上海欣谕XY-FD-S40 (SIP、CIP)真空冷冻干燥机

制造标准Manufacture Standards

cGMP

A、干燥箱（含41.86m²板层）Chamber (with41.86m² 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

尺寸：2000×1495×24mm

Dimensions：2000×1495×24mm

14+1层

3

箱门Door

AISI 316L 不锈钢(部分)

AISI 316L stainless steel (Section)

1套

4

干燥箱视镜

Viewing port (chamber)

DN150 mm 带延时照明灯

DN150 mm With time delay head lamp

1个

5

箱门视镜

Viewing port (door)

DN150 mm

1个

6

验证孔Validation port

3D设计 3D design

1个

7

安全插销门锁系统

Door lock system with safe bolt

“XY”独特设计

Unique design by XINYU

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

0.15Mpa(绝对压力0.25MPa)

2

设计温度

Design temperature

128℃

3

光洁度Finish

Ra≤0.4µm

4

平整度Level

±0.5mm/m

5

板层最低温度(导热油进口)

Shelves temperature Min

-55℃

6

板层最高温度(导热油进口)

Shelves temperature Max

+80℃

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

120mm

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

T型硅橡胶 T-shaped silicone rubber

技术优势Technical advantages

1

保证箱体表面光洁度，从而保证无菌要求；

Ensure the finish of chamber surfaces, and then ensure the asepsis requirement.

2

国际先进的3D管口设计，更符合彻底灭菌要求；

International advanced nozzle design of 3D more accords with the requirements of thorough sterilization.

3

专利设计的安全插销门锁系统，独立监控，联锁运行，更加安全可靠；

Door lock system with safe bolt which is patented designed is independent monitoring and interlock working. It makes the performance be more safe and relibale.

4

板层具有很高强度，能够耐受长期使用； 

Shelves has high intensity and can be able to bear the long term usage.

5

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.

6

板层油缸装有AISI 316L不锈钢波纹管，可防止液压油扩散，并且具有在线检测完整性功能；

Shelves cylinder is equipped with the AISI 316L stainless steel bellows which can prevent cylinder oil from spreading and has a integrity function of in place inspection.

7

板层控温精度±0.5℃（PID调节）；

Temperature control accuracy±0.5℃ (adjusted by PID)

8

特殊T型门密封条，可防止积水，更加符合无菌要求；

Special T-shaped sealing strips for doors can prevent ponding which more accords with the asepsis requirement.

9

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

DN150mm 带延时照明灯

DN150 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

0.15Mpa(绝对压力0.25MPa)

2

设计温度

Design temperature

128℃

3

光洁度Finish

Ra≤0.4um

4

盘管最低温度

Coiled temperature Min

-75℃

5

冷凝器捕冰能力

Condenser frosting

capacity

800Kg/批

800Kg/batch

6

冷凝器外型

Condenser type

卧式圆桶体

Horizontal cylinder

技术优势Technical advantages

1

保证箱体表面光洁度，从而保证无菌要求；

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 316L 不锈钢

AISI 316L stainless steel

1套

2

蘑菇阀油缸

Mushroom valve cylinder

上海“SW”70/125

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

DN900mm

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

KEBELCO“日本神户制钢”KS10LTH

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

“法斯克”（天津）

2个

4

冷却水流量开关 Flow switch for cooling water

韩国 HFS

1个

6

电磁阀 Solenoid valve

丹麦 DANFOSS

10个

7

膨胀阀 Expansion valve

丹麦 DANFOSS

10个

8

顶盖阀 Tectum valve

意大利 CASTEL

10个

9

黄铜丝口闸阀 Brake valve with screwed brass

宁波 永享

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

安全阀 Safety valve

意大利 CASTEL

2个

12

储液罐角阀 Angle valve for fluid reserve tank

台湾 SY

4个

13

视液镜 Viewing port

丹麦 DANFOSS

2个

14

手动球阀

Manual globe valve

意大利 CASTEL

4个

15

单向阀 Check valve

HELDON或ARROW

2个

16

油冷却器  Oil condenser

“法斯克”（天津）

2个

17

油压差继电器 Oil differential pressure relay

丹麦“丹佛斯”DANFOSS

2个

18

压力表 Pressure meter

日本 KOBELCO

4个

19

高低压压力继电器

Pressure relay (high/low pressure)

丹麦“丹佛斯”DANFOSS

2个

20

温度指示计

Temperature indicator

日本 NESS

2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

压缩机采用日本神户制钢螺杆机组，性能非常稳定、可靠；

Adopting the KEBELCO KS10STH 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.

4

回气温度能够进行控制；Back temperature can be controlled.

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

英国“爱德华”EDWARDS E2M175

2台

2

罗茨泵Roots pump

英国“爱德华”EDWARDS EH1200

1台

3

泵阱隔离阀Isolation valve of pump well

德国“盖米”GEMU DN150mm

1个

4

泵头阀Pump head valve

西玛特SIEGV

2个

5

阀门反馈信号Feedback signal of valve

德国ROTECH

1套

6

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

1Pa

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

真空系统阀门具有反馈信号，可了解开关的真实性；

The valve in vacuum system has the feedback signal which reflects the authenticity of switch.

2

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.

3

罗茨泵可与真空泵同时启动；

The roots pump and vacuum pump can be started simultaneously.

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

3

隔膜阀Diaphragm valve

德国GEMU或BURKERT

1套

4

管道Pipeline

AISI 316L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

过滤器可进行在位蒸汽灭菌，操作更换方便；

Filter can be sterilized in place which makes the operation and replacement be more convient.

3

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“海密梯克” CNF 50-160

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

60Kw

1支

4

板式热交换器Plate heat exchanger

瑞典“阿法拉伐”ALFALAVAL

4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 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

意大利“海普液压” HYDR-APP

2

液压泵Hydraulic pump

意大利“海普液压” HYDR-APP

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

60L

1套

5

性能参数Performance parameters

1

压塞压力

Stoppering force

0~1.0bar（可调）

0~1.0bar（adjustable）

技术优势Technical advantages

1

液压系统设置有“背压阀”，在蒸汽灭菌时可对油缸腔室进行泄压，避免损坏；

There is a back pressure valve in hydraulic system by which cylinder chamber can release pressure when it is steam sterilizing in order to prevent damage.

2

压塞液压缸具有防滑落装置

Stoppering hydraulic cylinder has the antiskid device.

3

板层实现动态清洗

Dynamic washing for shelves is achieved.

4

能准确判断板层是否全部升起和板层是否全部落下

It is sure whether all the shelves rise or fall.

I、气动系统Pneumatic system

序号

SN

名称

Name

型号/规格/材质

Model/Specifications/Material

数量

Number

1

气动元件Pneumatic Units

台湾“AIRTAC”亚德客

1套

技术优势Technical advantages

1

带润滑的气动系统可以保证阀门有效开关；

Pneumatic system with lubrication device can ensure that valves turn ON or OFF effectively.

2

带过滤器的气动系统可以保证阀门稳定性；

Pneumatic system with filter can ensure stability of valves.

J、在线清洗、在线灭菌系统 （SIP、CIP）  CIP and SIP system (SIP、CIP)

序号

SN

名称

Name

型号/规格/材质

Model/Specifications/Material

数量

Number

1

喷嘴Nozzle

美国“喷雾”SSC

1套

2

管道Pipeline

AISI 316L

1套

3

进水进汽阀门Inlet Vavle

德国“盖米”GEMU或“宝帝”

1套

4

排水阀门 Drain Valve

新莱“King Lai”& 意大利“AT”

1套

5

安全阀Safety vavle

英国 GRESSWELL

2个

6

疏水器Steam trap

日本MIYAWAKA 

2个

7

电接点压力表

Electronic contactor

德国WIKA

1个

8

压力变送器

Pressure transmitter

英国GEMS

2个

9

水环泵Water-ring pump

山东“纳西姆”2BV-5110 或“斯特林”LEM150或者SIHI斯赫

1台

技术优势Technical advantages

1

与箱体连接管道全部采用符合卫生标准管材，更符合无菌要求；

All the pipes which link the chamber are pipes which accord with sanitary standard, and they accord more with asepsis requirement.

2

管道全部采用自动焊接，内窥镜检查；

Adopt automatic welding for all pipes, and inspect them by endoscope.

3

箱体带有冷却夹套，可以在蒸汽灭菌后迅速对箱体进行冷却；

Chamber has some cooling jackets which can cool it quickly after steam sterilizing.

4

排蒸汽冷却装置，避免地漏系统受到蒸汽影响；

Cooling device for steam draining prevents the floor draining system from being affected by steam

5

排水口设置有过滤网；

A filter screen set near the outfall.

6

排水系统设置有单向阀及压差控制功能，避免倒吸；

A check valve set in drain system and the function of difference pressure control can prevent backflow.

K、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

触摸屏Touch screen

日本OMRON

1个

5

空气开关Breaker

德国 SIEMENS

／

6

交流接触器AC contactor

德国 SIEMENS

／

7

电气保护等级

Protection class

IP22

／

8

UPS电源  

UPS power

SANTAK

1台

9

软件系统Software system

TF-HOS-V2

1套

10

软件备份光盘

CD for sofrware backup

1份

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

化霜（水浸泡、蒸汽）De-icing (water soak, steam)

3

在线清洗（手动、自动）Cleaning in place (manual, automatic)

4

在线灭菌（手动、自动）Sterilization in place (manual, automatic)

5

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

一键式体检功能，为冻干机的健康提供数据保障；

One touch function for examination provides data protection for the health of lyophilizer.

4

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.

5

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.

6

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.

7

“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”.

8

“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”.

9

“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.

10

“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.

11

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.

12

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.

13

可存储无数条数据、曲线记录；

It can save countless data and curves records.

14

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.

15

“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.

16

“在线清洗”可实现自动控制；

“Cleaning in place”can be automatically controled.

17

“在线消毒”功能具有安全连锁保护；脉动预热消毒

There is a safety interlock protection device in the“Sterilization in place”system, and it sterilizes by pulsant preheating.

18

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.

19

软件系统符合FDA 21CFR PART II；

Software system accords with FDA 21CFR PART II.

20

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.

21

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.

L、公用工程清单Utility list

1

总装机功率Total power

186Kw (380V, 50Hz, 3Phase, 5Wire)

2

用于制冷系统的冷却水

Cooling water for refrigerant cooling

45m³/hr (1.5≤P≤2bar, T≤25°C)

3

冻干箱清洗用水Water for chamber cleaning

380L/min (P≥5bar, T=80°C)

4

用于气动阀的压缩空气

Compressed air for pneumatic valve

100L/min (5≤P≤8bar)

5

SIP纯蒸汽用量 Pure steam consumption for SIP

600kg/batch (2≤P≤3bar)

6

化霜用蒸汽Steam for de-icing

190kg/batch (2≤P≤3bar)

以上数据仅供参考，以实际设计图纸为准

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

1

整机结构

Machine construction

分体式

Split

2

外型尺寸 Dimension of unit

约10100*2850*3600mm

3

整机重量 Weight of unit

约30T  (About )30T

4

西林瓶装量

Filling volume of vial

Ф22mm  87600支

Ф16mm  172000支

5

冻干原料装量（建议值）

Capacity of raw material for freeze drying

(suggestive value)

最大640Kg/批

640kg/batch (Max)

以上数据仅供参考，以实际设计图纸为准

O、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

压力容器质量证书  Quality certificate for pressure vessel

1套

14

材质报告  Material report

1套

15

校验报告  Verification report

1套