资源描述
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X宽X高）mixing room （LxWxH）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 tank 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 of Tank Solution Preparation罐体Tank浓配罐Tank A1: concentrate d稀配罐Tank A2: Diluted储液罐A3Tank3: 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 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 temperature 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(7 C)Chilled water: 7deg.c冷冻水(0 C)Chilled water: 0deg.c乙二醇(-10 C) ethylene glycol Ethylene 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-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 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(after 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 fillingport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Pipe 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最新文件仅供参考已改成word文本方便更改
展开阅读全文