中英文对照胶囊机URS(用户需求标准).doc

USER REQUIREMENT SPECIFICATIONS用 户 需 求 标 准Document No.文件编号 URS-QA-DOC-004Document Title文件标题 URS for Capsule fillingDocument Version版本号01Effective Date生效日期Authority 职责Job Title 职位Signature 签字Date 日期Author起草: Mike YeSenior ProcessEngineerChecked By校对: Petit MarcProcess ManagerApproved By批准: Tadeusz Project ManagerProcess Owner(s)执行部门审核QA ReviewerQA审核Technical Approver技术批准Technical Approver技术批准Distribution分发至DepartmentsCopiesDepartmentsCopiesCrossReferences引用文件Document No.Document TitleIndex索引1 INTRODUCTION 简介1.1 PROJECT INTRODUCTION 项目介绍1.2 SCOPE AND PURPOSE OF THE DOCUMENT 文件的范围和目的1.3 GLOSSARY 术语2 GENERAL DESCRIPTION 总述2.1 SCOPE OF SUPPLY 供货范围2.2 PROCESSES 工艺过程2.3 MAIN CHARACTERISTICS 主要特点3 PROCESS RELATED USER REQUIREMENTS 工艺用户需求3.1 CAPACITY 产量3.2 OPERATIVE ENVIRONMENT 工作环境4 MECHANICAL USER REQUIREMENTS 机械用户需求4.1 GENERAL MECHANICAL USER REQUIREMENTS 机械用户需求概述4.1.1 Available Utilities 可得到的配套公用设施4.1.2 Materials 材质4.1.3 Finishing 表面处理4.1.4 Electrical equipment 电器设备4.1.5 Layout 布局图4.1.6 Process equipment interfaces 工艺设备接口4.1.7 Delivery boundaries 交货范围5 AUTOMATION USER REQUIREMENT 1自动控制用户需求5.1 GENERAL 总述5.2 SAFETY 安全5.3 DATA 参数5.4 INTERFACES 接口5.5 TECHNICAL SYSTEM REQUIREMENT 技术系统要求5.5.1 PLC 可编程控制器6 USER REQUIREMENTS FOR THE PROJECT EXECUTION 项目实施用户需求6.1 SCHEDULE 进度表6.2 LEGAL AND REGULATORY REQUIREMENT法律和常规要求6.3 MAINTENANCE 维修7 LIFE CYCLE 供货过程7.1 DEVELOPMENT 发展7.2 TESTING 测试7.2.1 FAT 工厂测试7.2.2 IQ/OQ 安装/操作验证7.3 DELIVERY 交货7.3.1 Delivery of goods 货物的运输7.3.2 Installation 安装7.3.3 Documentation 文件7.3.4 Training 培训7.4 DELIVERABLES WITH THE QUOTATION 可交货的报价单8 ATTACHMENTS 附件Introduction介绍1.1 Project introduction项目介绍The project is a new facility mainly for the production of solid dosage forms of narcotic products initiallyfor the China market but could also serve as a regional supply unit for the Asia market in the future.The capsule filling is the key and critical process of OSD. The system will be consisted with capsule filling machine, a set capsule size change parts for power、vacuum unit、suction aspirator、column lifter or vacuum feeding machine、, metal detector ,dedusting unit、capsule selection unit 。The equipment will be installed in the new Building located in Pudong area, Shanghai , People s Republic ofChina.这个项目主要是生产麻醉固体制剂药品的生产设施主要供应中国市场，但也可作为亚洲市场的一个区域供应者胶囊填充是口服固体制剂生产中一个关键且极为重要的工艺过程，本系统将由协调配套的胶囊充填机、粉剂充填模具、大流量真空泵、大流量吸尘器、胶囊筛选和进给系统、提升机或真空上料装置、金属检测、抛光机、充填后胶囊筛选装置、自动称量和取样装置。这个设备将被安装在中华人民共和国上海市浦东1.2 Scope and purpose of the document文件的范围和目的This document will be used as basis for the preparation of a specification to obtain competitive tenders.The supplier shall use proven standard technology preferably standard equipment and control as far aspractical. The supplier must advise where his standards do not comply with the specification.这个文件将作为设备标准的编制基础以进行竞争性招标。供应商应该提供迄今为止被证实的标准技术，尤其是被证实的标准的设备和控制系统，供应商必须指出他的标准与该用户需求标准的不符之处；1.3 Glossary概述BMPC 新的药品生产厂FAT Factory Acceptance TestFAT 工厂接收测试SAT Site Acceptance TestSAT 现场接收测试FDA Food and Drug Administration (US regulation body for pharmaceutical market)FDA 食品和药品管理局（美国药品市场管理机构）HMI Human Machine Interface (Operational Panel).HMI 人机界面（操作面板）I/O Input/OutputI/O 输入/输出IQ Installation QualificationIQ 安装验证OQ Operational QualificationOQ 操作验证2 General Description总述2.1 Scope of supply供货范围The scope of supply includes:供货范围包括;1、1 High Speed Capsule filling Machine with passive valve part and supporting frame to support thematerial in-feeding with hoist to be lifted.一台可对由提升机送入的原料进行胶囊充填的高速胶囊充填机，带有支持框架和完整的功能部件 The Intermittent motion capsule filling machine with rotating powder bowl and protection guards. Production up to 85,000 capsules/hour max.),consist of capsule infeed and opening 、available for size change-over、powder, pellet and liquid dosing、pellet and tablet dosing、powder, pellet and liquid dosing、faulty capsules selection and removal、capsule closing、capsule discharge and bushings cleaning.间歇式全自动胶囊充填机配备旋转粉剂槽及保护罩，最高产量为85000粒胶囊/小时,共包含空胶囊进给和打开、更换规格部件工位、充填粉剂丸剂和灌装液体工位、充填片剂和丸剂工位，充填粉剂丸剂灌装液体工位、不良胶囊挑选和剔除工位、胶囊锁合工位和胶囊排出和清洁工位和与之配套的完整的功能件。2、 one set capsule size change parts for powder 一套指定规格的胶囊粉剂充填模具3、 1 suction aspirator.一台配套的大流量吸尘器4、 1 Vacuum unit一台配套的大流量真空泵5、1 empty capsule selection and feeding system 空胶囊筛选和进给系统6、1 Column Lifters（Up to 150kg）柱式提升机 (提升重量150KG，带安全自锁装置) 7.1 Metal Detector.1台金属检测器 用于检测片剂或胶囊中的金属异物 按照优良制造规范制造 自动平衡与稳定频率控制确保灵敏度性能总是处于最优状态 使用触摸面板键盘可以方便地进行设置与操作开口尺寸150 mm x 35 mm( 取决于片剂或胶囊大小) 故障安全剔除机构 剔除确认 AuditCheck 性能自动检测 镜面抛光不锈钢结构 设备高度和倾斜度可调节 整体的剔除收集箱8、 1 capsule De-duster1台胶囊抛光机Even for the large size capsules(ooo、oo)hourly production exceed 160,000 units. 即使对最大的000、00号胶囊也可超过16万粒/小时。 9、 1 capsule selection .1台胶囊（填充后）筛选装置10 Documentation & qualification as requested by this specification.该规格型号胶囊机所需的验证文件11 Spare Parts for two years operation.2年操作使用的备件12 Design and integrate of the system.设计和系统组合13 FAT工厂接收测试14 Packaging and transport of the equipment包装和运输15 Installation安装16 SAT现场接受测试17 Commissioning and Training.试车和培训18 IQ Performance.l 安装验证Installation Qualification (IQ) Installation qualification will be performed at our factory in accordance with the procedures of our quality management system and our documentation as follows:- Identification of all critical components- Calibration of all measuring points and instruments with traceable, calibrated equipment. Delivery includes the production and application of all documents verifying installation qualification. Documents comprise the specification of all procedures necessary for the implementation of IQ and test result sheets.安装验证安装验证可按照质量管理系统程序及文件在卖方工厂完成：- 所有关键部件的验证- 通过可追踪、校准的工具来对所有测量点及设备进行校准所有校验安装验证的文件的递交。此文件包括安装验证执行的程序说明及测试结果清单19 OQ Performance. 操作验证Operational Qualification (OQ) - Master Documentation Delivery of OQ-master documentation for a standard system.操作验证控制文件。提供一套经验证的标准操作验证控制文件。19.Standard documentation for operation & maintenance will be provided together with all documentation necessary for the validation of the capsule filling system.胶囊充填系统的所有需要的安装、操作、维修等各种技术资料和说明书都完整提供。2.2 Processes工艺1. Active OEL活性OEL 0.01mg/m32. Batch Size: 150 kg (500,000 capsules about)每批产量:150公斤（大约50万粒胶囊）3.Capacity: 85,000 capsules/hr胶囊充填能力：8.5万粒/小时4.Capsule Size： Product Size A : size 1胶囊规格：1号胶囊5.Material Transferring:原料输送 Granulated and blended product from blending to capsule filling room 混合的物料从混料室输送到胶囊室 The IBC will be loaded to the hopper of capsule filling machine via hoist.通过提升机将IBC装入胶囊机的料斗内2.3 Main Characteristics主要特点1. The material contacted with the medicines, especially the mould is the stainless steel与药粉接触的材料均为不锈钢，尤其是模具必须是不锈钢2 .The products do not have metal pollution 产品无金属粉末污染3. Fast and easy cleaning with easy disassembly when changing product .does not need any adjustment at the time of installation. 模具易于拆卸且可方便的快速清洗,安装模具时不需要任何调整。4.the dosing amount adjust flexibly and conveniently, the range adjusted is very big , such as from sixty to several hundreds milligrams powder,does not need to add any other parts,and only need to adjust one adjuster.装量调整灵活方便，可调整的范围很大，例如从60毫克到几百毫克粉剂的装量调整，不需要增加任何部件，而且只需要松开调整一个调整件即可。5.Use the same powder disc for different specifications capsule and dosing different amount power. 对所有不同装量的粉剂、不同规格的胶囊均使用同一粉盘6. The powder with static has no effect on filling带静电的粉剂对胶囊充填没有影响7. Can be filled with the powder that is sticky or fluid well.对非常粘或者是流动性非常好的粉剂均可良好充填8. Can fill the powder that is light or there is air in the powder可以充填轻泡粉和含气粉剂9. Can be filled with 10-50 milligrams of little dose可以进行10-50毫克的微计量充填10. faulty capsules selection and removal不良胶囊挑选和剔除11. Modular design.模块设计12Additional equipment may be specified to enable the capsule filling machines to dose into the capsules different forms of product, i.e. powder or granulate form, pellets, tablets, in single combination.更换不同的模具可以充填不同形式的产品，例如：粉剂、丸剂、片剂的充填和他们两两混合充填。3 Process related User Requirements工艺用户需求3.1 Capacity生产能力Batch Size: 150kg (500,000 tablets about)每批产量： 150公斤（大约50万粒胶囊）Capsule filling Machine output: 85,000 capsules/hr)胶囊机产量（8.5万粒/小时）3.2 Operative environment运行环境Clean Room Class D(Class 100,000)D级洁净室（10万级）4 Mechanical User Requirements机械用户需求4.1 General Mechanical User Requirements机械用户需求总述4.1.1 Available Utilities可获得的公用设施BMPC will provide all utilities as recommended by the Supplier.新建药厂将提供供应商所必需的所有公用设施The Supplier shall provide the minimum and maximum consumption of each utility.供应商需要提供每项公用设施的最大和最小参数The Supplier shall provide the values of temperature and pressure for each utility required to safelyoperate the equipment.供应商要提供可使设备安全正常运行所需的每项公用设施的温度和压力值All equipment to change the characteristics of the utilities (e.g. pressure reduction for compressed air,absolute filters, etc.) forms part of the Supplier s scope of work and delivery.供应商的一项重要工作就是提供的诸如压缩空气气压压、流量等这样的参数确保准确。Generally, the following utilities are available:总的来讲以下的公用设施是可获得的：Electric Power 3 x 380 V (3 Ph, N, E)三相电源Potable Water 3 5 bar3-5巴的水源Purified Water 5bar5巴的净化水Industrial Steam 6.5bar6.5巴的工业蒸汽Compressed Air 6 bar6巴的压缩空气The supplier shall provide the consumption details of each utility including minimum, average and peakflows.供应商应当提供每种公用设施的从最小到中间到峰值的消耗量。4.1.2 Materials材质The capsule filling system will be constructed from stainless steel.胶囊充填系统整体由不锈钢构成All surfaces in contact with the products shall be AISI grade 316L.所有与产品接触的设备表面应该是美国钢铁学会规定的316L等级不绣钢All surfaces not contact with products could be AISI grade 304.所有不与产品接触的设备表面可以是美国钢铁学会规定的304等级不绣钢4.1.3 Finishing表面处理All surfaces in product contact shall be free from cracks & crevices with no sharp edges or creviceswhich may impede proper cleaning.所有与产品接触的表面应该没有任何可能妨碍正确清洗的裂缝和尖锐的边缘及缝隙。Internal surface finishes to suppliers standard for Pharmaceutical Facilities.内表面的光洁度必须达到制药设备标准External finishes to suppliers standard for pharmaceutical facilities and/or must be at least ra 0.4m.外表面光洁度有供应根据药业规范进行，但不得低于ra 0.6m.All welds within the equipment must be flush ground. All other welding shall be brushed and fullycleaned.所有设备内部的焊接必须抛光，其它的焊接至少经过仔细的打磨和全面的清洁。4.1.4 Electrical equipment电器设备Minimal IP protection level classification is IP55.最低的IP保护等级水平是IP55级4.1.5 Layout布局图The supplier shall advise on its suitability and provide his compliant layout and section.供应商应该推荐合适的型号并提供完备的各个部分的布局图。The room heightis 3.5m initially and could be adjusted partly according to the suppliers advice.房间的起始高度为3.5米以上，并可根据供应商的要求部分调节。The supplier shall advise on any pit required in the ground slab if necessary.供应商应建议任何有必要的在地面上的预设承重坑4.1.7 Delivery boundaries发货范围The supplier shall furnish all material within the battery limit of his defined scope.供应商要将规定范围内的所有物品配齐Generally the battery limit includes all machine component interconnection piping & ducts, the ownerwill supply electrical power for the main panel and utility connections to an agreed position.总的来讲，集装箱内要包含所有的机器部件，包括互相连接的管件，客户要给设备提供电源 All distributed cabling piping or ductwork to his components will be within his package.和一些分散的预设接口的各种公用设施的管路All calculations for pipe and cable size shall be in the scope of supplier.设备供应商应该提供管路和电缆的参数All ductwork and piping must be prefabricated including loose flanges and fitting segments, preparedfor quick installation. Prefabricated material will be inspected during FAT.为了快速的安装，所有的管路和预制件和法兰和固定部分会预先布置好，而且这些要在进行FAT前做好 The supplier shall indicate foreach main utility connection the diameter at the battery limit and where necessary additionalinformation such as the maximal allowed pressure drop for the air suction pipe or discharge duct ormaximum discharge length.供应商要标出每个附件的在箱内的尺寸和其它需要的额外信息，如：最大的承压力等等Supplier shall provide all specifications and workshop drawings for ductwork piping and electricalcabling within this scope.供应商在其提供范围内的提供所有的标准及车间管路和电缆图。5 Automation User Requirement自动控制的用户需求5.1 General概述The supplier will provide a functional specification and description of the automated processes to beundertaken within tabletting and an operational description within this his tender.供应商要提供压片整个自动控制过程的工艺描述和功能标准和操作的详细说明Automation will meet the requirement of EU GMP and GAMP 4.自动控制需要符合EU GMP 和 GAMP 4的要求5.2 Safety安全The capsule filling system will be capable of totally safe operation. The supplier shall provide with his tendera safety and alarm concept for the operation of the system and the appropriate action for resetting.胶囊机的操作需要完全安全，供应商应该提供给操作者一个明确的安全和报警的适用范围，并在报警后可以以合适的行动进行复位Alarm and events log will be provided and will be time and date stamped.需要有注明报警日期和时间的运行记录A log file will be provided to record all alarms in order to prepare an analysis in case breakdown etc.所有的报警记录需要有专门的日志文件保存，以便分析。The log should contain at least 60 days of information capable of offline analysis.报警记录可以离线分析，并且至少包含60天以上的内容。5.3 Data参数The equipment shall have fully validated capsule filling cycles. A clear concept will be developed duringproject development what data is deemed to be critical.提供的胶囊充填系统需要经过充分的验证，对项目有清晰的概念并且知道那些参数是至关重要的。5.4 Interfaces界面It is envisaged that capsule filling system will with a stand alone single PLC controlled unit.从正面来看，胶囊机应有一个单独站立的专门的PLC控制系统In the future this equipment may have to be connected to a SCADA system. The control should be ableto be upgraded to meet these requirements.所提供的设备在将来可以连接到SCADA系统，控制系统应该能够升级以满足这些要求。5.5 Technical System Requirement技术系统的要求5.5.1 PLCPLC software must backup up by a non-volatile data carrier i.e. EEPROM.PLC的软件必须有备份，而且储存在象EEPROM这样不可更改数据的存储器里All input and output both digital and analogue must be galvenically isolated.所有输入和输出的模拟和数字信号必须绝缘任何流电The voltage supply for the input and output must be 24 VDC.输入和输出信号的电压是24VDCPreferably the i/o supply voltage shall be an independent supply.最好输入、输出信号的电源各自独立提供。5.5.2HMI 集线器管理接口 The computer must be equipped with a full keyboard, (see also section regarding touch screen).计算机必须要有完整的键盘（也同时适用于触摸屏）As an option a touch screen could be used, depending on Suppliers choice and standards. 作为选择之一，触摸屏也可根据供应商的选择和采用标准之一6 User Requirements for the project execution项目实施的用户需求6.1 Schedule进度Design completion date: 1 Oct., 2006设计完成日期：2006年月-日Delivery Time: 31st July, 2007交货日期：2007年7月31日Qualification completion date: 1st Nov., 2007验收完成日期;2007年 月 日6.2 Legal and regulatory requirements法律和常规需求Delivery must be compliant with all EC and local laws. This includes, but is not limited to, CEcertification rules.交货必须符合欧共体法律，而不是仅只限于CE认证等The equipment and the software shall be compliant to cGMP rules applied by the EU, US FDA andChina SFDA.设备和软件应当符合欧洲cGMP规定、美国的FDA规定和中国的SFDA6.3 Maintenance维护The equipment shall be designed for continuous as 2 shift (5 days/week) operation. Any plannedinspections and or maintenance in addition to the yearly inspection shall be kept to a minimum.设备应该至少适合于连续双班操作（5天/周），除年度的检查外，其它任何计划内的检查和维护应保持在最少水平7 Life cycle使用周期7.1 Development发展The system will be used for the capsule filling of pharmaceutical OSD products and has to fulfil cGMPrequirements as set by the authorities (China SFDA, EU and US FDA.), and will be subject ofqualification / validation activities.机器用于胶囊剂生产需要符合Cgmp或其它机构（如美国FDA、中国SFDA）等的授权或批准，并且符合他们的规定 Therefore adequate project documentation has to be prepared fromthe initial time of working on the project (e.g. material certificates, etc.).因此合格的文件需要从项目开始就开始准备（例如材质证明等等）The Supplier shall develop a Quality Plan for the project.供应商需要为这个项目进行一个周密的质量计划7.2 Testing测试7.2.1 FAT工厂接收测试Before delivery, equipment and software has to be accepted by a Factory Acceptance Test (FAT)executed in the suppliers (or sub suppliers) workshop or factory.在发货前，设备和软件必须接受在供应商工厂或车间里进行的工厂接收测试（FAT）Test protocols are to be prepared by the Supplier and approved by BMPC prior to the FAT. The Suppliershall execute tests at their premises and premise will indicate which tests will be witnessed by them.测试草案应当由供应商提前准备并在进行FAT前获得新建制药厂的批准，供应商应当提前做这些测试，要提前决定那些测试要现场见证。7.2.2 IQ/OQ测试草案必须由供应商提前准备并获得新建制药厂的批准BMPC will integrate the Suppliers Protocols in its templates as one test point. The Supplier shall execute tests with BMPC personnel in attendance and will witness all IQ/OQ tests. 新建制药厂将结合供应商的草案和他们的规定做出批准，供应商和新建制药厂现场见证人员将共同进行这些测试In OQ the critical functions defined must be tested including conditions or set of conditionsencompassing upper and lower operating limits covering the defined range of tolerances.在OQ测试中，至关重要的是要包含操作条件的上限和下限 Furthermore alarms, interlocks, timers, displays and registration must be checked.The machine will be subject to PQ for capsule filling validation. 此外，报警、互锁、定时器、显示器和控制器必须检测，机器必须符合胶囊填充PQ包衣性能确认的要求。The supplier will provide all the required documentation for the preparation of the PQ protocol. He will guarantee the operating integrity of his machine.供应商需要提供所有PQ要求的文件，这将确保其提供机器操作的完整性。According to BMPC standard all qualification documents shall be in Bi-lingua(Chinese and English)根据新建制药厂的标准