parameters and operator’s ID.
进行诸如登录登出、设定或更改参数、更改安全配置等活动，确认操作人员活动被正确追
溯，包括时间日期、参数值和操作人员 ID。
Print audit trail and system log records.
打印审计追溯和系统日志记录。
Attach the printed audit trail and system log records to this test.
此项测试附上打印的审计追溯和系统日志记录。

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Audit Trail Test

审计追溯测试
Item Yes/No
项目是否能被记录
Log in
Yes ( ) No ( )
登入
Log out
Yes ( ) No ( )
登出（注销）
Modify parameters
Yes ( ) No ( )
修改参数
Create user
Yes ( ) No ( )
新建用户
Delete user
Yes ( ) No ( )
删除用户
Information recorded includes (the printed copy can be attached).

被记录的信息包括（可附上打印件）。
Att. ID 附件编号：_______________________________________________________________

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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

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10.12. Data Back-Up and Recovery Qualification 数据备份和还原确认

Purpose 目的
Verify the system data can be stored correctly and can be back-up correctly through an appropriate
way.
确认系统数据能被正确存储并能通过合适的方式进行备份。
Verify that the back-up data can be restored correctly.
确认备份的数据能被正确还原。
The system data should be saved to a defined address.
系统数据可以被存储到指定的地址。
The format of system data cannot be modified.
系统数据为不可修改的格式。
System data can be back-up correctly.
系统数据可以被正确备份。
System data can be restored correctly.
系统数据可以被正确还原。
Procedure 程序
Perform the test referring to the test table.
参见测试表格。

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型号
Version V 1.0
Tofflon Science
页码
Data Back-Up and Recovery Qualification

数据备份和还原确认
No. Description Result Yes/No

序号描述结果是否符合要求
Visit the system by using an
administrator ID and visit the data
1 storage page. Yes ( ) No ( )
以管理员身份访问系统，并进入数
据存储页面。
Record the address of data storage.
2 Yes ( ) No ( )
记录数据存储的地址。
Record the format of database.

3 Yes ( ) No ( )
记录数据库的格式。
Try to modify the system data.

4 Yes ( ) No ( )
尝试修改系统数据。
Perform a data back-up, record the
approach and result of data back-up.
5 Yes ( ) No ( )
执行一次数据备份操作，记录数据
备份的处理方式和处理结果。
Perform a data restore, record the
approach and result of data restore.
6 Yes ( ) No ( )
执行一次数据还原操作，记录数据
还原的处理方式和处理结果。
Data storage capacity.
7 Yes ( ) No ( )
数据存储容量。

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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

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型号
Version V 1.0
Tofflon Science
页码
10.13. Entry Field Boundary Test 输入字段边界测试

Purpose 目的
Verify the control system limits the range of user entered data to the system. Entered data outside
of the range is rejected by the system.
确认控制系统限制了用户输入到系统的数据范围。输入的数据超出范围会被系统拒绝。
Values outside of the acceptable range are rejected; values within the acceptable range are
accepted.
数值超出接受范围会被拒绝；数值在接受范围之内会被接受。
Procedure 程序
Perform the test referring to the test table.
参见测试表格。

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型号
Version V 1.0
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页码
Entry Field Boundary Test

输入字段边界测试
Test Procedure Acceptance Criteria Yes/No

测试程序可接受标准是否符合要求
Select a numeric data field and type a

numeric value with the permitted range All numeric data field accept the
and the values permitted, repeat for all the numeric data and the data typed are
numeric data field (if applicable). correctly memorized. Yes ( ) No ( )
选择数字栏输入范围内的允许数值，在所有数字栏能够输入数据并且能够正
所有数据栏中重复此操作（如果存确保存。
在）。

numeric value out of the permitted range All numeric data field do not accept the
(less than low limit), repeat for all the numeric data out of the range and the
numeric data field (if applicable). data typed are not memorized. Yes ( ) No ( )
选择数字栏输入范围之外的数值（超出所有数据栏均不能接受和保存范围之
下限），在所有数据栏中重复此操作外的数据。
（如果存在）。

numeric value out of the permitted range All numeric data field do not accept the
(more than upper limit), repeat for all the numeric data out of the range and the
numeric data field (if applicable). data typed are not memorized. Yes ( ) No ( )
选择数字栏输入范围之外的数值（超出所有数据栏均不能接受和保存范围之
上限），在所有数据栏中重复此操作外的数据。
（如果存在）。

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2021-054LTc-OQ
文件编号
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Model
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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

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型号
Version V 1.0
Tofflon Science
页码
10.14. Differential Pressure Test 压差测试

Purpose 目的
This test is to check that the static set values of the differential pressure and the dynamic
oscillations at transient conditions are within the specified limits at the cooling zone (quantitative
test).
本测试检查烘箱冷却段的静态压差和运行时的动态压差在规定的范围内（定量测试）。
Under all test conditions of the differential pressure between cooling zone and room:  p  0 Pa.
冷却段与房间的压差在每个检查状态时 p  0 Pa。
Procedure 程序
Prior to the test, the person executing the test has to verify whether the last calibration of the
reference devices to be used is still valid.
在测试之前，测试执行人必须确认所使用的相关仪器经过校验且仍在有效期内。
The tunnel has to be heated up to its normal operation conditions (Dependent on customer and
format).
加热烘箱至正常生产条件（根据客户和规格确定）。
Tunnel started for the production mode.
烘箱开始以生产模式运行。
In the test sheets defined operation and transition conditions will be set and the differential
pressure in the different conditions will be record in the follow table..
根据测试表单，设定操作和传送条件，所有不同条件下冷却段压差需被记录在表格中。
If applicable, attach the machine recipe for this test.
如适用，附上该测试所用的配方。
Note 备注：
If the differential pressure transmitter installed on the machine has been verified and within the
validity period, the differential pressure data can be read directly.
若机器上的压差变送器已被校验且在有效期内，可直接读取数据。

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型号
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页码
Differential Pressure in Tunnel

烘箱压差确认
Conditions Expected Result Actual Result Yes/No

状态预期结果实际结果是否符合要求
Gate between cooling zone and
heating zone is open  p  0 Pa
冷却段与加热段之间的门打开
filling room is opening  p  0 Pa Yes ( ) No ( )
冷却段与灌装间的门打开中
filling room is closing  p  0 Pa
冷却段与灌装间的门关闭中
Attached the photos
附照片

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2021-054LTc-OQ
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Model
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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

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文件编号
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FT0140
型号
Version V 1.0
Tofflon Science
页码
10.15. Empty Chamber Temperature Distribution Test 空载温度分布测试

Purpose 目的
Test the temperature distribution in width of empty chamber.
测试烘箱空载时整个宽度上的温度均匀性。
Within the heating zone, the value of each thermocouple is equal to the temperature set ± 15°C
(after all thermocouples heat up and stabilization).
加热区内，每个热电偶温度值在设定值的± 15°C 范围内（升温稳定后）。
Procedure 程序
Prior to the test, the person executing the test has to verify whether the last calibration of the
reference devices to be used is still valid.
在测试之前，测试执行人必须确认所使用的相关仪器经过校验且仍在有效期内。
Before the test, the thermocouples have to be calibrated.
在测试之前，校准热电偶。
The calibration will be performed on three temperatures: at a temperature of 160.0 °C for the lower
value, at a temperature of setting value and at a temperature of 350.0 °C for the upper value.
进行三个温度值的校验：低温度值 160.0℃，设定的温度值和高温度值 350.0℃。
Tunnel must be in operation mode without heating.
需在生产模式下运行烘箱，但是不启动加热功能。
Before the test, the conveyor speed has to be measured. This will be done with help of a measuring
stick or tape with defined length. The measuring stick will be placed on the tunnel belt and will be
transported through the tunnel under production conditions. The time will be measured, that the
measuring stick needs to cover the distance. The conveyor speed is within ±5% of set value.
测试前需要测量传送带速度，测量使用特定长度的标尺或卷尺。在生产条件下将刻度尺放
置在烘箱传送带上，随着传送带运动而移动，测量标尺移动特定距离的时间。传送带速度
在设定值的±5%以内。
The tunnel has to be heated up to its normal operation conditions with run-empty mode (Dependent
on customer and format).
将烘箱加热至正常生产条件（根据客户和规格确定），运行排空模式。
The thermocouples are fixed at the metal unit (or something similar) along with a thermos resistant
tape, so that the tips of the thermocouples show on top and are surrounded completely by the
environment air. There is no any direct contact of the measuring tips to the metal unit.
用高温胶带把热电偶固定在与网带等宽的金属装置（或者类似固定物）上，保持热电偶的
测温头在装置以上，以使热电偶的测温头完全处在空气中而不与金属装置有任何接触。
The thermocouples are distributed evenly via the conveyor width, please refer to below table.
热电偶按照传送带宽度均匀分布，如下表所示。

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The recorder has to be activated (The print out is an additional information).

激活记录仪（记录仪的打印记录需作为附件信息）。
The prepared metal unit with thermocouples will be positioned at the pre-heating section of the
tunnel.
将绑好热电偶的金属装置放置在预热段。
After passing the tunnel, the metal unit with thermocouples has to be taken out at the end of tunnel.
The test will be done three times.
通过烘箱之后，将金属装置和热电偶从烘箱出口取下。本测试进行 3 次。
After finalizing the measurement the printout of the recorder has to be taken out and attached to
documentation for information.
测量结束后，取出记录仪的打印记录，并附在文件中作参考。
After finishing of the test, verification has to be carried out. If an unaccepted deviation is
determined during the verification, the result for this thermocouple has to be refused. If there are
more unaccepted deviations, a new calibration has to be carried out and if necessary the
measurement has to be repeated with new thermocouples.
测试完成后，对热电偶进行后校验。如果在后校验中发现一个热电偶不合格，不使用该不
合格热电偶的结果。如果在后校中发现多个热电偶不合格，需重新进行校验，如有需要，
使用新的热电偶重新进行此测试。
Attach all the data print-out of the test. If applicable, attach the recipe during this test.
将所有打印数据附上。如适用，附上测试所用的配方。

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Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Empty Chamber Temperature Distribution Test

空载温度分布测试
Direction of container transport / 容器传送方向: 
SP__ SP__ SP__ SP__ SP__ SP__ SP__ SP__ SP__ SP__ SP__ SP__
SP: Sensor Position 探头位置

“01”is sensor position serial number
“01”为探头位置顺序号
“TC01”is sensor number

eg.例如： “TC01”为探头编号
Execute Items/执行项目 Date / 日期
Calibration before test/

测量前的校验
Test 1
测试 1
Test 2
测试 2
Test 3
测试 3
Re-calibration after test /
测量后再校验
Test 1 Test 2 Test 3
Information / 信息
测试 1 测试 2 测试 3
Temperature of air in heating zone set value /
加热段的温度设定值 [°C]
Average of conveyor speed set value /
传送带速度设定值[mm/min]
Average of conveyor speed actual value /
传送带速度实际值[mm/min]
Maximum temperature reached in the heating zone
加热区所达到最高温度
Minimum temperature recorded in the heating zone
加热区所达到最低温度
Yes/No
Results / 结果
是否符合要求

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Within the heating zone, the value of each thermocouple is

equal to the temperature set ± 15°C (after all
thermocouples heat up and stabilization) Yes ( ) No ( )
加热区内，每个热电偶温度值在设定值的± 15°C 范围内
（升温稳定后）
Test sheet for recorder printout / 记录仪的打印记录

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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

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10.16. Operational Process Test 运行程序测试

Purpose 目的
Verify that the machine can run as per the set procedure.
确认设备能够按照设定的程序运行。
The operations of the machine are the same as those set in the program.
设备运行情况与设定程序相同。
Procedure 程序
Start the production; Observe whether the operations of the machine are the same as those set in
the program.
按照运行程序步骤启动设备生产模式，观察设备运行情况是否与设定程序相同。

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Operational Process Test

运行程序测试
No. Description Yes/No
序号描述是否符合要求
Enter control system
1. Yes ( ) No ( )
进入控制系统
Click to control screen

2. Yes ( ) No ( )
点击控制界面
Click" Recipe Selection" ,View and download recipe

3. Yes ( ) No ( )
点击"配方选择"，查看并下载配方
Click "Batch management",create new batch number.

4. Yes ( ) No ( )
点击"批号管理"，建立批号
Click "Production",enter product control

5. Yes ( ) No ( )
点击"生产"，进入生产控制
Enters into “Step1 Mode select”, select “Produce Mode” , the machine
will enter the next step automatically.
6. Yes ( ) No ( )
进入“步骤 1 模式选择”，选择“生产模式”，点击“启动”，
机器逐步执行下一步。
When all production condition is met , enters into “Production Mode”

7. automatically to produce. Yes ( ) No ( )
所有生产条件满足时，自动进入“生产模式”，负载生产。
Click the “Pause” button, the converyor belt stops

8. Yes ( ) No ( )
点击“暂停”，网带停止运行。
Click the “Start” button, the converyor belt restart

9. Yes ( ) No ( )
点击“启动”，网带重新启动
At the end of production, when the feed stack sensor detects insufficient
vials, the conveyer belt will be stop. At this time, press the “Empty”
10. button and the device will enter the “Empty” mode. Yes ( ) No ( )
生产要结束时，进料堆积传感器检测西林瓶不足时，网带将暂停
运行，此时按下“排空”按钮，设备进入“排空”程序。
The other operation mode in the HMI can be executed, eg. “Night”
11. mode or “Time” mode. Yes ( ) No ( )
界面上的其它运行模式，均可执行，如夜间模式、定时模式等等

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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

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10.17. System Operational Test 系统运行测试

Purpose 目的
Test the correct operation of each system.
测试各个系统能够正确运行。
All the actual results should comply with the expected results.
所有实际结果与预期结果相符。
Procedure 程序
Load vials onto the conveyor and start the process. The cycle should last at least 30 minutes.
Observe the operation of each system.
装载西林瓶至输送网带上，启动程序，运行 30 分钟，观察各系统运行状况。
Production speed = recorded production number/recorded operation time
生产速度= 记录的生产数量 /记录的运行时间
Requirement of Production Speed
生产速度要求
No. Container Size Container Dimensions (diameter x height) Production Speed

序号规格容器尺寸（直径 x 高）生产速度
1 2R Φ16(±0.15)X35(±0.5) 400VPM
2 6R Φ22(±0.2)X 40(±0.5) 370VPM
Perform this tests as described for three times.

执行测试三次。
T1/T2/T3 respectively represent test1,test2,test3
T1/T2/T3 分别代表测试 1，测试 2，测试 3。
Record every test condition and data in the following form or Conclusion/Remarks.
将每次测试中需要记录的情况及数据记录在相应的表格及结论/备注中。

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System Operational Test

系统运行测试
Test No.
测试号 Test 1 Test 2 Test 3
Item 测试 1 测试 2 测试 3
项目
Vial Size
西林瓶规格
Setting Speed
设定速度
Vials Total
西林瓶数量
Start Time
运行开始时间
End Time
运行结束时间
Downtime
停机时间
Yes/No
Action Performed Expected Result 是否符合要求
执行动作预期结果 T1 T2 T3
测试 1 测试 2 测试 3
Arrange the sterilizing
depyrogenating tunnel with the
The machine starts without
correct operational configuration, and Yes ( ) Yes ( ) Yes ( )
any failure
start the machine No ( ) No ( ) No ( )
机器正确启动
按正确运行配置安装隧道烘箱并启
动机器
The shutter can ascend and
decline , its distance from the
Lift the shutters vials mouth should be 5- Yes ( ) Yes ( ) Yes ( )
提升闸门 10mm No ( ) No ( ) No ( )
闸门能升降，且与瓶口距离
为 5-10mm
Load vials onto the conveyor and
start the process, operate the machine
For all the 30 minutes of test
for at least 30 minutes, observing that
all the vials are fed and
the vials are fed and downloaded Yes ( ) Yes ( ) Yes ( )
downloaded correctly
correctly No ( ) No ( ) No ( )
在整个 30 分钟测试时间内所
装载西林瓶到输送网带上并开始运
有都能正确进料及卸料
行，运行机器至少 30 分钟，观察
机器能够正确进料及卸料
Verify the production speed can The production speed can
Yes ( ) Yes ( ) Yes ( )
reach URS requirement reach URS requirement
No ( ) No ( ) No ( )
确认生产速度能满足 URS 要求生产速度满足 URS 要求

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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

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10.18. Full Load Temperature Penetration Test 满载热穿透测试

Purpose 目的
Verify that the heat penetration of the load when the tunnel is full.
确认烘箱满载时对其负载物的热穿透能力。
Based on the reference temperature of 170℃, Z (value) is 54℃, FH ≥1365 minutes;
基于参考温度 170℃，Z 值为 54℃，满足 FH≥1365 分钟；
Based on the reference temperature of 250℃, Z (value) is 46.4℃, FH≥30 minutes.
基于参考温度 250℃，Z 值为 46.4℃，满足 FH≥30 分钟。
Procedure 程序
Before the test, the thermocouples have to be calibrated.
在测试之前，校准热电偶。
The calibration will be performed on three temperatures: at a temperature of 160.0 °C for the lower
value, at a temperature of the setting value and at a temperature of 350.0 °C for the upper value.
进行三个温度值的校验：低温度值 160.0℃，设定的温度值和高温度值 350.0℃。
Tunnel must be in operation mode without heating.
需在生产模式下运行烘箱，但是不启动加热功能。
Before the test, the conveyor speed has to be measured. This will be done with help of a measuring
stick or tape with defined length. The measuring stick will be placed on the tunnel belt and will be
transported through the tunnel under production conditions. The time will be measured, that the
measuring stick needs to cover the distance. The conveyor speed is within ±5% of set value.
测试前需要测量传送带速度，测量使用特定长度的标尺或卷尺。在生产条件下将刻度尺放
置在烘箱传送带上，随着传送带运动而移动，测量标尺移动特定距离的时间。传送带速度
在设定值的±5%以内。
If the conveyor speed has to be measured during the empty chamber temperature distribution test,
the test results are allowed to be leveraged.
如果空载温度分布测试时已经测量传送带速度，允许引用其测试结果。
The tunnel has to be heated up to its normal operation conditions (Dependent on customer and
format).
将烘箱加热至正常生产条件（根据客户和规格确定）。
The packaging material is transported into the tunnel of pre-heating section via the washing
machine.
通过洗瓶机将包材传送至烘箱预热段。
The thermocouples are fixed with thermos resistant tape in the containers.it is important that the
end of each thermocouple has direct contact to the bottom and side of the glass (refer to below
Figure). Smaller containers can be taped/ bundled together with the container including the
thermocouple, to avoid pulling out during the run.
用高温胶带把热电偶固定在容器中，每根热电偶顶部处于瓶壁与瓶底的连接点上，参考下
图。如果容器较小，可以将包含热电偶的容器与其他绑在一起，以避免在运行过程中脱出。

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文件编号
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Model
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型号
Version V 1.0
Tofflon Science
页码
The recorder has to be activated (The print out is an additional information).

激活记录仪（记录仪的打印记录需作为附件信息）。
As soon as the containers are reaching the pre-heating zone of the tunnel, the containers with the
thermocouples are inserted in the first wave. The thermocouples shall be evenly distributed over
the whole tunnel width, twelve probes pre wave. The containers have to be placed directly behind
the pusher. (Refer to below figure).
当容器到达烘箱预热段时，将带有热电偶的容器插入第一波。每波 12 个探头，热电偶均匀
分布至烘箱整个宽度，容器必须直接放置在档杆后面。（参考下图）。
The second or third wave can be started, if the previous wave leaves the last heating section and
enters into the cooling section and their temperature are lower than 170℃.
当上一波离开加热段进入冷却段的时候，所有热电偶温度低于 170℃后，开始进行第二和第
三波的测试。
After passing the tunnel, the thermocouples have to be taken out at the end of the last cooling
section.
当所有热电偶通过烘箱时，从冷却段末端取出热电偶。
After finalizing the measurement the printout of the recorder has to be taken out and attached to
documentation for information.
测量结束后，取出记录仪的打印记录，并附在文件中作参考。
After finishing of the test verification has to be carried out. If an unaccepted deviation is
determined during the verification, the result for this thermocouple has to be refused. If there are
Doc. No.
2021-054LTc-OQ
文件编号
OQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
more unaccepted deviations a new calibration has to be carried out and if necessary the
measurement has to be repeated with new thermocouples.
测试完成后，对热电偶进行后校验。如果在后校验中发现一个热电偶不合格，不使用该不
合格热电偶的结果。如果在后校中发现多个热电偶不合格，需重新进行校验，如有需要，
使用新的热电偶重新进行此测试。
Attach all the data print-out of the test. If applicable, attach the recipe during this test.
将所有打印数据附上。如适用，附上测试所用的配方。

Doc. No.
2021-054LTc-OQ
文件编号
OQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Full Load Temperature Penetration Test

满载热穿透测试
Direction of container transport / 容器传送方向: 
1.Wave / 第 1 波
2.Wave / 第 2 波
3.Wave / 第 3 波
SP: Sensor Position 探头位置
“01”is sensor position serial number

“01”为探头位置顺序号
“TC01”is sensor number

eg.例如： “TC01”为探头编号
Calibration of the system/系统校验 Date / 日期
Calibration before measurement /

测量前的校验
Re-calibration after measurement /

测量后再校验

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2021-054LTc-OQ
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Model
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型号
Version V 1.0
Tofflon Science
页码
Information / 信息
Conveyor width /
传送带宽度[cm]
Container size /
容器规格
Temperature of air in heating zone set value /
加热段温度设定值[°C]
Average of conveyor speed actual value 1.wave /

第 1 波传送带平均速度[mm/min]


Start of the test / 开始测试
End of the test / 结束测试
Reference temp. /参考温度. [°C]

Calculation, evaluation /
计算, 评估
z [°C]
Yes/No
Results / 结果
是否符合要求
Based on the reference temperature of 170℃, Z (value) is 54℃,

FH ≥1365 minutes;
基于参考温度 170℃，Z 值为 54℃，满足 FH≥1365 分钟；
Yes ( ) No ( )
Based on the reference temperature of 250℃, Z (value) is 46.4℃,
FH≥30 minutes.
基于参考温度 250℃，Z 值为 46.4℃，满足 FH≥30 分钟。
Min. FH-value /最小 FH 值[min]
Sensor No.：
探头编号：
Max. FH-value /最大 FH 值[min]

Sensor No.：
探头编号：

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2021-054LTc-OQ
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Model
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Version V 1.0
Tofflon Science
页码
Test sheet for recorder printout / 记录仪的打印记录

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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

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2021-054LTc-OQ
文件编号
OQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
10.19. Surface Temperature Test 箱体表面温度测试

Purpose 目的
Verify that the zone surface temperature conforms to the requirement.
确认箱体表面温度符合要求。
The zone surface temperature should not exceed 55°C. (not contain entrance area).
箱体表面温度应不高于 55℃（不含入口处）。
Procedure 程序
Wait for the machine to bring in steady state and measure the temperature at 12 points choosing
from the machine using a hand-held temperature sensor. All the test positions are shown below:
等到机器稳定后选择 12 个点用手持式温度传感器进行温度测量，测试点参考下图：

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2021-054LTc-OQ
文件编号
OQ
Model
FT0140
型号
Version V 1.0
Tofflon Science
页码
Surface Temperature Test

箱体表面温度测试
Test Point Temperature °C Acceptance Criteria Conclusion

测试点温度可接受标准结论
1 Yes ( ) No ( )
2 Yes ( ) No ( )
3 Yes ( ) No ( )
4 Yes ( ) No ( )
5 Yes ( ) No ( )
6 Yes ( ) No ( )
Temperature °C
7 Yes ( ) No ( )
8 Yes ( ) No ( )
9 Yes ( ) No ( )
10 Yes ( ) No ( )
11 Yes ( ) No ( )
12 Yes ( ) No ( )

Doc. No.
2021-054LTc-OQ
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OQ
Model
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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-OQ
文件编号
OQ
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 required for each deviation. Numbering principle: 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 and record all observed deviations during the OQ execution.
收集 OQ 执行中发生的所有偏差并记录。
Tofflon should provide correction actions to all observed deviations during OQ execution, solutions
should be checked and approved by customer.
OQ 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-OQ
文件编号
OQ
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-OQ
文件编号
OQ
Model
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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 required for each change. Numbering principle: 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 and record all changes during the OQ execution.
收集 OQ 执行过程中的所有变更并记录。
Tofflon should provide correction actions to all changes during OQ execution, solutions should be
checked and approved by customer.
OQ 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-OQ
文件编号
OQ
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 ( )
N/A ( ) Yes ( )
Att. ID: No ( )
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

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文件编号
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Model
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型号
Version V 1.0
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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 required for each punch point. Numbering principle: P+section number-sequence
number, such as the P10.1-01, means the first punch 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 OQ execution.
收集 OQ 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.
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Version V 1.0
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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 ( )
N/A ( ) Yes ( )
Att. ID: No ( )
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

Doc. No.
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文件编号
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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。

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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

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页码
15. OQ Summary OQ 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:
IQ Punch List Closeout N/A ( ) N/A ( )

10.2 Qualification Yes ( ) No ( )
IQ 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:
SOP Qualification N/A ( ) N/A ( )

10.5 Yes ( ) No ( )
SOP 确认 Dev. ID: PL. ID:
HMI Navigation Test N/A ( ) N/A ( )

10.6 Yes ( ) No ( )
HMI 导航测试 Dev. ID: PL. ID:
System Access Test N/A ( ) N/A ( )

10.7 Yes ( ) No ( )
系统访问测试 Dev. ID: PL. ID:
Alarm Test N/A ( ) N/A ( )

10.8 Yes ( ) No ( )
报警测试 Dev. ID: PL. ID:
Power Recovery Test N/A ( ) N/A ( )

10.9 Yes ( ) No ( )
断电恢复测试 Dev. ID: PL. ID:
Recipe Function Qualification N/A ( ) N/A ( )

10.10 Yes ( ) No ( )
配方功能确认 Dev. ID: PL. ID:
Audit Trail Test N/A ( ) N/A ( )

10.11 Yes ( ) No ( )
审计追溯测试 Dev. ID: PL. ID:
Data Back-Up and Recovery N/A ( ) N/A ( )

数据备份和还原确认 Dev. ID: PL. ID:
Entry Field Boundary Test N/A ( ) N/A ( )

10.13 Yes ( ) No ( )
输入字段边界测试 Dev. ID: PL. ID:

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页码
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
Differential Pressure Test N/A ( ) N/A ( )

10.14 Yes ( ) No ( )
压差测试 Dev. ID: PL. ID:
Empty Chamber Temperature N/A ( ) N/A ( )

10.15 Distribution Test Yes ( ) No ( )
空载温度分布测试 Dev. ID: PL. ID:
Operational Process Test N/A ( ) N/A ( )

10.16 Yes ( ) No ( )
运行程序测试 Dev. ID: PL. ID:
System Operational Test N/A ( ) N/A ( )

10.17 Yes ( ) No ( )
系统运行测试 Dev. ID: PL. ID:
Full Load Temperature Penetration N/A ( ) N/A ( )

10.18 Test Yes ( ) No ( )
满载热穿透测试 Dev. ID: PL. ID:
Surface Temperature Test N/A ( ) N/A ( )

10.19 Yes ( ) No ( )
箱体表面温度测试 Dev. ID: PL. ID:
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

Doc. No.
2021-054LTc-OQ
文件编号
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Model
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型号
Version V 1.0
Tofflon Science
页码
15.2. OQ Conclusion OQ 结论
Review the test result and data, and give a final conclusion for OQ 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运行确认的最终结论。
OQ Review and Approval:

OQ 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）


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OPERATIONAL QUALIFICATION

Tofflon Science and NO./编号:

OPERATIONAL QUALIFICATION FOR

EXPERTISE IN PHARMACEUTICAL INDUSTRY

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

Operational 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

11. Deviation Handling 偏差处理.................................................................................................................92

EXPERTISE IN PHARMACEUTICAL INDUSTRY

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Correction of Mistakes 更改错误：

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EXPERTISE IN PHARMACEUTICAL INDUSTRY

8. Test List 测试列表

Test No. Test Name

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9. Personnel Identification 人员确认

Name Signature Company Title Date

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10. Qualification Procedure 确认程序

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The protocol for Sterilizing Depyrogenating Tunnel:

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

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

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IQ Punch List Closeout Qualification

Attach the copy of IQ Punch List.

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

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10.3. Test Leveraging 测试引用

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

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

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Test Instruments Calibration Qualification

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

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10.5. SOP Qualification SOP 确认

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Doc. Name Doc. No. Ver. No. Status

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

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10.6. HMI Navigation Test HMI 导航测试

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HMI Navigation Test

Execution Items Expected Result Yes/No

Control System Menu Verification

Control System Graphic Pages Navigation Verification