1、生產(chǎn)工藝信息Information Request藥液屬性Property of product粉針Powder Injection水針 liquid injections有色 Colored無色 Colorless有毒Poisonous無毒 Non-poisonous澄清液 Clarified Liquid混懸液Suspension化學(xué)藥品 Chemicals生物藥品Bio-product生產(chǎn)批次 Batch Number藥液黏度Liquid viscosity攪拌時(shí)是否容易起泡Some bubble when mixing與不銹鋼是否反應(yīng)React with stainless steel

2、是否怕氧化、怕光Oxidizable or light sensitivity是否易燃易爆、易揮發(fā) Flammable or volatile詳細(xì)的藥液配制工藝Detailed Solution preparation process詳細(xì)的平面布局圖Layout drawing details配液間（長寬高）mixing room (LWH)灌裝間回風(fēng)口的尺寸以及位置（管路設(shè)計(jì)避開）The size and position of air return in filler room(pipeline should avoid)灌裝機(jī)分配器（緩沖罐）高度 Height of buffer tan

3、k in filler配液至灌裝管路走向 The pipeline arrangement from mixing room to filling room走技術(shù)夾層 Through dusk直接穿墻進(jìn)入灌裝間 Through the wall配液至灌裝管路CIP/SIP排口 The outlet(CIP/SIP) from mixing room to filling room回流至配液間Back-flow to mixing room洗瓶間/膠塞清洗間Vial washing room /rubber washing room配液系統(tǒng)的詳細(xì)配置 Detailed Configuration

4、 of Tank Solution Preparation罐體Tank濃配罐Tank A1: concentrated稀配罐Tank A2: Diluted儲液罐A3 Tank3: Storage儲液罐A4Tank4: Storage罐體形式Tank Structure夾套 Jacket保溫層Insulation layer外表面鏡面拋光/亞光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溫度WFI Temperature直接80度配液Solution preparation is 80deg.c冷卻后進(jìn)罐配液After cooling WFI, and then, flowing to tank solution preparation進(jìn)罐后冷卻配液WFI flowing to tank cooling, and then, solution preparation藥液輸送Liquid Transfer無菌空氣壓送 Through aseptic

6、 air氮?dú)鈮核蚑hrough nitrogen泵輸送Through the pump預(yù)過濾Pre-filtration是否有鈦棒過濾Titanium stick filter鈦棒回流Back-flow回流泵形式Back-flow pump活性炭用量Dosage of active carbon預(yù)過濾為多少Filter aperture預(yù)過濾尺寸Filter size溫度控制Temperate Control恒溫范圍The range of constant temperature降溫時(shí)間Temperature fall down time溫控精度Precision of temperatur

7、e control熱交換器Heat ExchangerWFI水系統(tǒng)提供WFI system supply配液系統(tǒng)提供Solution preparation system supply夾套工藝介質(zhì)Media in Jacket冷凍水(7C)Chilled water: 7deg.c冷凍水(0C)Chilled water: 0deg.c乙二醇(-10C) ethylene glycolEthylene glycol: -10deg.c飲用水City water工藝熱水Plant hot water工業(yè)蒸汽Plant steamPH值檢測方式PH Control在線On-line取樣離線Off-

8、line取樣方式Sampling Method無菌/有菌 aseptic/non-aseptic單次/多次Single/multiply times側(cè)取樣/底取樣Side /bottom sampling配液計(jì)量Metering Method稱重方式/品牌 Weighting/brand液位計(jì)方式/品牌Liquid level sensor/brand攪拌方式Mixing Method上機(jī)械攪拌Top mechanical mixing下磁力攪拌Bottom magnetic mixing剪切力（低/中/高）Shear force (low/medium/high攪拌速度、時(shí)間 mixing

9、speed, time攪拌形式Method mixing品牌Brand除菌過濾Decontamination Filter過濾器尺寸Filter size過濾器安裝位置Location of filter品牌brand無菌接點(diǎn)Aseptic Connection一級0.22后After 1x0.22mciro filter二級0.22后After 2x0.22 micro filter完整性測試Integrity Test離線測試 Off-line testing在線測試（SIP前）On-line testing(before CIP)在線測試（SIP后）On-line testing(aft

10、er CIP)藥液過濾后離線/在線測試 After the filtration, offline/online liquid testing罐裝緩沖罐Buffer Tank容積大小VolumeCIP/SIP方式 Method of CIP/SIP稱重/液位開關(guān)Weighting/liquid level switch罐裝點(diǎn)距離及數(shù)量The distance and quantity of filling port緩沖罐位置 The location of buffer tank管道標(biāo)準(zhǔn)Piping StandardsSMS-1.2mmASME BPE-1.6mm品牌 Brand管路保溫Pip

11、e Insulation不銹鋼套管包覆硅酸鋁板 Aluminum silicate coated is covered by stainless steel還是PVC膜包覆硅酸鋁板Aluminum silicate coated is covered by PVC film工藝閥門Process Valve鑄造/鍛造Casting/forging閥門品牌Brand公用工程UtilityWFI壓力Pressure of WFI純蒸汽壓力Pressure of pure steam壓縮空氣壓力Pressure of compressed air氮?dú)鈮毫ressure of nitrogen冷卻介質(zhì)及溫度 The cooling media and temperature夾套排放要求 Requirement of jacket outletCIP介質(zhì)Media of CIP是否需用CIP站 Whether request the CIP stationWFI注射用水 Water for injectionPW純化水 Pure water酸液循環(huán) Acid circulation堿液循環(huán) Alkali circulationCIP/SIP方式CIP/SIP Method