Tender Notice
Hastelloy reaction kettle 2000L one
DIGA PHARMACEUTICAL GROUP LIMITED
Dijia Pharmaceutical Group Co., Ltd.
Hastelloy Reactor URS
Urs for Lining Hastelloy Reactor
Scheme No:URS-C9.22
Directory
1.0 Scheme Approval
2.0 Introduction
3.0 regulations and guidelines
4.0 terminology
5.0 user and system requirements
6.0 Parameter Change Description
1.0 Scheme Approval
| Development Department | Signature of the formulator | Date |
| Equipment Department |
| Audit Department | Signature of Reviewer | Date |
| Equipment Department | ||
| Production Department | ||
| Quality Assurance Department |
| Approver | Signature | Date | |
| Quality Director | |||
| Effective Date | Number of prints | 1 | |
2.0 Introduction
This user requirement statement (URS) is to specify the technical requirements of Hastelloy reaction kettle used in C9 workshop of Dijia Pharmaceutical Group Co., Ltd., provide technical basis for the bidding of the equipment, and serve as the basis for subsequent verification work.2.1 Overview
2.2 Purpose
The purpose of this user demand is to put forward the specific content of the user demand of the Hastelloy reaction kettle to the equipment manufacturing supplier. After the confirmation of the equipment manufacturing supplier, the preliminary selection, functional design and final detailed design of the Hastelloy reaction kettle are carried out on the basis of the control standards proposed by our company, so as to provide sufficient basis for future equipment confirmation.
Scope of 2.3
The scope of this scheme involves Hastelloy reactor in C9 workshop of dijia pharmaceutical group co., ltd., including equipment main body, stirring, reducer, jacket and other parts, and is designed according to explosion-proof requirements. equipment manufacturers use URS as the basis for detailed design and quotation, and party a uses URS as the standard for on-site acceptance of equipment after delivery and on-site acceptance after entering the factory.2.4 responsibility
The equipment manufacturing supplier is responsible for providing all equipment, software and devices necessary for the normal operation of the HALLOY reactor and related ancillary facilities.The equipment manufacturing supplier shall provide relevant equipment, facilities and services in strict accordance with the regulations, standards, technical requirements and service requirements specified in this URS, and the supplier shall be responsible for the confidentiality of the URS provided by the demander. Deviations shall be notified to the user in writing.
3.0 regulations and guidelines
The systems within the scope of this URS shall meet the requirements of the following regulations and guidelines:1) China GMP(2010 Revision) and its Appendices
2)GB150-2011 steel pressure vessel
3) Safety Technical Supervision Regulation for TSG R0004-2009 Stationary Pressure Vessels
4) Standard for steel plates for GB24511 pressure components
5)NB/T47010-2010 Forging Material Standard
6)HG/T20583-2011 welded joint structure
7)GB3280-92 stainless steel cold rolled sheet
8)GB4293-91 stainless steel and heat resistant steel cold rolled steel strip
9) Combination, selection and technical requirements of HG21563-1995 stirring transmission device system
10)HG/T4113-2009 kettle with mechanical seal leakage test method
11) Vertical reducer for HG/T3139-2001 kettle
4.0 terminology
| Term Terminology | Definition 定义 |
| GMP | Good Manufacturing Practices drug production quality management practices |
| DQ | Design Qualification Design Validation |
| ISO | International Standards Organization 国际标准组织 |
| IQ | Installation Qualification 安装确认 |
| OQ | Operational Qualification 运行确认 |
| SOP | Standard Operating Procedures for Standard Operating Procedures |
| URS | User Requirement Specification User Requirements Standard |
| PQ | Performance Qualification 性能确认 |
| CGMP | Current Good Manufacturing Practice the current pharmaceutical production quality management practices |
5.0 User and system requirements
| No. | Model | Quantity | Installation position |
| URS01 | 2000L | 1 | 1）S206A-A23 |
| Remarks | |||
5.1 Ha styleOverall design requirements of alloy reactor
| No. | Requirements | Response |
| URS02 | 2000-litre Hastelloy Reactor (effective use volume, charging coefficient calculated according to 0.8). The main contact materials are sodium chloride, bromine, n-butyl lithium n-hexane and EG5 solution. C276 material is required for the contact parts of all materials, and 304 stainless steel is required for other substrates and jackets (factory material certificate and material inspection report are required, on-site acceptance can be traced back to the proof material) production standards must comply with the pressure vessel national manufacturing norms and industry standards, design service life of 15 years. | □ Yes □ No |
| URS03 | The equipment adopts the heat exchange design of internal liquid nitrogen pipeline and external jacket. The internal liquid nitrogen pipeline requires temperature resistance of -194-144 ℃, pressure resistance of 0-3MPa, service temperature of kettle body of -90 to 100 ℃ above zero, pressure resistance of -0.1-0.4MPa, and external jacket of steam and circulating water. The temperature range is -15 ℃-150 ℃, pressure resistance of 0-0.6MPa. The above temperature pressure is the design maximum value, not the actual service pressure and temperature, please click here to design, no need to enlarge | □ Yes □ No |
| URS04 | The diameter of the reaction kettle is required to be 1300mm, the design pressure of the jacket is 0.6Mpa, the design pressure of the inner container is 0.4MPa, and the negative pressure is 0.1MPa MPa. The pressure design shall meet the requirements of using both the negative pressure of the kettle body and the positive pressure of the jacket at the same time (only the kettle body is resistant to negative pressure and the steam pressure of the jacket is 0.6MPa when used). The thickness of the upper head shall not be less than 12mm, the cylinder and the lower head, please refer to the suggestions provided by Party A for secondary design. | □ Yes □ No |
| URS05 | The jacket of the reaction kettle requires thermal insulation treatment, aluminum silicate is used for thermal insulation, 10cm aluminum silicate is used for jacket and lower head, 8cm aluminum silicate is used for upper head, 304 stainless steel plate is coated, the thickness is required to be ≥ 2mm, and the outer surface is brushed and matt treated. | □ Yes □ No |
| URS06 | The reactor adopts a closed structure with a top opening. If the equipment design allows, sufficient equipment interfaces are reserved. Standard quick-opening sanitary manhole, solid feeding port, viewing hole lamp, observation port, distillation port, reflux port, solvent feeding port, nitrogen and vacuum port, liquid nitrogen port, thermometer sleeve port, dripping port, explosion venting port, etc. shall be adopted as far as possible. The specific size and location shall be subject to the confirmation of drawings, requirements: large solvent feed inlet kettle, small solvent drop inlet as internal annular drop pipe, all flanges adopt standard HG20592 of 1.6MPa (nozzle height should consider insulation thickness) material flange adopts material C276, looper flange is not allowed | □ Yes □ No |
| URS07 | The reactor support is in the form of ear support. For the reactor with suspended type (4 ears) and 304 stainless steel, the T-shaped weld part of the jacket and the cylinder body needs to be reserved with a detection plate, and the fillet weld of the steam inlet is not outsourced. | □ Yes □ No |
| URS08 | It needs to be equipped with M20 * 1.5 or standard ISO quick-opening pressure gauge interface and 360 cleaning spray ball. The cleaning ball can be quickly removed from the top of the reaction kettle. The inner surface of the equipment needs to be mirror polished with Ra ≤ 0.6. The inside of the equipment should be easy to clean and have no dead corners in accordance with GMP requirements. | □ Yes □ No |
| URS09 | Equipped with pressure-resistant clean viewing hole glass and installed 36V,LED explosion-proof viewing hole lamp (with automatic closing function) | □ Yes □ No |
| URS10 | The reaction kettle manhole or feeding port adopts sanitary manhole cover or feeding cover | □ Yes □ No |
| Remarks | ||
5.2 Ha stylealloy reaction kettleThermowell、Liquid nitrogen pipe, dripping pipeTechnical requirements for kettle bottom valve
| No. | ToAsk | Response |
| URS11 | The upper part of the reaction kettle needs to be equipped with a top plug-in flange temperature measuring thermometer sleeve. The thermometer sleeve and the kettle body are fully welded. The inner sleeve and the reaction kettle are provided with 2 additional supports, and the material is C276 | □ Yes □ No |
| URS12 | A bottom temperature measuring sleeve is added to the bottom of the reaction kettle. The thermometer sleeve is fully welded with the kettle body. The sleeve adopts an oblique insertion design from top to bottom. The sleeve mouth must be quickly opened and installed. The installation position is located at the thermometer with the minimum stirring amount of the reaction kettle. The material is C276 | □ Yes □ No |
| URS13 | The liquid nitrogen pipe is made of DN25 seamless steel pipe with a pressure resistance of 3MPa. The kettle is equipped with a fixed plate. The laying range is from the cylinder to the lower head (as much as possible, and the area drawing is confirmed). The material is C276 | □ Yes □ No |
| URS14 | The top of the reaction kettle is provided with DN50 liquid feed inlet, which is probed to the bottom of the kettle. The material is C276 | □ Yes □ No |
| URS15 | The top of the reaction kettle is provided with DN25 annular dropping pipe, with 8 evenly distributed dropping ports, made of C276 | □ Yes □ No |
| URS16 | The reaction kettle shall be equipped with DN80 manual low temperature resistant discharge bottom valve, material C276 | □ Yes □ No |
| Remarks | ||
5.3 哈式合金反应釜搅拌桨技术Requirements
| No. | ToAsk | Response |
| URS17 | 搅拌形式：纯C276材质的组合式搅拌，搅拌形式采用上部双层桨式，下部轴流式搅拌，要求搅拌光滑无死角，尽量减少螺栓连接，所有反应釜的搅拌最小搅拌量为自身容积的10% | □ Yes □ No |
| URS18 | 搅拌轴按照国标设计接处采用轴套连接，不接受底部增加搅拌支撑轴承的设计，若设备厂家的搅拌为专业搅拌供应商提供，可单独提供搅拌图纸并注明 | □ Yes □ No |
| Remarks | ||
5.4 Ha stylealloy reaction kettle电机及减速机技术要求
| No. | ToAsk | Response |
| URS19 | 反应釜配备防爆定频电机，电机品牌：江苏大中或者南阳品牌 | □ Yes □ No |
| URS21 | 变频搅拌转速：0-110 r/min可调，减速机采用SEW、诺德品牌齿轮减速机，立式安装，并配备减速机支架护罩（冲孔板） | □ Yes □ No |
| Remarks | ||
5.5 Ha stylealloy reaction kettle焊接要求
| No. | ToAsk | Response |
| URS22 | 保证焊缝牢固和平整光滑，符合GMP要求 | □ Yes □ No |
| URS23 | 所有焊缝都需要进行无损探伤检测，并达到检测标准 | □ Yes □ No |
| URS24 | 所有焊接点有记录（包括焊接参数），并且操作员需要持有焊工资格证书 | □ Yes □ No |
| URS25 | 焊接结束后，罐体及夹套需要进行耐压实验 | □ Yes □ No |
| Remarks | ||
5.6 Ha style合金反应釜机械密封技术要求
| No. | ToAsk | Response |
| URS26 | 具体型号按照设备型号标配，与物料接触部分采用哈氏合金 | □ Yes □ No |
| URS27 | 机械密封应该确保设备在正常使用状态下的测试都可以做到无渗漏 | □ Yes □ No |
| URS28 | 机械密封的用油需要采用食用级润滑油，不得对药品生产产生污染 | □ Yes □ No |
| URS29 | 采用密友或同等品牌的204B系列干磨式机械密封，需要配备防尘罩 | □ Yes □ No |
| Remarks | ||
| No. | ToAsk | Response |
| URS30 | 设备符合国家环境保护的法律、法规及GMP的相关要求。 | □ Yes □ No |
| URS31 | 设备在使用、操作、维修等方面的结构设计要合理、方便，需要考虑设备日常维护的可操作性，确保设备使用安全可靠 | □ Yes □ No |
| URS32 | 设备边缘应该平整，没有潜在的尖角 | □ Yes □ No |
| URS33 | 反应釜在结构设计和紧固件设计方面需要做到拆卸自如，方便快捷，没有清洁死角 | □ Yes □ No |
| URS34 | 各电气元件均需采用防爆元件，确保使用安全，设备符合GMP的有关要求 | □ Yes □ No |
| Remarks | ||
| No. | ToAsk | Response |
| URS35 | 设备竣工图及压力容器证书详细的单元尺寸图 | □ Yes □ No |
| URS36 | 部件列表清单及材质证明（必要的使用手册） | □ Yes □ No |
| URS37 | 备件列表清单及材质证明（必要的使用手册） | □ Yes □ No |
| URS38 | 压力容器产品质量证明书，压力容器安全性能监督检验证书 | □ Yes □ No |
| URS39 | 设备出厂合格证，制造许可证，带国家防爆电气产品质量监督检验中心出具的防爆电机合格证（16开） | □ Yes □ No |
| URS40 | 装箱单（详细的各备品备件名称及数量），必须带设备粗糙度的检测报告 | □ Yes □ No |
| URS41 | 焊接文件及资格证明（包括焊接记录、焊工资格证书、焊缝射线检测报告、压力试验报告） | □ Yes □ No |
| Remarks | ||
| Serial Number | Requirements | Response |
| URS42 | 包装满足运输和装卸要求，防潮干、防磕碰、防振动，由于包装不良而造成的任何锈损，卖方承担全部损失和费用 | □ Yes □ No |
| URS43 | 运输时间包含在供货周期内，供方负责运输，并承担运输费用 | □ Yes □ No |
| URS44 | 包装箱应清晰标出发货及运输作业标志 | □ Yes □ No |
| URS45 | 设备到货清单必须详列每装箱内容物 | □ Yes □ No |
| URS46 | 卖方应提供设备所需易耗、易损件清单及更换周期 | □ Yes □ No |
| Remarks | ||
5.10 维修Requirements
| Serial Number | Requirements | Response |
| URS47 | 设备的设计和制造应该具有方便、快速、简洁的维修保养方法 | □ Yes □ No |
| URS48 | 设备供应商为用户提供长期有效的维护保养服务及计划 | □ Yes □ No |
| URS49 | 设备及其配件应免费保修期限至少1年，有效日为安装试车完成验收日起。设备试用后，于保修期限内出现故障需由供应商负责免费供应修缮或更换，且维修需要在24小时内到现场 | □ Yes □ No |
| URS50 | 如因设备故障导致停止生产时，需要延长保修期限。同时故障备件供应商需无条件负责免费更换 | □ Yes □ No |
| URS51 | 供应商保证十年内能方便的采购到所供货物的相关配件，并以不高于市场的价格提供优质的零配件 | □ Yes □ No |
| Remarks | ||
5.11 培训Requirements
| Serial Number | Requirements | Response |
| URS52 | 供应商对用户操作人员、技术人员提供原理、操作、维修保养等全方位的培训，使其能够对系统进行操作和日常维修保养和常见故障的自行排出工作 | □ Yes □ No |
| Remarks | ||
| Serial Number | Requirements | Response |
| URS53 | 为了确保需方的要求，供应商应在设计、制造和测试的所有阶段执行质量确认项目计划，包括对伙伴供货商提供的零部件的质量检测和控制，便于需方在设备出厂验收时查验 | □ Yes □ No |
| URS54 | 所有的货物或测试都应考虑GMP认证的需要 | □ Yes □ No |
| URS55 | 供应商必须通过合理的方法来制定和分析详尽的进度计划（包括设计、制造、测试等等），这有利于实施质量控制，确定关键工序和阶段，并优化工作程序，反复检查工作进展 | □ Yes □ No |
| URS56 | 每一项检查和测试（甲方代表见证的或未见证的），乙方都应出具检测报告和检测证书，这些文件包含在最终竣工文件包内 | □ Yes □ No |
| URS57 | 文件是乙方工作范围内的不可分割的一部分。乙方提供的货物和文件必须满足甲方的要求并且必须满足现行GMP认证的要求 | □ Yes □ No |
| Remarks | ||
| Serial Number | Requirements | Response | |
| URS58 | 乙方已充分阅读、理解并接受本URS里面的各项条款和规定，且均无异议 | □ Yes □ No | |
| Remarks | |||
| 乙方代表签字/日期 | |||
6.0 参数变更说明
变更申请| Serial Number | 执行日期 | 变更原因 | 变更详细描述 | |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| Remarks | ||||
| 汇报人/日期 | 批准人/日期 | |||