详细介绍
Lyophilizer Technical Parameters 技术参数表
1、XY-FD-S5E真空冷冻干燥机
制造标准Manufacture Standards |
cGMP |
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A、干燥箱（含0.54m2板层）Chamber (with0.54m2shelves) |
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序号SN |
名称 Name |
型号/规格/材质 Model/Specifications/Material |
数量 Number |
1 |
干燥箱 Chamber |
316L不锈钢 |
1套 |
2 |
板层 Shelves |
316L不锈钢 |
1套 |
尺寸：450×300×12mm Dimensions：450×300×12mm |
4+1层 |
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3 |
箱门Door |
透明树脂 colophony |
1套 |
4 |
验证孔 Validation port |
1个 |
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5 |
制品测温探头 Product sensors |
Pt-100热电阻A级 Pt-100Hot resistanceALevel |
2支 |
6 |
导热油温度探头 Temperature sensors (thermal fluid) |
Pt-100热电阻A级 Pt-100Hot resistanceALevel |
2支 |
性能参数Performance parameters |
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1 |
设计压力 Design pressure |
常压Normal pressure |
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2 |
设计温度 Design temperature |
常温Normal temperature |
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3 |
光洁度Finish |
Ra≤0.4µm |
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4 |
平整度Level |
±0.5mm/m |
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5 |
板层Z低温度 （搁板进口） Shelves temperature Min |
-55℃ |
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6 |
板层Z高温度 Shelves temperature Max |
+80℃ |
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7 |
板层温度均匀性 Shelves temperature uniformity |
±1°C（空载平衡后） ±1°C（soak stage） |
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8 |
搁板间距 Spacing |
80mm |
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9 |
干燥箱外形 Chamber type |
圆桶体cylinder |
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10 |
保温层Insulation |
硅酸铝和聚氨酯发泡材料 Aluminum silicate and polyisocyanurate foam |
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11 |
开门方向 Open direction |
根据用户要求确定According to user's requirements |
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12 |
开门角度 Open angle |
大于110度More than 110° |
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13 |
门密封条 Sealing strips for doors |
O型硅橡胶O-shaped silicone rubber |
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技术优势Technical advantages |
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1 |
不锈钢板材均采用卫生级不锈钢板材,保证箱体表面光洁度,从而保证无菌要求； Stainless steel plates are all sanitary stainless steel plates.Ensure the finish of chamber surfaces, and then ensure the asepsis requirement. |
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2 |
板层具有很高强度,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. |
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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. |
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4 |
板层控温精度±0.5℃（PID调节）； Temperature control accuracy±0.5℃(adjusted by PID) |
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5 |
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. |
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B、冷凝器（含盘管）Condenser (with coiled pipe) |
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序号 SN |
名称 Name |
型号/规格/材质 Model/Specifications/Material |
数量 Number |
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1 |
冷凝器 Condenser |
304不锈钢 |
1套 |
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2 |
冷凝盘管 Condensercoiled pipe |
304不锈钢 |
1套 |
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3 |
冷凝器测温探头 Temperature sensors (condenser) |
Pt-100热电阻A级 Pt-100Hot resistanceALevel |
1支 |
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性能参数Performance parameters |
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1 |
设计压力 Design pressure |
常压Normal pressure |
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2 |
设计温度 Design temperature |
常温Normal temperature |
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3 |
光洁度Finish |
Ra≤0.4um |
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4 |
盘管Z低温度 Coiled temperature Min |
-75℃ |
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5 |
冷凝器捕冰能力 Condenser frosting capacity |
10Kg/批 10Kg/batch |
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6 |
冷凝器外型 Condenser type |
圆桶体 cylinder |
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技术优势Technical advantages |
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1 |
不锈钢板材均采用卫生级不锈钢板材,保证箱体表面光洁度,从而保证无菌要求； Stainless steel plates are all sanitary stainless steel plates.Ensure the finish of chamber surfaces, and then ensure the asepsis requirement. |
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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. |
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C、中隔阀Big Isolation valve |
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序号 SN |
名称 Name |
型号/规格/材质 Model/Specifications/Material |
数量 Number |
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1 |
电动碟阀Electric valve |
DN-100 |
1套 |
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D、制冷系统Refrigeration system |
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序号 SN |
名称 Name |
型号/规格/材质 Model/Specifications/Material |
数量 Number |
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1 |
压缩机型号及数量 Compressor model and number |
BITZER"比泽尔"S4T-5.2Y |
1台 |
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2 |
制冷剂 Refrigerant |
R404a绿色环保型 R404a Environment Friendly |
适量 Right quantity |
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3 |
油分离器 Oil separator |
美GEMERSON |
1个 |
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4 |
回气过滤器 Filter for return air |
外壳EMERSON,滤芯EMERSON Shell EMERSON,Filter Core EMERSON |
1个 |
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5 |
油压差控制器 Oil differential pressure controller |
丹麦DANFOSS |
1个 |
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6 |
油平面视镜 Viewing port (oil level) |
丹麦DANFOSS |
1个 |
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7 |
压力自动保护装置 Automatic protective device for pressure |
丹麦DANFOSS |
1个 |
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8 |
自动收液装置 Automatic liquid recycling device |
丹麦DANFOSS |
1个 |
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9 |
气液分离器 Gas-liquid separator |
DANHUA |
1个 |
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10 |
除酸干燥过滤器 Filter for disacidifying and drying |
外壳EMERSON,滤芯EMERSON Shell EMERSON,Filter Core EMERSON |
1套 |
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11 |
压力表Pressure meter |
瑞士REFCO |
1个 |
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12 |
顶盖阀Tectum valve |
意大利CASTEL |
1个 |
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13 |
继电器Relay |
丹麦DANFOSS |
3个 |
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14 |
安全阀Safety valve |
意大利CASTEL |
1个 |
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15 |
膨胀阀Expansion valve |
丹麦Danfoss |
3个 |
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16 |
电磁阀Solenoid valve |
丹麦Danfoss |
2个 |
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17 |
低压避震管 Low-pressure vibration absorber |
美GYORK PA |
1套 |
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18 |
高压避震管 High-pressure vibration absorber |
航天"晨光" |
1套 |
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性能参数Performance parameters |
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1 |
板层制冷速度（空载） （搁板进口） Shelf cooling time (empty) |
+20～-40°C ≤60minutes |
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2 |
冷凝器制冷速度（空载） Condenser cooling time (empty) |
+20～-40°C ≤ 30 minutes |
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技术优势Technical advantages |
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1 |
压缩机采用"比泽尔"机组,性能更加稳定、可靠； Adopting theBITZERcompressor makes the performance be more stable and relibale. |
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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. |
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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. |
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① |
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. |
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② |
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. |
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③ |
压缩机电机多重保护功能； The poly-protection function of compressor motor |
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E、真空系统Vacuum system |
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序号 SN |
名称 Name |
型号/规格/材质 Model/Specifications/Material |
数量 Number |
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1 |
真空泵 Vacuum pump |
优成TRP-24 |
1台 |
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2 |
泵阱隔离阀Isolation valve of pump well |
DN-25mm |
1个 |
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3 |
泵头阀 Pump head valve |
西玛特SIEGV |
1个 |
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4 |
真空探头Vacuum gauge |
英G"爱德华"EDWARDS APG |
1个 |
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性能参数Performance parameters |
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1 |
J限真空Final vacuum |
5Pa |
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2 |
抽气速度Evacuation time |
从大气压抽至10pa≤30min From atm to 10pa≤30min |
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3 |
泄漏率Leakage rate |
5×10-3pa.m3/sec |
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技术优势Technical advantages |
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1 |
GX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. |
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F、复压掺气系统Aeration system for repressing |
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序号 SN |
名称 Name |
型号/规格/材质 Model/Specifications/Material |
数量 Number |
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1 |
过滤器Filter |
0.22µm |
1个 |
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2 |
掺气阀Aeration valve |
西玛特SIEGV |
1个 |
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3 |
管道Pipeline |
316L不锈钢 |
1套 |
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技术优势Technical advantages |
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1 |
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. |
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G、循环系统Circulation system |
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序号 SN |
名称 Name |
型号/规格/材质 Model/Specifications/Material |
数量 Number |
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1 |
循环泵 Circulation pump |
德G"威乐"WILO TOP-SD32/7 |
1台 |
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2 |
导热油 Thermal fluid |
低粘度硅油 Silicon oil (low viscosity) |
适量 Right quantity |
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3 |
电加热Heater |
1Kw |
1支 |
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4 |
板式热交换器 Plate heat exchanger |
瑞典"阿法拉伐"ALFALAVAL |
1个 |
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5 |
导热油测温探头 Temperature sensors(thermal fluid) |
Pt-100热电阻A级 Pt-100Hot resistanceALevel |
2支 |
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6 |
温度控制器 Temperature controller |
丹麦"丹佛斯"DANFOSS |
1个 |
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性能参数Performance parameters |
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1 |
加热速度 Heating rate |
1°C/min |
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2 |
硅油粘度 Silicon oil viscosity |
2cSt 25℃ |
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技术优势Technical advantages |
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1 |
电加热采用PID能量调节控制,可以Z有效的利用加热能源； Electric heating is controled by PID which can use the heating energy most effectively. |
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H、液压系统Hydraulic system |
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序号 SN |
名称 Name |
型号/规格/材质 Model/Specifications/Material |
数量 Number |
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1 |
液压元件Hydraulic units |
柔肯ROKEN |
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2 |
液压泵Hydraulic pump |
柔肯ROKEN |
1套 |
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3 |
液压油Hydraulic oil |
46#抗磨液压油 46#anti-wear hydraulic oil |
1套 |
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4 |
油箱Tank |
14L |
1套 |
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性能参数Performance parameters |
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1 |
压塞压力 Stoppering force |
0~1.0bar（可调） 0~1.0bar（adjustable） |
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I、电气控制系统Electric control system |
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序号 SN |
名称 Name |
型号/规格/材质 Model/Specifications/Material |
数量 Number |
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1 |
电气标准 Electric standard |
IEC60204-1 |
／ |
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2 |
PLC |
日本OMRON |
1套 |
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3 |
计算机 Computer |
联想LENOVO |
1台 |
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4 |
触摸屏 Touch screen |
日本OMRON |
1个 |
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5 |
空气开关 Breaker |
正泰 |
／ |
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6 |
交流接触器 AC contactor |
施耐德 |
／ |
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7 |
电气保护等级 Protection class |
IP22 |
／ |
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9 |
软件系统Software system |
XY-HMI-V2 |
1套 |
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10 |
软件备份光盘 CD for sofrware backup |
1份 |
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控制方式Control type |
手动及自动控制Manual and automatic |
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软件功能Software function |
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1 |
冷冻干燥（手动、自动,可任意切换） Freeze drying (switch the type between manual and automatic randomly) |
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2 |
工艺设定（配方管理） Technique setting (recipe management) |
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技术优势Technical advantages |
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1 |
符合FDA欧盟标准,电子签名,多组密码； It accords with European standard FDA.There areelectronic signatures and multiple passwords. |
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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. |
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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. |
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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. |
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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 thefriendlyhuman machine interface. |
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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". |
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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 beachievedin the"recipe management". |
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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. |
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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. |
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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. |
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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. |
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12 |
可存储无数条数据、曲线记录； It can save countless data and curves records. |
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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. |
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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.Thesecan be saved as the detailed batch records of a batch of product. |
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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. |
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16 |
软件系统符合FDA 21CFR PART II； Software system accords withFDA 21CFR PART II. |
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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. |
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18 |
UPS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. |
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J、公用工程清单Utility list |
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1 |
总装机功率 Electricity-total electrical load |
8Kw (380V, 50Hz, 3Phase, 5Wire) |
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2 |
用于制冷系统的冷却水 Cooling water for refrigerant cooling |
4m3/hr (1.5≤P≤2bar, 15℃≤T≤30℃) |
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以上数据仅供参考,以实际设计图纸为准 |
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K、设备主要参数The equipment's main technique parameter |
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1 |
整机结构 Machine construction |
一体式 Union |
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2 |
外型尺寸 Dimension of unit |
约1815×900×1780mm |
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3 |
整机重量 Weight of unit |
约1.5T(About )1.5T |
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4 |
西林瓶装量 Filling volume of vial |
Ф22mm1160支 Ф16mm2260支 |
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5 |
冻干原料装量（建议值） Capacity of raw material for freeze drying (suggestive value) |
Z大8Kg/批 8kg/batch(Max) |
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以上数据仅供参考,以实际设计图纸为准 |
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L、验证文件系统（电子光盘1份）详细验证文件系统Verification documents system(one set of CD) The details of verification documents system |
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序号SN |
名称 Name |
数量 Number |
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1 |
安装确认Installation qualitation（IQ） |
1套 |
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2 |
操作确认Operation qualitation（OQ） |
1套 |
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3 |
性能确认Performance qualitation（PQ） |
1套 |
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4 |
工厂验收测试Factory acceptance test（FAT） |
1套 |
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5 |
客户现场验收测试Site acceptance test（SAT） |
1套 |
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6 |
操作手册Operation manual (OM) |
1套 |
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7 |
维护手册Maintenance manual (MM) |
1套 |
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8 |
安装手册Installation manual (IM) |
1套 |
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9 |
平面布置图Layout drawing |
1套 |
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10 |
工艺流程图P&ID |
1套 |
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11 |
电气线路图Wiring drawing |
1套 |
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12 |
主要部件说明书Instruction for the main parts |
1套 |
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13 |
材质报告Material report |
1套 |
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14 |
校验报告Verification report |
1套 |
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M、备品备件 |
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序号 Serial number |
名称 Name |
型号/规格/材质 Model/Specifications/Material |
数量 Number |
1 |
氟利昂Freon |
R404A |
10.9kg |
2 |
冷冻机油 Refrigeration oil |
BITZER专用 |
5.0L |
3 |
电磁阀 Solenoid valve |
DANFOSS |
1 |
4 |
电磁阀线圈 Solenoid valve coil |
DANFOSS |
2 |
5 |
测温探头 Temperature probe |
PT-100单支 |
5 |
6 |
高压压力表 High-pressure gage |
REFCO |
1 |
7 |
低压压力表 Low-pressure gage |
REFCO |
1 |
8 |
干燥过滤器 Dry filter core |
DANFOSS |
2 |
9 |
真空泵油 Vacuum pump oil |
优成 |
4L |
10 |
制冷专用板手 Special wrench for cooling |
COOLMAX |
1把 |
11 |
制冷专用加液管 Special liquid inlet tube for cooling |
HONGSEN |
1根 |
12 |
制冷剂加液表 Dosingtablefor refrigerant |
HONGSEN |
1套 |
