欣谕XY-FD-S10E真空冷冻干燥机(冰冻干燥机) 制造标准 Manufacture Standards | cGMP | |||||||
A、干燥箱(含1.08m2板层) Chamber (with1.08m2 shelves) | ||||||||
序号SN | 名称 Name | 型号/规格/材质 Model/Specifications/Material | 数量 Number | |||||
1 | 干燥箱 Chamber | AISI 316L 不锈钢 | 1套 | |||||
2 | 板层 Shelves | AISI 316L 不锈钢 | 1套 | |||||
Dimensions:600×450×20mm | ||||||||
3 | 箱门 Door | 部分AISI 316 不锈钢 Part AISI 316 stainless steel | 1套 | |||||
4 | 干燥箱视镜 Viewing port (chamber) | DN-200 mm 带延时照明灯 DN-200 mm With time delay head lamp | 1个 | |||||
5 | 箱门视镜 Viewing port (door) | DN-200 mm | 1个 | |||||
6 | 验证孔 Validation port | 1个 | ||||||
7 | 手动门锁系统 Door lock system with safe | 蝶形手柄设计 The butterfly handles | 1套 | |||||
8 | 制品测温探头 Product sensors | Pt-100 热电阻 A级 Pt-100 Hot resistance A Level | 3支 | |||||
9 | 导热油温度探头 Temperature sensors (thermal fluid) | Pt-100 热电阻 A级 Pt-100 Hot resistance A Level | 2支 | |||||
性能参数 Performance parameters | ||||||||
1 | 设计压力 Design pressure | 常压 Normal pressure | ||||||
2 | 设计温度 Design temperature | 常温 Normal temperature | ||||||
3 | 光洁度 Finish | Ra≤0.5µm | ||||||
4 | 平整度 Level | ±1mm/m | ||||||
5 | 板层Z低温度(导热油进口) Shelves temperature Min | -50℃ | ||||||
6 | 板层Z高温度(导热油进口) Shelves temperature Max | +70℃ | ||||||
7 | 板层温度均匀性 Shelves temperature uniformity | ±1°C(空载平衡后) ±1°C(soak stage) | ||||||
8 | 搁板间距 Spacing | 100mm | ||||||
9 | 干燥箱外形 Chamber type | 长方型 Rectangular | ||||||
10 | 保温层 Insulation | 硅酸铝和聚氨酯发泡材料 Aluminum silicate and polyisocyanurate foam | ||||||
11 | 开门方向 Open direction | 根据用户要求确定 According to user’s requirements | ||||||
12 | 开门角度 Open angle | 大于110度 More than 110° | ||||||
13 | 视镜方向 Position of viewing port | 根据用户要求确定 According to user’s requirements | ||||||
14 | 门密封条 Sealing strips for doors | O型硅橡胶 O-shaped silicone rubber | ||||||
技术优势 Technical advantages | ||||||||
1 | 不锈钢板材均采用优质板材,保证箱体表面光洁度,从而保证无菌要求; Stainless steel plates are superior. Ensure the finish of chamber surfaces, and then ensure the asepsis requirement. | |||||||
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. | |||||||
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 accuracy±0.5℃ (adjusted by PID) | |||||||
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 Number | |||||
1 | 冷凝器 Condenser | AISI 316L不锈钢 | 1套 | |||||
2 | 冷凝盘管 Condenser coiled pipe | AISI 316L 不锈钢 | 1套 | |||||
4 | 视镜 Viewing port | DN-150mm 带延时照明灯 DN-150 mm With time delay head lamp | 1个 | |||||
5 | 冷凝器测温探头 Temperature sensors (condenser) | Pt-100 热电阻 A级 Pt-100 Hot resistance A Level | 2支 | |||||
6 | 化霜喷球 Spray ball for de-icing | AISI 316L 不锈钢 | 2个 | |||||
性能参数 Performance parameters | ||||||||
1 | 设计压力 Design pressure | 常压Normal pressure | ||||||
2 | 设计温度 Design temperature | 常温Normal temperature | ||||||
3 | 光洁度 Finish | Ra≤0.5um | ||||||
4 | 盘管Z低温度 Coiled temperature Min | ≤-70℃ | ||||||
5 | 冷凝器捕冰能力 Condenser frosting capacity | 60Kg/批 60Kg/batch | ||||||
6 | 冷凝器外型 Condenser type | 长方型 Rectangular | ||||||
技术优势 Technical advantages | ||||||||
1 | 不锈钢板材均采用优质板材,保证箱体表面光洁度,从而保证无菌要求; Stainless steel plates are superior. 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. | |||||||
C、蘑菇阀 Mushroom valve | ||||||||
序号 SN | 名称 Name | 型号/规格/材质 Model/Specifications/Material | 数量 Number | |||||
1 | 蘑菇阀mushroom valve | AISI 316 不锈钢 AISI 316 stainless steel | 1套 | |||||
2 | 蘑菇阀油缸 mushroom valve cylinder | 上海“晶盛”30/80 Shanghai“jingsheng” 30/80 | 1个 | |||||
性能参数 Performance parameters | ||||||||
1 | 工作动力 Motivation | 液压驱动 Hydraulic driven | ||||||
2 | 蘑菇阀尺寸 Mushroom valve dimension | DN-250mm | ||||||
技术优势 Technical advantages | ||||||||
1 | 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 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 | 新型蘑菇阀板法兰采用二次加工,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 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 Number | |||||
1 | Compressor model and number | BITZER“比泽尔”S4G-5.2Y | 1台 | |||||
2 | Refrigerant | R404a Environment Friendly | 适量 Right quantity | |||||
3 | Emerson | 1个 | ||||||
4 | 回气过滤器 Filter for return air | Emerson | 1个 | |||||
5 | Oil differential pressure controller | 1个 | ||||||
6 | Viewing port (oil level) | 丹麦 DANFOSS | 1个 | |||||
7 | Automatic protective device for pressure | FNC KOREA | 1个 | |||||
8 | Automatic liquid recycling device | FNC KOREA | 1个 | |||||
9 | Gas-liquid separator | DANHUA | 1个 | |||||
10 | Filter for disacidifying and drying | 外壳Emerson,滤芯Emerson Shell Emerson,Filter Core Emerson | 1套 | |||||
11 | 压力表 Pressure meter | ARRON | 4个 | |||||
12 | 顶盖阀 Tectum valve | 意大利 CASTEL | 1个 | |||||
13 | ARRON | 1个 | ||||||
14 | 3个 | |||||||
15 | 丹麦 Danfoss | 5个 | ||||||
16 | Low-pressure vibration absorber | 1套 | ||||||
17 | 高压避震管 High-pressure vibration absorber | 航天“晨光” | 1套 | |||||
性能参数 Performance parameters | ||||||||
1 | 板层制冷速度(空载) (搁板进口) Shelf cooling time (empty) | +20 ~ -40°C ≤ 60 minutes | ||||||
2 | 冷凝器制冷速度(空载) Condenser cooling time (empty) | +20 ~ -40°C ≤ 30 minutes | ||||||
技术优势 Technical advantages | ||||||||
1 | 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. | |||||||
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. | |||||||
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. | |||||||
③ | 压缩机电机多重保护功能; The poly-protection function 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 Number | |||||
1 | 真空泵Vacuum pump | ULVAC VDN401 | 1台 | |||||
2 | 泵阱隔离阀Isolation valve of pump well | DN-50mm | 1个 | |||||
3 | 泵头阀Pump head valve | 西玛特 SIEGV | 2个 | |||||
4 | 真空探头Vacuum gauge | 英G“爱德华”EDWARDS APG | 2个 | |||||
性能参数 Performance parameters | ||||||||
1 | J限真空Final vacuum | ≤5Pa | ||||||
2 | 抽气速度Evacuation time | 从大气压抽至10pa≤30min From atm to 10pa≤30min | ||||||
3 | 泄漏率Leakage rate | 5×10-3pa.m3/sec | ||||||
技术优势 Technical advantages | ||||||||
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. | |||||||
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 Number | |||||
1 | 过滤器Filter | 0.22µm | 1个 | |||||
2 | 掺气阀Aeration valve | 西玛特 SIEGV | 1个 | |||||
4 | 管道Pipeline | AISI 316不锈钢 | 1套 | |||||
技术优势 Technical advantages | ||||||||
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. | |||||||
2 | 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. | |||||||
G、循环系统 Circulation system | ||||||||
序号 SN | 名称 Name | 型号/规格/材质 Model/Specifications/Material | 数量 Number | |||||
1 | 循环泵 Circulation pump | 德G“威乐” WILO TOP-SD32-7 | 1台 | |||||
2 | 导热油 Thermal fluid | 低粘度硅油 Silicon oil (low viscosity) | 适量 Right quantity | |||||
3 | 电加热 Heater | 2Kw | 1支 | |||||
4 | 板式热交换器Plate heat exchanger | 瑞典“阿法拉伐” ALFALAVAL 技术 | 2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 Level | 2支 | |||||
6 | 温度控制器 Temperature controller | 丹麦“丹佛斯”DANFOSS | 1个 | |||||
7 | 压力控制器 Pressure controller | 丹麦“丹佛斯”DANFOSS | 1个 | |||||
性能参数 Performance parameters | ||||||||
1 | 加热速度Heating rate | 1°C/min | ||||||
2 | 硅油粘度 Silicon oil viscosity | 5cSt 25℃ | ||||||
技术优势 Technical advantages | ||||||||
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 |