1、JW-SMP-IR-001-01Page: 1 of 8生产工艺信息Information Request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
2、steel是否怕氧化、怕光Oxidizable or light sensitivity药液属性Property of product是否易燃易爆、易挥发 Flammable or volatileJW-SMP-IR-001-01Page: 2 of 8详细的药液配制工艺Detailed Solution preparation process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（
3、缓冲罐）高度 Height of buffer tank in filler走技术夹层 Through dusk配液至灌装管路走向 The pipeline arrangement from mixing room to filling room 直接穿墙进入灌装间 Through the wall回流至配液间Back-flow to mixing room详细的平面布局图Layout drawing details配液至灌装管路 CIP/SIP 排口 The outlet(CIP/SIP) from mixing room to filling room洗瓶间/胶塞清洗间Vial washi
4、ng 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: concentrated稀配罐Tank A2: Diluted储液罐 A3 Tank3: Storage储液罐 A4Tank4: Storage夹套 Jacket罐体形式Tank Structure 保温层Insulation layerJW-SMP-IR-001-01Page: 3 of 8外表面镜面抛光/亚光External surface mirror/satin polish
5、ing最大配液量Maximum working volume配液量Working Volume 最小配液量Minimum working volume人工手孔投料 Manual feeding hole真空上料 Vacuum feeding投料方式Feeding Mode其它方式 Others feeding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 preparationWFI 温度WFI Temperature进罐后冷却配液WFI f
6、lowing to tank cooling, and then, solution preparation无菌空气压送 Through aseptic air氮气压送Through nitrogen药液输送Liquid Transfer泵输送Through the pump预过滤Pre-filtration是否有钛棒过滤Titanium stick filterJW-SMP-IR-001-01Page: 4 of 8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Fil
7、ter size恒温范围The range of constant temperature降温时间Temperature fall down time温度控制Temperate Control温控精度Precision of temperature controlWFI 水系统提供WFI system supply热交换器Heat Exchanger 配液系统提供Solution preparation system supply冷冻水(7C)Chilled water: 7deg.c冷冻水(0C)Chilled water: 0deg.c乙二醇(-10C) ethylene glycolEt
8、hylene glycol: -10deg.c夹套工艺介质Media in Jacket饮用水City waterJW-SMP-IR-001-01Page: 5 of 8工艺热水Plant hot water工业蒸汽Plant steam在线On-linePH 值检测方式PH Control 取样离线Off-line无菌/有菌 aseptic/non-aseptic单次/多次Single/multiply times取样方式Sampling Method侧取样/底取样Side /bottom sampling称重方式/品牌 Weighting/brand配液计量Metering Method
9、液位计方式/品牌Liquid level sensor/brand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搅拌方式Mixing Method品牌JW-SMP-IR-001-01Page: 6 of 8Brand过滤器尺寸Filter size过滤器安装位置Location of filter除菌过滤Decontamination Filter品牌brand一级 0.22
10、 后After 1x0.22mciro filter无菌接点Aseptic Connection 二级 0.22 后After 2x0.22 micro filter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)完整性测试Integrity Test药液过滤后离线/在线测试 After the filtration, offline/online liquid testing容积大小VolumeCIP/SIP 方式 Method of CIP/SIP
11、称重/液位开关Weighting/liquid level switch罐装缓冲罐Buffer Tank罐装点距离及数量The distance and quantity of filling JW-SMP-IR-001-01Page: 7 of 8port缓冲罐位置 The location of buffer tankSMS-1.2mmASME BPE-1.6mm管道标准Piping Standards 品牌 Brand不锈钢套管包覆硅酸铝板 Aluminum silicate coated is covered by stainless steel管路保温Pipe Insulation
12、还是 PVC 膜包覆硅酸铝板Aluminum silicate coated is covered by PVC film铸造/锻造Casting/forging工艺阀门Process Valve 阀门品牌BrandWFI 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公用工程Utility冷却介质及温度 The cooling media and temperatureJW-SMP-IR-001-01Page: 8 of 8夹套排放要求 R
13、equirement of jacket outlet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 circulationCIP 介质Media of CIP碱液循环 Alkali circulation手动/半自动/自动 Manual/Semi-auto/Auto过滤器 CIP 在线/离线Filter CIP On-line/off-lineCIP/SIP 方式CIP/SIP Method过滤器 SIP 在线/离线Filter SIP On-line/off-line技术夹层Dusk电器柜进线方式Power cable inlet methods electrical cabinet 预埋电缆Embedded cable
