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1、生产工艺信息Information Request药液属性Property of product粉针Powder Injection水针 liquid injections有色 Colored无色 Colorless有毒Poisonous无毒 Non-poisonous澄清液 Clarified Liquid混悬液Suspension化学药品 Chemicals生物药品Bio-product生产批次 Batch Number药液黏度Liquid viscosity搅拌时是否容易起泡Some bubble when mixing与不锈钢是否反应React with stainless steel
2、是否怕氧化、怕光Oxidizable or light sensitivity是否易燃易爆、易挥发 Flammable or volatile详细的药液配制工艺Detailed Solution preparation process详细的平面布局图Layout drawing details配液间（长宽高）mixing room (LWH)灌装间回风口的尺寸以及位置（管路设计避开）The size and position of air return in filler room(pipeline should avoid)灌装机分配器（缓冲罐）高度 Height of buffer tan
3、k in filler配液至灌装管路走向 The pipeline arrangement from mixing room to filling room走技术夹层 Through dusk直接穿墙进入灌装间 Through the wall配液至灌装管路CIP/SIP排口 The outlet(CIP/SIP) from mixing room to filling room回流至配液间Back-flow to mixing room洗瓶间/胶塞清洗间Vial washing room /rubber washing room配液系统的详细配置 Detailed Configuration
4、 of Tank Solution Preparation罐体Tank浓配罐Tank A1: concentrated稀配罐Tank A2: Diluted储液罐A3 Tank3: Storage储液罐A4Tank4: Storage罐体形式Tank Structure夹套 Jacket保温层Insulation layer外表面镜面抛光/亚光External surface mirror/satin polishing配液量Working Volume最大配液量Maximum working volume最小配液量Minimum working volume投料方式Feeding Mode人
5、工手孔投料 Manual feeding hole真空上料 Vacuum feeding其它方式 Others feedingWFI温度WFI Temperature直接80度配液Solution preparation is 80deg.c冷却后进罐配液After cooling WFI, and then, flowing to tank solution preparation进罐后冷却配液WFI flowing to tank cooling, and then, solution preparation药液输送Liquid Transfer无菌空气压送 Through aseptic
6、 air氮气压送Through nitrogen泵输送Through the pump预过滤Pre-filtration是否有钛棒过滤Titanium stick filter钛棒回流Back-flow回流泵形式Back-flow pump活性炭用量Dosage of active carbon预过滤为多少Filter aperture预过滤尺寸Filter size温度控制Temperate Control恒温范围The range of constant temperature降温时间Temperature fall down time温控精度Precision of temperatur
7、e control热交换器Heat ExchangerWFI水系统提供WFI system supply配液系统提供Solution preparation system supply夹套工艺介质Media in Jacket冷冻水(7C)Chilled water: 7deg.c冷冻水(0C)Chilled water: 0deg.c乙二醇(-10C) ethylene glycolEthylene glycol: -10deg.c饮用水City water工艺热水Plant hot water工业蒸汽Plant steamPH值检测方式PH Control在线On-line取样离线Off-
8、line取样方式Sampling Method无菌/有菌 aseptic/non-aseptic单次/多次Single/multiply times侧取样/底取样Side /bottom sampling配液计量Metering Method称重方式/品牌 Weighting/brand液位计方式/品牌Liquid level sensor/brand搅拌方式Mixing Method上机械搅拌Top mechanical mixing下磁力搅拌Bottom magnetic mixing剪切力（低/中/高）Shear force (low/medium/high搅拌速度、时间 mixing
9、speed, time搅拌形式Method mixing品牌Brand除菌过滤Decontamination Filter过滤器尺寸Filter size过滤器安装位置Location of filter品牌brand无菌接点Aseptic Connection一级0.22后After 1x0.22mciro filter二级0.22后After 2x0.22 micro filter完整性测试Integrity Test离线测试 Off-line testing在线测试（SIP前）On-line testing(before CIP)在线测试（SIP后）On-line testing(aft
10、er CIP)药液过滤后离线/在线测试 After the filtration, offline/online liquid testing罐装缓冲罐Buffer Tank容积大小VolumeCIP/SIP方式 Method of CIP/SIP称重/液位开关Weighting/liquid level switch罐装点距离及数量The distance and quantity of filling port缓冲罐位置 The location of buffer tank管道标准Piping StandardsSMS-1.2mmASME BPE-1.6mm品牌 Brand管路保温Pip
11、e Insulation不锈钢套管包覆硅酸铝板 Aluminum silicate coated is covered by stainless steel还是PVC膜包覆硅酸铝板Aluminum silicate coated is covered by PVC film工艺阀门Process Valve铸造/锻造Casting/forging阀门品牌Brand公用工程UtilityWFI压力Pressure of WFI纯蒸汽压力Pressure of pure steam压缩空气压力Pressure of compressed air氮气压力Pressure of nitrogen冷却介
12、质及温度 The cooling media and temperature夹套排放要求 Requirement of jacket outletCIP介质Media of CIP是否需用CIP站 Whether request the CIP stationWFI注射用水 Water for injectionPW纯化水 Pure water酸液循环 Acid circulation碱液循环 Alkali circulationCIP/SIP方式CIP/SIP Method手动/半自动/自动 Manual/Semi-auto/Auto过滤器CIP 在线/离线Filter CIP On-line/off-line过滤器SIP 在线/离线Filter SIP On-line/off-line电器柜进线方式Power cable inlet methods electrical cabinet技术夹层Dusk预埋电缆Embedded cable第 12 页