自动进出料系统技参.docx

1、自动进出料系统技参东富龙冻干机的设计与制造基于中国现行药品生产的GMP法规，符合现行中国设计与安全标准，特别是压力容器制造工艺和电器系统相关的安全标准。一Lyophilizer Technical Parameters冻干机技术参数表(自动进出料型)1、Lyo-25 (SIP，CIP)真空冷冻干燥机 Lyophilizer-25(SIP，CIP)制造标准Manufacture StandardscGMPA、 干燥箱（含26.55m2板层）Chamber (with26.55m2 shelves)序号SN名称Name型号/规格/材质Model/Specifications/Material数量N

2、umber1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：1525149524mm12+1层3箱门DoorAISI 316L 不锈钢(部分)AISI 316L stainless steel (Section)1套4干燥箱视镜Viewing port (chamber)DN-150 mm 带延时照明灯DN-150 mm With time delay head lamp2个5验证孔Validation port3D设计 3D design1个6安全插销门锁系统Door lock system with safe bolt“东富

3、龙”独特设计Unique design by Tofflon1套7制品测温探头Product sensorsPt-100 热电阻 A级Pt-100 Hot resistance A Level3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 pressure0.15Mpa2设计温度Design temperature1283光洁度FinishRa 0.4m4平整度Level0.5mm/m5板层最

4、低温度Shelves temperature Min-556板层最高温度Shelves temperature Max+807板层温度均匀性Shelves temperatureUniformity1C（空载平衡后）1C（soak stage）8搁板间距Spacing120mm9干燥箱外形Chamber type长方型 Rectangular10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 requirement

5、s12开门角度Open angle等于90度 Up to 9013视镜方向 Position of viewing port根据用户要求确定 视镜在等高位置 方便观察According to users requirements14门密封条Sealing strips for doorsT型硅橡胶 T-shaped silicone rubber15门特殊结构侧面开大门+正面小门Side door open+Front pizzza door16小门材料Material of pizza doorAISI 316L17小门外包壳External cover of pizza doorAISI

6、30418小门开启方式Opening type of pizza door 自动上下往复运动 优选翻转式Automatic seesaw motion19小门粗糙度Finish of pizza doorRa0.4m20小门驱动电机Drive motor for pizza door德国 SEW21小门密封Gaskets for pizza door真空时硅橡胶O型圈密封O-shaped silicone rubber gasket in vacuum state正压时硅橡胶M型圈密封M-shaped silicone rubber gasket under positive pressure

7、22进料方式Feed way等高进料，进料高度950mm Equal height, the height for feeding is 950mm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国际先进的3D管口设计，更符合彻底灭菌要求；International advanced

8、nozzle design of 3D more accords with the requirements of thorough sterilization.3专利设计的安全插销门锁系统，独立监控，联锁运行，更加安全可靠；Door lock system with safe bolt which is patented designed is independent monitoring and interlock working. It makes the performance be more safe and relibale.4板层具有很高强度，能够耐受长期使用； Shelves

9、has high intensity which can be able to bear the long term usage.5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.6板层油缸装有AISI 316L不锈钢波纹管，可防止液压油扩散，并且具有在线检测完整性功能；Shelves cylinder is equipped with the AISI 316L stainless steel bellows which can prevent cylinde

10、r oil from spreading and has a integrity function of in place inspection.7板层控温精度0.5（PID调节）；Temperature control accuracy0.5 (adjusted by PID)8特殊T型门密封条，可防止积水，更加符合无菌要求；Special T-shaped sealing strips for doors can prevent ponding which more accords with the asepsis requirement.9箱体、板层、软管均采用氦质谱仪进行泄漏检验；Ch

11、amber, 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 ，Solvent collection device)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 316L 不锈钢1套2冷凝盘管Condenser coiled pipeAISI 316L 不锈钢1套3视镜Viewing port

12、DN-150mm 带延时照明灯DN-150 mm With time delay head lamp1个4冷凝器测温探头Temperature sensors(condenser)Pt-100 热电阻 A级Pt-100 Hot resistance A Level2支5化霜喷球Spray ball for de-icingAISI 316L 不锈钢2个性能参数 Performance parameters1设计压力Design pressure0.15Mpa2设计温度Design temperature1283光洁度FinishRa0.4um4盘管最低温度Coiled temperature

13、Min-755冷凝器捕冰能力Condenser frostingCapacity500Kg/批500Kg/batch6冷凝器外型Condenser type卧式圆桶体Horizontal barrel body 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

14、行泄漏检验；Condenser and coiled pipe are all carried out the leak test by helium mass spectrometer.C、 蘑菇阀Mushroom valve序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1蘑菇阀Mushroom valveAISI 316L 不锈钢AISI 316L stainless steel1套2蘑菇阀油缸Mushroom valve cylinder上海“晶盛”1个3压力传感器Pressure sensor意大利“阿托斯”ATOS1个性

15、能参数 Performance parameters1工作动力Motivation液压驱动Hydraulic driven2蘑菇阀尺寸Mushroom valve dimensionDN-700mm技术优势 Technical advantages1蘑菇阀球头采用模压制造，球头表面光洁易清洗；The head of mushroom valve is manufactured by molding, the head surface is glabrous and easy clean.2蘑菇阀可通过减压阀进行调整，防止关闭压力过大；Mushroom valve can be adjusted

16、 by reducing valve to prevent the over closing pressure.3蘑菇阀的“打开”或“关闭”具有反馈信号，能够真实的了解工作状态；When mushroom valve is ON or OFF there is a feedback signal which can be in favor of knowing the working state truly.4新型蘑菇阀具有很高的密封性和准确性，可完全防止内泄漏；New-fashioned plate flange of mushroom valve is used the secondary

17、 process which has very high sealing quality and accuracy. These can thoroughly prevent the inside leak.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 andNumberKEBELCO“日本神户制钢”KS10LTH2台2制冷剂 RefrigerantR404a 绿色环保型R404a Environment Friendly适量

18、Right quantity3油分离器 Oil separator中港“特艺”（上海）2个4冷却水流量开关 Flow switch for cooling water韩国 HFS1个5电磁阀 Solenoid valve丹麦 DANFOSS10个6膨胀阀 Expansion valve丹麦 DANFOSS6个7顶盖阀 Tectum valve意大利 CASTEL10个8黄铜丝口闸阀 Brake valve with screwed brass 宁波 永享2个9除酸干燥过滤器Filter for disacidifying and drying外壳ALCO，滤芯ALCOShell ALCO，Fi

19、lter Core ALCO2套10安全阀 Safety valve意大利 CASTEL2个11储液罐角阀 Angle valve for fluid reserve tank台湾 SY4个12视液镜 Viewing port丹麦 DANFOSS2个13手动球阀Manual globe valve法国 LEGRIS4个14单向阀 Check valveHELDON或ARROW2个15油冷却器 Oil condenser中港“特艺”（上海）2个16油压差继电器 Oil differential pressure relay日本 鹭宫2个17压力表 Pressure meter日本 KOBELCO

20、4个18高低压压力继电器Pressure relay (high/low pressure)日本 鹭宫2个19温度指示计Temperature indicator日本 NESS2个性能参数Performance parameters1板层制冷速度（空载）Shelf cooling time (empty)+20 -40C60 minutes2冷凝器制冷速度（空载）Condenser cooling time(empty)+20 -40C 30 minutes技术优势Technical advantages1压缩机采用日本神户螺杆机组，性能非常稳定、可靠；Adopting the KEBELCO

21、 KS10STH 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.4回气温度能够进行

22、控制；Back temperature can be controlled.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

23、 of compressor motor.E、 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英国“爱德华”EDWARDS E2M802台2罗茨泵Roots pump英国“爱德华”EDWARDS EH12001台3泵阱隔离阀Isolation valve of pump well德国“盖米”GEMU DN-125mm1个4泵头阀Pump head valve西玛特SIEGV2个5阀门反馈信号Feedbacksignal of valve德国ROTECH1套6真空探头V

24、acuum gauge英国“爱德华”EDWARDS APG2个性能参数Performance parameters1极限真空Final vacuum1Pa2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真空系统阀门具有反馈信号，可了解开关的真实性；The valve in vacuum system has the feedback signal which reflects the authenticity of sw

25、itch.2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.3罗茨泵可与真空泵同时启动；The roots pump and vacuum pump can be started simultaneously.F、复压掺气系统Aeration system for repress

26、ing序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1过滤器Filter0.22m PALL1个 安装在洁净区2掺气阀Aeration valve西玛特SIEGV1个3隔膜阀Diaphragm valve德国GEMU或BURKERT1套4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

27、 and outer surface.2过滤器可进行在位蒸汽灭菌，操作更换方便；Filter can be sterilized in place which makes the operation and replacement be more convient.3复压系统预留了可进行充氮气接口；A interface by which it can inject nitrogen reserves in the repressing system.4复压系统能实现过滤器在位手动测试功能；The manual test function in place of filter can be a

28、chieved in the repressing system.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德国“威乐” WILO SD80/101台2导热油 Thermal fluid低粘度硅油5CST Silicon oil (low viscosity)适量Right quantity3电加热Heater48Kw1支4板式热交换器Plate heat exchanger瑞典“阿法拉伐”ALFALAVAL4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7压力控制器Pressure controller丹麦“丹佛斯”DANFOSS1个性能参数Perf