URS-2100 loading system (1)
冻干制剂自动进出料系统
用户采购要求说明书
User’s Requirements Specification
数量 2 套（包括相关附件等）
买方
地址
卖方
地址
版本历史
本采购说明适用于以下设备：
名称冻干制剂自动进出料系统
型号
数量共2 套
1. 总说明General
本项目是一个系统工程项目。项目编号：2008—03—NP15。甲乙双方均为此设立项目组和项目经理，项目经理即为联系人。
This project is a system project. Project No: 2008-03-NP15. Both XX and the Vendor should set up a Project Team for this project. Project Manager should be the contact person
本用户要求说明书（URS-2102）是对冻干制剂线（西林瓶）自动进出料系统（Automatic Loadingand Unloading System）的设计、制造、材质、控制系统、检查和测试、文件、包装运输发货、安装调试、验证、操作使用培训的说明和最低要求。
This URS-2102 is used for the minimum requirement for design, fabrication, material, control system, FAT, documentation, packing& transportation, installation/commissioning, validation and training for a lyophilisation line (vial) automatic loading and unloading system
所有设备的设计、制造、材质、检查和测试、制造厂内测试（FAT）(包括试运行与验证)、用户现场最终检查和测调试(SAT)等活动由卖方负责并由买方人员参加复核及批准，SAT 部分将由双方人员共同实施并签署各项调试、验收的有关报告。以上活动必须严格按照本说明和相关的标准与规范来执行。
All design, fabrication, materials, inspection, test, FAT including validation, SAT are responsible by Seller and involved by the Buyer for approval and check. SAT report should be done by both parties and duly signed. All above mentioned activity should follow this URS and corresponding standard and regulations
遵照相关的标准和规范以及本采购要求既不能减轻卖方也不能减轻制造商对货物交付(包括软硬件和文件资料)、对材质和零部件的正确的设计和制造安装、对所有功能描述和操作条件的完全满足、对设备性能保证应负的所有责任。
Follow the URS, standard and regulation will not abate any responsibilities of the Seller and manufacturer to the performance of the equipment, the proper design of the components, proper fabrication.
买方对设备的建议、检查和确认并不能减轻卖方对所供货物及所有工作所应负的责任。Suggestion, check and approval from the Buyer will not abate any responsibility of the Seller.
本次采购的自动进出料系统将在XXX无菌冻干制剂车间内使用，该车间有两条独立的生产线，每条生产线包括3 台冻干机和1 套自动进出料系统，自动进出料系统可与3 台冻干机进行良好连接，用于冻干制剂（主要是下文所述之2 种规格西林瓶）的自动装箱、出箱等操作，避免与人员的交叉污染，并减少人员在无菌区域内的活动及其劳动强度。
The loading/unloading system will be installed in XXX. It is a completely now
workshop for sterile lyophilisation line. This Unit has two independent line. Each line includes 3 FD and 1 loading system. The loading/unloading system should integrate with the freeze dryer properly, suitable for two kinds of vials. Used for loading and unloading of the freeze dryers and avoid cross contamination of the
personnel. At the same time, decrease the activity of the operator in cleanroom and labor intensive.
需要达到的标准和水平：卖方提供的设备系统和文件须满足买方的操作、使用、认证等项要求，
并且须满足中国、美国、欧盟的cGMP 认证的要求。
The equipment and documentation should satisfy the operation, production and validation purpose of the Buyer. Follow the Chinese, American and European validation requirement
供应商在提交技术方案与报价时，须一并提交下列内容：
Vendor should supply following documents together with the offer
供货范围及其配置的详细说明，以及平立面图、剖面图，完整的PID。
Scope of supply and detailed specification and configuration. Including Layout drawing, PID, side
view drawings
该项目拟定之项目组织结构图
Project team structure drawing
初版项目进度计划时间表
First version of project plan (schedule)
2. 工作描述Description of the process
该自动进出料系统，把来自灌装线的完成药液灌装半加塞的西林瓶，通过与冻干机小门自动联动，自动装入3 台冻干机冻干箱内的搁板上，其过程包括与冻干机搁板进行对接，并把产品装入前箱内进行冻干，冻干完毕后把箱体内的产品转移输送至轧盖机，并且最大限度防止转运过程中产品污染。生产线配备二套模具。
在上述条件下，自动进出料系统之最慢稳定运行生产速度须不低于3 小时装满一柜。
3. 技术参数详述Technical Spec Requirement
3.1 自动进出料系统组成
Comprise of the system
该系统由自动进出料系统、与灌装机、轧盖机连接轨道，层流系统（LAF）、附属配件及控制系统等组成。各部件易清洁、消毒。
Loading and unloading system, conveyer to filling line, conveyor to capper, LAF, Control system
All components need to be easy for cleaning
现有产品按常温进料考虑设计，但，低温进料予设菜单可使之在使用时很容易地转换。Design for room temperature loading, but should have low temperature loading possibility in the future. Recipe can select for low temperature loading
整个系统的噪音级别应控制在60 分贝以下。
Noise of the system less than 60db
3.2 自动进出料系统
Loader
厂家提供该自动进出料系统详细配置要求，并提供详细图纸和技术参数。
The supplier should provide the detailed configuration, layout drawings and specification
3.3 层流系统（LAF Class100 and RABS)
自动进出料系统所有产品暴露的位置（如传送带、蓄瓶位置等等）上方，均设置垂直层流（LAF）保护，于报价时，厂家须提供层流罩的设计图纸（如平立剖等）和详细技术参数，及其验证方案。
All exposed area above the system should be protected by vertical LAF. Together with the offer, the vender should supply detailed drawings (side view and Top view) and detailed specification. Validation protocol also needed
3.4 框架
Frame
进出料系统框架各部件采用不锈钢等适用于无菌制药环境的材质，具有良好的强度，表面光滑，
焊缝抛光处理，无死角。但，须考虑到能够耐受VHP 灭菌或无菌室房间熏蒸等因素。Protection frame with SS material or other materials with good hardness, smooth suitable for pharmaceutical environment. VHP sterilization suitable
3.5 电气系统
Electrical system
电气设备元件（空开、接触器、热保护等）采用进口知名品牌，所选型号要满足电流的运行规则，电气柜和控制柜使用不锈钢材质，设计要符合安装于无菌室环境。
所有要求安装在电气柜和控制柜的开关、控制元件，都是紧凑性设计。同时，它们被分为强电控制区和弱电控制区及仪表监控部分。
所有在电器柜内的电气元件的连接线都接到端子排上，连线的端口有清楚的识别编号。
All components should be supplied from well-known international brand. Electrical & control cabinet should be made by SS, suitable for cleanroom environment
Compact design. Good separation of power and control circuit
Good tag and numbering of the cable
3.6 控制系统
Control system
总控制系统应与冻干机、灌装线以及轧盖机能够进行正常通讯以保证系统控制顺利集成In case Central Control should communicate with FD, filling line, capper
控制系统中的PLC、触摸屏都采用进口知名品牌产品，具有良好的性能。
PLC, touch screen should be well-known international brand
控制系统设置三级密码保护。
3 level password
提供可编程控制器用的电源，连接220V 交流电源。
Supply PLC power, connected to 220V A/C
用于接收数字传感器（开关信号），输入暂存器反映输入信号状态。
Used to receive digital sensors on/off signal, in-out register indicate signal input status
输出点反映输出锁存器状态用于输出控制外部的执行机构，可连接控制接触器、指示灯和电机启动器等。
Output point reflects status of output flip-latch and controls the outer mechanisms. Can connect control contactor, motor, light etc
通过A/D 模块可将模拟传感器的电流、电压信号转化为数字信号供CPU 模块处理。
Through the A/D module, current/voltage signal can be converted to digital signal for CPU
整套系统可完全自动的实现由灌装至轧盖之间的进出瓶的所有操作。
The system can fulfill all the operation between filler to capper
供货方提供自动进出料系统的详细配置清单：包括各零部件的规格、型号、材质、厂家、技术参数等。
The vendor should supply detailed configuration of the system: include the model type of the components, materials, manufacturer, spec.
3.7 应提供进料和出料的备用系统。（一旦自动系统不能正常运行的时候，手动工作方式的设计与方案说明。）
An emergency operation method should be provided in case automatic system blocked
3.8 适用于不同规格西林瓶的模具清单。
Change parts for different vials should be supplied
4. 卖方的责任Seller’s responsibility
4.1 卖方的供货范围Scope of Supply
卖方提供的货物及文件应完全符合本用户采购要求说明书，及其附件以及相关标准和规范。The equipment and documentation should follow the URS and related standard and regulation
卖方供货范围包括所有本采购要求中说明的设备、附属零部件、辅助设备等等，以及保证整套装置良好性能所必须的所有设备、零部件与相关文件。
The scope of supply should include the equipment required in URS, spare parts, ancillary equipment and other components, documents needed for the complete line operation.
供货范围如下：
Required scope
详细的文件资料(例如技术规格书，合格证书等)的准备和交付，以便满足相关现行规
范的要求
Detailed documents (Specification, certificate, manual)
本文要求的所有材料、部件和设备及控制系统
All materials, components and control system required
专用工具(如果需要)
Tools (if needed)
安装调试、验证、试运行所需要的所有配件、仪器和工具
Tools, instrument, spares needed for installation, validation and trial
设备运行两年备件清单
Two years spare parts
现场组装、安装
Installation at site
提供竣工资料及各种有关资料及图纸。
Drawings as build and related documents
提供DQ、IQ、OQ 等文件并协助买方完成其他如URS、RA、PQ 等文件。
DQ,IQ,OQ documents and support to the clients for URS, RA, PQ
卖方应对货物的设计、制造、出厂前检查测试FAT、交付、买方现场组装安装、最终检查测试验收SAT 负责。
Seller responsible fo r design, fabrication, FAT, dispatch, assembly and installation at the Buyer’s site, final SAT
卖方应对其供货商提供的材料、零部件和设备的质量、性能及其可追溯性负全部责任。
The Seller should responsible for the quality of material, components and the equipment and its Retroactivity
4.2 卖方的工作范围
Seller’s job scope
设计和计算
Design and calculation
设备制造，正确选材。所有选材及结构件等，应能确保该产品无死角易清洁、灭菌，
符合无菌药品生产GMP 规范之各项要求。
Fabrication and material select. All materials and structure components
should be suitable for sterile production, easy for sterilization, easy for
clean
制造厂内验收检查与测试，及提供各项相关报告
FAT and internal test. Provide corresponding report
包装、运输及运输保险
Packing, transportation and insurance
在买方现场的组装、安装、调试、试运行，直至成功交付使用并由双方签署验收合格
报告书。
Assambly, Installation, commissioning, trial, SAT and sign acceptance report
with the clients
提供完整的竣工资料三套，并装订成册。
3 sets documents as build
使用与维护的有关培训
Maintenance and operating training
售后服务
After sales service
5. 双方界限划分Battery Limit of each party
卖方提供设备范围自液体灌装机出瓶轨道接起，至轧盖机的进瓶轨道止；并负责进出料系统与灌装线的控制集成及与轧盖机之间的控制集成系统。
Seller supply from the output conveyor of the filling line to the infeed conveyor of the capper. Also responsible of the control integration of the filling line and capper
6. 安装位置Installation location
该冻干生产车间厂房拟建于，XX
7. 依据的标准和规范CODE and Standard APPLICABLE
（1）设计、制造、材料、所有部件的供应以及配置必须基于并符合中国、欧盟和美国的相关规范对无菌注射类药品的要求和准则。
The design, fabrication, material, components should follow the Chinese, Americian and European requirement for sterile injectable products
（2）安全：依照CE 标准。
Safety: CE
（3）所有的电气设备和电缆必须根据GB、IEC 标准或其他标准。
Electricity: GB, IEC
（4）现场安装的电机及仪表必须适合于无菌制药洁净区。
Local motor and instruments suitable for sterile cleanroom
（5）cGMP 规范：
------中国现行GMP《药品生产质量管理规范》
------欧盟现行最新GMP 及FDA。
cGMP follow Chinese and FDA and European latest version
8. 原材料、零部件和控制系统的可追溯性
Retroactivity of materials, components and control systems
所有原材料、零部件、设备、电气及控制系统都要保留原始资料，并且必须经过检查并形成文件，确保其具有可追溯性。项目执行的各个方面要形成追溯矩阵(TM)文件。
All original documents of the materials, components, equipment and control system should be reserved and checked to keep the retroactivity. The execution of the project should form TM ( Matrix) documents
各个零部件、设备、电气及仪表部件都配上带有唯一编号的永久性标牌以便于识别。编号清单应提交买方预先审阅。
All components, equipment, electrical and instrumental parts should be tagged clearly with a permanent tag. Tag list should be provided to the Buyer for check.
原材料需有材质证书、合格证等，证书中应包含制造商、产地、批号、炉号、成份等信息。Raw material should have certificate indicate manufacturer, origin, batch no., and ingredient etc. 9. FAT 工厂内验收测试FAT and internal test
设备所有部件的制作、装配、检测和整体检测均在卖方自己的工厂内完成。
All assembly, test, manufacturing should be finished in Seller’s factory
卖方应说明出厂前工厂内验收测试的项目。卖方应提供验收测试方案和工作步骤，以取得买方的认可和批准，此方案需要带有各种应有的验收测试参数。买方要指明哪些测试需派代表亲眼见证。
The Seller should advise the items of FAT. The FAT protocol should be provided to the Buyer for approval. The buyer will advise which items need to be inspected by the buyer
所有设备都要经历功能检测。检测方案和报告将形成书面文件，并作为整个验收测试的不可缺少部分。这些文件应该在交货时一并提供给买方。
As a integral part of the test, performance test should be finished and form a written report.
设备在工厂制作完成，出厂前由制造商进行性能检测，以便检查设备是否能够满足合同对设备的要求，而且必须经过双方确认
Before dispatch, the manufacturer does the performance test to see if the equipment fulfills the requirement of the contract and confirmed by both parties.
9.1 FAT 工作范围：相关项目详见厂家提供的FAT 文件
FAT scope: Vendor should supply the FAT protocol
设备组装安装确认
Installation qualification
技术参数确认
Specification qualification
配置确认
Configuration qualification
运行确认
Operation qualification
性能确认
Performance qualification
安全性确认
Safety qualification
文件确认
Documents qualification
10. 包装、运输Packing and transportation
10.1 运输的准备Preparation before transportation
交付的设备，卖方要做好各方面的支撑以防止运输和吊装过程中任何变形和损坏。Enough supporting to avoid damage during transportation and installation
卖方要在竣工资料中提供设备短期和长期储(保)存的详细操作规程。
Seller should supply short time or long time storage instruction
包装和运输必须确保货物长途和安全地到达交货地点。整个货物的运输安全和防护工作
由卖方负责。
Before arrival at destination, The Seller takes all transportation responsibility
10.2 运输Transportation
运输目的地：山东省济南市历城区董家镇849 号齐鲁天和惠世制药有限公司安装现场。
Qilu facility in Jinan, Shandong,China
包括：
Includes
适合海运和/或陆路远距离运输方式的包装
Seafreight
运费及保险(至运输目的地)
Insurance and transportation cost to destination
11. SAT 用户现场调试和验收测试（包括但不限于）
SAT
运输到货后，由卖方在买方现场进行组装，组装时间不得超过3 周。
After arrival at the Buyer’s facility, installation and assembly work sh ould be finished with 3 weeks by the Seller
安装组装完成后，在2 周内完成系统调试。
After installation, the commissioning should be finished with 2 weeks
设备在安装和调试完成后，要进行系统测试确认。按照所应用的标准和规范进行现场验收和检测,卖方应提前提交验收和检测项目及计划，并须得到买方批准后实施。对于每一项检查和测试(买方代表见证的或未见证的)，卖方都应出具检测调试报告，须由双方代表签字确认。这些文件包含在最终竣工文件内，调试完毕时提供给买方。
After installation and commissioning, system test qualification should be done. The Seller should
provide SAT protocol and approved by the Buyer. The Seller should give every test item a report ( with the witness of the Buyer’s representative or not) and signed by both parties. This documents should be handed over to the Buyer after SAT
如果调试、测试结果不合格，卖方工程师要留在现场继续调试，卖方要采取措施尽快调试合格，
11.1 测试和检查Test and check
注意：下列检查和测试是必须进行的，而且并不限于以下检测内容，根据相关的标准和规范所有应该进行的测试都要完成
Notice: following item must be tested but not limited to.
设备组装安装确认
Installation qualification
技术参数确认
Specification qualification
配置确认
Configuration qualification
运行确认
Operation Qualification
性能确认
Performance qualification
安全性确认
Safety qualification
文件确认
Documents qualification
11.2 验证Verification
包括但不限于以下内容：
Include but not limit to:
自动进出料系统运行测试
Operation of loading systems
100 级环境测试
100 class verification
装料、出料运行测试
Test of loading and unloading
噪声测试
Noise test
房间环境影响测试（目的：测试该系统对无菌室房间环境的影响有多大。如超标，视为不合格。）
Environmental affect test ( objective: to test the system affect to the cleanroom)
产品工艺验证
Process verification
其他验证
Others
卖方提供验证方案，并由买方确认，所有验证仪器及其相关证书、校验报告等均由卖方提供。The seller should provide verification protocol and approved by the Buyer. All instrument, certificate and report provided by the Seller
12. 文件资料Documentation
文件是卖方供货不可分割的一部分，延时提供文件或提供文件不完全卖方支付违约金。若不能提供文件，即使是部分的不能提供，也会被认为未能完全履行合同并且是不可被接受的。Documents is a integral parts of the Seller’s scope. Delay of supplying documents wil l leads to late supply penalty. Partial supply of the documents will be treated as not follow the contract
卖方提供的文件和图纸应达到无需卖方帮助买方即可安装、启动、维护和维修的深度。
The documents and drawings should be supplied enough to a level that the Buyer can install, start, maintenance the equipment by themselves
特别说明：方案、平面布局图和其他图纸设计完毕后经买方审查同意方可实施。
Special Note: Layout and other drawings should be approved before start the manufacturing
12.1. 文件格式Format of the documents
所有文件和图纸应标明订单号、工作号、客户号、设备位号
All the documents should list order number, job number, customer number, machine number
文件将通过书面和电子版方式按照附表中的时间提供。(平面图、总图和相关装配图纸的提供不仅是书面的还要同时提供电子版的；提供给买方的电子版图纸为CAD 格式(AutoCAD2004)。Documents should be in hard copy and e-format and supplied according to the attached time table.
E-format drawing should be AutoCAD 2004
语言：主要以中文为主，验证文件采用简体中文和英语
Language: Chinese. Qualification documents in Chinese and English
12.2. 文件形成/提交的时间(进度)表
DOCUMENTATION SCHEDULE
下表列出需要卖方提供的文件(包括但不限于以下文件)以及形成和提供的时间表：
13. 质量保证和责任Warantee and Responsibility
卖方供货的所有设备包括零部件、仪表、电气和控制系统的质保期至少为1 年(从最终调试验收合格之日起算)
At least one year ( after acceptance) for all equipments, components, instrument, control system
卖方对设备质量和综合性能负责，保证运行时的稳定性能至少需要达到第2 条所述。
The Seller responsible for the comprehensive quality and performance, guarantee the specification satisfy the requirements of Item 2 of URS
卖方全面负责设备的设计和检查测试。合同签订后由于设计问题进行必要的改动所需的费用由卖方负责，买方不承担此费用；制造商要负责该设备和所有部件(焊接件和非焊接件)
各种设计状况(包括起吊安装)下的机械设计和厚度设计。
The Seller responsible for the design and test. After contract signing, the cost for necessary modification of the design will be covered by the Seller. The Seller responsible for the thickness
and hardness of all components (includes welded parts or non-welded part)
卖方保证设计、制造和检测的安全可靠性、规范性和合理性
Safety, normalization, rationality should be guaranteed by the Seller
卖方保证所有工作内容及其执行必须考虑到并满足买方要求、验证和相关(中国、欧盟和美国的)GMP 认证的要求。
Guarantee for satisfying Chinese, European and US GMP regulation and qualification
报价时提供冻干机及自动进出料、LAF 整个系统有效灭菌及其验证措施方法的说明。Provide the sterilization methods and qualification methods for FD, loading system, LAF when
offer
14. 售后服务和培训Service and Training
报价时，卖方要提交售后服务和培训的相关内容的详细说明。
Provide description for service and training when offer
在交货时提交终版文件。
Final version should be supplied when dispatch
在质保期限内, 合同中所供货物和工作内容在操作规程内出现任何问题, 卖方负责无偿维修
或更换；质保期后, 卖方终生提供及时的维修、维护, 维修只收取材料成本费；
Any problems in warrantee time, the seller should solve free. After warrantee, only cost be recovered. Life time service available
卖方应定期进行回访，排除潜在的故障，解决机组运行当中可能出现的疑问，使机组保持良好的工作状态。卖方保证十年内能方便的采购到所供货物的相关配件，并保证以不高于市场的价格提供优质的零配件。
The seller should visit the Buyer in regular way to find the potential problems. The seller should guarantee supply spares in 10 years and the price should not higher than the market price
卖方免费对买方人员进行培训(包括制造厂内和安装现场的培训)，培训内容主要包括整个装
置和系统的工作原理、结构、流程、操作、维护维修、调整校准和故障解决等等。
Free training for the operators (including in Seller’s factory and at site) Including principle, structure, process, operation, maintenance, calibration, trouble shooting etc