A、干燥箱（含0.54m²板層） Chamber (with 0.54m² shelves)

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型號(hào)/規(guī)格/材質(zhì)

Model/Specifications/Material

數(shù)量

Number

1

干燥箱 

Chamber

316L 不銹鋼

1套

2

板層 

Shelves

316L 不銹鋼

1套

尺寸：450×300×12mm

Dimensions：450×300×12mm

4 +1層

3

箱門 Door

透明樹脂

colophony

1套

4

驗(yàn)證孔  

Validation port

1個(gè)

5

制品測(cè)溫探頭

Product sensors

Pt-100 熱電阻 A級(jí)

Pt-100 Hot resistance  A Level

2支

6

導(dǎo)熱油溫度探頭

Temperature sensors

(thermal fluid)

Pt-100 熱電阻 A級(jí)

Pt-100 Hot resistance  A Level

2支

性能參數(shù) Performance parameters

1

設(shè)計(jì)壓力 

Design pressure

常壓 Normal pressure

2

設(shè)計(jì)溫度

Design temperature

常溫 Normal temperature

3

光潔度 Finish

Ra≤0.4µm

4

平整度 Level

±0.5mm/m

5

板層Z低溫度

（擱板進(jìn)口）

Shelves temperature Min

-55℃

6

板層Z高溫度

Shelves temperature Max

+80℃

7

板層溫度均勻性

Shelves temperature

uniformity

±1°C（空載平衡后）

±1°C（soak stage）

8

擱板間距 

Spacing

80mm

9

干燥箱外形 

Chamber type

圓桶體cylinder

10

保溫層 Insulation

硅酸鋁和聚氨酯發(fā)泡材料

Aluminum silicate and polyisocyanurate foam

11

開門方向 

Open direction

根據(jù)用戶要求確定 According to user’s requirements

12

開門角度 

Open angle

大于110度 More than 110°

13

門密封條

Sealing strips for doors

O型硅橡膠 O-shaped silicone rubber

技術(shù)優(yōu)勢(shì) Technical advantages

1

不銹鋼板材均采用衛(wèi)生級(jí)不銹鋼板材，保證箱體表面光潔度，從而保證無(wú)菌要求；

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

3

板層通過(guò)機(jī)械加工，可保證高要求平整度；

Shelves are processed by machining which can ensure the demanding level.

4

板層控溫精度±0.5℃（PID調(diào)節(jié)）；

Temperature control accuracy±0.5℃ (adjusted by PID)

5

箱體、板層、軟管均采用氦質(zhì)譜儀進(jìn)行泄漏檢驗(yàn)；

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

B、冷凝器（含盤管） Condenser (with coiled pipe)

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1

冷凝器  

Condenser

304 不銹鋼

1套

2

冷凝盤管

Condenser coiled pipe

304 不銹鋼

1套

3

冷凝器測(cè)溫探頭

Temperature sensors

(condenser)

Pt-100 熱電阻 A級(jí)

Pt-100 Hot resistance A Level

1支

性能參數(shù) Performance parameters

1

設(shè)計(jì)壓力 

Design pressure

常壓Normal pressure

2

設(shè)計(jì)溫度

Design temperature

常溫Normal temperature

3

光潔度 Finish

Ra≤0.4um

4

盤管Z低溫度

Coiled temperature Min

-75℃

5

冷凝器捕冰能力

Condenser frosting

capacity

10Kg/批

10Kg/batch

6

冷凝器外型

Condenser type

圓桶體

cylinder

技術(shù)優(yōu)勢(shì) Technical advantages

1

不銹鋼板材均采用衛(wèi)生級(jí)不銹鋼板材，保證箱體表面光潔度，從而保證無(wú)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

冷凝器、盤管采用氦質(zhì)譜儀進(jìn)行泄漏檢驗(yàn)；

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

C、中隔閥 Big Isolation valve

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1

電動(dòng)碟閥Electric valve

DN-100

1套

D、制冷系統(tǒng) Refrigeration system

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1

壓縮機(jī)型號(hào)及數(shù)量

Compressor model and

number

BITZER“比澤爾"S4T-5.2Y

1臺(tái)

2

制冷劑 

Refrigerant

R404a 綠色環(huán)保型

R404a Environment Friendly

適量

Right quantity

3

油分離器

Oil separator

美G  EMERSON

1個(gè)

4

回氣過(guò)濾器

Filter for return air

外殼EMERSON，濾芯EMERSON

Shell EMERSON，Filter Core EMERSON

1個(gè)

5

油壓差控制器

Oil differential pressure

controller

丹麥 DANFOSS

1個(gè)

6

油平面視鏡

Viewing port (oil level)

丹麥 DANFOSS

1個(gè)

7

壓力自動(dòng)保護(hù)裝置

Automatic protective

device for pressure

丹麥 DANFOSS

1個(gè)

8

自動(dòng)收液裝置 

Automatic liquid recycling device

丹麥 DANFOSS

1個(gè)

9

氣液分離器

Gas-liquid separator

DANHUA

1個(gè)

10

除酸干燥過(guò)濾器

Filter for disacidifying and drying

外殼EMERSON，濾芯EMERSON

Shell EMERSON，Filter Core EMERSON

1套

11

壓力表 Pressure meter

瑞士 REFCO

1個(gè)

12

頂蓋閥 Tectum valve

意大利 CASTEL

1個(gè)

13

繼電器 Relay

丹麥 DANFOSS

3個(gè)

14

安全閥 Safety valve

意大利 CASTEL

1個(gè)

15

膨脹閥 Expansion valve

丹麥 Danfoss

3個(gè)

16

電磁閥 Solenoid valve

丹麥 Danfoss

2個(gè)

17

低壓避震管

Low-pressure vibration

absorber

美G YORK PA

1套

18

高壓避震管

High-pressure vibration

absorber

航天“晨光"

1套

性能參數(shù) Performance parameters

1

板層制冷速度（空載）

（擱板進(jìn)口）

Shelf cooling time (empty)

+20 ～ -40°C ≤ 60 minutes

2

冷凝器制冷速度（空載）

Condenser cooling time

(empty)

+20 ～ -40°C ≤ 30 minutes

技術(shù)優(yōu)勢(shì) Technical advantages

1

壓縮機(jī)采用“比澤爾"機(jī)組，性能更加穩(wěn)定、可靠；

Adopting the BITZER compressor makes the performance be more stable and relibale.

2

采用符合蒙特利爾公約的環(huán)保型制冷劑；

Adopt the environmental protection type refrigerant which accords with the Montreal Convention.

3

制冷系統(tǒng)具有各項(xiàng)保護(hù)功能，連鎖保護(hù)；

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

①

凍干后期低負(fù)荷條件下的壓力自動(dòng)調(diào)整功能；

The automatic adjustment function of pressure under the condition of low load in the late of freeze drying period.

②

制冷系統(tǒng)油壓壓力多重保護(hù)功能；

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

③

壓縮機(jī)電機(jī)多重保護(hù)功能；

The poly-protection function of compressor motor

E、真空系統(tǒng) Vacuum system

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型號(hào)/規(guī)格/材質(zhì)

Model/Specifications/Material

數(shù)量

Number

1

真空泵

Vacuum pump

優(yōu)成 TRP-24

1臺(tái)

2

泵阱隔離閥Isolation valve of pump well

DN-25mm

1個(gè)

3

泵頭閥

Pump head valve

西瑪特 SIEGV

1個(gè)

4

真空探頭Vacuum gauge

英G“愛(ài)德華"EDWARDS APG

1個(gè)

性能參數(shù) Performance parameters

1

J限真空Final vacuum

5Pa

2

抽氣速度Evacuation time

從大氣壓抽至10pa≤30min  From atm to 10pa≤30min

3

泄漏率Leakage rate

5×10^-3pa.m³/sec

技術(shù)優(yōu)勢(shì) Technical advantages

1

GX泵頭閥與真空泵同時(shí)打開和關(guān)閉，可大大防止真空泵油逆向擴(kuò)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、復(fù)壓摻氣系統(tǒng) Aeration system for repressing

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1

過(guò)濾器Filter

0.22µm

1個(gè)

2

摻氣閥Aeration valve

西瑪特 SIEGV

1個(gè)

3

管道Pipeline

316L不銹鋼

1套

技術(shù)優(yōu)勢(shì) Technical advantages

1

管道全部采用自動(dòng)焊接，保證內(nèi)外壁光潔；

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

G、循環(huán)系統(tǒng) Circulation system

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Number

1

循環(huán)泵 

Circulation pump

德G“威樂(lè)"WILO

TOP-SD32/7

1臺(tái)

2

導(dǎo)熱油 

Thermal fluid

低粘度硅油

Silicon oil (low viscosity)

適量

Right quantity

3

電加熱 Heater

1Kw

1支

4

板式熱交換器

Plate heat exchanger

瑞典“阿法拉伐"ALFALAVAL

1個(gè)

5

導(dǎo)熱油測(cè)溫探頭

Temperature sensors(thermal fluid)

Pt-100 熱電阻 A級(jí)

Pt-100 Hot resistance A Level

2支

6

溫度控制器

Temperature controller

丹麥“丹佛斯"DANFOSS

1個(gè)

性能參數(shù) Performance parameters

1

加熱速度

Heating rate

1°C/min

2

硅油粘度

Silicon oil viscosity

2cSt 25℃

技術(shù)優(yōu)勢(shì) Technical advantages

1

電加熱采用PID能量調(diào)節(jié)控制，可以Z有效的利用加熱能源；

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

H、液壓系統(tǒng) Hydraulic system

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Number

1

液壓元件Hydraulic units

柔肯ROKEN

2

液壓泵Hydraulic pump

柔肯ROKEN

1套

3

液壓油Hydraulic oil

46#抗磨液壓油

46# anti-wear hydraulic oil

1套

4

油箱Tank

14L

1套

性能參數(shù) Performance parameters

1

壓塞壓力

Stoppering force

0~1.0bar（可調(diào)）

0~1.0bar（adjustable）

I、電氣控制系統(tǒng) Electric control system

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Name

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Model/Specifications/Material

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Number

1

電氣標(biāo)準(zhǔn)

Electric standard

IEC60204-1

／

2

PLC

日本OMRON

1套

3

計(jì)算機(jī) 

Computer

聯(lián)想LENOVO

1臺(tái)

4

觸摸屏 

Touch screen

日本OMRON

1個(gè)

5

空氣開關(guān)  

Breaker

正泰

／

6

交流接觸器

AC contactor

施耐德

／

7

電氣保護(hù)等級(jí)

Protection class

IP22

／

9

軟件系統(tǒng) Software system

XY-HMI-V2

1套

10

軟件備份光盤

CD for sofrware backup

1份

控制方式 Control type

手動(dòng)及自動(dòng)控制 Manual and automatic

軟件功能 Software function

1

冷凍干燥（手動(dòng)、自動(dòng)，可任意切換）

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

2

工藝設(shè)定（配方管理）

Technique setting (recipe management)

技術(shù)優(yōu)勢(shì) Technical advantages

1

符合FDA歐盟標(biāo)準(zhǔn)，電子簽名，多組密碼；

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

2

自動(dòng)、手動(dòng)在任何節(jié)點(diǎn)任意切換；

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

3

系統(tǒng)操作可在無(wú)菌室、機(jī)房、凍干控制室進(jìn)行，并且相互具有互鎖功能，避免誤操作；

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

無(wú)菌室裝有液壓急停按鈕，可在緊急情況下強(qiáng)制停止板層運(yùn)行；

There is a hydraulic emergency button in sterilizing room. It can stop the shelves forcibly in an emergency.

5

友善的人機(jī)界面具有各種部件、閥門工作狀態(tài)及溫度、真空度參數(shù)顯示；

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"可設(shè)置無(wú)數(shù)條凍干工藝曲線；

It can set countless technologies curves for freeze drying in the “recipe management".

7

“配方管理"可實(shí)現(xiàn)：低溫進(jìn)箱、二次回凍（反復(fù)預(yù)凍）、壓力升測(cè)試、摻氣閥或者小碟閥選擇性摻氣控制、自動(dòng)放氣和壓塞、低溫出箱等個(gè)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

“冷凍干燥"自動(dòng)過(guò)程有階段顯示功能，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

“冷凍干燥"過(guò)程中可對(duì)配方進(jìn)行隨時(shí)調(diào)整；

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

10

操作畫面具有各個(gè)故障點(diǎn)顯示功能；

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

11

具有數(shù)據(jù)、曲線兩種記錄功能，可根據(jù)批號(hào)隨時(shí)調(diào)用或打??；

There is a function for recording both data and curves which can be used or printed momentarily according to the batch number.

12

可存儲(chǔ)無(wú)數(shù)條數(shù)據(jù)、曲線記錄；

It can save countless data and curves records.

13

各個(gè)真空度、溫度曲線由多種顏色顯示，并可任意設(shè)置“顯示"或“隱藏"；

Each curve of vacuum degree and temperature is displayed in multicolor, and it can be set for “displayed"or“hidden"randomly.

14

“冷凍干燥"完成后，可將“工藝配方"、“數(shù)據(jù)曲線"、“歷史記錄"、“操作記錄"、“報(bào)警記錄"等原始記錄一起打印，可作為批產(chǎn)品的詳細(xì)批記錄進(jìn)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

軟件系統(tǒng)符合FDA 21CFR PART II；

Software system accords with FDA 21CFR PART II.

17

電子簽名，三級(jí)用戶權(quán)限管理，曲線報(bào)表不可修改；

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

18

UPS不間斷電源可在緊急停電后20分鐘內(nèi)給PLC及各類傳感器提供電力；

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

J、公用工程清單 Utility list

1

總裝機(jī)功率 

Electricity-total electrical load

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

2

用于制冷系統(tǒng)的冷卻水

Cooling water for refrigerant cooling

4m³/hr (1.5≤P≤2bar, 15℃≤T≤30℃)

以上數(shù)據(jù)僅供參考，以實(shí)際設(shè)計(jì)圖紙為準(zhǔn)

K、設(shè)備主要參數(shù) The equipment’s main technique parameter

1

整機(jī)結(jié)構(gòu)

Machine construction

一體式

Union

2

外型尺寸 

Dimension of unit

約1815×900×1780mm

3

整機(jī)重量 

Weight of unit

約1.5T  (About )1.5T

4

西林瓶裝量

Filling volume of vial

Ф22mm  1160支

Ф16mm  2260支

5

凍干原料裝量（建議值）

Capacity of raw material for freeze drying

(suggestive value)

Z大8Kg/批

8kg/batch (Max)

以上數(shù)據(jù)僅供參考，以實(shí)際設(shè)計(jì)圖紙為準(zhǔn)

L、驗(yàn)證文件系統(tǒng)（電子光盤1份） 詳細(xì)驗(yàn)證文件系統(tǒng) Verification documents system(one set of CD)

The details of verification documents system

序號(hào)SN

名稱

Name

數(shù)量

Number

1

安裝確認(rèn)  Installation qualitation（IQ）

1套

2

操作確認(rèn)  Operation qualitation（OQ）

1套

3

性能確認(rèn)  Performance qualitation（PQ）

1套

4

工廠驗(yàn)收測(cè)試  Factory acceptance test（FAT）

1套

5

客戶現(xiàn)場(chǎng)驗(yàn)收測(cè)試  Site acceptance test（SAT）

1套

6

操作手冊(cè)  Operation manual (OM)

1套

7

維護(hù)手冊(cè)  Maintenance manual (MM)

1套

8

安裝手冊(cè) Installation manual (IM)

1套

9

平面布置圖 Layout drawing

1套

10

工藝流程圖 P&ID

1套

11

電氣線路圖 Wiring drawing

1套

12

主要部件說(shuō)明書 Instruction for the main parts

1套

13

材質(zhì)報(bào)告 Material report

1套

14

校驗(yàn)報(bào)告 Verification report

1套

序號(hào)

Serial number

名稱

Name

型號(hào)/規(guī)格/材質(zhì)

Model/Specifications/Material

數(shù)量

Number

1

氟利昂Freon

R404A

10.9kg

2

冷凍機(jī)油

Refrigeration oil

BITZER專用

5.0L

3

電磁閥

Solenoid valve

DANFOSS

1

4

電磁閥線圈

Solenoid valve coil

DANFOSS

2

5

測(cè)溫探頭

Temperature probe

PT-100單支

5

6

高壓壓力表

High-pressure gage

REFCO

1

7

低壓壓力表

Low-pressure gage

REFCO

1

8

干燥過(guò)濾器

Dry filter core

DANFOSS

2

9

真空泵油

Vacuum pump oil

優(yōu)成

4L

10

制冷專用板手

Special wrench for cooling

COOLMAX

1把

11

制冷專用加液管

Special liquid inlet tube for cooling

HONGSEN

1根

12

制冷劑加液表

Dosing table  for refrigerant

HONGSEN

1套