重庆连续废水灭活系统招标公告（重庆药友制药有限责任公司2025）
CIP站和浓碱分配系统、上游不锈钢配储液系统、下游不锈钢配储液系统、连续废水灭活系统采购公开招标公告
项目概况
招标项目编号:
XM202505170001
招标方:
重庆药友制药有限责任公司
项目实施地点:
重庆市北碚区京东方大道66号
项目情况:
重庆药友制药有限责任公司水土工厂202车间单抗项目需要采购CIP站和浓碱分配系统、上游不锈钢配储液系统、下游不锈钢配储液系统、连续废水灭活系统。
标段信息
标段名称:
CIP站和浓碱分配系统、上游不锈钢配储液系统、下游不锈钢配储液系统、连续废水灭活系统采购
标段编号:
XM202505170001-01
报名截止时间:
2025-05-30
供应商资质要求:
null
公告信息:
重庆药友制药有限责任公司水土工厂202车间单抗项目需要采购CIP站和浓碱分配系统、上游不锈钢配储液系统、下游不锈钢配储液系统、连续废水灭活系统。
公告附件:
点击附件：
CIP站和浓碱分配系统、上游不锈钢配储液系统、下游不锈钢配储液系统、连续废水灭活系统采购招标公告.doc
点击附件：
URS-013-2025 上游不锈钢配储液系统用户需求说明.docx
点击附件：
URS-014-2025 下游不锈钢配储液系统用户需求说明.docx
点击附件：
URS-019-2025 连续废水灭活系统用户需求说明.docx
点击附件：
URS-020-2025 CIP站和浓碱分配系统用户需求说明.docx
点击附件：
上海复星医药（集团）股份有限公司供应商行为准则（2.1版）.pdf
点击附件：
法人身份证明书和法人授权委托书模板 （分标段）.doc
招标方联系方式
招标方:
重庆药友制药有限责任公司
联系人:
米文杰
联系电话:
18996201002
CIP站和浓碱分配系统、上游不锈钢配储液系统、下游不锈钢配储液系统、连续废水灭活系统采购招标公告一、招标项目：1、招标内容：CIP站和浓碱分配系统、上游不锈钢配储液系统、下游不锈钢配储液系统、连续废水灭活系统采购2、招标类别：供货类二、招标项目概况：1、项目名称：CIP站和浓碱分配系统、上游不锈钢配储液系统、下游不锈钢配储液系统、连续废水灭活系统采购2、项目位置：重庆市北碚区京东方大道66号3、招标项目简介：重庆药友制药有限责任公司水土工厂202车间单抗项目需要采购CIP站和浓碱分配系统、上游不锈钢配储液系统、下游不锈钢配储液系统、连续废水灭活系统。4、本次招标范围及技术要求：标段一：CIP站和浓碱分配系统，具体以CIP站和浓碱分配系统的URS要求为准。标段二：上游不锈钢配储液系统，具体以上游不锈钢配储液系统的URS要求为准。标段三：下游不锈钢配储液系统，具体以下游不锈钢配储液系统的URS要求为准。标段四：连续废水灭活系统，具体以连续废水灭活系统的URS要求为准。5、数量：各标段的招标数量以URS中供货范围为准。三、入围条件和投标资格要求：1、企业证照齐全、信誉良好，无违法、违规行为，无行业处罚等不良记录。2、营业执照、资质证书等文件均要在有效期内。要求投标人注册资本2000万元及以上。3、至少提供3个2023年1月1日以来同本次标的物要求相当的业绩，以提供的有效合同（至少包括合同首页、标的物内容页、买卖双方盖章页等）为准。4、招标方免受第三方提出侵犯其专利权或其它任何知识产权的起诉。5、招标方有权根据投标方近两年的诉讼情况决定其是否入围。6、招标方有权要求投标方在规定时间内提供招标标的物相关的证明材料，结合招标方的需求符合性判断其是否入围。7、合格的投标方不应有腐败和欺诈行为。如果投标方在任何时候，被法院、检察院及政府有关管理部门认定有腐败和欺诈行为，招标方有权拒绝其投标、取消其中标资格、撤销已签署。8、投标方应认真阅读、充分理解招标文件的全部内容，投标方一经完成报名，即表明投标方已经仔细阅读、调查和了解与本次招标项目有关的一切情况，并已理解和知晓招标文件的全部内容。★特别注意事项：投标单位通过资格审查后，必须在网上完成回标，否则取消参与评标资格。四、投标报名应提交以下资料：1、有效期内的营业执照复印件（加盖公司鲜章）。2、法人身份证明书和法人授权委托书（模板详见附件）。3、提供3个2023年1月1日以来同本次标的物要求相当的业绩，以提供的有效合同（至少包括合同首页、标的物内容页、买卖双方盖章页等）为准。4、《上海复星医药（集团）股份有限公司供应商行为准则（2.1版）》（模板详见附件，加盖公司鲜章）。五、投标报名截止日期：以复星集团一链网采招平台报名截止时间为准。六、招标文件发出日期：报名时间截止、提交入围审核完成后发布。七、定标原则：详见“CIP站和浓碱分配系统、上游不锈钢配储液系统、下游不锈钢配储液系统、连续废水灭活系统招标文件”中18.4规定。八、报名联系人及地址：联系人：米文杰联系电话：18996201002E-mail：miwj@yaopharma.com联系地址：重庆市渝北区人和镇星光大道100号网址：http://onelinkplus.com，供应商必须在复星集团采招平台点击相应招标公告注册报名。九、投诉方式：企业投诉电话：电话：023-67527818李卉复星集团投诉电话：电话：021-23156633张女士邮箱：fosuncgts@fosun.com复星医药集团廉政督察部：电话:021-33987226纪先生邮箱:lianzhengdc@fosunpharma.com复星集团廉政督察部：电话:021-23156625严女士邮箱:lianzhengdc@fosun.com复星医药集团集中采购与采购管理部：电话：021-33987286邮箱：ep_procurement@fosunpharma.com重庆药友水土工厂202车间单抗项目上游配储液系统用户需求说明文件URSforUSPreparation&HoldingSSTankof202Project目录1.目的PURPOSE32.范围SCOPE33.系统描述SYSTEMDESCRIPTION44.定义/缩略语DEFINITIONSANDABBREVIATIONS65.参考资料及法规符合性REFERENCES®ULATIONS66.需求REQUIREMENTS77.版本历史REVISIONHISTORY338.附录APPENDIX351.目的PURPOSE本文件目的是定义重庆药友水土工厂202车间单抗项目15,000L生产线的上游配储液系统的用户需求。Thepurposeofthisdocumentistodefinetheuserrequirementsofup-streampreparation&holdingSStanksystemof15,000Lfermentationlineof202project.2.范围SCOPE本文连同其所有附件，涵盖了所有工作范围以及设计、制造、检查、交付、调试和性能测试的最低要求。本项目包括了15,000L生产线的上游不锈钢配储液系统及其辅助系统（钢平台、取样口等）Thisdocument,togetherwithallattachments,coversthescopeofworkandtheminimumrequirementsofthedesign,fabrication,inspection,delivery,start-up,andperformancetesting.Theplantconsistsofup-streampreparation&holdingStainlesssteeltanksystemandsupportsystem(SSPlateformandsoon).本项目包含以下部分：Thescopeofsupplyincludes:-1套200L培养基配制罐200Lmediapreparationtank,1set-1套1000L培养基配制罐1000Lmediapreparationtank,1set-1套4,000L培养基配制罐4,000Lmediapreparationtank,1set-1套10,000L培养基配制罐10,000Lmediapreparationtank,1set-2套500L培养基补料罐500Lmediaholdingtank,6sets-4套4,000L培养基补料罐4,000Lmediaholdingtank,4sets-4套1,000L培养基补料罐1,000Lmediaholdingtank,4sets-所有培养基配制罐附属的取样口Samplingportsforallmediapreparationtanks-所有罐各自附属的电控柜ElectricalandcontrolCabinetforalltanks-所有罐附属钢平台Stainless-steelplateformsforalltanks-工艺料液输送系统Theprocessliquidtransfersystem-用于不锈钢反应器搅拌器检修维护的吊装装置Theliftingdeviceisusedfortherepairandmaintenanceofstainlesssteelreactoragitator本系统服务于202生产楼15,000L生产线。Thesystemserviceforproductionbuilding202#of15,000Lfermentationline.需要提供的范围包括Thescopeofsupplyshallinclude:详细设计DetailDesign设计确认DesignQualification建造Fabrication工厂接收测试FAT交付Delivery调试以及现场接收测试Commissioning&SAT安装确认和运行确认IQ&OQ性能确认协助PQAssistance操作人员的培训OperationPersonnelTraining文件Documentation移交Handover3.系统描述SYSTEMDESCRIPTION3.1.1.设施/设备/仪器/系统描述Facility/Equipment/Instrument/SystemDescription本系统应满足每天24小时连续工作，并且连续时间不少于每周7*24小时。Thesystemshouldworkcontinuously24hoursaday,andthecontinuoustimeshouldnotbelessthan7*24hoursperweek.本系统内容包括：Thesystemincludes:-15,000L原液线上游不锈钢配储液系统StainlesssteelMediaPreparation&HoldingTanksystemfor15,000Lfermentationline200L培养基配制罐*1，1000L培养基配制罐*1，4,000L培养基配制罐*1，10,000L培养基配制罐*1，位于202生产楼D级区的培养基配制间。100Lmediapreparationtank*1,500Lmediapreparationtank*1,4,000Lmediapreparationtank*1,10,000Lmediapreparationtank*1,arelocatedinthemediapreparationroomofgradeDareaofproductionbuilding202#.500L培养基补料罐*2，4,000L培养基补料罐*4，1,000L培养基补料罐*4，位于202生产楼细胞培养间。500Lmediaholdingtank*2,4,000Lmediaholdingtank*4,1,000Lmediaholdingtank*4,arelocatedinthecellreactionroomofproductionbuilding202#.培养基原物料经过称量后，量大的物料（大于40L）放置在IBC中，量小的物料放置在投料袋中。投料时，通过提升机将IBC提升至合适的高度后，由软连接将IBC口和罐体投料口连接后，进行投料。投料袋则直接由人工投料。配制完成的培养基经过一级过滤后通过不锈钢管道传输至各个补料罐，各个补料罐通过不锈钢管道与不同的反应器链接，根据不同的反应器所需的补料阶段传输培养基。Aftertherawmaterialsofthemediamaterialareweighed,thelargeamountofmaterial（morethan40L）isplacedintheIBC,andthesmallamountofmaterialisplacedinthefeedingbag.Whenfeeding,aftertheIBCisliftedtoasuitableheightbythehoist,theIBCportandthefeedingportofthetankareconnectedbyasoftconnection,andthenthefeedingiscarriedout.Thefeedingbagisdirectlyfedmanually.Themediaafterpreparationistransferredtoeachfeedtankthroughstainlesssteelpipesafterfirststagefiltration,andeachholdingtankisconnectedtodifferentreactorsthroughstainlesssteelpipes,andthemediaistransmittedaccordingtothefeedingstagerequiredbydifferentreactors.上述设备之间需要有联动功能。Associatedinterconnectionamongabovelistedequipment.3.2.2.布局/安装条件Layout/ConstructionConditions供应商需根据业主的平面布局图进行上游不锈钢配储液系统以及辅助设备的设计。若设备有额外的高度要求，应告知业主并由业主批准。Vendorshoulddesignthestainless-steelMediaPreparation&HoldingTanksystemandsupportsystemaccordingtotheowner'slayout.AnyadditionalheightrequirementsfortheequipmentmustbenotifiedandapprovedbyOwner.3.2.1.1.1布局Layout序号No.描述Description信息Information3.2.1.1.1.1.房间温度要求Room Temp. Requirement18~25℃3.2.1.2.2.2.房间湿度要求Room Humidity Requirement30%~70%RH(D级)3.2.1.3.3.3.房间布局图Room Layout参见布局图See Layout3.2.2.2.2公用介质Utility业主负责提供以下公用工程。Theownerisresponsibletoprovidethefollowingutility.序号 No.公共设施 Utilities用途 Function范围/容量 Conditions3.2.1.1.1.1.注射用水 WFI清洗 Washing压力 Pressure：0.3~0.35 MPa温度 Temp. : 80~85℃3.2.1.2.2.2.纯化水 PW清洗 Washing压力 Pressure：0.3~0.35 MPa温度 Temp. : 20~25℃3.2.1.3.3.3.电气 Electric供电 Power380V/50Hz220V/50Hz3.2.1.4.4.4.压缩空气 Compressed air动力 Drive压力 Pressure：0.6 MPa3.2.1.5.5.5.压缩空气Compressed air工艺 Process压力 Pressure：0.6 MPa3.2.1.6.6.6.洁净蒸汽Clean steam灭菌 Sterilization压力 Pressure：0.3 MPa3.2.1.7.7.7.工业蒸汽Plant steam加热 Heating压力 Pressure：0.6 MPa4.定义/缩略语DEFINITIONSANDABBREVIATIONS4.1.1.DQ：设计确认DesignQualification4.2.2.FAT：工厂验收测试FactoryAcceptanceTest4.3.3.SAT：现场验收测试SiteAcceptanceTest4.4.4.IQ：安装确认InstallationQualification4.5.5.OQ：运行确认OperationalQualification4.6.6.PQ：性能确认PerformanceQualification4.7.7.P&ID：管道和仪表流程图PipingandInstrumentDiagram4.8.8.PW：纯化水PurifiedWater4.9.9.WFI：注射用水WaterforInjection4.10.10.MCC：马达控制中心MotorControlCenter4.11.11.PCS：工艺自控系统ProcessControlSystem4.12.12.PD：工艺描述规程Processdescription4.13.13.CU洁净公用工程CleanUtility5.参考资料及法规符合性REFERENCES®ULATIONS在编写本URS的内容时已参考，且供应商需要满足下列文档的当前修订版：ThecontentsofthisURShavebeenreferencedandthesupplierisrequiredtomeetthecurrentrevisionofthefollowingdocuments.中国GMP(2010版)NMPA:GoodManufacturingPracticeforDrugs(2010Version)USFDA:21CFRPart210and211USFDA:21CFRPart11EUGMPVolumeⅣASMEBPEGB150(2011版)GB50017-2003钢结构设计规范6.需求REQUIREMENTSURS的每条要求可按如下分类为：EachrequirementintheURScanbeclassifiedasfollowing:质量需求:质量需求是具有法规或合规相关影响的可测量需求，需在确认阶段进行测试，质量需求可能是以下之一：QualityRequirementsaremeasurablerequirementsthathavearegulatoryorcompliancerelatedimpactandwillbetestedduringqualification.Aqualityrequirementmaybeoneofthefollowing:关键质量属性(CQA)关键工艺参数(CPP)关键操作参数（KOP）关键方面(CA)其他需求如GMP法规及组织质量要求等OtherrequirementsuchasGMPregulatory,organizationqualityrequirement,etc.商业需求：不影响产品质量的商业需求Business:Businessrequirementsthatdonotimpactproductquality安全EHS(Environment,Health&Safety)商务需求：与商务合同相关的非技术性需求，不影响产品质量，无需在DQ和RTM中追溯Commercialrequirements:non-technicalrequirementsrelatedtocommercialcontractsthatdonotaffectproductquality,donotneedtobetracedinDQandRTM.6.1.1.通用要求GeneralRequirement序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1供应商需提供设备的三维图纸，配合业主完成厂房立体布局图。The supplier shall provide the 3D drawings of the equipment and cooperate with the owner to complete the 3D layout of the plant.质量Quality1.1.2.2.2系统部件及仪器仪表的品牌参考业主的零部件品牌推荐表。所有零部件选型应依据URS及P&ID要求，提交业主审核；若选型不一致，需提交业主批准后方可执行。The brand of system components and instruments shall refer to the owner's parts brand recommendation table. The selection of all parts should be submitted to the Client for review according to URS and P&ID requirements; if the type selection is inconsistent, it should be submitted to the Client for approval before implementation.商务Commerce1.1.3.3.3设备应贴有统一的设备铭牌，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。The equipment should be attached with a unified nameplate. The equipment name, origin, date of manufacture, type, weight and other important technical parameters should be specified on the nameplate.质量Quality1.1.4.4.4所有模块设计需满足附录8.3中工艺仪表流程图的逻辑功能要求。All the module design shall follow the logical function requirement from the P&ID attached in Appendix 8.3. 质量Quality1.1.5.5.5供应商应在业主提供的P&ID基础上深化设计，并提交业主审核，批准后负责执行。The supplier shall deepen the design based on the P&ID provided by the Client, submit the design to the owner for review, and be responsible for implementation after approval.商务Commerce6.2.2.工艺需求ProcessRequirement序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1配制罐配液量范围的需要满足以下要求：The preparation tanks should be able to produce media every batch as below:200L 配制罐的工作体积为40L~200L；40L~200L working volume for 200L media preparation tank;1000L 配制罐的工作体积为200L~1000L；200L~1000L working volume for 1000L media preparation tank;4,000L配制罐的工作体积为1000L~4,000L；1000L~4,000L working volume for 4,000L media preparation tank;10,000L配制罐的工作体积为2,000L~10,000L；2,000L~10,000L working volume for 10,000L media preparation tank.质量Quality1.1.2.2.22000L以下的配制罐应至少在30min内完成物料的完全溶解且混合均匀。5000L至10000L的配制罐则需要至少在1小时内达到上述要求。The preparation tank below 2000L should complete dissolution of the material and mix it evenly within 30min at least. The 5000L 10,000L preparation tank needs to meet the above requirements within at least 1h.质量Quality1.1.3.3.3应使用CIP循环清洗来去除罐体和管道内的颗粒、污迹和残余溶液。冲洗将使用纯化水，最终淋洗也将使用纯化水。CIP cycle cleaning should be used to remove particles, stains and residual solution in the tank and piping. Purified water will be used for flushing and purified water will be used for final rinsing.质量Quality1.1.4.4.4必须使用核黄素做罐体以及所有关联部件的覆盖检测，包括呼吸器底部，罐顶预留口背面，上封头喷淋测试和罐体全覆盖喷淋测试等。Riboflavin must be used to perform coverage tests for tanks and all associated components, including the bottom of the vent filter, the back of the tank top reserve, spray tests for the upper head and full coverage spray tests for tanks.质量Quality1.1.5.5.5罐和管道在每步CIP的结束步骤，可以实现吹扫。The tank and pipe should be able to blow dry at the per CIP end step.质量Quality1.1.6.6.6系统的SIP应设计为121℃以上纯蒸汽灭菌。Sip of the system shall be designed for clean steam sterilization above 121 ℃.质量Quality1.1.7.7.7所有接触产品、物料、清洗水以及蒸汽冷凝水的设备应设计确保设备能够自排尽。All equipment in contact with product materials, wash water and clean steam condensate shall be designed to ensure that the equipment can be self-drained.质量Quality1.1.8.8.8. 所有走液体管道均需要自排空。最低点的排空坡度考虑至少1%。例如物料输送管路，冷凝水排水管路，CIP清洗管路，排污管路。All liquid pipelines need to be self-emptying. The lowest point of the drainage slope should be considered at least 1%. Such as product delivery pipelines, condensate drainage pipelines, CIP cleaning lines, sewage pipelines.质量Quality1.1.9.9.9系统模块设计以及物料输送管路设计应尽可能减少死体积，死管段接受标准需满足先行版本ASME BPE的L/d对不同管径的对应要求。System module design and product transfer pipelines design shall minimize dead volume, and the acceptance standards for dead pipe sections shall meet the corresponding requirements of ASME BPE L/d for different pipe sizes.质量Quality1.1.10.10.10对于每台设备，每种公用工程管路（包括进/出）只提供一个确定位置的出入接口。公用工程接口至设备之间的连接（包括材料和安装）属于供应商的范围。若有必要，供应商应在公用工程管道上安装必要减压阀和安全阀。Only one utility connection will be foreseen for each fluid (including in and out) at agreed position for each equipment. Connections between utility interfaces and equipment (including materials and installation) fall within the scope of suppliers. If needed, Vendor will insert on the utilities lines the necessary pressure-reducing valves and safety devices.商业Business1.1.11.11.11所有可拆连管道和仪表接均为快卡连接。All detachable pipe and instruments connections are clamps.商业Business1.1.12.12.12软管应尽量做到自排尽和垂直安装。Hose should be self-draining or vertical installation as far as possible质量Quality1.1.13.13.13管路内容物和流向应在管路上标明，不同内容物采用不同颜色区分。The contents and direction of the pipeline should be marked, and different contents should be distinguished by different colors.商业Business1.1.14.14.14机械部件和管路的标识样式由业主提供，供应商设计交业主确认。例如阀门，传感器，泵等。The identification pattern of mechanical parts and piping shall be provided by the owner, and the supplier's design shall be submitted to the Owner for approval. Such as valves, sensors, pumps, etc.商务Commerce1.1.15.15.15需要考虑CU如何取样，且产品取样，检修，滤器的拆装，管道的连接都要保证有足够的操作空间，安全和人体工程学。取样需要安装接水盘。It is necessary to consider how to sample CU, and to ensure sufficient operating space, safety and ergonomics for product sampling, maintenance, filter disassembly, and pipeline connection. Sampling requires installation of a water tray.商务Commerce6.3.3.关键参数CriticalParameter序号ID No.参数 Parameter要求 Requirement需求分类Requirement Category1.1.1.1.1罐体设计温度Tank design temperature-10~150℃质量Quality1.1.2.2.2罐体设计压力Tank design pressure-1~3 bar质量Quality1.1.3.3.3高径比Height diameter ratio1.1~1.3商业Business1.1.4.4.4夹套设计温度Jacket design temperature-10~150℃商业Business1.1.5.5.5夹套设计压力Jacket design pressure-1~5 bar商业Business1.1.6.6.6搅拌速度Agitation speed建议50~1000rpm，具体数值根据搅拌选型，需满足最小混合时间要求（最小混合时间参见6.2.2）50-350rpm is recommended, depends on the mixing model selection, and the minimum mixing time should be met (see item 6.2.2)质量Quality1.1.7.7.7搅拌速度控制精度Agitation speed control accuracy±2%质量Quality1.1.8.8.8pH测量范围PH measurement range2~12质量Quality1.1.9.9.9pH测量精度PH measurement accuracy±0.01质量Quality1.1.10.10.10工艺电导率测量范围和测量精度Conductivity measurement range and measurement accuracy for process高电导率检测范围：0.1 mS/cm -500mS/cm；范围内精确度: ≤当前测试值±5%低电导率检测范围：0.1μS/cm ~1000μS/cm范围内精确度≤当前测试值±1%。High conductivity detection range: 0.1 mS/cm -500mS/cm; accuracy in range: ≤±5% of current test value.Low conductivity detection range: 0.1μS/cm ~1000μS/cm; accuracy in range: ≤±1% of current test value.质量Quality1.1.11.11.11工艺电导率离线和在线差值Process conductivity difference between off-line and on-line高电导范围/High conductivity range：±1 mS/cm低电导范围/Low conductivity range：±0.1μS/cm质量Quality1.1.12.12.12称重系统精度Weighing system accuracy系统精度：最小工作体积的0.3%（最小工作体积参见6.2.1条款）;System accuracy: 0.3% of the minimum working volume (the minimum working volume see item 6.2.1);质量Quality1.1.13.13.13液位计测量精度Measuring accuracy of liquid level gauge±5%质量Quality1.1.14.14.14管道耐压Piping withstand pressure不小于5bar质量Quality1.1.15.15.15过滤压力传感器Filter pressure sensor精度≤0.1barAccuracy ≤ 0.1bar质量Quality6.4.4.部件要求ComponentsRequirement6.4.4.1.1.1.不锈钢配制罐和补料罐Stainlesssteelpreparationtanks&holdingtanks序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1所有罐体均应配有带灯视镜、爆破片、罐体压力传感器、隔膜压力表、呼吸器、人孔/手孔、物料添加口、一次性取样器、pH探头、电导率探头、罐体温度探头、罐底阀。配制罐采用称重模块，补料罐则采用压差液位计。The process tanks shall be equipped with light mirror, rupture disk, tank pressure sensor, diaphragm pressure gauge, air filter, manhole / hand hole, material delivery port, disposable sampler, pH probe, conductivity probe, tank temperature probe, and tank bottom valve. The preparation tanks should use weighing module, and the holding tanks should use differential pressure level gauge.The holding tank need not stirrer, and use differential pressure level gauge instead weighing module.质量Quality1.1.1.2.2.2.2对于200L~1000L配制罐，原辅料通过人孔人工加料。对于5000L以上的配制罐是通过IBC提升加料，罐体需要配合设置加料口，具体界面参见相关的工艺仪表流程图。For 200L~1000L preparation tanks, the raw material will be charged through manhole by manual. For 5,000L preparation tanks and above, the raw material will be charged through IBC, the tank should set a charge port. The interface refer to P&ID.质量Quality1.1.1.3.3.3.3系统供应商需提供5000L以上的配制罐加料口尺寸相对应的软连接，加料口尺寸建议为DN250，系统供应商需提供连接面的具体规格尺寸。The system supplier should provide the soft connection corresponding to the feeding port size of the topping tank above 5000L. The feeding port size is suggested to be DN250. The system supplier shall provide the specific specification and size of the connecting surface.商务Commence1.1.1.4.4.4.4配制罐需要带夹套控温单元，用于罐内液体温度控制。夹套形式由供应商提交业主审批确认。储存罐只预留夹套，不带控温单元。The preparation tanks shall be equipped with a jacket temperature control unit for liquid temperature control in the tank. The jacket form shall be submitted by the supplier to the owner for approval. Storage tanks only reserved jacket, without temperature control unit.质量Quality1.1.1.5.5.5.5爆破片的规格应与容器尺寸相适应，并配有信号反馈。Specification of rupture disk shall be suitable to vessel size and equipped with signal feedback.质量Quality1.1.1.6.6.6.6人孔盖应配制人孔助力器和有限位设施，方便开闭。且开闭不会对操作人员或设备造成损害。The cover of manhole should be equipped with a manhole booster and a limited bit facility to facilitate opening and closing. And the opening and closing will not cause damage to the operator or equipment.商业Business1.1.1.7.7.7.7培养基配制罐采用柱塞式罐底阀。补料罐使用隔膜式罐底阀。The media preparation tanks adopts plunger type tank bottom valve. The holding tank adopts a diaphragm tank bottom valve.1质量Quality1.1.1.8.8.8.8罐底阀的最低点和洁净室地面之间的距离至少为800mm。The distance between tank bottom lowest point and cleanroom floor shall be at least 800mm.商业Business1.1.1.9.9.9.9pH电极能够连续显示，具有在线校正功能，且带3点校准功能。能够启用/禁用温度补偿功能。PH electrode can be displayed continuously, with online correction function, and with 3 point calibration function. and can be capable to use or not to use temperature compensate function.质量Quality1.1.1.10.10.10.10电导率电极能够连续显示，能够启用/禁用温度补偿功能。The conductivity electrode can display continuously, and can be capable to use or not to use temperature compensate function.质量Quality1.1.1.11.11.11.11罐体温度探头应能够连续显示温度，采用套筒形式，可与罐体拆卸方便校验。The tank temperature probe shall be able to continuously display the temperature, sleeve form, which can be easily separated from the tank for calibration. 质量Quality1.1.1.12.12.12.12供应商需要结合搅拌桨叶的清洗要求设置喷淋球的位置和数量，罐体/管道清洁无死角。喷淋球为固定式，清洗压力在1.5~2 bar范围内。The system supplier shall set the position and number of spray balls according to the cleaning requirements of the stirring blades, and the tank / pipeline shall be clean without dead angle. The spray ball is fix-type. The clean pressure is within 1.5~2 bar.质量Quality1.1.1.13.13.13.13所有喷淋球和内伸管需要设置定位销。Spray balls and inlet pipe all require directional pins.质量Quality1.1.1.14.14.14.14用于进气/出气的0.22μm的呼吸器应与罐体一同进行CIP/SIP。A 0.22 μm filter for air in / out shall be CIP/SIP with the tank together.质量Quality1.1.1.15.15.15.15需要配制灭菌所需的装置，例如蒸汽疏水装置，温度传感器等。Instrument required for sterilization to be provided, example steam traps, temperature sensor etc..质量Quality6.4.4.2.2.2.搅拌Stirrer序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.14000L和10000L配制罐还需要配备机械搅拌器，200L和1000L配制罐及补料罐配制磁力搅拌器。搅拌桨形式由搅拌桨供应商设计，经业主审核后提供。The 4000L and 10000L preparation tanks should be equipped mechanically top stirred to achieve the stirring effect, the 200Land 1000L preparation tank and holding tanks should be equipped magnetic stirrer. The stirred type should be designed by stirred supplier, and approval by Client.质量Quality1.1.1.2.2.2.2机械搅拌可调速，可显示实际转速，同时CIP过程中100%覆盖，无清洁死角。The magnetic stirring and mechanical stirring can adjust the speed, display the actual speed, and have the self-cleaning function. It shall be covered 100% in CIP process without cleaning dead angle.质量Quality1.1.1.3.3.3.3搅拌器应易于拆卸，需配置至少一套拆装工具，且可以适用于不同型号搅拌器型号，可实现CIP和SIP，不会造成产品残留。The agitator should be easy to disassemble and equipped with at least one set of disassembly tools. It can be applied to different types of agitators and can realize CIP and SIP without causing product residue.质量Quality1.1.1.4.4.4.4搅拌器的位置应与人孔/手孔相匹配，方便后期维护将搅拌桨取出。The position of the stirrer shall match the manhole / handhole to facilitate the later maintenance and take out the stirrer.商业Business1.1.1.5.5.5.5桨叶清洗形式建议采用喷淋球清洗。It is recommended to use spray ball cleaning for the blade cleaning form.商业Business1.1.1.6.6.6.6供应商需要提供用于后期搅拌轴检修维护的吊装装置，比如轨道提升装置等，要求用于洁净室的吊装装置。The supplier needs to provide hoisting devices for later overhaul and maintenance of mixing shaft, such as track lifting devices, which are required to be used in clean rooms.商业Business6.4.4.3.3.3.吊装装置（用于不锈钢反应器搅拌器）Hoistingdevice(forstainlesssteelreactoragitator)序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1最大不锈钢反应器15000L的搅拌器的搅拌轴和搅拌桨叶总重量不小于1000kg。The total weight of the agitator shaft and impeller of the maximum stainless steel reactor of 15000L is not less than 1000kg.质量Quality1.1.1.2.2.2.2吊装装置用于后期搅拌轴检修维护的，比如轨道提升装置等，要求选用满足洁净室卫生要求的吊装装置。Hoisting device used for later overhaul and maintenance of stirring shaft, such as track lifting device, requires the selection of hoisting device that meets the hygiene requirements of clean room.质量Quality6.4.4.4.4.4.钢平台StainlessSteelPlatform序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1钢平台应符合人体工程学，方便操作人员投放物料、处理滤器等。The steel platform shall conform to the ergonomics, which is convenient for the operator to put materials and handle the filter, etc.商务Commerce1.1.1.2.2.2.2罐体钢平台底部需预留足够的空间用于维护。Sufficient space should be reserved at the bottom of the steel platform for process tank for maintenance.商务Commence1.1.1.3.3.3.3钢平台需在合适位置预留电源插座，供辅助设备使用。（如蠕动泵等）Power socket shall be reserved in proper position on the steel platform for auxiliary equipment. (such as peristaltic pump, etc.)商务Commence1.1.1.4.4.4.4钢平台应考虑对空间气流组织的影响，应安全、坚固、耐用。钢平台上表面/底面均应方便清洁，不得有死角。钢平台下表面用钢板封闭平整，接缝满焊。The steel platform shall consider the impact on the air distribution of the space, and shall be safe, solid and durable. The upper surface / bottom surface of the steel platform shall be easy to clean without dead angle.商业Business1.1.1.5.5.5.5不锈钢平台下方需要考虑300LX的照度。设置开关。Under the stainless steel platform, the minimum 300LX illumination is required. And it should set the switch.商务Commence1.1.1.6.6.6.6在设计上需要考虑EHS的要求，如坡度较陡（40°以上）的钢梯尽量避免使用。EHS should be considered in design, for example, the steep ladder shall avoid to be used.EHS1.1.1.7.7.7.7钢平台与设备模块，支架，管道没有空间上的干涉，人员在平台上行动操作没有阻碍。There is no space interference between the steel platform and the equipment modules, supports and pipes, and there is no obstacle for personnel to move and operate on the platform.商业Business6.4.4.5.5.5.蠕动泵Peristalticpump序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1对于小体积液体料液，配制罐共用蠕动泵来补入称重过的料液。供应商应考虑提供摆放蠕动泵和补料瓶的平台，以及就近的公用介质接口。For small volume liquid addition, preparation tank will be equipped with a shared peristaltic pump to transfer the liquid from bottles. The liquid materials will be pre-weighted. The supplier shall provide a platform with adequate space and utilities connection ports nearby for the peristaltic pumps and bottles.商业Business1.1.1.2.2.2.2蠕动泵流量需满足按照具体P&ID要求，需配置远程/就地控制功能，并支持Profibus-DP协议接入PCS系统，可实现蠕动泵的远程/就地切换、转速设定/实际值、启动/停止指令、运行状态反馈及故障等信号与PCS系统交互。The flow rate of peristaltic pump should meet the requirement of P&ID, and the remote/local control function should be configured. Profibus-DP protocol should be supported to access the PCS system, which can realize the remote/local switch of peristaltic pump, speed setting/actual value, start/stop command, running status feedback and fault signal interaction with PCS system.质量Quality1.1.1.3.3.3.3蠕动泵的流量精度要应小于或达到±1%。The flow accuracy of peristaltic pump should be less than or reach to ±1%.质量Quality6.4.4.6.6.6.过滤器Filter序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1为防止交叉污染，应为罐体提供滤芯材质为PTFE的0.22μm呼吸器，带适配电加热套。呼吸器具体尺寸见P&ID。To prevent cross contamination, 0.22 μm Gas filter in/out shall be provided for compounding vessel, and the filter material should be PTFE. The dimension of gas filter refer to P&ID.质量Quality1.1.1.2.2.2.2供应商每个过滤器需要配备符合工艺条件的滤芯以满足PQ之前（不包括PQ）的检测使用，直到验证通过为止。Each filter of supplier should be equipped with filter elements that meet the process conditions to meet the test use before PQ (excluding PQ) until verification is passed.商务Commerce1.1.1.3.3.3.3需要为罐体空气滤器配置CIP专用替换件，保证系统整体清洗效果。CIP special replacement parts for air filter are required to ensure the cleaning effect of the system.质量Quality1.1.1.4.4.4.4管道液体过滤器采用在线清洗的方式，需要配制专用的滤壳清洗喷淋球及相关设施。喷淋球的安装设计成可拆卸形式。The pipeline liquid filter is cleaned online, and special filter shell cleaning spray ball and related facilities need to be prepared. The spray ball is mounted in a detachable form.质量Quality1.1.1.5.5.5.5呼吸器和液体过滤器安装位置应便于维修拆卸和操作。对于过滤器滤壳拆装需要提供液压提升拆装设备。 The liquid filter and gas filter in/out should be installed in a position that is easy to service, remove and operate. For filter shell disassembly, hydraulic lifting equipment should be provided.商业Business1.1.1.6.6.6.6滤芯和滤壳之间的接口应采用Code 7-226型式。The interface between filter element and filter shell should be Code 7-226.质量Quality6.4.4.7.7.7.阀门、排水Valves/Draining序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1关键部位阀门需配置单反馈装置，使用感应式反馈装置，反馈装置需要配置LED灯。反馈装置和阀门应采用同一品牌。没有反馈装置的阀门需要配置可视化装置用于现场观察阀门状态。Valves at key parts shall be equipped with single feedback device, and it should use inductive feedback unit. The feedback device needs to be equipped with LED lights. Feedback device and valves should use the same brand. And the valves without feedback device need to be equipped with visualization device to observe the valve status on site.质量Quality1.1.1.2.2.2.2与物料和洁净介质接触的阀门采用隔膜阀，隔膜阀的安装角度须与隔膜阀供应商的要求一致，膜片材质应采用EPDM/PTFE复合膜片，材质符合FDA和NMPA的要求，附相关材质证书；Valves in contact with materials and clean utility are diaphragm valves. The installation angle of diaphragm valves should be in accordance with the requirements of valves suppliers. The diaphragm materials should be EPDM/PTFE composite diaphragm, the material should meet the requirements of FDA and NMPA, and the relevant material certificate should be attached.质量Quality1.1.1.3.3.3.3所有与物料和洁净介质接触的阀门须提供与阀体一一对应的材质证明。All valves in contact with materials and clean utility should be provided with material certification corresponding to the valve body.质量Quality1.1.1.4.4.4.4所有与物料、纯蒸汽或清洗用水接触的阀门采用锻造隔膜阀。Forged diaphragm valves should be equipped in contact with product, pure steam or cleaning water.质量Quality1.1.1.5.5.5.5纯蒸汽通过PID调节阀和压力传感器联锁实现调压的目的。工业蒸汽减压阀采用直接作用式减压阀。压缩空气减压阀采用有过滤减压功能。Pure steam through P&ID control valve and pressure sensor interlock to achieve the purpose of regulating pressure. The industrial steam pressure reducing valve uses the direct action type pressure reducing valve. The compressed air pressure reducing valve has the function of filtration and decompression.质量Quality1.1.1.6.6.6.6无菌取样阀门采用无菌取样袋的形式（5孔），选型为2mm取样针，供应商需要提供Holder 堵头，无菌取样袋不在供应商范围内。Aseptic device (5 holes) shall be used for all tank sampling, choose 2mm sampling needle. The vendor shall provide holder and cap, but the sampling bags are not in vendor's scope.商务Commerce1.1.1.7.7.7.7纯蒸汽疏水阀应使用的可自调节洁净型热静力平衡型疏水阀。需根据罐体积匹配合适的疏水量。疏水阀选用快装卡箍连接。Provide self-adjusting balanced thermostatic type steam trap designed for clean steam sanitary operation. Suitable water retention should be matched according to the tank volume. The type of trap is tri-clamp.质量Quality1.1.1.8.8.8.8模块内纯蒸汽总管末端需配备洁净型热静力平衡型疏水阀。The end of the pure steam main in the module shall be equipped with thermostatic type steam trap.质量Quality1.1.1.9.9.9.9每根排放总管应设置空气隔断。空气隔断的位置建议设置在模块内部，便于维护。Each discharge main should be provided with an air breaking. It is recommended that the air breaking should be installed inside the module for easy maintenance.质量Quality6.4.4.8.8.8.验证口PortforValidation序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1所有罐体侧面预留至少1个1.5” NA接口和1个2”的NA接口用于验证取样。At least one 1.5 " NA interface and one 2" NA interface for verification sampling on the side of all tanks.质量Quality1.1.1.2.2.2.2工艺系统清洗水排水口需安装取样阀；取样阀设置位置需便于操作，不易污染。Sampling valves should be installed in the water drain of Stainless steel Process System. The setting position of sampling valve shall be easy to operate and not easy to pollute.质量Quality1.1.1.3.3.3.3所有疏水管路温度探头前端就近预留TC接口（卡盘50.5mm），用于布置验证探头。供应商给出接口位置的建议。TC (50.5mm)interface shall be reserved nearby in front of temperature probes of all drain pipes for arrangement of verification probes. The supplier gives advice on the location of the interface.质量Quality6.4.4.9.9.9.仪表Instruments序号ID No.需求描述Requirement Description需求分类Requirement Category6.4.6.仪器仪表应提供由第三方校验机构出具的检验合格证。检验有效期需覆盖至PQ完成。Certificates for instruments issued by third-party verification agency shall be provided. The validity period of verification agency should be covered until PQ is completed.质量Quality6.4.6.温度传感器采用卫生型卡箍连接，与介质直接接触的部分采用316L材质，带4~20mA或RTD信号输出。若采用其他连接形式须经过业主同意。The sanitary tri-clamp connection is for the temperature sensor, and the part in direct contact with the medium is made of 316L, with 4-20mA signal output or RTD signal output. Any other connection forms shall be approved by the owner.质量Quality6.4.6.现场压力表采用卫生级隔膜式压力表，与介质直接接触的部分采用316L材质。油表油质选用食品级润滑油。The on-site pressure gauge adopts sanitary diaphragm pressure gauge, and the part directly contacting with the medium adopts 316L material. Food grade lubricating oil is selected as the oil quality. 质量Quality6.4.6.液位计：采用卫生级差压式液位计，与介质直接接触的部分采用316L材质，带4~20mA信号输出，带高低液位和密度输入、现场显示和“零点复位”功能。Liquid level gauge: sanitary differential pressure type liquid level gauge is used, 316L material is used for the part directly contacting with the medium, with 4 ~ 20mA signal output, high and low liquid level and density input, field display and "zero point reset" function.质量Quality6.4.6.5 液位计的测量结果应不受液体温度变化的影响。The measurement results of the liquid level gauge should not be affected by the change of liquid temperature.质量Quality6.4.6.pH探头：罐体采用N.A.连接形式，管道上采用卫生型连接（卡箍），应考虑CIP时，探头的取出和保护，并对探头孔密封，CIP无死角。PH probe: The tank use the N.A. connection form, the pipe use the sanitary connection (clamp). During CIP, the probe shall be taken out and protected, and the probe hole shall be sealed, and CIP shall have no dead angle.质量Quality6.4.6.电导率探头：罐体采用NA法兰接口形式，管道上采用卫生型连接（卡箍）。根据不同工艺要求选择相对应的电导率探头。Conductivity probe: The tank use the NA flange connection form, Sanitary connection (clamp). Select corresponding conductivity probe according to different process requirements.质量Quality6.4.6.每个疏水阀（除蒸汽供应管路前端疏水阀以外）上端均应配置温度探头（距离疏水阀至少300mm），用于监控和记录灭菌温度，最冷点的温度探头用于控制。The front of each steam trap (except the steam supply pipeline trap) should be equipped with a temperature probe (the distance to steam trap at least 300mm) for monitoring and recording the sterilization temperature, the cold point probe for control.质量Quality6.4.6.配制罐应采用称重传感器。重量变送器包括重量值的数字传输、并支持PCS系统远程清零、去皮、清除去皮等控制功能。The preparation tanks shall include load cells. The weight transmitter includes digital transmission of weight values, and supports remote zeroing, , clearing and peeling of PCS system质量Quality6.5.5.机械要求MechanicalRequirement6.5.5.1.1.1.材质及表面处理Material&SurfaceFinish序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1所有与产品和溶液接触的金属材质均应为不锈钢SS316L，内表面电抛光至粗糙度不大于0.4μm并钝化处理； All metal in contact with product or buffer shall be stainless steel SS 316L. The inner surface should be electropolished to a roughness of no more than 0.4 μm and passivated.质量Quality1.1.1.2.2.2.2所有不接触产品及所有介质的金属材质均应为不锈钢SS304材质（包括所有支腿、框架、外罩、取样口和钢平台等），表面无毛刺。All metal materials which is not touch the product and all media should be stainless steel SS304 (including all legs, frames, enclosures, sampling ports and steel platforms, etc.) without burrs on the surface.质量Quality1.1.1.3.3.3.3所有罐体外表面抛光处理，管件外表面应抛光，光滑无毛刺。外表面应抛光至粗糙度不大于1.0μm。The external surfaces of all tanks shall be polished and pipe fittings shall be smooth without burrs. The outer surface should be polished to a roughness of no more than 1.0 μm.商业Business1.1.1.4.4.4.4设备外表面应易于清洁。不允许出现尖角、锐边、突出物等导致设备难以清洁或清洁用具破损的异常状况。Equipment external surface shall be easy to clean. No sharp corners, sharp edges or protrusions are allowed, which leads to some abnormal situation, such as difficult to thoroughly clean or easy to break the cleaning tools.商业Business1.1.1.5.5.5.5与产品接触的非金属材质（如软管、波纹管、垫圈）表面应符合FDA和NMPA的要求，并提供材质证明（FDA或USP ClassVI）。Non-metal surfaces in contact with product (e.g. hoses, bellows, gaskets) have to be FDA and NMPA and compliant such as PTFE/PUR, etc.质量Quality1.1.1.6.6.6.6与产品接触或洁净室内的表面不允许进行表面喷涂（电机外壳除外）。There shall be no painted surfaces local to product or in cleanroom (except motor housing).质量Quality1.1.1.7.7.7.7所有设备与产品接触的不锈钢原材料均须追溯至炉批号。Raw material traceability must be maintained for all materials of construction used to manufacture the equipment.质量Quality1.1.1.8.8.8.8制造材料不得释放颗粒物（不脱落、无添加、不反应、不会因清洗或湿热灭菌而降解）。Materials of construction shall not release particles. (MOC’s shall be non-shedding, non-additive, non-reactive and will not degrade due to cleaning or autoclaving).质量Quality1.1.1.9.9.9.9所有需高温灭菌的设备/部件材质应能够耐受135℃高温，持续时间至少30分钟。All equipment/components requiring high temperature sterilization should be material to withstand temperatures up to 135°C for at least 30 minutes.质量Quality1.1.1.10.10.10.10洁净室内设备/部件的外表面应能经受消毒剂。The surface of non-product contact parts shall be resistant to the sanitizing agents:- 30%的双氧水 30% H2O2- 70%酒精 70% alcohol- 4.5%的过氧乙酸4.5% peracetic acid- 杀孢子剂 Sporicide- 甲醛 Formaldehyde- 异丙醇 IPA商业Business1.1.1.11.11.11.11所有运动部件均应经过润滑。有润滑的设备需保证润滑剂不会泄漏到工艺系统和公用工程中也不会泄漏到洁净室环境中。All moving parts shall be lubricated. The design of the lubrication equipment shall ensure that the lubricant cannot leak into the process, direct utilities or into the cGMP area.商业Business1.1.1.12.12.12.12如使用润滑剂，应使用易于清洗的食品级润滑剂。供应商应提供所有润滑剂的相关证明文件。Food grade lubricants that are easy to clean using WFI, shall be used for all locations where mechanical failure of lubricant seals would allow the lubricant to leak into areas where it may come into contact with the vials. The Vendor shall provide supporting documentation for each lubricant.质量Quality6.5.5.2.2.2.保温Insulation序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1保温材料不得含有氯离子和石棉。The insulation should be made of high quality insulation material (not including chloride ion and asbestos).商业Business1.1.1.2.2.2.2操作员易接触到的设备/部件外表面温度在任何时候都应低于45°C，并且不能表面结霜滴水（特殊位置，如疏水阀以上500mm和罐顶等，除外）。The external surface temperature of the equipment/parts accessible to the operator should be less than 45°C at all times and no frosting and dripping (except in special locations such as 500mm above the trap and tank roof).商务Commerce6.5.5.3.3.3.焊接要求Welding序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1所有洁净管路应尽可能采用符合现行ASME BPE要求的自动焊接。All clean tubing will be orbital welded as per requirement of current ASME BPE.质量Quality1.1.1.2.2.2.2所有的人工焊接，包括焊工和焊接信息均应记录在供应商焊接记录中。All manual welding, including welder and welding information, should be recorded in the supplier's welding record.质量Quality1.1.1.3.3.3.3所有焊缝均应正确标识，标识号应刻印在管道上且与文件中的记录保持一致。All weld beams shall be correctly tagged and tag number shall be permanently marked on pipe in correspondence with that in documents.质量Quality1.1.1.4.4.4.4供应商应根据交付文件列表中的要求交付焊接相关文件。Supplier shall deliver the welding documents according to the requirements of the delivery documents list.质量Quality1.1.1.5.5.5.5洁净管道需充氩保护焊接，避免内部氧化，接用惰性保护气体纯度必须达到99.999%，需要提供正式的报告。Hygienic pipes need to be filled with argon protection welding to avoid internal oxidation, and the purity of the inert shielding gas used must reach 99.999%, and an official report needs to be provided.质量Quality1.1.1.6.6.6.6自动焊接和手动焊接都必需提供焊接工艺评定。WPS must be provided for both automatic and manual welding.质量Quality1.1.1.7.7.7.7焊样留取的要求：(1)焊样应保留原色，不得处理。(2)在更换参数时必需提供焊样。（管道尺寸或焊接参数）(3)焊样必需是对焊，不得假焊。(4)焊样的记录必需递交，并对每个焊样进行编号。焊样应作为竣工资料的一部分保存备查，不得丢弃。Requirements for the retention of weld samples.(1) The weld sample shall be retained in its original color and shall not be processed.(2) Weld samples must be provided when changing parameters. (pipe size or welding parameters)(3) welding samples must be butt weld, no false welding.(4) Records of weld samples must be submitted and each weld sample must be numbered.Weld samples shall be kept as part of the as-built data and shall not be discarded.质量Quality1.1.1.8.8.8.8内窥镜摄像要求：(1)须为实时彩色摄像片段，提供照片，且必需刻制成光盘。(2)必须显示完整的焊道。(3)必须可以看到氧化区的颜色。Borescope video requirements.(1) Must be a live color video clip, supply photos and must be burned to CD.(2) The complete weld path must be visible.(3) The color of the oxide area must be visible.质量Quality1.1.1.9.9.9.9焊点验收：(1)所有焊接质量应至少应达氧含量小于100 ppm，目测内表面显淡黄色。(2)所有手动氩弧焊必需100%做彩色内窥镜检测，并留有记录。(3)所有自动氩弧焊，最少随机抽取焊缝总量的20%要做彩色内窥镜摄影，并留有记录。(4)焊接标准应参照现行版ASME BPE的标准。焊接位置应该在焊接图上有文件记录可以追溯到焊缝施工人员，焊接记录上要有焊接两侧的材料的炉号。Welded joint acceptance:(1) All welding quality should be at least up to oxygen content less than 100 ppm, visual inspection of the inner surface shows light yellow.(2) All manual argon arc welding must do 100% color borescope inspection and keep records.(3) All automatic argon arc welding, at least 20% of the total number of randomly selected welds to do color borescope video, and keep records.(4) Welding standards should refer to the current version of the ASME BPE standards.Welding position should be documented on the welding diagram and can be traced back to the welder, welding log should indicate the heat number of the material on both sides of the weld.质量Quality6.6.6.自控系统-硬件部分Controlsystem-Hardware6.6.6.1.1.1.通用General序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1PCS系统服务器、工程师站、批量服务器、历史服务器、杀毒服务器、OPC服务器等功能站、系统网络交换机及控制器、AI、AO卡件不包含在系统供应商合同范围内。The PCS system server, engineer station, batch server, history server, antivirus server, OPC server and other functional stations, system network switches and controllers, AI, AO cards are not included in the contract scope of this system vender.商务Commerce1.1.1.2.2.2.2以下上游不锈钢配储液系统的电气元器件需支持Profibus-DP协议或经甲方许可的通讯协议总线：The following stainless steel system electrical components shall support Profibus-DP protocol or communication protocol bus approved by Owner:-称重仪表；Weighting system;-阀岛模块；Valve island module; 商务Commerce1.1.1.3.3.3.3pH、电导率等电极的仪表变送器需支持带hart协议的4~20mA信号输出.The instrument transmitter with pH, conductivity and other electrodes should support 4~20mA signal output with hart protocol.商务Commerce1.1.1.4.4.4.4系统模块上或系统所在房间需安装声光报警灯，报警灯至少包括3种颜色显示。The audible and visual alarm shall be install on stainless steel system module or in process room where the stainless steel system is located. The alarm lights shall have three colors at least.商业Business6.6.6.2.2.2.远程IO柜及仪表RemoteIOCabinetandinstruments序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1上游不锈钢配储液系统的供应商需配置远程IO控制柜，用于集成和安装系统远程IO模块、阀岛、仪表、开关电源等电气元件。远程IO柜需安装在不锈钢模块上。The UP SS preparation & holding system supplier shall provide remote IO control cabinet to integrate and install the system remote IO module, valve island, instrument, power supply and required electrical components.商务Commerce1.1.1.2.2.2.2远程IO柜材质采用SS304不锈钢。The remote IO cabinet shall be ss304 stainless steel.商业Business1.1.1.3.3.3.3远程IO柜需配置远程IO模块。远程IO模块支持Profibus-DP协议总线或经甲方许可的通讯协议总线，用于集成上游不锈钢配储液系统所有阀门反馈DI信号，DI卡件需预留10%的备用通道。The remote IO cabinet shall install remote IO module which shall support Profibus-DP protocol bus or communication protocol bus approved by Owner. The remote IO module will be used to integrate all valve feedback DI signals of the stainless steel system. The remote IO module shall reserve 10% spare channels for DI signals respectively.商业 Business1.1.1.4.4.4.4远程IO柜需配置单层信号端子用于4-20mA信号线缆接线，4~20mA模拟量传感器及仪表需支持HART协议。The remote IO cabinet shall install single-layer terminal which is used for connecting 4-20mA signal cable, HART protocol shall be supported for 4~20mA analog sensor and instrument.商业 Business1.1.1.5.5.5.5远程IO柜需配置阀岛，采用Profibus-DP通讯协议与PCS通讯。每个远程IO柜中阀岛需预留10%的电磁阀片备用量。The remote IO cabinet shall install Valve Island which will communicate with PCS via Profibus-DP protocol. The valve island shall reserve 10% spare valve blocks in each remote IO cabinet.商业Business1.1.1.6.6.6.6远程IO柜需配置磁力搅拌转速信号转换器，转速信号采用4-20mA信号类型接入PCS系统监测磁力搅拌器实际转速。The remote IO cabinet shall install magnetic stirring speed signal converter. The speed signal, which is 4-20 mA signal, shall be connect to PCS for monitoring the actual speed.商业 Business1.1.1.7.7.7.7远程IO柜需配置冗余24VDC开关电源。开关电源报警信号需接入PCS。The remote I/O cabinet shall be equipped with redundant 24VDC power supply. The alarm of 24VDC power supply shall be connected to PCS.质量Quality1.1.1.8.8.8.8远程IO柜需配置仪表屏蔽层接线铜条，该铜条需与机柜绝缘。The remote IO cabinet shall be equipped with shield bar for instrument wiring, the shield bar shall be insulated from the cabinet.质量Quality1.1.1.9.9.9.9远程IO柜需配置就地急停旋钮和安全继电器。The remote I/O cabinet must be equipped with local emergency stop and safety relay.安全EHS1.1.1.10.10.10.10远程IO柜需配置过滤减压阀，用以过滤及调节压缩空气。并将压力低报警信号需接入PCS。The remote I/O cabinet shall be equipped with filter relief-pressure valve to filtrate the compressed air and adjust the pressure of compressed air. The pressure low alarm shall be connected to PCS.质量Quality1.1.1.11.11.11.11传感器及变送器由不锈钢工艺系统供应商负责安装。The installation and wiring of sensor, instrument and transmitter shall be done by stainless steel system supplier.商务Commerce1.1.1.12.12.12.12需在合同签署后1个月，提供仪表及变送器信号分配表（I/O 清单）。Instrument and transmitter signal distribution form shall be provided one month after signing the contract (I/O list).商务Commerce1.1.1.13.13.13.13IO柜接线与接管的工作应尽可能在系统供应商工厂内完成，系统供应商应根据模块设计设置IO柜数量。IO cabinet wiring and take-over should be completed in the factory of the system supplier as far as possible. The system supplier should set the number of IO cabinets according to the module design.商务Commerce1.1.1.14.14.14.14远程IO柜与外部设备及系统连接的气管及线缆均需采用下进线方式。The gas pipes and cables must be underwired for the remote I/O cabinet to external devices and system.商务Commerce6.6.6.3.3.3.马达控制中心（Motorcontrolcenter,MCC）序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1MCC柜不在此次招标范围内，由整厂PCS系统供应商供货。MCC cabinet is not included in the bidding scope and is supplied by PCS system supplier.商务Commerce1.1.1.2.2.2.2上游不锈钢配储液系统供应商需提供系统中的电机的详细电气参数。系统供应商需配合完成变频器参数设置。The supplier of system shall provide detailed electrical parameters of the motor used in the process equipment. The vender should cooperate to complete the parameter setting of frequency converter.商务Commerce1.1.1.3.3.3.3上游不锈钢配储液系统供应商需设计和安装电机紧急停止，远程/就地切换按钮、运行和故障状态指示灯。The supplier of Stainless steel preparation & holding tanks system shall design and install the motor emergency stop, remote/local switch button, run and fault status indicator lamp.商业Business6.6.6.4.4.4.现场操作员站Fieldoperatorstation序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1现场操作员站HMI将采用悬臂或立柱式安装于模块上，不锈钢供应商需设计HMI的安装位置并安装悬臂或立柱，并在模块上预留安装接口。The onsite operator station HMI, which will be mounted via cantilever or vertical column, to be installed on the stainless steel system module. The stainless steel system supplier shall design the installation location of HMI and reserve the installation interface on the stainless steel system module.商务Commerce1.1.1.2.2.2.2现场操作员站HMI及其悬臂或立柱不在此次招标范围内。现场操作员站的HMI及悬臂或立柱由PCS系统供应商设计、供货。The onsite operator station HMI and its cantilever and column is not included in the bidding scope of stainless steel system supplier. And the onsite operator station is designed, supplied and installed by the PCS system supplier.商务Commerce6.6.6.5.5.5.电缆和接线Cablesandwiring序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1.1.1模块内电缆桥架设计及安装由系统供应商完成。罐体和模块应配有合理的管槽用于电缆走线，管槽应美观、坚固。罐体和模块适当位置需有用于固定电缆/电线的支架。电缆的铺设由供应商负责。Tanks and modules shall be equipped with reasonable wire casing for cable routing, and the wire casing shall be beautiful and solid. Tanks and modules shall be provided with brackets for fixing cables / wires in place. The design and installation of cable tray in the module shall be completed by the stainless steel system supplier.商务Commerce1.1.1.2.2.2.2系统至PCS控制系统主桥架的辅助桥架或线缆管，由不锈钢配储液系统供应商负责设计及安装。The cable tray or cable pipe from stainless steel system to PCS main cable tray shall be designed and install by supplier.商务Commerce1.1.1.3.3.3.3系统内部电源、仪表、阀门反馈、各类传感器至远程IO柜内线缆由系统供应商提供并完成接线。The cabling and wiring from power supply, instrument, valve feedback and other device within stainless steel system module to remote IO cabinet shall be done by stainless steel system supplier.商务Commerce1.1.1.4.4.4.4系统内所有的信号电缆要求为阻燃屏蔽或以上线缆，4~20mA线径≥1.0 mm2。The signal cable within system shall be anti-flaming and shield cable, the cable diameter shall be more than 1.0 mm2.商业Business1.1.1.5.5.5.5系统内的Profibus-DP链路线缆敷设、接线由系统供应商完成。所有采用Profibus-DP的电气元件必须支持DP V0协议，必须与甲供PCS系统兼容。系统供应商需提供DP通讯设备的GSD文件及数据交互表。The system supplier shall be in charge of cabling and wiring of Profibus-DP segment within stainless steel system. All Profibus-DP device must support DP V0 protocol and must be compatible with the PCS, and supplier shall provide the GSD files and data exchange list. 商务Commerce1.1.1.6.6.6.6系统供应商需为其提供Profibus-DP设备配备Profibus-DP通讯接头，该通讯接头具备ON/OFF选择终端电阻的功能。The system supplier shall provide the Poribus-DP connecter for Porfibus DP device, the DP comment shall have terminal resistance ON/OFF switch.商业Business1.1.1.7.7.7.7远程IO柜至PCS的信号线缆及网线由PCS供应商提供，本系统侧信号接线和线缆连接由系统供应商负责完成。The signal cable and network cable from PCS cabinet to remote IO cabinet shall be provided by PCS supplier. The cable wiring on this system side shall be done by system supplier.商务Commerce1.1.1.8.8.8.8远程IO柜及上游不锈钢配储液模块至接地箱之间的接地线缆，由系统供应商提供和敷设。The grounding cable from remote IO cabinet and system to grounding box shall be laid and wired by system supplier.商务Commerce1.1.1.9.9.9.9远程IO柜、仪表接线箱等柜内及接线端子电缆线号标识清晰。The cable numbers in the valve terminal cabinet, instrument junction box and terminal block shall be clearly marked.商务Commerce1.1.1.10.10.10.10上游不锈钢配储液供应商应提供上游不锈钢配储液模块系统信号接线图，并配合完成系统至PCS的信号接线图。The system supplier shall provide the wiring diagram of system, and support to design wiring diagram of wiring from the system to PCS.商务Commerce1.1.1.11.11.11.11MCC柜到上游配储液系统及其辅助设备电机电缆由PCS供应商提供，PCS供应商完成MCC柜侧接线，系统供应商完成上游配储液系统设备侧接线。The cable of motor from MCC cable to US preparation and holding system shall be provided by PCS supplier, the PCS supplier shall be responsible for wiring the motor cables on MCC cabinet side and the system supplier shall be responsible for wiring the motor cable on motor side.商务Commerce1.1.1.12.12.12.12每一根电缆需配置电缆标签，模块内电缆标签由上游配储液系统供应商提供，与PCS系统连接电缆标签由PCS供应商提供，电缆标签规则需协商一致。Each cable shall be equipped with cable label. The label of the cable in the module shall be provided by the system supplier. The label of the cable connected with the PCS system shall be provided by the PCS supplier. The cable label rules shall be agreed by consensus.质量Quality1.1.1.13.13.13.13上游配储液模块与PCS控制系统联合FAT调试期间的临时线缆由上游配储液模块供应商提供，并负责完成PCS控制系统侧接线和测试后线缆的拆除工作。联合测试期间的线缆走线需采用桥架或穿线管，线缆不可以直接敷设在地面上。The cable used for integrated test shall be provided by system supplier, and the cable connection and disconnection on PCS side shall be done by system supplier as well. The cable shall be laid within cable tray or cable pipe, it is not allowed to lay cable on the ground directly.商务Commerce1.1.1.14.14.14.14上游配储液系统供应商需为联合FAT期间的PCS系统提供UPS电源，并确保PCS系统在联合测试期间的环境满足如下需求：The US preparation & holding system supplier shall provide the UPS for the PCS during integrated FAT, and ensure the environment for PCS system as follow:-温度在10-35℃之间；Temperature within 10-35℃-湿度在20-80%之间；Humidity within 20-80%; 商务Commerce6.7.7.安全要求SafetyRequirement序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1设备、钢平台、标识和铭牌等任何部位不应有锋利的边缘和尖角。There shall be no sharp edge and sharp angle at any part of equipment, steel platform, logo, nameplate, etc.安全EHS1.1.2.2.2所有设备应满足在最大负荷和运行速度的情况下，距设备任何方向1m处的噪音不超过80dBA。All equipment shall conform to peak noise of 80 dBA measured at 1 meter in any direction from the equipment when operating at all maximum loads and speeds.安全EHS1.1.3.3.3设备的安全阀、爆破片的出口管应导向地面，防止喷溅到人员。The outlet pipe of the safety valves and the rupture discs of the equipment should be directed to the ground to prevent splashing to the personnel.安全EHS1.1.4.4.4供应商应在冷、热或高压工况管道，以及超重设备/部件的周边设置明显的标识和保护措施。The supplier shall provide evident identification and protection measures in the vicinity of the cold, hot or high pressure utility pipeline and superheavy equipment/components.安全EHS1.1.5.5.5设备框架和钢平台需充分考虑人员的安全防护（如护栏、台阶宽度和防滑）。The safety protection of personnel should be fully considered in the design of system frame and steel platform. (e.g. Guardrails, wide steps and anti-skidding)安全EHS1.1.6.6.6热点周边应有标识和保护措施。Hot spots access shall be signaled and protected.安全EHS1.1.7.7.7系统供应商应负责设备模块和建筑接地装置的接线工作。The system supplier should be responsible for the wiring of equipment modules and building grounding devices.安全EHS6.8.8.验证要求ValidationRequirement序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1供应商应提供一份质量计划，由业主审核批准。The supplier shall develop a Quality Plan for owner’s review and approval.商务Commerce1.1.2.2.2供应商需要完成的质量工作须包括，但不限于：The quality work required by the supplier shall include, but not limited to:-验证计划 Verification Plan-风险评估 Risk assessment-设计确认 DQ-预FAT(工厂内部测试) Pre-FAT(VIT)-工厂验收测试 FAT-现场验收测试 SAT-调试 Commissioning-安装/运行确认 I/OQ -协助性能确认 PQ assistance商务Commerce1.1.3.3.3DQ工作应在设备开始制造前完成，避免DQ结果对设备制造过程造成影响。It is recommended to complete DQ before equipment manufacturing to avoid DQ results affecting equipment manufacturing process.商务Commerce1.1.4.4.4在进行正式的工厂验收测试之前，供应商必须完成以下测试项目。测试项目的相关文件需在FAT时可以查阅。Prior to the performance of the main Factory Acceptance test, the supplier must complete the items listed below. Documentation of these activities will be available for review at the FAT.-100%图纸检查(机械和电气) 100% Drawings checks (Mechanical & Electrical)-PID一致性检查 P&ID compliance check-布局图一致性检查 GA compliance check -制造材质确认 Material of construction verification.-100%表面抛光度确认100% Surface finish verification -坡度确认 Slope verification.-电气检查，包括接线、终端等 Electrical verification including wiring, terminations etc.-绝缘检查 Insulation inspection-控制面板检查、设备盘点及实物检查 Control panel visual inspection, equipment inventory & physical checks-标签标牌检查 All items tagged and labelled as per specification-100%文件检查 Documentation check; all documents-容器、管道压力测试 Pneumatic/vacuum testing of vessels & pipe works.商务Commerce1.1.5.5.5出厂前系统供应商需与PCS系统供应商配合完成联合FAT，所有的设备须接受工厂验收测试（FAT）确认。Before delivery, system supplier shall cooperate with PCS system supplier to complete joint FAT, and all equipment shall be subject to factory acceptance test (FAT).商务Commerce1.1.6.6.6FAT方案由系统供应商和PCS系统供应商共同起草并在FAT执行前由业主批准。联合FAT测试将在系统供应商工厂进行，业主将见证所有的测试执行。Fat protocol shall be drafted jointly by system supplier and PCS system supplier and approved by the owner before FAT execution. The joint FAT will be carried out at the system supplier's factory, and the owner will witness the execution of all tests.商务Commerce1.1.7.7.7只有在所有FAT文件经业主验收关闭后设备方可打包运输以交付。The system will only be released for delivery when all FAT documents are closed out by the owner商务Commerce1.1.8.8.8在FAT期间，须编制故障日志以及偏差/备注日志，记录每天FAT中发现的问题。During FAT, the fault log and deviation/comment log should be compiled to record the problems found in FAT every day.商务Commerce1.1.9.9.9在FAT前，供应商应对温度、压力和流量仪表进行校准。Primary calibration will be carried out by the Vendor, prior to FAT, on temperature, pressure and flow instruments.商务Commerce1.1.10.10.10FAT测试应包括，但不限于：The FAT tests shall include, but not be limited to, the following tests:- 设备尺寸检查Dimensional Check- 与房顶/墙壁/地面的界面检查Interface with Ceiling / Walls / Floor- 公用工程连接位置检查 Utilities Connection Location x, y and z- PID检查 P&ID Check- 核黄素和全排放测试Riboflavin and Full Discharge Test- 坡度检查 Slopes- 排水检查 Drainability- 组件安装及方向检查 Component installation and orientation Check- 仪器仪表安装检查 Instrument Installation- 保温检查 Insulation inspection- 标签检查 Labeling inspection- 材质证书检查 Material Certificates- 焊接检查 Welding Certificates- 100%内窥镜检查 100%Endoscope Welding Shots- 焊工资质检查 Welders Certification- 压力容器报告检查 Pressure Vessel Certificates- 压力测试报告检查 Pressure Test Reports- 管道清洁报告检查 Welding and Piping Cleaning Reports- 管道钝化报告检查 Welding and Piping Passivation Reports商务Commerce1.1.11.11.11工厂验收测试的内容应在现场验收测试中重复执行，但根据项目质量计划和验证计划中关于测试引用的描述，部分的测试可以引用FAT的结果或进行抽样检查。In general FAT tests shall be repeated in SAT. According to the description of test references in Project Quality Plan and Validation Plan, part of the tests can refer to the results of FAT or be confirmed by spot check.商务Commerce1.1.12.12.12SAT的方案由供应商起草，业主审核批准。Protocols for the site acceptance test (SAT) shall be produced by the Vendor and approved by Owner.商务Commerce1.1.13.13.13IQ方案由供应商起草并在IQ执行前由业主批准。IQ测试将在业主现场进行，业主将见证所有的测试执行。IQ protocols are to be prepared by the supplier and approved by owner prior to the IQ. The supplier shall execute tests on the owner’s site and owner will witness all the tests.商务Commerce1.1.14.14.14OQ方案由供应商起草，必要时方案中应包含程序运行时的功能检查，最终OQ方案由业主审核批准。OQ protocol should be drafted by the supplier. If necessary, the plan shall include the functional inspection during the operation of the program. The final OQ protocol should be reviewed an approved by Client.商务Commerce1.1.15.15.15系统供应商应与自控系统供应商积极配合，共同完成设备运行/系统功能方面的测试，业主将见证所有的测试执行。The stainless steel system supplier shall actively cooperate with the automatic control system supplier to complete the equipment operation / system function test together, and the owner will witness the implementation of all tests.商务Commerce1.1.16.16.16供应商需协助业主进行PQ方案的起草和执行。The supplier shall assist the owner in the drafting and implementation of PQ scheme.商务Commerce1.1.17.17.17调试阶段包括校准、回路调整和确保设备运行满足需求说明的所有调整。The commissioning stage shall include calibration, loop tuning and all other adjustments required to ensure the equipment performs as specified in the Requisition.商务Commerce1.1.18.18.18供应商应对整个调试阶段负责，包括配合现场施工团队。供应商应估计完成调试所需的天数，并给出每日工作安排。The supplier shall be responsible for the entire commissioning phase, including cooperation with the site construction team. Vendor shall estimate the number of days required to complete the commissioning and quote a daily rate for Site attendance.商务Commerce1.1.19.19.19供应商应配备足够的备件和材料以确保调试过程能够顺利完成。调试用的备件和材料应与设备一同运至业主现场。The Vendor shall include for adequate spares and materials to ensure that the commissioning process can be successfully carried out. These shall be delivered to Site in the same shipment as the equipment.商务Commerce6.9.9.培训要求Training序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1供应商负责所有技术指导和人员培训，包括：图纸、工艺、操作、设备维护、设备性能及问题解答等。Supplier is responsible for all technical guidance and personnel training, including drawings, processes, operations, equipment maintenance, equipment performance and problem solving.商务Commerce1.1.2.2.2供应商应给出培训计划，并在计划内明确培训内容和时长。The supplier should provide the training plan, and specify the training content and duration in the plan.商务Commerce1.1.3.3.3提供每台设备不少于10个名额的培训，培训内容应包括设备基本原理和操作技能培训，应确保培训的系统全面。The provision of not less than 10 training places for each equipment should include training in basic principles and operational skills of the equipment, and ensure that the training system is comprehensive.商务Commerce6.10.10.维护保养Maintenance序号ID No.需求描述Requirement Description需求分类Requirement Category1.1.1.1.1设备所有部件必须便于维护、维修和清洗。供应商应提供常规维护中必须拆卸部分的吊装点。供应商应告知设备维护中哪些部分需要提吊。 All parts of the equipment must be readily accessible for maintenance, servicing and cleaning. The Vendor shall provide lifting points for equipment that must be removed for routine maintenance. The Vendor shall advise where lifting aids are required to maintain equipment.商务Commerce1.1.2.2.2设备周围应留有足够的维护空间，开门
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