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欣谕中试型XY-FD-S5E冷冻干燥机实验室多肽冻干机高配冷冻干燥机

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添加时间: 2017-10-26 18:31:26
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Lyophilizer Technical Parameters冻干(gan)机(ji)技(ji)术参数表

1XY-FD-S5E真空冷(leng)冻(dong)干燥(zao)机

制造标准 Manufacture Standards

cGMP

A、干燥箱(含(han)0.54m2板层(ceng)) Chamber (with 0.54m2 shelves)

序号SN

名称(cheng)

Name

型号/规(gui)格/材质(zhi)

Model/Specifications/Material

数量

Number

1

干(gan)燥箱(xiang) 

Chamber

316L 不锈钢

1套(tao)

2

板层 

Shelves

316L 不锈钢

1

尺寸:450×300×12mm

Dimensions450×300×12mm

4 +1

3

箱门 Door

透明树脂

colophony

1

4

验(yan)证孔(kong)  

Validation port


1个(ge)

5

制(zhi)品测温探(tan)头

Product sensors

Pt-100 热电阻 A

Pt-100 Hot resistance  A Level

2

6

导热油温(wen)度(du)探头

Temperature sensors

(thermal fluid)

Pt-100 热电阻 A

Pt-100 Hot resistance  A Level

2

性能参(can)数 Performance parameters

1

设计(ji)压力(li) 

Design pressure

常压 Normal pressure

2

设计(ji)温(wen)度

Design temperature

常温 Normal temperature

3

光洁度 Finish

Ra≤0.4µm

4

平整(zheng)度 Level

±0.5mm/m

5

板(ban)层Z低温度

(搁板进口(kou))

Shelves temperature Min

-55

6

板层(ceng)Z高温度

Shelves temperature Max

+80

7

板层温度均(jun)匀性

Shelves temperature

uniformity

±1°C(空载平衡(heng)后)

±1°Csoak stage

8

搁(ge)板间(jian)距 

Spacing

80mm

9

干燥(zao)箱外形 

Chamber type

圆桶体cylinder

10

保温层 Insulation

硅酸(suan)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 users requirements

12

开门角(jiao)度 

Open angle

大于110 More than 110°

13

门(men)密封条

Sealing strips for doors

O型(xing)硅橡胶 O-shaped silicone rubber

技(ji)术优势 Technical advantages

1

不锈钢板材均采用卫(wei)生级不(bu)锈钢(gang)板材保(bao)(bao)证箱(xiang)体(ti)表面光洁度(du),从(cong)而(er)保(bao)(bao)证无菌要求

Stainless steel plates are all sanitary stainless steel plates. Ensure the finish of chamber surfaces, and then ensure the asepsis requirement.

 

2

板层(ceng)具有高强度,能够耐受长期(qi)使用(yong);

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(xie)加工,可(ke)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(jing)度(du)±0.5(PID调节);

Temperature control accuracy±0.5 (adjusted by PID)

5

箱体(ti)、板层、软管均采用氦质谱(pu)仪进行泄漏(lou)检验

Chamber, shelves, flexible hoses are all carried out the leak test by helium mass spectrometer.

B、冷凝器(含(han)盘管) Condenser (with coiled pipe)

序号

SN

名称

Name

型号/规格/材质(zhi)

Model/Specifications/Material

数(shu)量(liang)

Number

1

冷凝器  

Condenser

304 不锈钢

1

2

冷(leng)凝盘管

Condenser coiled pipe

304 不(bu)锈钢

1套(tao)

3

冷凝器测温探头

Temperature sensors

(condenser)

Pt-100 热电阻(zu) A

Pt-100 Hot resistance A Level

1

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(guang)洁度(du) Finish

Ra≤0.4um

4

盘管Z低(di)温度

Coiled temperature Min

-75

5

冷(leng)凝器捕冰能力

Condenser frosting

capacity

10Kg/

10Kg/batch

6

冷凝器外型(xing)

Condenser type

圆桶体(ti)

cylinder

技术优势 Technical advantages

1

不锈钢(gang)板材均采用卫(wei)生级不锈钢(gang)板材保证箱体(ti)表面光洁度(du),从而保证无菌(jun)要(yao)求

Stainless steel plates are all sanitary stainless steel plates. 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(jin)行泄(xie)漏检验

Condenser and coiled pipe are all carried out the leak test by helium mass spectrometer.

C中隔 Big Isolation valve

 

序号(hao)

SN

名称

Name

型号/规格(ge)/材质

Model/Specifications/Material

数量(liang)

Number

1

电动碟阀(fa)Electric valve

DN-100

1

D、制(zhi)冷系(xi)统 Refrigeration system

序号

SN

名称(cheng)

Name

型(xing)号/规格/材质

Model/Specifications/Material

数量(liang)

Number

1

压(ya)缩机型号及数(shu)量

Compressor model and

number

BITZER比(bi)泽尔S4T-5.2Y

1

2

制冷剂(ji) 

Refrigerant

R404a 绿色环保型

R404a Environment Friendly

适量

Right quantity

3

油(you)分离(li)器

Oil separator

美G  EMERSON

1

4

回气过(guo)滤器(qi)

Filter for return air

外壳EMERSON,滤芯(xin)EMERSON

Shell EMERSONFilter Core EMERSON

1

5

油压差控制器

Oil differential pressure

controller

丹麦 DANFOSS

1

6

油平面视镜(jing)

Viewing port (oil level)

丹麦 DANFOSS

1

7

压力自动保护装置

Automatic protective

device for pressure

丹麦(mai) DANFOSS

1

8

自动(dong)收液(ye)装置(zhi) 

Automatic liquid recycling device

丹(dan)麦 DANFOSS

1

9

气液(ye)分(fen)离器

Gas-liquid separator

DANHUA

1个(ge)

10

除(chu)酸干(gan)燥过滤器

Filter for disacidifying and drying

外壳EMERSON,滤芯EMERSON

Shell EMERSONFilter Core EMERSON

1套(tao)

11

压力表(biao) Pressure meter

瑞士 REFCO

1个(ge)

12

顶盖(gai)阀 Tectum valve

意大利 CASTEL

1

13

继(ji)电器(qi) Relay

丹麦 DANFOSS

3

14

安全(quan)阀 Safety valve

意大(da)利 CASTEL

1

15

膨胀(zhang)阀(fa) Expansion valve

丹麦 Danfoss

3个(ge)

16

电磁阀 Solenoid valve

丹麦 Danfoss

2个(ge)

17

低压避震管(guan)

Low-pressure vibration

absorber

美(mei)G YORK PA

1

18

高压避震管

High-pressure vibration

absorber

航天(tian)晨光(guang)

1套(tao)

性(xing)能参数 Performance parameters

1

板(ban)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(du)(空(kong)载)

Condenser cooling time

(empty)

+20 -40°C ≤ 30 minutes

技术优势(shi) Technical advantages

1

压缩机采用“比泽尔”机组(zu),性能更加稳定、可靠(kao);

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(zhi)冷系统具有各项保(bao)护(hu)功能,连锁保(bao)护(hu);

The refrigeration system has all kinds of protection functions and interlock protection.

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.

制冷(leng)系统(tong)油压(ya)压(ya)力多(duo)重保(bao)护功能;

The poly-protection function of oil pressure in the refrigeration system.

压缩机电机多(duo)重保护(hu)功能;

The poly-protection function of compressor motor

E、真空系统 Vacuum system

序号

SN

名称

Name

型号(hao)/规格/材(cai)质

Model/Specifications/Material

数量

Number

1

真空泵

Vacuum pump

优成 TRP-24

1

2

泵阱隔离阀Isolation valve of pump well

DN-25mm

1

3

泵(beng)头阀

Pump head valve

西特(te) SIEGV

1

4

真空探(tan)头Vacuum gauge

英G爱(ai)德华EDWARDS APG

1

性能参(can)数 Performance parameters

1

J限真空Final vacuum

5Pa

2

抽气速度Evacuation time

从大气压抽至10pa30min  From atm to 10pa30min

3

泄漏率Leakage rate

5×10-3pa.m3/sec

技(ji)术(shu)优势 Technical advantages

1

GX泵(beng)头阀(fa)与真空(kong)泵(beng)同时打开和关(guan)闭,可大大防止真空(kong)泵(beng)油(you)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(fu)压掺(chan)气系统 Aeration system for repressing

序号

SN

名称(cheng)

Name

型(xing)号/规(gui)格/材质

Model/Specifications/Material

数量

Number

1

过滤器Filter

0.22µm

1

2

掺气阀Aeration valve

西 SIEGV

1

3

管道Pipeline

316L不锈(xiu)钢

1套(tao)

技术(shu)优势(shi) Technical advantages

1

管道全部采用自(zi)动焊接,保证内外壁(bi)光洁;

All the pipelines use the automatic welding which will ensure the finish of inner and outer surface.

G、循(xun)环系(xi)统 Circulation system

序号

SN

名称

Name

型(xing)号/规(gui)格/材质(zhi)

Model/Specifications/Material

数(shu)量

Number

1

循环泵 

Circulation pump

德G“威乐(le)”WILO

TOP-SD32/7

1

2

导热(re)油 

Thermal fluid

低粘度硅油

Silicon oil (low viscosity)

适量(liang)

Right quantity

3

电(dian)加(jia)热 Heater

1Kw

1

4

板(ban)式热交换器

Plate heat exchanger

瑞(rui)典“阿(a)法拉伐(fa)ALFALAVAL

1

5

导热油测(ce)温探头

Temperature sensors(thermal fluid)

Pt-100 热电阻(zu) A

Pt-100 Hot resistance A Level

2支(zhi)

6

温(wen)度控制(zhi)器(qi)

Temperature controller

丹麦丹佛斯DANFOSS

1

性能参数(shu) Performance parameters

1

加热速度(du)

Heating rate

1°C/min

2

硅(gui)油粘度

Silicon oil viscosity

2cSt 25

技术优势 Technical advantages

1

电(dian)加(jia)热采用PID能(neng)量(liang)调节控制(zhi),可以Z有效的(de)利用加热能(neng)源(yuan);

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

H、液(ye)压系统(tong) Hydraulic system

序号

SN

名称

Name

型号/规格(ge)/材质

Model/Specifications/Material

数量

Number

1

液压元件Hydraulic units

柔肯ROKEN


2

液(ye)压泵Hydraulic pump

柔肯ROKEN

1

3

液压油Hydraulic oil

46#抗磨液压油

46# anti-wear hydraulic oil

1

4

油箱Tank

14L

1

性能参数 Performance parameters

1

压塞压力

Stoppering force

0~1.0bar(可调)

0~1.0baradjustable

I、电气控制系统(tong) Electric control system

序(xu)号

SN

名称(cheng)

Name

型号/规格/材质

Model/Specifications/Material

数量

Number

1

电(dian)气标准(zhun)

Electric standard

IEC60204-1

2

PLC

日本OMRON

1

3

计算(suan)机(ji) 

Computer

联想LENOVO

1

4

触摸屏 

Touch screen

日(ri)本OMRON

1

5

空气(qi)开关  

Breaker

正泰

6

交流接触器

AC contactor

施耐(nai)德

7

电(dian)气保(bao)护(hu)等级

Protection class

IP22

9

软件系(xi)统(tong) Software system

XY-HMI-V2

1套(tao)

10

软(ruan)件备份光盘

CD for sofrware backup


1

控制方式 Control type

手动及自动控制 Manual and automatic

软(ruan)件功能 Software function

1

冷(leng)冻(dong)干燥(手动(dong)、自动(dong),可任意切换)

Freeze drying (switch the type between manual and automatic randomly)

2

工艺设定(配(pei)方(fang)管(guan)理)

Technique setting (recipe management)

技术优势 Technical advantages

1

符合FDA欧盟标准(zhun),电(dian)子签名(ming),多(duo)组(zu)密(mi)码;

It accords with European standard FDA. There are electronic signatures and multiple passwords.

2

自动、手动在(zai)任何节点任意切换;

Switch the type between manual and automatic at any point randomly.

3

系统操(cao)作可在无菌室、机房(fang)、冻(dong)干控(kong)制室(shi)进(jin)行,并且(qie)相(xiang)互(hu)(hu)具(ju)有互(hu)(hu)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(shi)装有液(ye)压急(ji)停按(an)钮(niu),可在紧急(ji)情况下强制停止板层运(yun)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(mian)具(ju)有各(ge)种部(bu)件(jian)、阀门工作状态及温度、真(zhen)空度参数显(xian)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(fang)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(fang)管理”可(ke)实(shi)现:低(di)温进箱(xiang)、二次回(hui)冻(反(fan)复预冻)、压力升测试(shi)、掺气(qi)阀或者(zhe)小碟(die)阀选择性(xing)掺气(qi)控制、自动(dong)放气(qi)和压塞(sai)、低(di)温出箱(xiang)等个(ge)性(xing)功(gong)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(dong)干(gan)燥”自(zi)动过程有阶段(duan)(duan)显示功能,并可任意跳段(duan)(duan);

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(zheng);

The recipe can be adjusted momentarily in the freeze drying process.

10

操作画面具有各个故障点显(xian)示功(gong)能;

There is a function for displaying various trouble points on the operation interface.

11

具(ju)有(you)数(shu)据、曲线两种记录(lu)功能,可根(gen)据批(pi)号随时调用或打(da)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(ke)存储无数条数据、曲线记(ji)录;

It can save countless data and curves records.

13

各(ge)个真空度(du)、温度(du)曲线(xian)由多种(zhong)颜色显示,并(bing)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(gan)燥”完成后,可(ke)将“工艺配方”、“数据曲线”、“历史记(ji)录”、“操作记(ji)录”、“报警记(ji)录”等(deng)原始记(ji)录一起打印(yin),可(ke)作为批(pi)产(chan)品的(de)详细批(pi)记(ji)录进行(xing)保存(cun);

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(shi)际使(shi)用需要增加(jia)相(xiang)应软件功能;

It can increase corresponding software function according to actual requirements of customer.

16

软件系统符合(he)FDA 21CFR PART II

Software system accords with FDA 21CFR PART II.

17

电(dian)子签名,三级用户权限管理,曲(qu)线报(bao)表不可修改;

There are electronic signatures and three stage authorization managements. The curve charts can not be modified.

18

UPS不间断电源可(ke)在紧急停电后20分钟内给PLC及各(ge)类传感器提供电(dian)力(li);

UPS(uninterrupted power supply) will supply power to PLC and various sensors in 20 minutes after emergency power shut off.


J、公(gong)用(yong)工程清(qing)单(dan) Utility list


1

总装(zhuang)机功(gong)率 

Electricity-total electrical load

8Kw (380V, 50Hz, 3Phase, 5Wire)


2

用于制冷(leng)系统(tong)的冷(leng)却水

Cooling water for refrigerant cooling

4m3/hr (1.5≤P≤2bar, 15≤T≤30)


以(yi)上数据(ju)仅供参考(kao),以(yi)实际设计(ji)图纸为(wei)准


K、设(she)备主要(yao)参数(shu) The equipments main technique parameter


1

整机结(jie)构

Machine construction

一体式

Union


2

外型尺寸 

Dimension of unit

1815×900×1780mm


3

整机重量 

Weight of unit

1.5T  (About )1.5T


4

西林瓶装量(liang)

Filling volume of vial

Ф22mm  1160支(zhi)

Ф16mm  2260


5

冻干原料装量(建议(yi)值)

Capacity of raw material for freeze drying

(suggestive value)

Z大8Kg/

8kg/batch (Max)


以上数(shu)据仅供参(can)考,以实际设计图纸(zhi)为准

L、验证(zheng)文件(jian)系统(电(dian)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(hao)SN

名称(cheng)

Name

数量

Number

1

安装确认  Installation qualitationIQ

1

2

操作确认  Operation qualitationOQ

1套(tao)

3

性能确认  Performance qualitationPQ

1套(tao)

4

工厂验收(shou)测(ce)试  Factory acceptance testFAT

1

5

客户(hu)现场(chang)验收测试  Site acceptance testSAT

1

6

操作手册(ce)  Operation manual (OM)

1套(tao)

7

维护手册(ce)  Maintenance manual (MM)

1套(tao)

8

安装手(shou)册 Installation manual (IM)

1套(tao)

9

平面(mian)布置图 Layout drawing

1

10

工艺流程图 P&ID

1套(tao)

11

电气(qi)线路(lu)图 Wiring drawing

1套(tao)

12

主要部件说(shuo)明书 Instruction for the main parts

1

13

材质报告 Material report

1

14

校验报Verification report

1

 


 

 

M、备(bei)品备(bei)件

序号

Serial number

名称

Name

型号/规格/材质

Model/Specifications/Material

数(shu)量

Number

1

氟(fu)利(li)昂Freon

R404A

10.9kg

2

冷冻机油

Refrigeration oil

BITZER专(zhuan)用

5.0L

3

电(dian)磁阀

Solenoid valve

DANFOSS

1

4

电磁阀线圈

Solenoid valve coil

DANFOSS

2

5

测温(wen)探(tan)头(tou)

Temperature probe

PT-100单支

5

6

高压压力表(biao)

High-pressure gage

REFCO

1

7

低压(ya)压(ya)力表

Low-pressure gage

REFCO

1

8

干燥过滤器

Dry filter core

DANFOSS

2

9

真空泵油

Vacuum pump oil

优成

4L

10

制冷专用板手

Special wrench for cooling

COOLMAX

1

11

制冷专(zhuan)用(yong)加液管

Special liquid inlet tube for cooling

HONGSEN

1

12

制冷剂加液表

Dosing table  for refrigerant

HONGSEN

1

 图片1_副本.jpg


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产品中心

冷水机,超低温冰(bing)箱,冷冻干燥机,冻干机,低温槽,制冰(bing)机,层(ceng)析(xi)冷柜,气(qi)溶胶喷雾器,程序冷冻装置,染色(se)体分析(xi)系统。

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上海欣谕仪器有(you)限公司(si)主要产品:冷(leng)(leng)(leng)(leng)水(shui)机(ji)冷(leng)(leng)(leng)(leng)冻(dong)水(shui)机(ji),冷(leng)(leng)(leng)(leng)却水(shui)循(xun)环(huan)机(ji),冰水(shui)机(ji),超低温冰箱,冻(dong)干(gan)机(ji)冷(leng)(leng)(leng)(leng)冻(dong)干(gan)燥机(ji),低温槽,恒温槽,制冰机(ji),层析冷(leng)(leng)(leng)(leng)柜(ju),冷(leng)(leng)(leng)(leng)藏柜(ju),气溶胶喷雾器,程(cheng)序冷(leng)(leng)(leng)(leng)冻(dong)装置,冷(leng)(leng)(leng)(leng)冻(dong)仪,染(ran)色(se)体分(fen)析系统(tong)。

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