药机冻干机XY-FD-S0.5E压盖型科研疫苗药机欣谕风冷0.5平方冷冻干燥机体外诊断试剂冻干设备

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药机冻干机XY-FD-S0.5E压盖型科研疫苗药机欣谕风冷0.5平方冷冻干燥机体外诊断试剂冻干设备的照片

药机冻干机XY-FD-S0.5E压盖型科研疫苗药机欣谕风冷0.5平方冷冻干燥机体外诊断试剂冻干设备

   技术规格 TECHNICAL SPECIFICATIONSLyophilizer 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..
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技术规格   

TECHNICAL SPECIFICATIONS 

 

Lyophilizer Technical Parameters冻干机技术参数表

1XY-FD-S0.5E真空冷冻干燥机制药0.5或1平方水冷.jpg

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

   

1.130units of vials 22mm diameter

外径22毫米冻干瓶1.130

3

Maximum ice capacity

最大捕冰力

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

 

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

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

极限温度

≤-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

德国wilo

 

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

最大加热功率

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    (法国原装)

 

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    (法国原装)

 

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

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

双极旋片

 

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

 

Manual

手动

Included

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

2

Temperature failure protection

温度失败保护

Included

3

Compressor protection

压缩机保护

Included

4

Other motors protection

其它电机保护

Included

5

Interlock protection

连锁保护

Included

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 offreeze 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 displayedorhiddenrandomly.

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 dryingit 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 qualitationIQ

1

2

操作确认  Operation qualitationOQ

1

3

性能确认  Performance qualitationPQ

1

4

工厂验收测试  Factory acceptance testFAT

1

5

客户现场验收测试  Site acceptance testSAT

1

6

操作手册  Operation manual (OM)

1

7

维护手册  Maintenance manual (MM)

1

8

安装手册 Installation manual (IM)

1

9

平面布置图 Layout drawing

1

10

工艺流程图 P&ID

1

11

电气线路图 Wiring drawing

1

12

主要部件说明书 Instruction for the main parts

1

13

材质报告 Material report

1

14

校验报Verification report

1

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18918321013(同微信)

 


 

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