Lyo-0.5水冷技术参数.doc

东富龙 冻干机 专业技术服务于制药工业Tofflon Lyophilizer Expertise in pharmacentical industry TFL/RD7.2.2-01-02Lyophilizer Technical Parameters冻干机技术参数表1、Lyo-0.5真空冷冻干燥机 Lyophilizer-0.5制造标准 Manufacture StandardscGMPA、干燥箱（含0.54m2板层） Chamber (with 0.54m2 shelves)序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1干燥箱 Chamber进口AISI 316L 不锈钢1套2板层 Shelves进口AISI 316L 不锈钢1套尺寸：45030012mmDimensions：45030012mm4 +1层3板层软管Shelves flexible hosesAISI 316L 不锈钢10根4箱门 DoorAISI 316L 不锈钢(部分)AISI 316L stainless steel (Section)1套5箱门视镜Viewing port (door)DN-100 mm1个6验证孔 Validation port1个7制品测温探头Product sensorsPt-100 热电阻 A级Pt-100 Hot resistance A Level2支8导热油温度探头Temperature sensors(thermal fluid)Pt-100 热电阻 A级Pt-100 Hot resistance A Level2支性能参数 Performance parameters1设计压力 Design pressure常压 Normal pressure2设计温度Design temperature常温 Normal temperature3光洁度 FinishRa0.4m4平整度 Level0.5mm/m5板层最低温度Shelves temperature Min-556板层最高温度Shelves temperature Max+707板层温度均匀性Shelves temperatureuniformity1C（空载平衡后）1C（soak stage）8搁板间距 Spacing100mm9干燥箱外形 Chamber type圆桶体cylinder10保温层 Insulation硅酸铝和聚氨酯发泡材料Aluminum silicate and polyisocyanurate foam11开门方向 Open direction根据用户要求确定 According to users requirements12开门角度 Open angle大于110度 More than 11013视镜方向 Position of viewing port根据用户要求确定 According to users requirements14门密封条Sealing strips for doorsO型硅橡胶 O-shaped silicone rubber技术优势 Technical advantages1不锈钢板材均采用进口板材，保证箱体表面光洁度，从而保证无菌要求；Stainless steel plates are all importation. Ensure the finish of chamber surfaces, and then ensure the asepsis requirement.2板层具有很高强度，耐压试验可到0.3Mpa，能够耐受长期使用；Shelves has high intensity and its maximum valve reaches to 0.3Mpa in the pressure test which can be able to bear the long term usage.3板层通过机械加工，可保证高要求平整度；Shelves are processed by machining which can ensure the demanding level.4板层控温精度0.5（PID调节）；Temperature control accuracy0.5 (adjusted by PID)5特殊O型门密封条，可防止积水，更加符合无菌要求；Special O-shaped sealing strips for doors can prevent ponding which more accords with the asepsis requirement.6箱体、板层、软管均采用氦质谱仪进行泄漏检验；Chamber, shelves, flexible hoses are all carried out the leak test by helium mass spectrometer.B、冷凝器（含盘管） Condenser (with coiled pipe)序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1冷凝器 Condenser进口AISI 304 不锈钢1套2冷凝盘管Condenser coiled pipeAISI 304 不锈钢1套3冷凝器测温探头Temperature sensors(condenser)Pt-100 热电阻 A级Pt-100 Hot resistance A Level1支性能参数 Performance parameters1设计压力 Design pressure常压Normal pressure2设计温度Design temperature常温Normal temperature3光洁度 FinishRa0.4um4盘管最低温度Coiled temperature Min-755冷凝器捕冰能力Condenser frostingcapacity10Kg/批10Kg/batch6冷凝器外型Condenser type圆桶体cylinder技术优势 Technical advantages1不锈钢板材均采用进口板材，保证箱体表面光洁度，从而保证无菌要求；Stainless steel plates are all importation. Ensure the finish of chamber surfaces, and then ensure the asepsis requirement.2冷凝器、盘管采用氦质谱仪进行泄漏检验；Condenser and coiled pipe are all carried out the leak test by helium mass spectrometer.D、制冷系统 Refrigeration system序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1压缩机型号及数量Compressor model andnumberBITZER“比泽尔”S4T-5.2Y1台2制冷剂 RefrigerantR404a 绿色环保型R404a Environment Friendly适量Right quantity3油分离器Oil separator美国 ALCO1个4回气过滤器Filter for return air外壳ALCO，滤芯ALCOShell ALCO，Filter Core ALCO1个5油压差控制器Oil differential pressurecontroller丹麦 DANFOSS1个6油平面视镜Viewing port (oil level)丹麦 DANFOSS1个7压力自动保护装置Automatic protectivedevice for pressure丹麦 DANFOSS1个8自动收液装置 Automatic liquid recycling device丹麦 DANFOSS1个9气液分离器Gas-liquid separatorDANHUA1个10除酸干燥过滤器Filter for disacidifying and drying外壳ALCO，滤芯ALCOShell ALCO，Filter Core ALCO1套11压力表 Pressure meter瑞士 REFCO1个12顶盖阀 Tectum valve意大利 CASTEL1个13继电器 Relay丹麦 DANFOSS3个14安全阀 Safety valve意大利 CASTEL1个15膨胀阀 Expansion valve丹麦 DANFOSS3个16电磁阀 Solenoid valve丹麦 DANFOSS2个17低压避震管Low-pressure vibrationabsorber美国 YORK PA1套18高压避震管High-pressure vibrationabsorber航天“晨光”1套性能参数 Performance parameters1板层制冷速度（空载）Shelf cooling time (empty)+20 -40C 60 minutes2冷凝器制冷速度（空载）Condenser cooling time(empty)+20 -40C 30 minutes技术优势 Technical advantages1压缩机采用“比泽尔”机组，性能更加稳定、可靠；Adopting the BITZER compressor makes the performance be more stable and relibale.2采用符合蒙特利尔公约的环保型制冷剂；Adopt the environmental protection type refrigerant which accords with the Montreal Convention.3制冷系统具有各项保护功能，连锁保护；The refrigeration system has all kinds of protection functions and interlock protection.冻干后期低负荷条件下的压力自动调整功能；The automatic adjustment function of pressure under the condition of low load in the late of freeze drying period.制冷系统油压压力多重保护功能；The poly-protection function of oil pressure in the refrigeration system.压缩机电机多重保护功能；The poly-protection function of compressor motorE、真空系统 Vacuum system序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1真空泵Vacuum pump优成 TRP-241台2泵阱隔离阀Isolation valve of pump wellDN-25mm1个3泵头阀Pump head valve西玛特 SIEGV1个4真空探头Vacuum gauge英国“爱德华”EDWARDS APG1个性能参数 Performance parameters1极限真空Final vacuum2.6Pa2抽气速度Evacuation time从大气压抽至10pa30min From atm to 10pa30min3泄漏率Leakage rate510-3pa.m3/sec技术优势 Technical advantages1高效泵头阀与真空泵同时打开和关闭，可大大防止真空泵油逆向扩散；The efficient pump head valve and vacuum pump start or close simultaneously. These can prevent the vacuum pump oil from spreading in reverse effectively.F、复压掺气系统 Aeration system for repressing序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1过滤器Filter0.22m1个2掺气阀Aeration valve西玛特 SIEGV1个3管道PipelineAISI 316L不锈钢1套技术优势 Technical advantages1管道全部采用自动焊接，保证内外壁光洁；All the pipelines use the automatic welding which will ensure the finish of inner and outer surface.G、循环系统 Circulation system序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1循环泵 Circulation pump丹麦“格兰富”GRANDFOSUPS 25-801台2导热油 Thermal fluid低粘度硅油Silicon oil (low viscosity)适量Right quantity3电加热 Heater1Kw1支4板式热交换器Plate heat exchanger瑞典“阿法拉伐”ALFALAVAL1个5导热油测温探头Temperature sensors(thermal fluid)Pt-100 热电阻 A级Pt-100 Hot resistance A Level2支6温度控制器Temperature controller丹麦“丹佛斯”DANFOSS1个性能参数 Performance parameters1加热速度Heating rate1C/min2硅油粘度Silicon oil viscosity5cSt 25技术优势 Technical advantages1电加热采用PID能量调节控制，可以最有效的利用加热能源；Electric heating is controled by PID which can use the heating energy most effectively.H、液压系统 Hydraulic system序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1液压元件Hydraulic units意大利“布雷维尼” BREVINI2液压泵Hydraulic pump意大利“布雷维尼” BREVINI1套3液压油Hydraulic oil46#抗磨液压油46# anti-wear hydraulic oil1套4油箱Tank7L1套性能参数 Performance parameters1压塞压力Stoppering force01.0bar（可调）01.0bar（adjustable）K、电气控制系统 Electric control system序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1电气标准Electric standardIEC60204-12PLC日本OMRON1套3计算机 Computer联想LENOVO1台4触摸屏 Touch screen日本TE1个5空气开关 Breaker瑞典ABB6交流接触器 AC contactor瑞典ABB7电气保护等级Protection classIP228UPS电源 UPS powerSANTAK1台9软件系统 Software systemTofflonMaster-40001套10软件备份光盘CD for sofrware backup1份控制方式 Control type手动及自动控制 Manual and automatic软件功能 Software function1冷冻干燥（手动、自动，可任意切换）Freeze drying (switch the type between manual and automatic randomly)2工艺设定（配方管理）Technique setting (recipe management)技术优势 Technical advantages1符合FDA欧盟标准，电子签名，多组密码；It accords with European standard FDA. There are electronic signatures and multiple passwords.2自动、手动在任何节点任意切换；Switch the type between manual and automatic at any point randomly.3系统操作可在无菌室、机房、冻干控制室进行，并且相互具有互锁功能，避免误操作；The operation can be in the sterilizing room, machine room and control room for freeze drying. And they have the interlock functions which prevent faulty operation.4无菌室装有液压急停按钮，可在紧急情况下强制停止板层运行；There is a hydraulic emergency button in sterilizing room. It can stop the shelves forcibly in an emergency.5友善的人机界面具有各种部件、阀门工作状态及温度、真空度参数显示；There are working state of all kinds of parts and valves and parameter display of temperature and vacuum degree on the friendly human machine interface.6“配方管理”可设置无数条冻干工艺曲线；It can set countless technologies curves for freeze drying in the “recipe management”.7“配方管理”可实现：低温进箱、二次回冻（反复预冻）、压力升测试、掺气阀或者小碟阀选择性掺气控制、自动放气和压塞、低温出箱等个性功能；These personalized functions such as getting in chamber at low temperature, refreezing, testing of pressure rise, selective aerification control between aeration valve and butterfly valve, automatic degassing and stoppering, and getting out chamber at low temperature and so on can be achieved in the “recipe management”.8“冷冻干燥”自动过程有阶段显示功能，并可任意跳段；There is a function for displaying by stages in the automatic process of“freeze drying ”, and it can skip randomly.9“冷冻干燥”过程中可对配方进行随时调整；The recipe can be adjusted momentarily in the “freeze drying ”process.10操作画面具有各个故障点显示功能；There is a function for displaying various trouble points on the operation interface.11具有数据、曲线两种记录功能，可根据批号随时调用或打印；There is a function for recording both data and curves which can be used or printed momentarily according to the batch number.12可存储无数条数据、曲线记录；It can save countless data and curves records.13各个真空度、温度曲线由多种颜色显示，并可任意设置“显示”或“隐藏”；Each curve of vacuum degree and temperature is displayed in multicolor, and it can be set for “displayed”or“hidden”randomly.14“冷冻干燥”完成后，可将“工艺配方”、“数据曲线”、“历史记录”、“操作记录”、“报警记录”等原始记录一起打印，可作为批产品的详细批记录进行保存；After “freeze drying”it can print the original records together such as “technology formula”, “data curve”, “history file”, “operation record”, “alarm reporting” and so on. These can be saved as the detailed batch records of a batch of product.15可根据用户实际使用需要增加相应软件功能；It can increase corresponding software function according to actual requirements of customer.16软件系统符合FDA 21CFR PART II；Software system accords with FDA 21CFR PART II.17电子签名，三级用户权限管理，曲线报表不可修改；There are electronic signatures and three stage authorization managements. The curve charts can not be modified.18UPS不间断电源可在紧急停电后20分钟内给PLC及各类传感器提供电力；UPS(uninterrupted power supply) will supply power to PLC and various sensors in 20 minutes after emergency power shut off.L、公用工程清单 Utility list1总装机功率 Electricity-total electrical load8Kw (380V, 50Hz, 3Phase, 5Wire)2用于制冷系统的冷却水Cooling water for refrigerant cooling4m3/hr (1.5P2bar, T25C)M、设备主要参数 The equipments main technique parameter1整机结构Machine construction一体式Union2外型尺寸 Dimension of unit145011002100mm3整机重量 Weight of unit约1.5T (About )1.5T4西林瓶装量Filling volume of vial22mm 1200支 16mm 2300支 5冻干原料装量（建议值）Capacity of raw material for freeze drying(suggestive value)最大8Kg/批8kg/batch (Max)O、验证文件系统（电子光盘1份） 详细验证文件系统 Verification documents system(on