欣谕3平方冷冻干燥机，在线清洗小型生产冻干机

制造标准 Manufacture Standards

cGMP

A、干燥箱（含3.24m²板层） Chamber (with3.24m² 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 304 不锈钢

1套

2

板层 Shelves

AISI 304 不锈钢

1套

尺寸：900×600×20mm

Dimensions：900×600×20mm

6+1层

3

箱门 Door

AISI 304 不锈钢

AISI 304 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

板层最低温度(导热油进口)

Shelves temperature Min

-50℃

6

板层最高温度(导热油进口)

Shelves temperature Max

+70℃

7

XY冻干板层温度均匀性

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 304不锈钢

1套

2

冷凝盘管

Condenser coiled pipe

AISI 304 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 304 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

盘管最低温度

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 304 不锈钢

AISI 304 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

压缩机型号及数量

Compressor model and

number

BITZER“比泽尔”S4G-8.2Y

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

Emerson

2个

4

回气过滤器

Filter for return air

外壳Emerson，滤芯Emerson

Shell Emerson，Filter Core Emerson

2个

5

油压差控制器

Oil differential pressure

controller

丹麦 DANFOSS

2个

6

油平面视镜

Viewing port (oil level)

丹麦 DANFOSS

2个

7

压力自动保护装置

Automatic protective

device for pressure

FNC KOREA

2个

8

自动收液装置 

Automatic liquid recycling device

FNC KOREA

2个

9

气液分离器

Gas-liquid separator

DANHUA

2个

10

除酸干燥过滤器

Filter for disacidifying and drying

外壳Emerson，滤芯Emerson

Shell Emerson，Filter Core Emerson

2套

11

压力表 Pressure meter

ARRON

8个

12

顶盖阀 Tectum valve

意大利 CASTEL

2个

13

继电器 Relay

ARRON

8个

14

安全阀 Safety valve

意大利 CASTEL

2个

15

膨胀阀 Expansion valve

丹麦 Danfoss

5个

16

电磁阀 Solenoid valve

丹麦 Danfoss

2个

17

低压避震管

Low-pressure vibration

absorber

美国 YORK PA

2套

18

高压避震管

High-pressure vibration

absorber

航天“晨光”

2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

德国“莱宝”LEYBOLD D30C

2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

英国“爱德华”EDWARDS APG

2个

性能参数 Performance parameters

1

极限真空Final vacuum

≤10Pa

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

0.22µm

1个

2

掺气阀Aeration valve

西玛特 SIEGV

1个

4

管道Pipeline

AISI 304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

德国“威乐” WILO

TOP-SD40-10

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

7.5Kw

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，可以最有效的利用加热能源；

Electric heating is