配液系统技术交流表

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1、JW-SMP-IR-001-01生产工艺信息InformationRequest药液属性Propertyofproduct粉针PowderInjection水针liquidinjections有色Colored无色Colorless有毒Poisonous无毒Non-poisonous澄清液ClarifiedLiquid混悬液Suspension化学药品Chemicals生物药品Bio-product生产批次BatchNumber药液黏度Liquidviscosity搅拌时是否容易起泡Somebubblewhenmixing与不锈钢是否反应Reactwithstainlesss

2、teel是否怕氧化、怕光Oxidizableorlightsensitivity是否易燃易爆、易挥发FlammableorvolatilePage:8of8JW-SMP-IR-001-01详细的药液配制工艺DetailedSolutionpreparationprocess详细的平面布局图Layoutdrawingdetails配液间（长×宽×高）mixingroom(L×W×H)灌装间回风口的尺寸以及位置（管路设计避开）Thesizeandpositionofairreturninfillerroom(pipelineshouldavoid)灌装机分配器（缓冲罐）高度Hei

3、ghtofbuffertankinfiller配液至灌装管路走向Thepipelinearrangementfrommixingroomtofillingroom走技术夹层Throughdusk直接穿墙进入灌装间Throughthewall配液至灌装管路CIP/SIP排口Theoutlet(CIP/SIP)frommixingroomtofillingroom回流至配液间Back-flowtomixingroom洗瓶间/胶塞清洗间Vialwashingroom/rubberwashingroom配液系统的详细配置DetailedConfigurationofTankSolut

4、ionPreparation罐体Tank浓配罐TankA1:concentrated稀配罐TankA2:Diluted储液罐A3Tank3:Storage储液罐A4Tank4:Storage罐体形式TankStructure夹套Jacket保温层InsulationlayerPage:8of8JW-SMP-IR-001-01外表面镜面抛光/亚光Externalsurfacemirror/satinpolishing配液量WorkingVolume最大配液量Maximumworkingvolume最小配液量Minimumworkingvolume投料方式FeedingMode人

5、工手孔投料Manualfeedinghole真空上料Vacuumfeeding其它方式OthersfeedingWFI温度WFITemperature直接80度配液Solutionpreparationis80deg.c冷却后进罐配液AftercoolingWFI,andthen,flowingtotanksolutionpreparation进罐后冷却配液WFIflowingtotankcooling,andthen,solutionpreparation药液输送LiquidTransfer无菌空气压送Throughasepticair氮气压送Throughnitrogen

6、泵输送Throughthepump预过滤Pre-filtration是否有钛棒过滤TitaniumstickfilterPage:8of8JW-SMP-IR-001-01钛棒回流Back-flow回流泵形式Back-flowpump活性炭用量Dosageofactivecarbon预过滤为多少Filteraperture预过滤尺寸Filtersize温度控制TemperateControl恒温范围Therangeofconstanttemperature降温时间Temperaturefalldowntime温控精度Precisionoftemperaturecontrol热交

7、换器HeatExchangerWFI水系统提供WFIsystemsupply配液系统提供Solutionpreparationsystemsupply夹套工艺介质MediainJacket冷冻水(7︒C)Chilledwater:7deg.c冷冻水(0︒C)Chilledwater:0deg.c乙二醇(-10︒C)ethyleneglycolEthyleneglycol:-10deg.c饮用水CitywaterPage:8of8JW-SMP-IR-001-01工艺热水Planthotwater工业蒸汽P