2014-001LFc Filling Machine灌装机IQ

INSTALLATION QUALIFICATION OF
FILLING MACHINE
灌装机安装确认
SUPPLIER NAME: CUSTOMER NAME:

Shanghai Tofflon Laboratorios Vencofarma
Science&Technology CO.,
LTD. Do Brasil Ltda
NO.: 2014-001LFc
MODEL: FFS-20/06NL0
INSTALLATION QUALIFICATION PROTOCOL
2014-001LFc-11-IQ. date: Apr.20,2014
EXPERTISE IN PHARMACEUTICAL INDUSTRY
ADD: 2199, FANGHE RD.,SHANGHAI-201109 CHINA

TEL: +86 21 64906201
FAX: +86 21 64906202
Http:// www.tofflon.com
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文件编号
Shanghai Tofflon Science &
Supplier Equipment
Technology CO., LTD. FFS-20/06NL0
制造商 Installation Qualification 设备型号
上海东富龙科技股份有限公司
安装确认 Revision
V 1.0
版本号
INSTALLATION QUALIFICATION
安装确认
FOR
Shanghai Tofflon Filling Machine
灌装机
MODEL: FFS-20/06NL0
SERIAL No.: 2014-001LFc
CUSTOMER
LABORATORIOS VENCOFARMA DO BRASIL LTDA.
THIS DOCUMENT CANNOT BE COPIED OR OTHERWISE DISTRIBUTED

WITHOUT THE WRITTEN CONSENT OF SHANGHAI TOFFLON!
未经上海东富龙事先书面同意，不得复制或以任何其它方式散布本文件！
Issued by: Shanghai Tofflon
Classification: company confidential
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INSTALLATION QUALIFICATION OF
FILLING MACHINE
灌装机安装确认
Document 2014-001LFc-11-IQ，Rev.1.0, Date Apr.20,2014
Produced by Shanghai Tofflon

由上海东富龙制作
Revision History/版本历史记录
Revision 版本 Change 变更 Name 姓名 Date 日期
1.0 Initial Ivy Liu Apr.20,2014
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EXECUTION APPROVAL SIGNATURES

批准执行签名
The signatures below indicate the approval of this protocol and its attachments and indicate that it is ready for
execution. Any changes or a modification to the intent or the acceptance criteria 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及其附件，且表明已经为执行作好了准备。在批准后，任何对本文件的原
意或验收标准而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。
Installation Qualification (IQ)/安装确认（IQ）
Type of Equipment/设备名称 Filling Machine/灌装机

Customer/客户 LABORATORIOS VENCOFARMA DO BRASIL LTDA.
Model/型号 FFS-20/06NL0
Revision/版本 1.0
Department/部门 Packaging Machine Department /分装机事业部
IQ Protocol Approval/IQ 草案批准
Name Department Signature and Date

姓名部门签名/日期
Prepared by Ivy Liu Packaging Machine Department

编制刘桂江分装机事业部
Reviewed by Carol Ning Packaging Machine Department

审核宁晓丹分装机事业部
Approved by Jackson Zhao Packaging Machine Department

批准人赵国性分装机事业部
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Table of Contents
目录
1. SCOPE 范围.........................................................................................................................................................5
2. PURPOSE 目的................................................................................................................................................... 5
3. INTRODUCTION 介绍...................................................................................................................................... 5
4. EQUIPMENT DESCRIPTION 设备说明........................................................................................................6
4.1. General Overview 总概述................................................................................................................................6
4.2. Machine functional groups 机器功能组......................................................................................................... 7
4.2.1. Vials Transfer 西林瓶输送............................................................................................................................. 7
4.2.2. Vials Filling 灌装............................................................................................................................................8
4.2.3. Vials Stoppering 加塞..................................................................................................................................... 8
4.2.4. Defective Vials Rejection 剔废.......................................................................................................................9
4.2.5. Outfeed System 出料系统.............................................................................................................................. 9
4.2.6. Vial Automatic Sampling 取样.....................................................................................................................10
4.3. Control system 控制系统............................................................................................................................... 10
4.4. Critical utilities 关键公用工程...................................................................................................................... 10
5. TESTING PROCEDURES 测试程序..............................................................................................................11
5.1. Documentation Requirements 文件要求......................................................................................................11
5.2. Documentation Procedure 文件执行规程.................................................................................................... 12
6. APPLICABLE DOCUMENTATION 参考文件规范.................................................................................... 13
7. EXEUTANT OF DOCUMENTS 文件执行人员............................................................................................ 13
8. LIST OF ATTACHMENT 附件清单.............................................................................................................. 17
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1. SCOPE 范围
This document is applicable to the vials filling machine, model FFS-20/06NL0, installed at
LABORATORIOS VENCOFARMA DO BRASIL LTDA.. This protocol describes component qualification
and installation, a certain testing are done. Meanwhile, relevant datum and certificates are supplied.
本文件适用于安装在 LABORATORIOS VENCOFARMA DO BRASIL LTDA.的 FFS-20/06NL0 型灌装

机；文件涉及机器部件的确认、安装以及对部分部件的测试，并提供相关数据记录以及证书等。
2. PURPOSE 目的
The purpose of this Installation Qualification protocol is to verify the following items:
本安装确认书的目的是验证以下事项：
The equipment installation has been executed according to the URS.
设备安装是按照 URS 要求实施。
To demonstrate that the equipment is installed following the design specifications.
证明设备是按照设计规范安装的。
The equipment installation has been executed taking into account the GMP.
设备安装遵照 GMP 规范实施。
Meanwhile, approved signature is included in this document and provided for describing the responsibilities
of Shanghai Tofflon and LABORATORIOS VENCOFARMA DO BRASIL LTDA..
同时，本文件包含了相关的批准签名，也描述了上海东富龙与 LABORATORIOS VENCOFARMA DO

BRASIL LTDA.之间的权责。
3. INTRODUCTION 介绍
IQ is used for qualification during the installation to verify and document that the machine has been installed
with the proper supporting utilities, services, and components.
本文件用于上海东富龙在安装过程中的检查，以确认和记录设备已经与相关的公用工程、服务和部件
连接。
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The documentation associated with this machine, such as machine drawings, component specification sheets,
materials lists, installation diagrams, and other data, etc., are reviewed in this report.
在本文件执行过程中对设备相关文件进行审核，如用户手册、设备图纸、部件材料清单、平面布局图
和其他的数据等。
All deviation or others will be recorded during the qualification to supply for deviation report.
所有与文件或规范出现的偏差或者遇到任何意外情况都要记录在偏差报告表中。
4. EQUIPMENT DESCRIPTION 设备说明
4.1. General Overview 总概述
The filling machine shall fill and stopper pharmaceutical vials with the following functions:
灌装机通过以下功能实施灌装和加塞：
 Accumulation in turntable of the vials coming from the depyrogenation tunnel ;
将来自灭菌隧道的瓶子收集在过渡转盘上；
 Transfer at constant speed into infeed of the filling machine ;
匀速送瓶至灌装机进瓶侧；
 Vial filling ;
西瓶林灌装；
 Vial stoppering ;
加塞；
 Defective vial reject ;
剔废；
 Vial outfeed;
出瓶。
 Vial automatic sampling for QC ;
自动取样.
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The filling machine operation must be performed in strict conformance with GMP for the packaging of
finished injectable pharmaceuticals.
灌装机的运行必须严格符合 GMP 中规定的注射针剂成品的包装标准。
4.2. Machine functional groups 机器功能组
The filling machine fill and stopper glass vials with liquids for aseptic solutions.
灌装机将药瓶用无菌药液灌装并加塞。
The vials out of the tunnel are conveyed on a accumulation turntable running at the same constant speed.
将出自灭菌隧道的西林瓶匀速传送并收集在过渡转盘上。
The filling and stoppering machine are equipped with a positive continuous motion in-line transport system it
will suitable for filling liquid solutions into glass vials and for rubber stoppers insertion.
灌装加塞机配备直线正向持续传送系统，利用药液对药瓶适量灌装并加塞。
The machine will be designed to be exposed to VHP sterilization gas agent (hydrogen peroxide vapors) and to
configured any type of R.A.B.S. ( Restricted Access Barrier systems)
此机器设计可采用 VHP（过氧化氢蒸汽）灭菌，能配置任何类型的 R.A.B.S。
The filling is made by nozzles vials tracking with descent and ascent moving during the dosing.
灌装针在上下动作给料时跟随西林瓶移动而实现定量灌装的。
The filling machine will be properly designed with the overall structure, the main mechanical movements
should not come in-and-out from the grey area, in order to avoid contamination of the vials being processed.
灌装机整体结构设计合理，主要的机械运动部件不在关键区域出入，最大可能避免西林瓶受到污染。
4.2.1. Vials Transfer 西林瓶输送
A turntable system must be provided for collecting, transporting and lining up the vials coming from the
outfeed tunnel for the filling machine.
转盘系统收集来自灭菌隧道出料处的西林瓶，并排队输送给灌装机。
The accumulation turntable must interface with the filling machine and the tunnel so as not to obstruct or
reduce the efficiency of the tunnel and filling line.
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为了避免妨碍和降低灭菌隧道和灌装线的效率，将过渡转盘与灌装机和灭菌隧道连接。
Glass vials are transferred orderly through the turntable without contamination and breakage.
转盘将西林瓶依次有序输送，并保证无污染无破损。
The turntable must be managed with a speed control to allow the table to be synchronized with the line speed.
转盘转速可控，能与灌装线速度同步。
The turntable must be capable of operating at the appropriate maximum filling speed, blockages, scratches
and drops must be avoided during the transport of the individual vial or a mass of vials.
转盘必须能满足最大的灌装速度，避免输送过程因少瓶或挤瓶造成拥堵、划伤和倒瓶。
The accumulation turntable is provided with a fallen vial removal system.
过渡转盘有倒瓶剔除系统。
4.2.2. Vials Filling 灌装
The filling system must be equipped with 6 filling devices and 6 needles.
灌装系统须配备 6 个灌装装置和 6 根灌装针。
The filling precision is in the range of ±1% when the filling capacity is not more than 2ml;
当灌装量小于或等于 2ml，灌装精度必须控制在±1%之内；
The filling precision is in the range of ±0.5% when the filling capacity is more than 2ml。
当灌装量大于 2ml，灌装精度必须控制在±0.5%之内。
The machine filling system must be provided with a system for the dosage regulation of the individuals filling
devices.
机器灌装系统可调节灌装量。
\The filling system must be provided with a system for detecting missing vials, positions not occupied by
vials, in the occurrence of one of these events, in the related position the dosing cycle should be avoided.
灌装系统设有无瓶检测系统，也就是说，空瓶位状况发生后，相应位置不灌装。
4.2.3. Vials Stoppering 加塞
The filling machine are provided with an integrated stoppering mechanism to fully or partially stopper vials
after filling.
灌装机设有加塞装置，对已灌装药瓶实施全加塞或半加塞。
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The integrated stoppering mechanism are provided with the following key features:
加塞装置拥有以下关键特点：
 The stoppering system are capable of fully seating stoppers for nonlyophilized product or partially
seating stoppers for lyophilized product.
加塞系统为非冻干产品进行全加塞或为冻干产品进行半加塞
 The stoppering system not damage the vial being stoppered or the stopper any way.
加塞系统不会损坏加塞药瓶或瓶塞
 Stopper presence verification are provided after stopper placement.
加塞后对瓶子胶塞在位检测
 If a vial is missed the stoppering system are capable to avoid the stopper placement in the empty position
如果无瓶，加塞系统对其无瓶位不加塞
The stoppering system are provided with a stopper feed bowl. The feed bowl have the following key features:
加塞系统配有胶塞供料料斗，料斗具有以下特点：
 The drives of the stopper feed bowl are fully enclosed and sealed inside the machine covers.
胶塞供料料斗驱动装置全部隔离并密封在设备罩壳内。
4.2.4. Defective Vials Rejection 剔废
A defective vial reject system are provided after stoppering. The defective vial reject system are provided at
least with the following key features to permit the automatic removing vials for the following faults and
defects:
加塞后剔废系统进行剔废。剔废系统有以下关键功能对以下加塞缺陷的瓶子自动剔除。
 Vials with no stopper present.
缺塞药瓶
 The vial reject station reject vials to a reject area without the rejected vials falling over.
剔废站将废瓶剔入剔废区，无废瓶流入下工序。
4.2.5. Outfeed System 出料系统
To the outfeed system is required to transport the vials away from filling machine It must be designed such
that the vials are handled without breakages and fall or overturning of the vials. The outfeed system must be
designed to allow the emptying of the filling machine at the end of a production batch without manual
operator intervention.
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出料系统将非破损、倾倒药瓶输出灌装机，出料系统在批次生产最后时无人为介入便可清空灌装机。
The filled vials are transported and sorted in a row to the following equipment.
已灌装药瓶排成一列传送至下游设备。
4.2.6. Vial Automatic Sampling 取样
A vial automatic sampling system are provided after stoppering. This system can be sampled by the operator
according to demand
加塞后自动取样系统对药瓶进行取样。此系统可由操作员根据需求取样。
4.3. Control system 控制系统
A dedicated control system provide the full filling machine control capability, by pre-established recipes . The
control system is able to ensure the repeatability of the vials filling. The control system allows also to perform
safely all the setup and maintenance activities necessary for the conduct of the filling machine.
灌装机的控制系统利用预先创建的配方对设备实施全面控制，控制系统可确保灌装的可重复性。控制
系统还可以安全地实施灌装机运行所必需的所有设定和维护操作。
The Control System user interface allows viewing and control within the standard functionality as follows:
控制系统用户界面允许在下述功能内查看和控制：
Set up parameters (filling volume, production speed, etc)
设定参数（灌装量，生产速度等等）
Representation of the parameters and values set to (filling cycle recipe, maintenance)
参数和设定值的描述（灌装循环程序，维护）
Representation, process recipe and reporting errors and alarms
工艺程序和报告错误和报警的描述
4.4. Critical utilities 关键公用工程
The following critical utilities are necessary for the correct filling machine operations:
灌装机正常运行所需的关键公用工程如下：
 Electrical connection 3 Phase, 220 V, 60 Hz. 10KW 3 相电力，220 伏，60 赫兹，10 千瓦
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 Pharmaceutical compressed air 2.5-4bar 无菌压缩空气 2.5-4bar
5. TESTING PROCEDURES 测试程序
5.1. Documentation Requirements 文件要求
All the data collected and recorded in this protocol must meet the following requirements:
本确认书内收集和记录的所有数据必须符合以下要求：
 The compilation and printing must be legible. All work must be documented using only permanent
ink.
编辑和打印必须做到字迹清晰。所有工作只可用不褪色的墨水做记录。
 All forms must be signed and dated by the performer and, where applicable, by the auditor.
所有表格必须由执行人员，在适当场合还要与审核人员一起署名并签署日期。
 Any corrections must be signed and dated.
任何一处改正都需要签名和签署日期。
 Mark through any unused spaces with a single line.
未使用的地方用单线标记。
 Mark spaces that do not apply to the machine with Not Applicable (N/A) and provide the explanation
where necessary.
用不适用（N/A）标明不适用机器的地方，并且在合适的地方写明理由。
 Any deviations must be included in the "Deviation Report", in which the executor of the test will
provide a brief and clear of the non-compliance discovered.
任何偏离都应该写入偏差报告，同时试验员须简洁清晰地描述所发现的不符合问题。
 In case of need to enter additional data to one of the modules in the protocol, duplicate and use the
"Data Collection Sheet", designed as "Appendix 1".
如果需要将补充数据输入到确认书内某一表格，可以使用和复制“附录 1”设计的“数据汇
总表” 。
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5.2. Documentation Procedure 文件执行规程
All the sections of this protocol must include all the original data coming from the verifications and tests.
本确认书的所有章节均须收入验证和试验所获得的全部原始数据。
Raw data collected on additional data sheets, created on and printed from a computer, or data sheets generated
by the machine, during execution of this protocol, must be inserted into the protocol. These additional sheets
must be annotated with executable date and signature of performer.
在实施本确认书期间，必须将附加数据表单收集到的、计算机创建和打印输出的原始数据或机器生成
的数据表单插入到确认书之中。这些附加的数据表单必须有实施日期和执行人员签名。
In order to document the verifications and tests included in this protocol, it will be possible to use previously
collected data, only if:
为了将验证和试验记入本确认书，可以采用先前收集到的数据只要：
 The methodology used for the verification or the test is documented.将验证或试验采用的方法记入

文件。
 The verification and/or test is executed by qualified personnel.由资质合格的人员实施验证和/或试

验。
 The equipment has not been modified after the verification and/or test.在验证和/或试验之后设备没
被修改。
 The document has been properly signed and dated by the person performing the testing and by a
qualified reviewer.文件由试验员和有资质的核查员正确署名并签署日期。
NOTE: Any deviation of this protocol must be fully investigated and documented. This IQ can be considered
acceptable with exceptional data only if the cause of the exception has been determined or an assignable
cause can be attributed to it and it can be proven that such data will not invalidate the protocol studies.
Quality Assurance is responsible for determining the acceptability of any exceptional data.
备注：对本文件中的任何偏差进行完全调查和记录。只有当偏差的原因已经确定，或可以归结为特
定的原因，且能证明该数据不会使文件无效时，这个有偏差数据的 IQ 才可以接受，QA 有权决定是
否接受偏差数据。
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6. APPLICABLE DOCUMENTATION 参考文件规范
The reference documents used for the preparation of this protocol are:
编制本确认书所用的参考文献如下：
 Good Manufacturing Practice and Appendix
药品生产质量管理规范及附录（2010 年修订）
 Eu GMP volume 4 Guidelines to Good Manufacturing Practice Medicinal Products for Human and
Veterinary Use December 2010 Revision
欧盟 GMP 第 4 卷《人用和兽用药品良好生产规范指南》，2010 年 12 月版。
 Eu GMP volume 4 Annex 1 Manufacture of Sterile Medicinal Products 01 March 2009
欧盟 GMP 第 4 卷附件 1《无菌药品》01 版，2009 年 3 月。
 Eu GMP volume 4 Annex 11 Computerized Systems June 2011
欧盟 GMP 第 4 卷附件 11《计算机系统》，2011 年 6 月
 Eu GMP volume 4 Annex 15 Qualification and validation September 2001
欧盟 GMP 第 4 卷附件 15《确认和验证》，2001 年 9 月
 CFR Title 21, Sec. 211 subpart D
21CFR 第 211 节 D 段
 CFR Title 21 part 11
21CFR 第 11 节
 GAMP5 Good Automated Manufacturing Practices, and Appendix D
GAMP5 良好自动化生产指南及附录 D
7. EXEUTANT OF DOCUMENTS 文件执行人员
Fill in the module “Personnel List of Document Executant” of this protocol, so that all personnel, involved in
the execution and revision of this protocol, is identified by name and job title.
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填写本确认书的“文件执行人员一览表”，可根据姓名和职衔鉴别参与本确认书执行和修改的所有人
员。
Quality control personnel and installation personnel of Shanghai Tofflon Science & Technology Co. Ltd. will
do the execution of this document. The installation personnel will examine every conclusion in the actual
design result, at the same time the QA personnel will check. If there is any modification in the design, it
should be filled in the deviation report and attached to the Final report of the document.
文件执行人员为上海东富龙科技股份有限公司安装人员和质量控制人员，安装人员对实际设计结果逐
个进行判断，同时由 QA 人员进行审核，如果有任何偏差发生，应按照“偏差管理制度”进行偏差处
理，并将偏差报告附于文件中。
The execution of the present Installation Qualification protocol will involve people in charge of ensuring the
following functions:负责执行本安装确认书的人员须保证履行以下职责：
 To provide the document and drawings, the manuals and all the required documentation for the
preparation and execution of the tests and/or verifications included in this qualification protocol.为
准备和执行本确认书中所包含的试验和/或验证提供并归档所需的图纸，手册和全部必要的
文件。
 To store the raw data and/or verifications and to compare test results to acceptance criteria declaring
conform/not conform.储存原始数据和/或验证结果并将试验结果与验收标准比较，声明合格/
不合格。
 To execute tests and/or verifications only after this qualification protocol has been approved.仅在本
确认书批准之后才可执行试验和/或验证。
 To assure that data from tests and/or verifications are properly recorded and/or test documentation
attached to this protocol.确保试验和/或验证中所获得的数据正确记录进试验文件并附在本确认
书后面。
 To assure that all raw data, attached to the Final report, are properly signed and dated.确保所有原始
数据均附入最终报告，并正确签名和注明日期。
 To assure that each instrument used for tests and/or verifications is calibrated before the use and that
a copy of the calibration certificate is included in the final report or the place where it is located is
identified.确保试验和/或验证所使用的每一台仪器在使用前均已校准且将一份校准证书副本
放入最终报告或标识其存放场所。
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Supplier Equipment
V 1.0
版本号
 To assure that each data worksheet is signed and dated by the person(s) performing the verification
and the data reviewer.确保每一份数据表单由执行验证人员和数据核查员签名并注明日期。
Whether events/non conformities occur during protocol execution the validation team will be in charge of
managing them according to directions reported in the company SOPs.
在执行本确认书期间，无论是否发生事件/不合格，验证团队均应遵照公司 SOP 中列出的指南负责实

施管理。
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Supplier Equipment
V 1.0
版本号
Personnel List of Document Executant

文件执行人员一览表
No. Name Signature Remarks

序号姓名签名备注
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Supplier Equipment
V 1.0
版本号
8. LIST OF ATTACHMENT 附件清单
Attachment 1 – Qualification of the General Data

附件 1 – 主要数据确认
Attachment 2 – Qualification of the Assembly
附件 2 – 组件系统确认
Attachment 3 – Qualification of the Main Components

附件 3 –主要零部件确认
Attachment 4 –Electric Component Qualification
附件 4 -电气部件确认
Attachment 5 – Qualification of the Components Material

附件 5 – 零部件材质确认
Attachment 6 – Qualification of the Surface finish
附件 6 – 表面处理确认
Attachment 7 – Final Installation Qualification

附件 7 - 安装总成确认
Attachment 8 – Qualification of the Utility
附件 8-公用工程确认
Attachment 9 – Qualification of the Drawings

附件 9 - 图纸确认
Attachment 10 – Qualification of the Documents
附件 10 – 文件确认
Appendix1-Data Collection Sheet

附录 1-数据汇总表
Appendix2-Deviation Report
附录 2-偏差报告
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Supplier Shanghai Tofflon Science & Technology CO., LTD. Equipment Model
FFS-20/06NL0
制造商上海东富龙科技股份有限公司 Installation Qualification 设备型号
V 1.0
版本号
Attachment 1 – Qualification of the General Data
附件 1 – 主要数据确认
Objective：Verify the parameters of the machine are conforming to design drawings and specifications.
目标：确认机器参数符合项目设计图纸和规范要求。
Serial
Item Expected result Actual Installation meet design Marks / Deviation report NO.
NO.
项目设计结果实际安装与设计是否相符备注 / 偏差报告编号
序号
Machine – ID
1.1 2014-001LFc Yes 是 ( ) No 否 ( )
机器编号
Manufacturer
1.2 品牌 TOFFLON Yes 是 ( ) No 否 ( )
Model
1.3 FFS-20/06NL0 Yes 是 ( ) No 否 ( )
型号
Year of manufacture
1.4 2014 Yes 是 ( ) No 否 ( )
生产年份
Production speed 200VPM
1.5 产量 200 瓶/分 Yes 是 ( ) No 否 ( )
Dimensions (L × W × H)
1.6 2500x2000x1750 Yes 是 ( ) No 否 ( )
尺寸（长×宽×高）
Control cabinet size [mm](L×H×T) Standard 1200×2200×500
1.7 控制柜尺寸[mm](L×H×T) 标准 1200×2200×500 Yes 是 ( ) No 否 ( )
FFP （Kg）
1.8 ≈2600 Yes 是 ( ) No 否 ( )
设备重量（ Kg）
FFP and box (shipping)
1.9 ≈3500 Yes 是 ( ) No 否 ( )
含箱重量（Kg）
Verification Method: verify visually the actual installation data in accordance with project drawings and specifications.
确认方法：参照图纸及规范文件进行目击确认。
附件 1-1
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Acceptance Criteria: all the data comply with drawings and specifications.
验收标准：所有数据与图纸及规范相符。
Conclusion& Comments:
结论和注释：
Item / 项目 Conclusion / 结论 Comments /备注
Meets Acceptance Criteria / 符合验收标准 Yes 是 ( ) No 否 ( )
Sign./ 签字 Date/日期
Checked by/检查
Reviewed by/审核
附件 1-2
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Attachment 2 – Qualification of the Assembly
附件 2 – 组件系统确认
Objective: In accordance with the actual installation, compare with the design drawings, material list or others to examine whether the installation of the machine can meet design
and customer’s URS or GMP requirements.
目标：通过工厂安装实物与设计图纸、材料配置表等的比照，确认安装与设计相符并能满足客户 URS 及 GMP 要求。
Serial
Component Item Design result Actual Installation meet design Marks / Deviation report NO.
NO.
部件项目设计结果实际安装与设计是否相符备注 / 偏差报告编号
序号
Infeed system Brand 品牌 TOFFLON Yes 是 ( ) No 否 ( )

2.1 进料系统 Quantity 数量 1 Yes 是 ( ) No 否 ( )
Main belt Brand 品牌 TOFFLON Yes 是 ( ) No 否 ( )
2.2 主网带 Quantity 数量 1 Yes 是 ( ) No 否 ( )
Filling system Brand 品牌 TOFFLON Yes 是 ( ) No 否 ( )
2.3 灌装系统 Quantity 数量 1 Yes 是 ( ) No 否 ( )
Stoppering system Brand 品牌 TOFFLON Yes 是 ( ) No 否 ( )
2.4 压塞系统 Quantity 数量 1 Yes 是 ( ) No 否 ( )
Outfeed system Brand 品牌 TOFFLON Yes 是 ( ) No 否 ( )
2.5 出料系统 Quantity 数量 1 Yes 是 ( ) No 否 ( )
Reject system Brand 品牌 TOFFLON Yes 是 ( ) No 否 ( )
2.6 剔废系统 Quantity 数量 1 Yes 是 ( ) No 否 ( )
Control system Brand 品牌 TOFFLON Yes 是 ( ) No 否 ( )

2.7 控制系统 Quantity 数量 1 Yes 是 ( ) No 否 ( )
附件 2-1
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V 1.0
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Verification Method: verify visually the actual installation in accordance with drawings or relevant material list.
确认方法：参照图纸及相关材料配置表进行目击确认。
Acceptance Criteria: all assemblies installed comply with drawings or relevant material list.
验收标准：所有安装组件与图纸与材料配置表相符。
结论和注释：
Checked by/检查
Reviewed by/审核
附件 2-2
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Attachment 3 – Qualification of the Main Components
附件 3 – 主要零部件确认
Objective ： In accordance with the actual installation, compare with the PID, material list or others to examine whether the installation of the machine can meet design and
customer’s URS or GMP requirements.
目标：通过工厂安装实物与 PID 图、材料配置表等的比照，确认安装与设计相符并能满足客户 URS 及 GMP 要求。
Serial
NO.
序号
Infeed system 进料系统
Brand 品牌 SIEMENS/西门子 Yes 是 ( ) No 否 ( )
Servo motor Feed the star wheel
3.1 Model 型号 1FK7022-5AK71-1LH3-ZX08 Yes 是 ( ) No 否 ( )
伺服电机进料星轮
Quantity 数量 1 Yes 是 ( ) No 否 ( )
Brand 品牌 TPG/阪神 Yes 是 ( ) No 否 ( )
Frequency conversion motor Feed mesh belt、Rotary table
3.2 Model 型号 FV-17-100-20S Yes 是 ( ) No 否 ( )
变频电机进料网带、转盘
Brand 品牌 WITTENSTEIN/威特斯坦 Yes 是 ( ) No 否 ( )
Reducer Feed the star wheel
3.3 Model 型号 TP010S-MF2-70-0B1 Yes 是 ( ) No 否 ( )
减速机进料星轮
Brand 品牌 IFM/易福门 Yes 是 ( ) No 否 ( ) Into the bottle of the maximum and the
Photoelectric reflex sensor
3.4 Model 型号 0J5086 滤光镜-E200994 反光板 Yes 是 ( ) No 否 ( ) minimum detection
镜片传感器
Quantity 数量 2 Yes 是 ( ) No 否 ( ) 进瓶最大量和最小量检测
Main belt 主网带

Servo motor Brand 品牌 SIEMENS/西门子 Yes 是 ( ) No 否 ( )
3.5
伺服电机 Model 型号 1FK7022-5AK71-1LH3-ZX08 Yes 是 ( ) No 否 ( )
附件 3-1
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Serial
NO.
序号
Reducer
减速机
Brand 品牌 Contrinex/科瑞 Yes 是 ( ) No 否 ( ) Before filling in the bottle detection no
Ultrasonic sensors bottle no filling
3.7 Model 型号 ZWS-15/CD/QS Yes 是 ( ) No 否 ( )
超声波传感器
Quantity 数量 1 Yes 是 ( ) No 否 ( ) 灌装前瓶子在位检测无瓶不灌装
Filling system 灌装系统

Servo motor
3.8 Model 型号 1FK7034-5AK71-1LH3 Yes 是 ( ) No 否 ( )
伺服电机
Servo motor
3.9 Model 型号 1FK7063-5AH71-1FB3 Yes 是 ( ) No 否 ( )
伺服电机
Brand 品牌 Sumitomo Drive Technologies Yes 是 ( ) No 否 ( )
Reducer
3.10 Model 型号 F2CS-C25-59 Yes 是 ( ) No 否 ( )
减速机
Reducer
3.11 Model 型号 TP004S-MF2-20-0C0 Yes 是 ( ) No 否 ( )
减速机
Reducer Brand 品牌 NERGAR/纽卡特 Yes 是 ( ) No 否 ( )
3.12
减速机 Model 型号 PLE80-40 Yes 是 ( ) No 否 ( )
附件 3-2
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V 1.0
版本号
Serial
NO.
序号
Brand 品牌 preFluid/普瑞 Yes 是 ( ) No 否 ( )
Peristaltic pump
3.13 Model 型号 F3-WF350-E505Y Yes 是 ( ) No 否 ( )
蠕动泵
Stoppering system 压塞系统
Servo motor
3.14 Model 型号 1FK7022-5AK71-1LH3-ZX08 Yes 是 ( ) No 否 ( )
伺服电机
Reducer
减速机
Brand 品牌 SITI/西帝 Yes 是 ( ) No 否 ( )
Reducer Tamponade lifting, bucket elevator
3.16 Model 型号 MI30-30/1-90/11 Yes 是 ( ) No 否 ( )
减速机压塞站升降、料斗升降
Brand 品牌 REO/雷欧 Yes 是 ( ) No 否 ( )
Reo controller
3.17 Model 型号 MFS 268 DP, 6A Yes 是 ( ) No 否 ( )
雷欧控制器
Brand 品牌 GOOD BOWL/艮博 Yes 是 ( ) No 否 ( )
total pressure, a pressure seal
Model 型号 470KC-S-N-6R(逆) Yes 是 ( ) No 否 ( )
Stopper bowl 全压塞、半压塞
3.18 Quantity 数量 1 Yes 是 ( ) No 否 ( )
胶塞料斗
Brand 品牌 GOOD BOWL/艮博 Yes 是 ( ) No 否 ( ) total pressure, a pressure seal
Model 型号 470KC-S-N-2R(逆) Yes 是 ( ) No 否 ( ) 全压塞、半压塞
附件 3-3
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版本号
Serial
NO.
序号
Brand 品牌 Contrinex/科瑞 Yes 是 ( ) No 否 ( )
Diffuse reflection sensor
3.19 Model 型号 LTK-1050-303-511 Yes 是 ( ) No 否 ( )
漫反射传感器
Brand 品牌 Contrinex/科瑞 Yes 是 ( ) No 否 ( )
Optical fiber sensor Hopper stopper and track detection
3.20 Model 型号 LFP-1002-020 Yes 是 ( ) No 否 ( )
光纤传感器胶塞料斗和轨道检测
Discharge system /出料系统
Frequency conversion motor
变频电机
Brand 品牌 IFM/易福门 Yes 是 ( ) No 否 ( )
Photoelectric reflex sensor Discharging the largest amount of
3.22 Model 型号 0J5086 滤光镜-E200994 反光板 Yes 是 ( ) No 否 ( )
镜片传感器出料最大量
Reject/sample system 剔废系统
Frequency conversion motor
变频电机
Brand 品牌 IFM/易福门 Yes 是 ( ) No 否 ( )
Photoelectric reflex sensor Take the maximum detection
3.24 Model 型号 0J5086 滤光镜-E200994 反光板 Yes 是 ( ) No 否 ( )
镜片传感器剔废最大量检测
附件 3-4
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V 1.0
版本号
Verification Method: verify visually the actual installation in accordance with drawings or relevant material list.
确认方法：参照图纸及相关材料配置表进行目击确认。
Acceptance Criteria: all components installed comply with drawings or relevant material list.
验收标准：所有安装组件与图纸与材料配置表相符。
Conclusion & Comments:

结论和注释：
Item / 项目 Conclusion / 结论 Comments/备注
Checked by/检查
Reviewed by/审核
附件 3-5
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V 1.0
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Attachment 4 –Electric Component Qualification
附件 4 -电气部件确认
Serial
NO.
序号
Double motor module
4.1 Model 型号 6SL3120-2TE13-0AA4 Yes 是 ( ) No 否 ( )
双轴电机模块
Double motor module
双轴电机模块
Single motor module
单轴电机模块
24 v power supply
4.4 Model 型号 6EP1437-2BA20 Yes 是 ( ) No 否 ( )
24V 电源
Movement controller
4.5 Model 型号 6AU1445-2AD00-0AA0 Yes 是 ( ) No 否 ( )
运动控制器
Ethernet exchanger
4.6 Model 型号 6GK5005-0BA00-1AB2 Yes 是 ( ) No 否 ( )
以太网交换机
附件 4-1
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Serial
NO.
序号
Touch screen
4.7 Model 型号 6AV7885-2AD20-1DA8(IPC 577C)“15” Yes 是 ( ) No 否 ( )
触摸屏
G120 inverter
4.8 Model 型号 6SL3210-1KE11-8UP1 Yes 是 ( ) No 否 ( )
G120C 变频器
ET200S IM151 interface Brand 品牌 SIEMENS/西门子 Yes 是 ( ) No 否 ( )
4.9 module Model 型号 6ES7151-1AA05-0AB0 IM151 Yes 是 ( ) No 否 ( )
ET200S IM151 接口模块 Quantity 数量 1 Yes 是 ( ) No 否 ( )
ET200S power module
4.10 Model 型号 6ES7138-4CA01-0AA0 Yes 是 ( ) No 否 ( )
ET200S 电源模块
Universal terminal module
4.11 Model 型号 6ES7193-4CA40-0AA0 Yes 是 ( ) No 否 ( )
万能端子模块
Terminal module
4.12 Model 型号 6ES7193-4CE00-0AA0 Yes 是 ( ) No 否 ( )
端子模块
4DI output module
4.13 Model 型号 6ES7131-4BD01-0AA0 Yes 是 ( ) No 否 ( )
4DI 输入模块
4DO output module
4.14 Model 型号 6ES7132-4BD00-0AA0 Yes 是 ( ) No 否 ( )
4DO 输出模块
Verification Method: verify visually the actual installation in accordance with drawings or relevant certificates.
附件 4-2
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版本号
确认方法：参照图纸及相关证书进行目击确认。
Acceptance Criteria: all components installed comply with design.

验收标准：所有安装部件与设计相符。
Conclusion & Comments:

结论和注释：
Checked by/检查
Reviewed by/审核
附件 4-3
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Attachment 5 – Qualification of the Components Material
附件 5 – 零部件材质确认
Objective：In accordance with the actual installation, compare with the design drawings, material list or others to examine whether the components material of the machine can meet
design and customer’s URS or GMP requirements.
目标：通过工厂安装实物与设计图纸、材料配置表等的比照，确认零部件材料与设计相符并能满足客户 URS 及 GMP 要求。
Serial NO. Item Design result Actual Installation meet design Marks/Deviation report NO.
序号项目设计结果实际安装与设计是否相符备注/偏差报告编号
Machine external surfaces
5.1 SS 304 Yes 是 ( ) No 否 ( )
机器外表面
Star-wheel
5.2 PET Yes 是 ( ) No 否 ( )
星轮
Guardrail
5.3 PE Yes 是 ( ) No 否 ( )
护栏
Stopper feed bowl
5.4 SS 316 L Yes 是 ( ) No 否 ( )
胶塞料斗
feed tracks
5.5 SS 316 L Yes 是 ( ) No 否 ( )
供料轨道
Peristaltic pump
5.6 SS 316 L Yes 是 ( ) No 否 ( )
灌装针
Pre -feed bowl
5.7 SS 316 L Yes 是 ( ) No 否 ( )
预给料料斗
Hoses
5.8 Silicone Yes 是 ( ) No 否 ( )
软管
Turntable
5.9 SS 304 Yes 是 ( ) No 否 ( )
转盘
Suction nozzle
5.10 SS 316 L Yes 是 ( ) No 否 ( )
吸嘴
Conveyor belt
5.11 POM Yes 是 ( ) No 否 ( )
网带
附件 5-1
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Liquid tank
5.12 SS 316 L Yes 是 ( ) No 否 ( )
药液罐
Acceptance Criteria: all the material of components installed comply with design.
验收标准：所有部件材料与设计相符。
结论和注释：
Checked by/检查
Reviewed by/审核
附件 5-2
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Attachment 6 – Qualification of the Surface Finish
附件 6 – 表面处理确认
Objective：Verify the surface finishing can meet design and customer’s URS or GMP requirements.
目标：确认表面处理与设计相符并能满足客户 URS 及 GMP 要求。
Machine external surfaces
6.1 Ra ≤ 3.2µm Yes 是 ( ) No 否 ( )
机械外表面
All the surfaces welded
6.2 Passivation 钝化 Yes 是 ( ) No 否 ( )
所有焊接表面
Filling Needles
6.3 Electro polished 电抛光，Ra ≤ 0.4 µm Yes 是 ( ) No 否 ( )
灌液针头
The stopper feed bowl and feed tracks
6.4 Electro polished 电抛光，Ra ≤ 0.6 µm Yes 是 ( ) No 否 ( )
胶塞料斗和供料轨道
Product piping and in contact product fluids
6.5 Electro polished 电抛光,，Ra ≤ 0.6 µm Yes 是 ( ) No 否 ( )
与产品和处理液接触的管子
Dosing devices
6.6 Ra ≤ 0.6 µm Yes 是 ( ) No 否 ( )
灌装装置
All metal part in the clean side of the machine movements
6.7 Ra ≤ 3.2µm Yes 是 ( ) No 否 ( )
在洁净侧运动的所有的金属部件
Acceptance Criteria: all items comply with design.

验收标准：所有表面处理相关项目与设计相符。
附件 6-1
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版本号
结论和注释：
Checked by/检查
Reviewed by/审核
附件 6-2
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Attachment 7 – Final Installation Qualification
附件 7 - 安装总成确认
Serial NO. Item Design result Actual Installation meet design Marks / Deviation report NO.
序号项目设计结果实际安装与设计是否相符备注 / 偏差报告编号
Total dimension of the machine See Layout Drawing
7.1 Yes 是 ( ) No 否 ( )
设备全尺寸见平面布局图
Working height
7.2 900 mm ±20 mm Yes 是 ( ) No 否 ( )
工作高度范围
All the necessary cabling for the equipment Included
7.3 Yes 是 ( ) No 否 ( )
设备所有必要的接线有
Interface with upstream machine Included
7.4 Yes 是 ( ) No 否 ( )
与上游机器的接口有
Interface with downstream machine Included
7.5 Yes 是 ( ) No 否 ( )
与下游机器的接口有
Surface treatment Included
7.6 Yes 是 ( ) No 否 ( )
表面处理有
Complete machine roughness
7.7 Ra<3.2μm Yes 是 ( ) No 否 ( )
整机粗糙度
Cleanliness No dust, oil or other objectives
7.8 Yes 是 ( ) No 否 ( )
洁净度无灰尘、油渍等异物
附件 7-1
Doc.Ref
IQ 2014-001LFc-11-IQ
文件编号
FFS-20/06NL0
V 1.0
版本号
验收标准：所有项目与设计相符。
结论和注释：
Checked by/检查
Reviewed by/审核
附件 7-2
Doc.Ref
IQ 2014-001LFc-11-IQ
文件编号
FFS-20/06NL0
V 1.0
版本号
Attachment 8 – Qualification of the Utility
附件 8-公用工程确认
A. Electrical 电气
Current type
8.1 3/N/PE Yes 是 ( ) No 否 ( )
电流类型
Voltage [V]
8.2 220 Yes 是 ( ) No 否 ( )
电压 [V]
Frequency [Hz]
8.3 60 Yes 是 ( ) No 否 ( )
频率 [Hz]
Total power[KW]
8.4 ≈12 Yes 是 ( ) No 否 ( )
总功率[KW]
8.5 Overload Protection Main breaker 主断路器 Yes 是 ( ) No 否 ( )
8.6 过载保护 Circuit breaker 回路断路器 Yes 是 ( ) No 否 ( )
B. Pharmaceutical compressed air 无菌压缩空气
Connected load [bar]
8.7 6-7 Yes 是 ( ) No 否 ( )
负荷[bar]
Consumption [L/min]
8.8 10 Yes 是 ( ) No 否 ( )
耗量[L/min]
Connection type
8.9 TC 1/2” Yes 是 ( ) No 否 ( )
接口类型
C. Vacuum 真空
Connected load [kPa]
8.10 ≤100 Yes 是 ( ) No 否 ( )
负荷[kPa]
Consumption [m3/h]
8.11 80 Yes 是 ( ) No 否 ( )
耗量[m3/h]
附件 8-1
Doc.Ref
IQ 2014-001LFc-11-IQ
文件编号
FFS-20/06NL0
V 1.0
版本号
Connection type
8.12 TC 3/2” Yes 是 ( ) No 否 ( )
接口类型
Verification Method: visually inspect in accordance with drawings and certificates.

验收标准：所有项目与设计相符。
结论和注释：
Item / 项目 Conclusion / 结论 Comments/备注
Checked by/检查
Reviewed by/审核
附件 8-2
Doc.Ref
IQ 2014-001LFc-11-IQ
文件编号
FFS-20/06NL0
V 1.0
版本号
Attachment 9 – Qualification of the Drawings
附件 9 - 图纸确认
Objective: To verify the drawings used for installation are current.
目的：确认所有现场安装过程中的图纸都是最新的。
Serial NO. Title Actual result
序号标题实际结果
9.1 Layout drawing 平面布局图 Yes 是 ( ) No 否 ( )
9.2 P&ID 管道和仪表流程图 Yes 是 ( ) No 否 ( )
9.3 Electric drawing 电路图 Yes 是 ( ) No 否 ( )
Acceptance Criteria 验收标准：
All drawing must be current.
所有图纸都是最新的。
The equipment assembly conforms to the latest version of the drawings.
设备安装同图纸的最新版本要一致。
Conclusion& Comments 结论和注释：

Checked by/检查
Reviewed by/审核
附件 9-1
Doc.Ref
IQ 2014-001LFc-11-IQ
文件编号
FFS-20/06NL0
V 1.0
版本号
Attachment 10 – Qualification of the Documents
附件 10 – 文件确认
Objective: Verify the existence of the documentation required for the correct installation, start-up, operation and maintenance of the filling machine.
目的：确认为保证灌装机正确安装、启动、运行和维护所需的文件是否存在。
Serial NO. Document title Doc. Reference code Revision # Location
序号文件名称文件编号版本号归档处
Documents provided with machine 随机文件
10.1 P&ID 管道和仪表流程图
10.2 Wiring drawing 电气原理图
10.3 Installation manual 安装手册
10.4 Operation manual 操作手册
10.5 Maintenance manual 维护手册（含爆炸图、润滑图）
10.6 Quality certificate 合格证
10.7 Manufacturer’s spare part list 制造商备件清单
10.8 Suitable parts list 规格件清单
Documents for validation 验证文件
10.9 Design qualification 设计确认
10.10 Installation qualification 安装确认
10.11 Operation qualification 运行确认
10.12 Performance qualification 性能确认
10.13 Material certificates 材质证明
10.14 FAT protocol and report FAT 方案及报告
10.15 SAT protocol and report SAT 方案及报告
附件 10-1
Doc.Ref
IQ 2014-001LFc-11-IQ
文件编号
FFS-20/06NL0
V 1.0
版本号
Acceptance Criteria:
验收标准：
All documents in the table must be present.
表格内所有文件都存在。
All documents must be current version.
所有文件都是最新版本。
结论和注释：
Checked by/检查
Reviewed by/审核
附件 10-2
Appendix1-Data Collection Sheet
附录 1-数据汇总表
Copy this page according necessity 必要时可复制此页..................................................... Page. _____ of _____

Test 试验#.:________ Test title 试验标题:
Attached to page 附于页#.:________
Checked by/检查
Reviewed by/审核
Appendix2-Deviation Report
附录 2-偏差报告
Copy this page according necessity 必要时可复制此页................................................No. _________________

Section A: Description and Reason of the Deviation
A 部分：偏差的描述和原因
Process in which deviation occurred
偏差发生的过程
Equipment position in which
deviation occurred
偏差发生的设备位置
Date on which deviation occurred
偏差发生的日期
Description and Reason of the Deviation
偏差的描述和原因
Section B: Analysis and Resolution of the deviation

B 部分：偏差的分析和处理
Section C:Impact Evaluation and Requirements to resolve the Deviation

C 部分：影响评估和偏差处理的需求
Validation Impact Review:

对验证影响审核：
GMP Impact 影响 GMP  No GMP Impact 不影响 GMP 
Impact on the equipment:
对机器的影响：
Completed by Signature: Date:
完成署名：日期：
Section D: Request approval to resolve the deviation

D 部分：偏差处理的审批
Signature Date Comments(Approval or others)
署名日期注释（同意或其他）
Reviewed By:
审核人：
Reviewed By:
审核人：
Approved By:
审批人：

2014-001LFc Filling Machine灌装机IQ

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INSTALLATION QUALIFICATION OF

SUPPLIER NAME: CUSTOMER NAME:

INSTALLATION QUALIFICATION PROTOCOL

2014-001LFc-11-IQ. date: Apr.20,2014

EXPERTISE IN PHARMACEUTICAL INDUSTRY

ADD: 2199, FANGHE RD.,SHANGHAI-201109 CHINA

LABORATORIOS VENCOFARMA DO BRASIL LTDA.

THIS DOCUMENT CANNOT BE COPIED OR OTHERWISE DISTRIBUTED

Issued by: Shanghai Tofflon

Classification: company confidential

Document 2014-001LFc-11-IQ，Rev.1.0, Date Apr.20,2014

Produced by Shanghai Tofflon

Revision 版本 Change 变更 Name 姓名 Date 日期

1.0 Initial Ivy Liu Apr.20,2014

EXECUTION APPROVAL SIGNATURES

Installation Qualification (IQ)/安装确认（IQ）

Type of Equipment/设备名称 Filling Machine/灌装机

IQ Protocol Approval/IQ 草案批准

Name Department Signature and Date

Prepared by Ivy Liu Packaging Machine Department

Reviewed by Carol Ning Packaging Machine Department

Approved by Jackson Zhao Packaging Machine Department

4. EQUIPMENT DESCRIPTION 设备说明........................................................................................................6

4.1. General Overview 总概述................................................................................................................................6

4.2. Machine functional groups 机器功能组......................................................................................................... 7

4.2.1. Vials Transfer 西林瓶输送............................................................................................................................. 7

4.2.2. Vials Filling 灌装............................................................................................................................................8

4.2.3. Vials Stoppering 加塞..................................................................................................................................... 8

4.2.4. Defective Vials Rejection 剔废.......................................................................................................................9

4.2.5. Outfeed System 出料系统.............................................................................................................................. 9

4.2.6. Vial Automatic Sampling 取样.....................................................................................................................10

4.3. Control system 控制系统............................................................................................................................... 10

4.4. Critical utilities 关键公用工程...................................................................................................................... 10

5. TESTING PROCEDURES 测试程序..............................................................................................................11

5.1. Documentation Requirements 文件要求......................................................................................................11

5.2. Documentation Procedure 文件执行规程.................................................................................................... 12

6. APPLICABLE DOCUMENTATION 参考文件规范.................................................................................... 13

7. EXEUTANT OF DOCUMENTS 文件执行人员............................................................................................ 13

8. LIST OF ATTACHMENT 附件清单.............................................................................................................. 17

本文件适用于安装在 LABORATORIOS VENCOFARMA DO BRASIL LTDA.的 FFS-20/06NL0 型灌装

The equipment installation has been executed according to the URS.

设备安装是按照 URS 要求实施。

To demonstrate that the equipment is installed following the design specifications.

设备安装遵照 GMP 规范实施。

同时，本文件包含了相关的批准签名，也描述了上海东富龙与 LABORATORIOS VENCOFARMA DO

4. EQUIPMENT DESCRIPTION 设备说明

4.1. General Overview 总概述

 Accumulation in turntable of the vials coming from the depyrogenation tunnel ;

 Transfer at constant speed into infeed of the filling machine ;

 Defective vial reject ;

 Vial automatic sampling for QC ;

灌装机的运行必须严格符合 GMP 中规定的注射针剂成品的包装标准。

4.2. Machine functional groups 机器功能组

此机器设计可采用 VHP（过氧化氢蒸汽）灭菌，能配置任何类型的 R.A.B.S。

4.2.1. Vials Transfer 西林瓶输送

The accumulation turntable is provided with a fallen vial removal system.

4.2.2. Vials Filling 灌装

4.2.3. Vials Stoppering 加塞

4.2.4. Defective Vials Rejection 剔废

4.2.5. Outfeed System 出料系统

欧盟 GMP 第 4 卷《人用和兽用药品良好生产规范指南》，2010 年 12 月版。

欧盟 GMP 第 4 卷附件 1《无菌药品》01 版，2009 年 3 月。