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欣谕冻干设备,食品级别冷冻干燥机XY-GY-2000 200平方材料真空冷冻干燥机
面议欣谕10公斤冻干机XY-FD-L10D冷冻干燥机1平方电加热真空冷冻干燥机
面议上海欣谕0.4平方实验室冻干机XY-FD-L4D普通型真空冷冻干燥机
面议上海欣谕小型冻干机XY-FD-L2真空冷冻干燥机0.2平方实验室科研冻干机
面议欣谕小型冷冻干燥机0.1平方智能控温XY-FD-L1冻干机
面议生产型食品冻干机咖啡香料冷冻干燥机欣谕水果真空冷冻干燥机
面议欣谕XY-FD-1SL冻干机、原位预冻卧式冷冻干燥机
面议XY-FD-27(压盖型)欣谕冷冻干燥机、0.3实验型冻干机
面议欣谕XY-FD-1压盖型冻干机,实验型冷冻干燥机
面议石墨烯大型辐射式冷冻干燥机,欣谕冻干机
面议实验型T型架冷冻干燥机,专业安剖瓶冻干机
面议实验型冷冻干燥机,XY-FD-1L普通,欣谕冻干机
面议技术规格
TECHNICAL SPECIFICATIONS
Lyophilizer Technical Parameters冻干机技术参数表
1、XY-FD-S0.5E真空冷冻干燥机
General Detail 总述 | ||
Sr. No. | Description 描述 | Specifications 规格 |
1 | Mode 型号 | XY-FD-S0.5E |
2 | Output (approx.) 产量(大约) | 2.160 units of vials 16mm diameter 外径16毫米冻干瓶2.160瓶 |
1.130units of vials 22mm diameter 外径22毫米冻干瓶1.130瓶 | ||
3 | Maximum ice capacity Z大捕冰力 | 10kg |
4 | Stoppering 压塞 | Hydraulic stoppering 液压压塞(sw) |
5 | Control 控制方式 | Microprocessor 微机处理【无菌窒增加一套扳层升降操作系统】 |
6 | Dimension of unit (approx.) (L × W × H) (mm) (with hydraulic cylinder) 外型尺寸(大约)(长×宽×高)(带液压缸) | 1,900 × 850 × 2,200 (Final dimension based on design) (以Z终设计尺寸为准) |
7 | Weight (approx.) 重量(大约) | 900kg |
Chamber 冻干箱 | ||
1 | Chamber type 冻干箱外型 | Rectangular 长方体 |
3 | Finish 内部抛光度 | Ra≤0.4um (0.4Mircon) |
4 | Corner 箱内角 | Coping 圆弧角 |
5 | Viewing port 视镜 | Illuminated 带远射灯【广角】 |
Number 数量 | 1 | |
Location 位置 | Side 侧面 | |
Dimension 尺寸 | DN150 (mm) | |
Material 材质 | ||
Internal 内部 | AISI 316L | |
Insulation 保温 | Aluminum silicate and polyisocyanurate foam 硅酸铝和聚氨酯发泡材料 | |
External cover 外部 | 304 | |
Door 箱门 | ||
1 | Finish 抛光度 | Ra≤0.4um (0.4Mircon) |
2 | Viewing port 视镜 | Included 有 |
Number 数量 | 1 | |
3 | Open direction 开门方向 | left (face to door, hinge on left side) 左开(面对箱门,铰链在左) |
4 | Open angle 开门角度 | More than 110o 大于110度 |
5 | Gasket 密封圈 | O-shaped silicone rubber single gasket O-型硅橡胶单密封 |
6 | Locking arrangement 门锁方式 | Manual handle 手柄 |
7 | Material 材质 | |
Internal 内部 | AISI 316L | |
Insulation 保温 | Aluminum silicate and polyisocyanurate foam 硅酸铝和聚氨酯发泡材料 | |
External cover 外部 | 304 | |
Sterile wall flange 无菌隔离围板 | 304 | |
Shelves 板层 (带西林瓶防护条) | ||
1 | Temperature range 温度范围 | -58°C to + 80°C |
2 | Temperature sensors (shelves) 板层温度探头 | 2 |
Silicone oil inlet 导热油进口 | ||
Silicone oil outlet 导热油出口 | ||
3 | Product sensors 产品温度探头 | 4 |
4 | Number of shelves 板层数 | 4+ 1(upper radiant shelf) (温度补偿板) |
5 | Dimension (L × W × T) (mm) 板层尺寸 | 450 × 300 × 12 |
6 | Total usable area (sq. m) 总使用面积 | 0.54 m2 |
7 | Spacing (mm) 板间距 | 95 |
8 | Hose of flexible connection 软管连接 | Welding 焊接 |
9 | Finish 抛光度 | Ra≤0.4um (0.4Micron) |
10 | Level 平整度 | ≤±0.5mm/m |
11 | Material 材质 | AISI 316L |
Stoppering Device 液压装置 | ||
1 | Stoppering condition 运行环境 | Under vacuum or under inert gas 真空或惰性气体保护 |
2 | Stoppering direction 压塞方向 | Top to bottom 从上到下或从下到上 |
Power motor 电机功率 | 0.88kW | |
Oil packing 装油量 | 15L | |
Stoppering force 液压力 | 0~1bar (adjustable) 可调 | |
Condenser 冷凝器 | ||
1 | Condenser type 冷凝器外型 | Rectangular 长方体 |
2 | Final temperature J限温度 | ≤-80°C |
3 | Cooling time (+20 to -40°C) 制冷速度(空载) | ≤30 minutes (empty) |
4 | Finish 抛光度 | Ra≤0.5um (0.5Mircon) |
5 | Coiled pipe welding 盘管焊接 | Orbitally welded 自动焊接 |
6 | Isolation valve 中隔阀 | |
Type 外型 | Mushroom 蘑菇阀 | |
Size 尺寸 | DN 70 (mm) | |
7 | Coiled pipe material 盘管材质 | |
Internal 内部 | AISI 304 | |
Insulation 保温 | Aluminum silicate and polyisocyanurate foam 硅酸铝和聚氨酯发泡材料 | |
External cover 外部 | 304 | |
Shelf Heating / Cooling 板层升温/降温 | ||
1 | Circulation pump 循环泵 | |
Brand 品牌 | 德Gwilo | |
Model 型号 | TOP S25/7 | |
Type 形式 | Shielding method 屏蔽式 | |
Number 数量 | 1 | |
Motor power 电机功率 | 0.28kW | |
2 | Plate heat exchanger 板式热交换器 | |
Brand 品牌 | Alfa Laval 阿法拉伐 | |
Type 方式 | Sealed brazed stainless steel 不锈钢封蜂窝式 | |
Number 数量 | 1 | |
3 | Heater 电加热 | PID control PID 控制(双组电加热系统) |
4 | Maximum heating power Z大加热功率 | 1.0kW |
5 | Thermal fluid 导热介质 | Silicone oil 5 cst 粘度5 cst硅油 |
6 | Shelf cooling time (+25°C to -40°C) 板层制冷速度(空载) | ≤60 minutes (empty) |
7 | Heating rate 加热速度(大约) | 1°C/min (approx.) |
8 | Shelves temperature uniformity 板层温度均匀性(空载平衡后) | ≤±1°C (soak stage) |
9 | Compressor 压缩机 | |
Brand 品牌 | 泰康 (法G原装) | |
Model 型号 | THF-2511Z | |
Type 方式 | 1台 | |
Number 数量 | 风冷 | |
Motor power 电机功率 | 2.25KW | |
10 | Refrigerant 制冷剂 | CFC-free R404A |
Brand 品牌 | 泰康 (法G原装) | |
Model 型号 | THF-2480Z | |
Number 数量 | 1台 | |
Type 方式 | 复叠 | |
Motor power 电机功率 | 1.5KW | |
11 | Refrigerant 制冷剂 | CFC-free R-23 |
Thermostatic expansion valve 热力膨胀阀 | Danfoss 丹佛斯 | |
Solenoid valve 电磁阀 | Danfoss 丹佛斯 | |
Sight glass 视液镜 | Danfoss 丹佛斯 | |
Liquid filter core 液体过滤芯 | Danfoss 丹佛斯 | |
Pressure meter 压力表 | Refco | |
Pressure controller 压力控制器 | Danfoss | |
Vacuum System 真空系统 | ||
1 | Final vacuum J限真空 | ≤2.6×10 -2mbar |
2 | Evacuation time 抽气速度 | ≤30minutes (1×103 mbar to 1×10-1 mbar) |
3 | Leakage rate 泄露率 | ≤5×10-2 mbar•lit/sec |
4 | pump 真空泵 | |
Brand 品牌 | BAOSI | |
Model 型号 | BSV-24 | |
Type 方式 | Bipolar vane 双J旋片 | |
Number 数量 | 1 | |
Flow rate 排气速度 | 20m3/hr (×1) | |
Motor power 电机功率 | 1.1Kw (×1) | |
5 | Pump isolation valve 泵阀隔离阀 | |
Type 方式 | Ball valve 球阀 | |
Size 尺寸 | DN 25 (mm) | |
6 | 掺气阀 | 控制真空度微调 |
Venting Filter 放气过滤器 | ||
Number 数量 | 1 | |
Aperture 孔径
| 0.22um | |
Control System 控制系统 | ||
1 | Software 软件 | XY – 5000(SCADA满足数据采集及监控) |
Automatic 自动 | Included 有 | |
Manual 手动 | Included 有 | |
2 | PLC 可编程控制器 | Omron |
3 | Computer 电脑 | 工控机电脑 |
可链接PC电脑,也可以手机下载欣谕专用APP软件进行监控操控设备(有无线情况下) | ||
4 | Vacuum gauge 真空探头 | Edwards 爱德华 |
5 | Temperature probe 温度探头 | Pt100 |
6 | Breaker 空开 | schneider |
7 | Contactor 接触器 | schneider |
8
| Relay 继电器 | Schneider |
9 | 共晶点测试装置 | 选配欣谕开发的共晶点测试功能 |
Safety System 安全系统 | ||
1 | Vacuum failure protection 真空失败保护 | Included 有 |
2 | Temperature failure protection 温度失败保护 | Included 有 |
3 | Compressor protection 压缩机保护 | Included 有 |
4 | Other motors protection 其它电机保护 | Included 有 |
5 | Interlock protection 连锁保护 | Included 有 |
Utility Requirement (approx.) 共用工程消耗(大约) | ||
1 | Electricity - total electrical load 总装机功率 | 6kW (380V, 50Hz, 3Phase, 5Wire) |
软件功能 Software function | |||
1 | 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 advantages | |||
1 | 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 | 无菌室装有液压控制按钮,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. | ||
以上数据仅供参考,以实际设计图纸为准 | |||
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 | |||
序号SN | 名称 Name | 数量 Number | |
1 | 安装确认 Installation qualitation(IQ) | 1套 | |
2 | 操作确认 Operation qualitation(OQ) | 1套 | |
3 | 性能确认 Performance qualitation(PQ) | 1套 | |
4 | 工厂验收测试 Factory acceptance test(FAT) | 1套 | |
5 | 客户现场验收测试 Site acceptance test(SAT) | 1套 | |
6 | 操作手册 Operation manual (OM) | 1套 | |
7 | 维护手册 Maintenance manual (MM) | 1套 | |
8 | 安装手册 Installation manual (IM) | 1套 | |
9 | 平面布置图 Layout drawing | 1套 | |
10 | 工艺流程图 P&ID | 1套 | |
11 | 电气线路图 Wiring drawing | 1套 | |
12 | 主要部件说明书 Instruction for the main parts | 1套 | |
13 | 材质报告 Material report | 1套 | |
14 | 校验报告 Verification report | 1套 |
以上为欣谕冻干标准款制药型设备,如需要增项选配功能可联系欣谕厂家具体沟通