制药压盖冻干机

制造标准 Manufacture Standards

cGMP

A、干燥箱（含0.2m²板层） Chamber (with 0.2m² shelves)

序号SN

名称

Name

型号/规格/材质

Model/Specifications/Material

数量

Number

1

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：400×300×12mm

Dimensions：400×300×12mm

2 +1层

3

箱门 Door

透明树脂

colophony

1套

4

验证孔  

Validation port

1个

5

制品测温探头

Product sensors

Pt-100 热电阻 A级

Pt-100 Hot resistance  A Level

2支

6

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≤0.5?m

4

平整度 Level

±0.5mm/m

5

板层最低温度

（搁板进口）

Shelves temperature Min

-60℃

6

板层最高温度

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

80mm

9

干燥箱外形 

Chamber type

矩形 Rectangle

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 all 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)

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

进口AISI 304 不锈钢

1套

2

冷凝盘管

Condenser coiled pipe

AISI 304 不锈钢

1套

3

冷凝器测温探头

Temperature sensors

(condenser)

Pt-100 热电阻 A级

Pt-100 Hot resistance A Level

1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≤0.5um

4

盘管最低温度

Coiled temperature Min

-85℃

5

冷凝器捕冰能力

Condenser frosting

capacity

4Kg/批

4Kg/batch

6

冷凝器外型

Condenser type

矩形 rectangle

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 all 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、中隔阀 Big Isolation valve

序号

SN

名称

Name

型号/规格/材质

Model/Specifications/Material

数量

Number

1

电动碟阀Electric valve

DN-100

1套

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

压缩机型号及数量

Compressor model and

number

法国泰康CAJ2464

2台

2

制冷剂 

Refrigerant

R404a 绿色环保型

R404a Environment Friendly

适量

Right quantity

3

油分离器

Oil separator

美国  EMERSON

1个

4

过滤器

Filter

丹麦 DANFOSS

2个

5

压力表 Pressure meter

HONGSENG

4个

6

膨胀阀 Expansion valve

丹麦 Danfoss

3个

7

电磁阀 Solenoid valve

卡士妥 CASTEL

3个

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“泰康”机组，性能更加稳定、可靠；

Adopting the Tesumsh 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.

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

德国莱宝D16C

1台

2

泵阱隔离阀Isolation valve of pump well

DN-25mm

1个

3

泵头阀

Pump head valve

西玛特 SIEGV

1个

4

真空探头Vacuum gauge

英国“爱德华”EDWARDS APG

1个

性能参数 Performance parameters

1

极限真空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

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.

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

0.22?m

1个

2

掺气阀Aeration valve

西玛特 SIEGV

1个

3

管道Pipeline

AISI 304L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.

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

德国“威乐”WILO

RS25/8

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

1Kw

1支

4

板式热交换器

Plate heat exchanger

瑞典“阿法拉伐”

ALFALAVAL技术

1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

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，可以最有效的利用加热能源；

Electric heating is controled by PID which can use the heating energy most effectively.

H、液压系统 Hydraulic system

序号

SN

名称

Name

型号/规格/材质

Model/Specifications/Material

数量

Number

1

液压元件Hydraulic units

Dorteck

2

液压泵Hydraulic pump

Dorteck

1套

3

液压油Hydraulic oil

46#抗磨液压油

46# anti-wear hydraulic oil

1套

4

油箱Tank

6L

1套

5

压塞油缸

Stop cylinder

上海“SW”

1个

性能参数 Performance parameters

1

压塞压力

Stoppering force

0~1.0bar（可调）

0~1.0bar（adjustable）

I、电气控制系统 Electric control system

序号

SN

名称

Name

型号/规格/材质

Model/Specifications/Material

数量

Number

1

电气标准

Electric standard

IEC60204-1

／

2

PLC

日本OMRON

1套

3

计算机 

Computer

联想LENOVO

1台

4

空气开关  

Breaker

施耐德

／

5

交流接触器

AC contactor

施耐德

／

6

电气保护等级

Protection class

IP22

／

7

UPS电源 UPS power

SANTAK

1台

8

软件系统 Software system

HOS-V2

1套

控制方式 Control type

手动及自动控制 Manual and automatic

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.

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

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.

17

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.

J、公用工程清单 Utility list

1

总装机功率 

Electricity-total electrical load

5Kw (380V, 50Hz, 3Phase, 5Wire)

以上数据仅供参考，以实际设计图纸为准

K、设备主要参数 The equipment’s main technique parameter

1

整机结构

Machine construction

一体式

Union

2

外型尺寸 

Dimension of unit

约1800×900×1780mm

3

整机重量 

Weight of unit

约1.0T  (About )1.0T

4

冻干原料装量（建议值）

Capacity of raw material for freeze drying

(suggestive value)

最大4Kg/批

4kg/batch (Max)

以上数据仅供参考，以实际设计图纸为准