12L不锈钢化浆罐URS
URS OF 12L STAINLESS STEEL SOLUTION PREPARATION VESSEL
| 姓名Name | 职位 Position | 签名Signature | 日期Date |
制定人 Drafted by |
| 生产工段长 Production section chief |
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审核人 Reviewed by |
| 车间主任 Workshop Officer |
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审核人 Reviewed by |
| 高级生产&技术部经理 Senior PRD&TD Manager |
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审核人 Reviewed by |
| ENG经理 ENG Manager |
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审核人 Reviewed by |
| QA部经理 QA Manager |
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批准人 Approved by |
| 质量总监 Quality Director |
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目 录 Catalogue
1 概述 Overview 3
1.1 介绍 Introduction 3
1.2 目的 Purpose 4
1.3 范围 Scope 4
1.4 职责 Responsibility 4
1.5 缩写与定义 Abbreviations and Definitions 5
2 功能要求 Functional Requirements 5
2.1 工艺要求 Process Requirements 6
2.2 设备及功能要求 Equipment and Functional Requirements 6
2.3 电气和自动化控制要求 Electric and Automation Control Requirements 9
2.4 仪表及在线检测要求 Instrument and On line Detection Requirements 9
3 法规和技术要求Regulatory and technical Requirements 9
3.1 法规标准要求 Regulatory and Standard Requirements 9
3.2 运行条件 Operating Conditions 10
3.3 材质要求 Material requirements 10
3.4 安装要求 Installation Requirements 11
3.5 清洁要求 Cleaning Requirements 12
3.6 EHS要求 EHS Requirements 12
4 服务要求 Service Requirements 13
4.1 供应商资质要求 Supplier Qualification Requirements 13
4.2 售后及维护保养要求 After-sales and Maintenance Requirements 14
4.3 校验、测试和确认要求 Calibration, Test and Qualification Requirements 14
4.4 文件要求 Files Requirements 15
4.5 包装和运输要求 Packaging & Transport Requirements 16
4.6 供应商对项目要求的确认Confirmation of Project Requirement by Suppliers 17
4.7 交付期限Term of Delivery 18
5 相关文件/记录Associated Documents and Records 18
6 附件Annexes 18
7 文件变更历史 History of Document Changes 18
8 语言要求 Language Requirements 18
1 概述 Overview
1.1 介绍 Introduction
Ø XX固体制剂车间需要新购一个化浆罐，该设备用于固体制剂车间（一号线），根据生产工艺技术要求，制定该设备的用户需求（URS），其内容主要包括生产工艺、设备功能、法规和技术、服务、文件、记录等具体需求。设备生产商应该规定的时间内完成并达到用户需求的设计目标和可接受的质量标准。
A solution preparation vessel is going to be purchased for OSD workshop (No.1 line). The user requirement specification (URS) of this equipment is created according to production process and technical requirements. It mainly includes the specific requirements of production process, equipment function, regulation and technology, service, documents and records. The equipment manufacturer shall complete and realize the design objective and acceptable specifications of this document within stipulated time.
Ø 本URS中用户仅提出基本的技术需求设备的基本要求，并未涵盖卖方设备具有更高的设计和制作标准、更完善的配置和性能、更加优异的部件和配件以及更高水平的控制系统和逻辑，卖方应该在满足本URS的前提下提供更高的制作标准、更加优异的性能、更高质量和服务的产品。
The user only proposes the basic technical demands and equipment requirements in the URS, but not covers that the equipment of the seller can have higher design and manufacturing standards, more perfect configuration and performance, more excellent components and accessories, as well as control system and logic at a higher level. The seller shall provide higher manufacturing standard, more excellent performance, and product with higher quality and service at the premise of meeting the requirements of the URS.
Ø 卖方的设备应满足中国有关设计、制造、安全、环保等规程、规范和强制性标准要求。本文件中未列举出的具体要求，以最新的相关版本的法律或行业标准为依据。如遇与卖方所执行的标准发生矛盾时，应按较高的标准执行（强制性标准除外）。
The seller’s equipment shall meet Chinese procedures, norms and compulsory standards related to design, manufacturing, safety, environmental protection, etc. The specific requirements not listed in the document shall be based on the laws or industrial standards of latest version. If there is any dispute on the standards executed by the seller, the higher standard shall prevail (except compulsory standards).
1.2 目的 Purpose
Ø 该要求文件是将URS描述为技术语言旨在从制造、安装、调试的角度阐述技术要求。包括用户对系统的需求和GMP对该系统的质量要求，最终目标是在满足工艺要求的同时符合中国2010版GMP有关规定以及能够满足现行欧盟GMP认证及美国cCMP认证要求。
The document is to describe URS and explain technical requirements from the aspects of manufacturing, installation and commissioning. It includes the specific requirements on system by the user and quality requirements on the system by GMP. The ultimate goal is to comply with relevant regulations of 2010 Chinese GMP, as well as the current version of EU GMP & US cCMP, meanwhile to meet the requirements of process.
本文件的执行将记录和证明对供应商提出的设别用户需求的具体内容，是设计制造、安装的文件基础，也是设备验证、验证的可接受标准的依据，同时也是与选定的设备供应商签订的购买协议的一个主要部分。
The implementation of the document will record and demonstrate the specific contents of user requirements specification proposed on the demand on the supplier. It is the documentary basis of design, manufacturing and installation, and the basis of acceptance criteria for equipment qualification and validation, and also it is an important part of purchase agreement signed with target equipment supplier.
1.3 范围 Scope
Ø 本URS定义了河北凯威制药有限责任公司康领分厂口服固体制剂车间化浆罐的用户需求，并为化浆罐的设计、制造、采购、验收和确认提供依据。
This URS defines the user requirements for solution preparation vessel used in the OSD workshop of KIVIPharm Co., Ltd. Camfield Plant, and provides basis for the design, manufacturing, purchase, acceptance and qualification of it.
1.4 职责 Responsibility
Ø 本文件由口服固体制剂车间制订，口服固体制剂车间主任、高级生产&技术部经理、工程部经理、QA部经理审核，质量负责人批准。设备供应商应依据本URS的要求完成化浆罐的设计和建造，供应商需对需方所提供的用户需求负保密责任。设备的设计、制造、材质、检查和测试、包装和交付、制造厂内测试（FAT）、用户现场最终检测和测试（SAT）等活动由供应商负责并由需方人员参加及批准，SAT部分将由双方人员共同实施并签署各项相关报告，以上活动必须严格按照本用户要求和相关的标准与规范来进行。
This document is drafted by OSD workshop, reviewed by OSD workshop officer, senior Production &TD manager, ENG manager, and QA manager, finally approved by QP. The equipment supplier shall complete the design and construction of the equipment according to the requirements of this URS and bear the confidentiality responsibility for the requirements provided by the user. The activities such as equipment design, manufacturing, material, inspection and testing, packaging and delivery, factory acceptance test (FAT), and site acceptance test (SAT) shall be in the charge of the supplier, attended and approved by the buyer. Both parties will implement SAT together and sign on the relevant reports. The above activities must be performed in strict accordance with this URS and relevant standards and regulations.
1.5 缩写与定义 Abbreviations and Definitions
专业术语 Terminology | 定义Definition |
URS | User Requirement Specification 客户需求说明 |
DQ | Design Qualification 设计确认 |
IQ | Installation Qualification 安装确认 |
OQ | Operational Qualification 运行确认 |
PQ | Performance Qualification 性能确认 |
EHS | Environment Health Safety 环境 健康 安全 |
FAT | Factory Acceptance Test 工厂验收测试 |
SAT | Site Acceptance Test 现场验收测试 |
2 功能要求 Functional Requirements
Ø 本设备主要用于口服固体制剂车间（一号线）车间湿法制粒机、流化床及高效包衣机浆液的配制，化浆罐采用立式夹套罐体，能够实现水浴或油浴加热，具有混合、加热、冷却、保温、搅拌等功能；罐体设计投料口、卸料口、夹套介质进口、夹套介质排放口，同时配有搅拌转速数显及夹套介质温度数显装置，满足化浆的全部条件。设备需运转平稳，噪音低，应能满足生产工艺要求同时符合中国2010版GMP、欧盟GMP及美国FDA GMP等相关标准对设备的要求。自控系统能够满足FDA21 CFR PART 11。
Ø The equipment is mainly used for the preparation of the solution of the wet granulator, fluidized bed and high-efficiency coating machine in the oral solid dosage workshop (line 1). The solution preparation vessel adopts the vertical jacketed tank, which can realize the heating of water bath or oil bath, and has the functions of mixing, heating, cooling, heat preservation, stirring, etc.; the tank body is designed with the feeding port, discharging port, jacketed medium inlet and jacketed medium discharge port, at the same time it is equipped with digital display of stirring speed and jacket medium temperature, which can meet all conditions of solution preparation. The equipment shall operate stably with low noise and meet the requirements of production process as well as the requirements of relevant standards such as China 2010 GMP, EU GMP and US FDA GMP. The automatic control system can meet FDA 21 CFR Part 11.
2.1 工艺要求 Process Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 化浆罐数量一个，化浆罐有效容积12L。 One solution preparation vessel with capacity of 12L. | 必需 Required |
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2 | 搅拌转速0-300转/分钟。 Stirring speed 0-300 RPM/Min. | 必需 Required |
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3 | 有效温度调节范围：常温—120℃，具有自动控温功能，控温精度不得超过±1℃。 Effective temperature regulation range: room temperature - 120 ℃, with automatic temperature control function, temperature control accuracy shall not exceed ± 1 ℃.. | 必需 Required |
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4 | 该化浆罐能够满足粘合剂和包衣液的配制。 The vessel can meet the requirements of the preparation of binder and coating solution. | 必需 Required |
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5 | 设计压力：夹套工作压力0.6Mpa，罐体和封头（或罐盖）工作压力满足0.6Mpa。 Design pressure: working pressure of jacket is 0.6MPa, and working pressure of tank body and head (or tank cover) can meet 0.6MPa. | 必需 Required |
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6 | 设备年运行不低于300天，每天两班，每班有效工作时间不低于6小时，每天至少能不间断运行12小时。设备能够平稳运转，保证设备能够平稳运转1万小时以上。 The annual operation of the equipment shall not be less than 300 days, two shifts a day, and the effective working time of each shift shall not be less than 6 hours, and the equipment shall be able to operate continuously for at least 12 hours a day without stop interval. The equipment can run smoothly to ensure that the equipment can run stably for more than 10000 hours. | 必需 Required |
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2.2 设备及功能要求 Equipment and Functional Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 罐体 Tank body | 闭式罐，立式一体式支脚结构，支脚即坚固又便于清洁，罐体材质为304或316L不锈钢材质，罐内温度采用在线数显方式就地显示，以便人工控制夹套介质温度。 Closed tank, vertical integrated support foot structure, the support foot is solid and easy to clean, the tank body is made of 304 or 316L stainless steel, the temperature in the tank is displayed locally by online digital display, so as to manually control the jacket medium temperature. | 必需 Required |
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2 | 罐体应设计有投料口、卸料口、夹套介质进水口及排水口口，接口为快装式接口，各接口不得有卫生死角。 The tank body shall be designed with feeding port, discharging port, jacket medium inlet and drain port. The interface shall be of quick loading type, and there shall be no sanitary dead angle at each interface. | 必需 Required |
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3 | 仪表接头与罐内壁结合处不得有缝隙，以免存料难以清洁。 There shall be no gap at the joint between the instrument joint and the inner wall of the tank, so as to avoid the difficulty of cleaning the stored materials | 必需 Required |
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4 | 罐底结构设计合理，卸料口能充分排尽所有物料，罐内无物料残留。 The tank bottom structure design is reasonable, the discharge port can fully drain out all materials, and there is no material residue in the tank. | 必需 Required |
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5 | 罐内需要安装必要的温度传感器，所安装的传感器不影响罐内的洁净度，供应商应说明温度的控制方式。 Necessary temperature sensor shall be installed in the tank. The installed sensor shall not affect the cleanliness of the tank. The supplier shall explain the temperature control mode. | 必需 Required |
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6 | 罐体采用封头密闭结构，封头为液压技术旋压而成，焊接采用高纯氩气保护焊。 The tank body adopts the sealed structure of the head, which is spun by hydraulic technology and welded by high-purity argon shielded welding. | 必需 Required |
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7 | 具有受热面积大、热效率高、加热均匀、液面沸腾时间短、加热温度容易控制等特点。 The equipment has the advantages of large heating area, high thermal efficiency, uniform heating, short boiling time of liquid level, easy control of heating temperature, etc. | 必需 Required |
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8 | 罐体带脚轮，可移动，脚轮有刹车装置。 Tank body with caster, movable, caster with brake device. | 必需 Required |
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9 | 加热方式：电加热的方式。 加热电压：220V±50HZ。 加热功率：3000W及以上。 Heating mode: electric heating mode. Heating voltage: 220V. Heating power: 3000W and above. | 必需 Required |
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10 | 搅拌器 Agitator | 采用气动搅拌方式，气源由需方空压站提供。 Pneumatic stirring mode is adopted, and the air source is provided by the compressed air station of the buyer. | 必需 Required |
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11 | 气动搅拌机可以无级调速，可通过控制进气阀或排气阀的开度，即控制压缩空气的流量，来调节马达的输出功率和转速，达到调节转速和功率的目的，搅拌转速需采用在线数显的方式就地显示。 The pneumatic stirrer can be adjusted steplessly, and the output power and speed of the motor can be adjusted by controlling the opening of the air inlet valve or the exhaust valve, i.e. controlling the flow of compressed air, so as to achieve the purpose of adjusting the speed and power. The mixing speed needs to be displayed locally by digital display. | 必需 Required |
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12 | 气动搅拌其配套的气动马达采用国内知名品牌，并配有减压阀进行过载保护，长时间满载连续运转时启动马达温升较小。 The matching pneumatic motor of pneumatic stirrer adopts domestic famous brand, and is equipped with pressure reducing valve for overload protection. The temperature rise of starting motor is small during long-term full load continuous operation | 必需 Required |
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13 | 气动马达具有结构简单，体积小，重量轻，马力大，使用压缩空气作为介质，操纵容易，维修方便。 The pneumatic motor has the advantages of simple structure, small volume, light weight, high horsepower, using compressed air as medium, easy operation and maintenance. | 必需 Required |
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14 | 气动搅拌器具有较高的起动力矩，可以直接带载荷起动；启动、停止均迅速，带负荷启动不会影响马达寿命及正常使用。 The pneumatic agitator has high starting torque and can be started directly with load; the start and stop are rapid, and the start with load will not affect the service life and normal use of the motor. | 必需 Required |
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15 | 搅拌浆形式：单层浆式搅拌，搅拌杆可自由伸缩，使搅拌浆最低可置于罐体最低处，最高可置于罐体二分之一处。 Stirrer form: single-layer impeller type stirring, the mixing rod can be freely retracted, so that the impeller can be touched the lowest part of the tank body and the half height of the tank body at most. | 必需 Required |
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16 | 搅拌器与轴连接处不得有缝隙，配合紧密，配备机械密封，防止物料进入，方便清洁。 There shall be no gap at the connection between the stirrer and the shaft, which shall be closely matched and equipped with mechanical seal to prevent materials from entering and convenient for cleaning. | 必需 Required |
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17 | 搅拌器轴承必须选用优质轴承，供应商应说明轴承品牌。 The bearing of agitator must be of high quality, and the supplier shall indicate the brand of bearing. | 必需 Required |
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18 | 气动马达、转动轴等传动系统应能满足及其最大负荷产量要求，转动系统的设计应充分考虑方便维护、保养与检修。 The pneumatic motor, rotating shaft and other transmission systems shall meet the requirements of maximum load output. The design of rotating system shall fully consider the convenience of maintenance and repair. | 必需 Required |
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19 | 保温层 Insulation layer | 带特级硅酸铝保温层，保温层厚度为50mm，保温层外敷2mm厚度的不锈钢保护层（304或316L），保护层外表面镜面抛光，外表面温度夏季不得超过30℃。 With super aluminum silicate insulation layer, the thickness of the insulation layer is 50mm, the insulation layer is coated with 2mm thick stainless steel protective layer (304 or 316L), the outer surface of the protective layer is mirror polished, and the outer surface temperature shall not exceed 30 ℃ in summer. | 必需 Required |
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20 | 保温效果：保温层外表面手接触无特别烫手，有较好的手感。 Heat preservation effect: the outer surface of the heat preservation layer has good hand feel without special hot hand touch feeling. | 必需 Required |
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21 | 罐体夹层 Interlayer of tankbody | 采用纯化水或导热油加热，加热温度最高为120℃。 Use purified water or heat conducting oil to heat, and the maximum heating temperature is 120 ℃. | 必需 Required |
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22 | 纯化水或导热油置于罐体夹套内，使罐体均匀受热，从而加热物料，可以通过电热棒的功率来控制调节纯化水或导热油的温度，从而达到控制物料温度的目的。 The purified water or heat-transfer oil is placed in the jacket of the tank body to evenly heat the tank body, so as to heat the material. The temperature of the purified water or heat-transfer oil can be controlled and adjusted by the power of the electric heating rod, so as to achieve the purpose of controlling the material temperature. | 必需 Required |
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23 | 检修口 Overhaul port | 供应商应预留可供罐体内部检修的检修口或者直接开盖可以满足检修要求，供应商应说明检修口方式。 The supplier shall reserve a overhaul port for internal maintenance of the tank body or directly open the cover to meet the maintenance requirements. The supplier shall specify the overhaul method. | 必需 Required |
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2.3 电气和自动化控制要求 Electric and Automation Control Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 设备所有接线段子必须在密闭的接线盒内，不得外露或接线盒有缝隙存在。 All wires of the equipment must be in a sealed junction box, and shall not be exposed or there is a gap in the junction box. | 必需 Required |
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2 | 所有关键性的电器元件需要有合格证。 All critical electrical components need to have certificates. | 必需 Required |
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2.4 仪表及在线检测要求 Instrument and On line Detection Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 用来读取数据或控制任何参数的所有关键传感器、检测器，在线仪表等仪器仪表应该校准，所有仪表应有相关检定证书，可以追溯到国家或国际标准。 All key sensors, detectors, online instruments and other instruments used to read data or control any parameter shall be calibrated, and all instruments shall have relevant calibration certificates, which can be traced to national or international standards | 必需 Required |
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2 | 每个传感器都要提供合格证书、详细资料、用户手册、说明书、示意图等。 Each sensor shall be provided with certificate of quality, detailed information, user manual, instruction manual, schematic diagram, etc. | 必需 Required |
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3 | 仪器仪表的检测范围和精度必须符合控制参数要求。 The detection range and accuracy of instruments must meet the requirements of control parameters. | 必需 Required |
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4 | 温度传感器要求A级精度，压力传感器压力应达到0.1-1%f.s.。 The temperature sensor requires class A accuracy, and the pressure of the pressure sensor should reach 0.1-1% F.S. | 必需 Required |
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5 | 温度显示单位要求为摄氏度，转速显示要求为转/分钟。 The temperature display unit is required to be Celsius, The speed display is required to be rpm/min. | 必需 Required |
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6 | 所有仪器仪表应易于拆卸、维护和校验，不能拆卸的可现场检定，与物料接触的仪表不会对产品造成污染。 All instruments and meters shall be easy to disassemble, maintain and calibrate, and those that cannot be disassembled can be verified on site, and instruments in contact with materials will not pollute products. | 必需 Required |
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3 法规和技术要求Regulatory and technical Requirements
3.1 法规标准要求 Regulatory and Standard Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 设备设计、制造、运输、包装、安装、运行操作、维护和调试等需符合中国2010版GMP、及现行欧盟GMP及美国cGMP的有关要求。 The design, manufacturing, transportation, packaging, installation, operation, maintenance and commissioning of the equipment shall meet the requirements of GMP 2010 in China, current EU GMP and cGMP in the United States. | 必需 Required |
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2 | 美国联邦法规21CFR Part 11。 United States federal regulation 21CFR Part 11 | 必需 Required |
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3 | 《制药机械符合药品生产质量管理规范的通则》（GB28670-2012）。 General rules for pharmaceutical machinery in conformity with the pharmaceutical production quality control norms(GB28670-2012) | 必需 Required |
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4 | 国家标准GB 5226.1-2008机械电气安全机械电气设备第一部分通用技术条件。 National standard GB 5226.1-2008 mechanical and electrical safety and equipment, part I General technical conditions. | 必需 Required |
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5 | 国家标准GB/T 8196-2003机械设计防护罩安全要求。 National standard GB / T 8196-2003 safety requirements for mechanical design protective cover. | 必需 Required |
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6 | 国家标准 GB-12265-90机械防护安全距离。 National standard GB-12265-90 mechanical protection safety distance. | 必需 Required |
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7 | 《GB 150-1998钢制压力容器》。 GB 150-1998 steel made pressure vessels. | 必需 Required |
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8 | 《GB 50231-2009机械设备安装工程施工及验收通用规范》。 GB 50231-2009 general norms for construction and acceptance of mechanical equipment installation engineering. | 必需 Required |
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9 | 《GB 12348-2008工业企业厂界环境噪声排放标准》。 GB 12348-2008 emission standard for noise at boundary of industrial enterprises. | 必需 Required |
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10 | IEC60439《低压成套开关设备和控制设备》标准。 Iec60439 standard of low voltage switchgear and control equipment. | 必需 Required |
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11 | 行业标准 欧盟标准化协调组织EN的电磁兼容性指令（EMC指令）89/336/EEC。 Industry standard: EMC of European Union standardization coordination organization EN. (EMC directive) 89 / 336 / EEC | 必需 Required |
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12 | 行业标准 ASTM A380（美国材料与实验协会）。 Industry standard ASTM A380 (American Society for testing and materials). | 必需 Required |
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13 | 除本URS特殊要求外，必须ISPE（国际制药工程师协会）所颁布的制药工程设备标准、中国制药装备协会所颁布的制药工程设备标准、ISO14001、OHSAS 18001。 In addition to the special requirements of this URS, the pharmaceutical engineering equipment standard issued by ISPE (International Society for Pharmaceutical Engineering), the pharmaceutical engineering equipment standard issued by China Pharmaceutical Equipment Association, ISO14001 and OHSAS 18001 are required. | 必需 Required |
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3.2 运行条件 Operating Conditions
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 供应商应提供设备所需全部公用系统的参数和仪表链接方式，如：电力、压缩空气、工业蒸汽压力等。 The supplier shall provide the parameters and instrument connection mode of all public systems required by the equipment, such as power, compressed air, industrial steam pressure, etc. | 必需 Required |
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2 | 设备运行综合性能：设备配备良好的减震、传动、变速、润滑装置，在维修保养周期内，连续满负荷生产条件下，没有明显漏油和温升现象、没有明显的震动和噪音恶化现象，始终符合出厂验收标准。 Comprehensive performance of equipment operation: the equipment is equipped with good shock absorption, transmission, speed change and lubrication devices. During the maintenance period, under the condition of continuous full load production, there is no obvious oil leakage and temperature rise, no obvious vibration and noise deterioration, and it always meets the factory acceptance test standard. | 必需 Required |
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3.3 材质要求 Material requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 任何与物料接触的工作部分必须采用304以上不锈钢或其他符合GMP要求的材质，并提供相关材质证明。 Any working part in contact with materials must be made of stainless steel above 304 or other materials meeting GMP requirements, and relevant material certificates shall be provided. | 必需 Required |
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2 | 不与物料接触部件：要求选用304不锈钢材质制作，如选用其他材质的必须确保不脱落、不渗透、耐腐蚀、易清洁；承力框架要求采用槽钢和钢板焊接而成，框架底部为304不锈钢方管。槽钢和普通钢板需喷漆喷塑料处理，不得有生锈腐蚀现象。 Parts not in contact with materials: it is required to select 304 stainless steel material, if other materials are selected, it must be ensured that they are not falling off, impermeable, corrosion-resistant and easy to clean; the bearing frame is required to be welded with channel steel and steel plate, and the bottom of the frame is 304 stainless steel square tube. Channel steel and ordinary steel plate shall be treated by spray painting and plastic spraying without rust corrosion. | 必需 Required |
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3 | 设备与物料接触的内表明应镜面抛光，抛光后Ra＜0.4μm，外表面亚光处理，粗糙度Ra＜0.8μm。 The inner surface of the equipment in contact with the material shall be polished with a mirror surface. After polishing, RA ＜ 0.4 μ m, the outer surface shall be Matt treated with a roughness Ra ＜ 0.8 μ M. | 必需 Required |
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4 | 所有转动机构有保护罩，保护罩要求304不锈钢或同等材质的材料，设备表面及安全门罩不能产生晃眼反光，供应商应说明防护罩材质及厚度。 All rotating mechanisms shall be provided with protective covers, which shall be made of 304 stainless steel or equivalent materials. The equipment surface and safety door covers shall not produce dazzling reflection. The supplier shall indicate the material and thickness of the protective covers. | 必需 Required |
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5 | 供方保证设备上所用组件全新未曾使用过；所用材料是优质材料，全新未曾使用过。 The supplier guarantees that the components used on the equipment are brand new and unused; the materials used are high-quality materials and brand new and unused. | 必需 Required |
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6 | 设备内外表面所有凹凸部件全部采用圆弧过度（R≥10mm），或采用不低于135度倒角过渡，提供最少的锐角转角、最少的接缝和平整光滑的连接，紧固方式不采用外漏螺钉。 All concave and convex parts on the internal and external surfaces of the equipment shall adopt arc transition (R ≥ 10 mm), or adopt chamfer transition of no less than 135 degrees to provide the minimum acute angle, minimum joint and smooth connection, and the fastening method shall not adopt the external leakage screw. | 必需 Required |
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7 | 设备所有的铸造和加工件没有加工缺陷。 All casting and machining parts of the equipment are free of machining defects. | 必需 Required |
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8 | 焊口以及设备、接管内表面要经酸洗钝化处理。 The inner surface of the welded junction, equipment and connecting pipe shall be pickled and passivated. | 必需 Required |
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9 | 密封材料：食品级硅橡胶，符合21CFR177的要求。 Sealing material: food grade silicone rubber, meeting the requirements of 21CFR177. | 必需 Required |
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10 | 设备应贴有标准设备铭牌，铭牌上应注明名称、产地、出厂日期、型号、重量及其他重要技术参数，铭牌应避免污染，易于清洁。 The equipment shall be attached with a standard equipment nameplate, on which the name, place of origin, date of manufacture, model, weight and other important technical parameters shall be indicated. The nameplate shall be pollution-free and easy to clean. | 必需 Required |
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3.4 安装要求 Installation Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 化浆罐放置于制粒操作间或包衣操作间使用，位于D级洁净区。 The solution preparation vessel is placed in the granulation room or coating room,which is located in the class D area. | 必需 Required |
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2 | 由供应商承担控制系统和仪表系统的施工、安装、调试、记录、试运行等工作，以及协助需方进行确认工作，直至拿到质量验收证书，未经需方同意不得将工程项目委托他方进行安装，安装人员需为有经验的熟练技工，供应商应说明设备安装、调试的周期及交验时间。 The supplier shall be responsible for the construction, installation, commissioning, recording, trial operation and other work of the control system and instrument system, as well as assisting the buyer to confirm the work until the quality acceptance certificate is obtained. Without the consent of the buyer, the project shall not be entrusted to another party for installation. The installation personnel shall be experienced skilled technicians. The supplier shall specify the period and delivery time of equipment installation commissioning and acceptance. | 必需 Required |
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3 | 设备安装调试过程中所发生的零部件寄送等费用应由供应商承担。 The supplier shall be responsible for the delivery of parts and components during the installation and commissioning of the equipment. | 必需 Required |
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4 | 供应商的现场施工人员须遵守用户的规章制度。 The supplier's site construction personnel shall comply with the user's rules and regulations. | 必需 Required |
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3.5 清洁要求 Cleaning Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 罐体的设计应提高清洁的可操作性，罐体表面积及内部便于清洁，不能有清洁死角。 The design of the tank body shall improve the operability of cleaning, and the surface area and interior of the tank body shall be easy to clean without dead angle. | 必需 Required |
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2 | 罐体、配电箱体所有外表面应平滑，易于用擦拭法进行清洁，无法清洁的部件必须被密封，应当不会被产品污染，也不会成为污染源。 All external surfaces of tank body and electrical distribution cabinet shall be smooth and easy to clean with wiping method. The parts that cannot be cleaned must be sealed and shall not be polluted by products or become pollution sources. | 必需 Required |
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3 | 所有工艺接口应全部采用快装快卸结构，以便于拆卸和清洗；不能拆卸清洗的部位应采用严密的措施防止粉尘进入。 All process interfaces shall adopt quick connection and quick disconnection structure to facilitate disassembly and cleaning; the parts that cannot be disassembled and cleaned shall adopt strict measures to prevent dust from entering. | 必需 Required |
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4 | 设备的所有部件应能够适应通常的清洁剂和消毒剂，如：纯化水、注射用水、75%乙醇、新洁儿灭、过氧化氢、过氧乙酸、臭氧等。 All parts of the equipment shall be able to adapt to common cleaning agents and disinfectants, such as purified water, water for injection, 75% ethanol, Benzalkonium Bromide, hydrogen peroxide, peracetic acid, ozone, etc. | 必需 Required |
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5 | 所有密封垫圈应该易于拆卸、清洗和装回。 All sealing washers shall be easy to remove, clean and replace. | 必需 Required |
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6 | 供应商需提供润滑油详细清单。 The supplier shall provide detailed list of lubricating oil. | 必需 Required |
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3.6 EHS要求 EHS Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 设备设计应符合人体仿生学原理，操作维修方便，并确保设备使用的安全可靠。 The equipment shall be designed in accordance with the principle of human bionics, convenient for operation and maintenance, and safe and reliable for use. | 必需 Required |
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2 | 能有效防止生产过程对产品、人员和环境的污染及交叉污染。 It can effectively prevent product, personnel and environment contamination and cross contamination in the process of production. | 必需 Required |
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3 | 正常运行时设备噪音小于75dB. Under normal operation, the equipment noise is less than 75db | 必需 Required |
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4 | 所有电气部位、旋转部位、容易夹伤部位以及高温发热的外表面要有警告和警示，所有机械运动、旋转不见，要有性能可靠的防护和密闭，旋转部件要有旋转方向标识，易伤害部位应有醒目的中文安全标志及防护措施。 All electrical parts, rotating parts, vulnerable parts and external surfaces with high temperature and heat shall be provided with warning sign, all mechanical movements and rotating parts shall be provided with reliable protection and sealing, rotating parts shall be provided with rotating direction signs, and vulnerable parts shall be provided with striking Chinese safety signs and protective measures. | 必需 Required |
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5 | 设备任何部位不能有锋利的边缘和尖角，以防伤害操作者。 Any part of the equipment shall not have sharp edges and corners to prevent injury to the operator. | 必需 Required |
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6 | 有接地装置且安装牢靠，电气系统的安全性能应符合相应的国家标准。 With grounding device and reliable installation, the safety performance of electrical system shall meet the corresponding national standards. | 必需 Required |
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7 | 加热系统应有过载、过热、缺相、漏电保护功能。 The heating system shall have overload, overheating, phase loss and leakage protection functions. | 必需 Required |
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8 | 设备配电箱必须配门锁，具有良好的密封性，能有效阻止灰尘、潮气进入，同时又能有效散热，避免电器元件受热。 The distribution cabinet of the equipment must be equipped with a door lock, which has good sealing performance, can effectively prevent the dust and moisture from entering, and can effectively dissipate heat and avoid the heating of electrical components. | 必需 Required |
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9 | 设备上使用的有可能与药品接触的润滑油，应为食品级，无毒性，须有有效的方式防止润滑油泄漏，污染环境。 The lubricating oil used on the equipment that may contact with the medicine shall be food grade, non-toxic, and effective ways shall be provided to prevent the leakage of lubricating oil and environmental pollution. | 必需 Required |
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10 | 当设备功能失调或者故障的情况下，必须配备必要的保护措施保证人员、设备和产品仍然处于安全状态。 In case of equipment dysfunction or failure, necessary protection measures must be provided to ensure that personnel, equipment and products are still in a safe state. | 必需 Required |
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4 服务要求 Service Requirements
4.1 供应商资质要求 Supplier Qualification Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 供应商具有独立承担民事责任的能力（即要有合法的营业执照、代码证、国地税税务登记证、一般纳税人资格）。需要提供以上复印件。 The supplier has the ability to bear civil liability independently (i.e. legal business license, code certificate, national and local tax registration certificate, general taxpayer qualification). The above copies are required. | 必需 Required |
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2 | 供应商具有履行合同所必需的物资和专业技术能力。 The supplier shall have the necessary material and professional technical ability to perform the contract. | 必需 Required |
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3 | 供应商具有设备研发、生产、加工的技术能力以及设备供货能力。 The supplier has the technical ability of equipment research and development, production and processing as well as the equipment supply ability. | 必需 Required |
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4 | 供应商具有软件设计和调试能力。 The supplier has the ability of software design and debugging. | 必需 Required |
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5 | 供应商具有一定规模的固定工作场所和专业技术人员。 The supplier has a certain scale of fixed workplace and professional technicians. | 必需 Required |
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6 | 设备生产如有强制性要求，设备生产商必须提供相应的制造许可证等资质证明文件。 If there are mandatory requirements for equipment production, the equipment manufacturer must provide the corresponding manufacturing license and other qualification certificates. | 必需 Required |
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7 | 供应商必须具有对设备调试和验收的能力。 The supplier must have the ability to debug and accept the equipment. | 必需 Required |
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8 | 供应商应具有对我方技术管理人员、操作人员、维修人员进行结构原理、工艺、性能操作、设备维护与维修、故障排除等基本知识培训的能力与资质。 The supplier shall have the ability and qualification to train our technical management personnel, operators and maintenance personnel on the basic knowledge of structure principle, process, performance operation, equipment maintenance and repair, trouble shooting, etc. | 必需 Required |
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9 | 供应商应具有供应设备备品备件的保证能力。 The supplier shall have the assurance ability to supply equipment spare parts. | 必需 Required |
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10 | 供应商应具有良好的售后服务能力。 The supplier shall have good after-sales service ability. | 必需 Required |
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4.2 售后及维护保养要求 After-sales and Maintenance Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 供应商对我方人员培训需达到以下标准：（1）维护人员熟练掌握设备基本原理，具备基本维护能力；（2）操作人员能够独立正确操作设备，会排除常见故障。 The supplier's training for our personnel shall meet the following standards: (1) the maintenance personnel shall be proficient in the basic principles of the equipment and have the basic maintenance ability; (2) the operators shall be able to operate the equipment independently and correctly, and can eliminate common faults. | 必需 Required |
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2 | 设备保修期自最终验收合格后算起12个月，控制系统保修期自最终验收合格后算起12月，重复出现的故障（质量问题）保修期顺延。 The warranty period of the equipment shall be 12 months after the final acceptance, and the warranty period of the control system shall be 12 months after the final acceptance. The warranty period of the repeated faults (quality problems) shall be extended. | 必需 Required |
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3 | 保修期内，卖方免费为买方维修设备（包括零部件费用）；保修期外，长提提供优惠的维修服务及零部件，维修响应时间24小时。 During the warranty period, the Seller shall repair the equipment (including the cost of spare parts) for the buyer free of charge; outside the warranty period, the Seller shall provide long-term preferential maintenance services and spare parts, and the maintenance response time shall be 24 hours. | 必需 Required |
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4 | 设备出现需方不能解决的故障，需方提出要求后，供方24小时内派遣专业人员到需方现场协助解决问题。 In case of any fault that cannot be solved by the buyer, the supplier shall send professional personnel to the user's site to assist in solving the problem within 24 hours upon the user's request. | 必需 Required |
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5 | 供应商应提供完整的故障类型和处理方式的清单。 The supplier shall provide a complete list of fault types and handling methods. | 必需 Required |
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6 | 供应商须提供完整的备品备件清单，清单需标明备件名称型号，单价，供货周期，使用寿命，生产商等。 The supplier shall provide a complete list of spare parts, indicating the name, model, unit price, supply cycle, service life, manufacturer, etc. | 必需 Required |
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4.3 校验、测试和确认要求 Calibration, Testing and Qualification Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 供应商应提供设备的使用年限。 The supplier shall provide the service life of the equipment. | 必需 Required |
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2 | 合同签订后四周内，供应商提供设计确认（DQ）草案。 Within four weeks after signing the contract, the supplier shall provide the draft of design qualification (DQ). | 必需 Required |
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3 | DQ文件中应对所采用的设计标准进行明确，提供仪器组件及备品备件清单，DQ文件中还应对该设备所具备的功能、能力等进行详细描述。 The DQ document shall specify the adopted design standards, provide the list of instrument components and spare parts, and describe the functions and capabilities of the equipment in detail. | 必需 Required |
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4 | 供应商与需方共同对设备完成（DQ）确认。 The supplier and the buyer shall jointly do the design qualification(DQ). | 必需 Required |
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5 | FAT/SAT由供货商按本文件的要求编写，由需方审核确认。FAT测试前一周，供应商提供FAT/SAT说明方案，应有需方人员参与F AT测试。 FAT / SAT shall be prepared by the supplier according to the requirements of this document and reviewed and confirmed by the buyer. One week before FAT , the supplier shall provide FAT / SAT protocol, and the buyer's personnel shall participate in the test. | 必需 Required |
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6 | 在制造商工厂进行F AT测试，FAT测试期间需方要对设备是否达到技术要求进行确认，并提出整改项目，FAT测试整改项目完成后，买方签字验收，设备才能进行包装和发运。 FAT test shall be carried out in the manufacturer's factory. During the test, the buyer shall confirm whether the equipment meets the technical requirements and propose rectification items. After completion of FAT test rectification items, the buyer shall sign for acceptance, and the equipment can be packaged and shipped. | 必需 Required |
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7 | 发货时供应商向需方提供安装确认（IQ）、运行确认（OQ）草案。 The supplier shall provide the buyer with installation qualification (IQ) and operation qualification (OQ) draft at the time of delivery. | 必需 Required |
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8 | 供货商应协助需方进行IQ和OQ，并协助完成相关报告。 The supplier shall assist the buyer in IQ and OQ and complete relevant reports. | 必需 Required |
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9 | 设备安装完成后，依原厂提供的机器性能条件及合约内容条件逐一验收或测试（SAT），双方代表签字，但该文件不作为设备最终验收。 After the installation of the equipment, the acceptance or test (SAT) shall be conducted one by one according to the performance conditions of the machine provided by the original factory and the contract content conditions, and the representatives of both parties shall sign, but the document shall not be regarded as the final acceptance of the equipment. | 必需 Required |
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10 | 在设备完全交付使用前，应完成下列验证：DQ、FAT、SAT、IQ、OQ（包括验证方案和验证执行，以及报告整理），PQ（共同完成）。 Before the equipment is completely delivered for use, the following verifications shall be completed: DQ, FAT, SAT, IQ, OQ (including qualification protocol and implementation, as well as report sorting), PQ (completion together). | 必需 Required |
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11 | 卖方负责协助卖方进行相关验证活动，并对验证中出现的问题提出对策和解决方案。 The Seller shall be responsible for assisting the seller to carry out relevant qualification activities, and proposing countermeasures and solutions for the problems in the qualification. | 必需 Required |
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4.4 文件要求 Files Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 供应商应提交一份URS条款响应目录清单，与URS格式不同的，供应商可以按照自己的格式，但要包括UES条款的所有内容。 The supplier shall submit a list of URS clause response catalogue, which is different from URS format. The supplier can follow its own format, but shall include all contents of UES clause. | 必需 Required |
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2 | 供应商应在提供项目进度计划表中列出响应程度，所有的文件应在最终验收通过前一并提交。 The supplier shall list the response degree in the provided project schedule, and all documents shall be submitted together before the final acceptance. | 必需 Required |
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3 | 供应商在接到URS一周内提交详细的功能说明书和示意图，及招标文件或报价。 Within one week after receiving URS, the supplier shall submit detailed functional specifications and schematic diagrams, as well as bidding documents or quotations. | 必需 Required |
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4 | 供应商应提供本文件中特别提出的设备部件、与物料直接接触的设备内表面等材质证明书。 The supplier shall provide material certificates of equipment parts, internal surfaces of equipment in direct contact with materials, etc. specially mentioned in this document. | 必需 Required |
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5 | 供应商应提供可通过最新版GMP审核的标准文件。 The supplier shall provide standard documents that can pass the latest GMP review. | 必需 Required |
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6 | 应提供所有外购件的合格证和说明书及相关资料及材质证明。 The quality certificate, instruction manual, relevant data and material certificate of all purchased parts shall be provided. | 必需 Required |
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7 | 供应商提供的确认文件包括DQ、FAT、SAT、IQ、OQ中英文文件，并协助用户完成验证确认（PQ）。 The confirmation documents provided by the supplier include DQ, FAT, SAT, IQ, OQ in Chinese and English, and assist the user to complete the verification and confirmation (PQ). | 必需 Required |
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8 | 设备说明书必须与所购设备一致，并有与设备一致的流程图，该部分文件必须在设备到达前1个月提供。 The equipment manual must be consistent with the purchased equipment and have the flow chart consistent with the equipment. This part of the document must be provided one month before the arrival of the equipment. | 必需 Required |
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9 | 技术文件中应有按功能部件区分、针对每一部件所做的序号建明图册，以便于维护迅速辨识，且能与厂家沟通无碍。 The technical documents shall be divided according to the functional parts, and the illustrated atlas shall be established for the serial number of each part, so as to facilitate the rapid identification of maintenance and communication with the manufacturer. | 必需 Required |
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10 | 所有文件几个说明书应提供纸质版和电子版各一份，电子版要求为Word和其他可编辑的格式。 A paper version and an electronic version shall be provided for several instructions of all documents. The electronic version shall be in word and other editable formats. | 必需 Required |
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11 | 对供应商所提供纸质版的各种文件内容进行如下规定： 1 文件统一用A4纸打印，采用A4尺寸塑料插页文件档案盒或其他形式。 2 所有大于A3的文件及图纸，应折叠成A4尺寸。 3 所有设备的文件及图纸应使用中文和英文对照，如不能达到上述要求，需经质量负责人批准。 The contents of various paper documents provided by the supplier shall be specified as follows: 1. The documents shall be printed with A4 paper, and the A4 size plastic insert file box or other forms shall be used. 2. All documents and drawings larger than A3 shall be folded into A4 size. 3. All equipment documents and drawings shall be in Chinese and English. If they fail to meet the above requirements, they shall be approved by the QP. | 必需 Required |
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4.5 包装和运输要求 Packaging & Transport Requirements
序号No. | 标准要求 Requirements | 期望/必需 Desired/Required | 供应商回复 Reply of Supplier |
1 | 设备在供应商场内检查和测试之后，必须清洁、干燥，各接口必须密封。 After the equipment is inspected and tested at the supplier's site, it must be clean and dry, and all interfaces must be sealed. | 必需 Required |
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2 | 供应商应按国际进行分段包装，并有醒目的起吊标志和文字标示。 The supplier shall pack in sections according to the international standards, with striking lifting marks and text marks. | 必需 Required |
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3 | 货物包装须符合相应标准，该包装应适于长途运输，具有良好的防潮、防水、防锈、防野蛮装卸等保护措施，以确保货物安全运抵现场，供应商应承担由于包装、运输不妥引起的货物锈蚀、损伤和丢失的责任。 The packaging of the goods shall conform to the corresponding standards. The packaging shall be suitable for long-distance transportation, with good protection measures such as moisture-proof, waterproof, rust proof and rough handling to ensure the safe arrival of the goods at the site. The supplier shall be responsible for the corrosion, damage and loss of the goods caused by improper packaging and transportation. | 必需 Required |
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4 | 供应商负责运输并承担运输费用，并负责运输过程中货物的安全和防护工作，设备到需方工厂后由需方负责搬运、吊装，供方派技术人员协助需方对机器进行安装、调试。 The supplier shall be responsible for the transportation and bear the transportation cost, and shall be responsible for the safety and protection of the goods during the transportation. After the equipment arrives at the buyer's factory, the buyer shall be responsible for the carrying and hoisting. The supplier shall send technical personnel to assist the buyer in the installation and commissioning of the machine. | 必需 Required |
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5 | 货物的开箱启包和检查在在设备安装现场进行，应由设备制造商、供应商、买方各派代表参加；滚局云淡和装箱单查对设备及其配套件的数量和质量；同时将检查结果准确填入《设备开箱验收记录》并签字。 Unpacking and inspection of the goods shall be carried out at the equipment installation site and shall be attended by representatives of the equipment manufacturer, supplier and the buyer; the quantity and quality of the equipment and its supporting parts shall be checked through discussion, at the same time, the inspection results shall be accurately filled in the equipment unpacking acceptance record and signed. | 必需 Required |
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6 | 机器到货拆箱时如供应商授权我方自行拆箱，拆箱后如发现机器及零配件有任何损坏、缺少，供应商应负全责，不得推诿。 When the machine arrives and unpacks, if the supplier authorizes us to unpack by ourselves, the supplier shall be fully responsible for any damage or lack of the machine and spare parts after unpacking, and shall not shirk the responsibility. | 必需 Required |
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4.6 供应商对项目要求的确认Confirmation of Project Requirement by Suppliers
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4.7 交付期限Term of Delivery
4.7.1 供应商应在收到本文件的2个星期内提交一份书面的方案。
The supplier shall submit one written scheme within two weeks since the receipt of this document.
4.7.2 用户应在收到功能规格文件2个星期内对其进行审核、评论、批准并将其返还给供应商。
The user shall review, evaluate, approve, and return FS documents within two weeks since the receipt of the documents.
4.7.3 应在 之前在供应商工厂进行工厂验收测试。
FAT should be done in supplier’s factory before______________________________.
4.7.4 整台设备应要在 之前送到河北凯威制药有限责任公司康领分厂现场。
The goods shall be delivered to the site of KIVIPharm Co., Ltd. Camfield Plant before_____ ___.
4.7.5 现场接受测试应在 之前进行。
SAT should be done before_______________________________________________________
4.7.6 确认/验证应在 之前进行。
Ø Qualification/Validation should be done before__________________________.
4.7.7 应 之前，将双方对设备整体验收合格并交付河北凯威制药有限公司康领分厂。
Ø The goods shall be finally accepted by both parties and delivered to the site of KIVIPharm Co., Ltd. Camfield Plant before _______ ____.
5 相关文件/记录Associated Documents and Records
6 附件Annexes
7 文件变更历史 History of Document Changes
版本号Version | 变更日期Date | 变更内容摘要Abstract of Changes |
00 |
| 文件新建File creation |
8 语言要求 Language Requirements
中文Chinese | ☐ | 英文English | ☐ | 中英文 Chinese & English | ☒ |
N/A | ☐ | N/A | ☐ | N/A | ☐ |
