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

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名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

干燥箱Chamber

AISI 316L 不銹鋼

1套

2

板層Shelves

AISI 316L 不銹鋼

1套

尺寸：2000×1495×24mm

Dimensions：2000×1495×24mm

14+1層

3

箱門Door

AISI 316L 不銹鋼(部分)

AISI 316L stainless steel (Section)

1套

4

干燥箱視鏡

Viewing port (chamber)

DN150 mm 帶延時照明燈

DN150 mm With time delay head lamp

1個

5

箱門視鏡

Viewing port (door)

DN150 mm

1個

6

驗證孔Validation port

3D設計 3D design

1個

7

安全插銷門鎖系統

Door lock system with safe bolt

“XY”D特設計

Unique design by XINYU

1套

8

制品測溫探頭

Product sensors

Pt-100 熱電阻 A級

Pt-100 Hot resistance  A Level

3支

9

導熱油溫度探頭

Temperature sensors

(thermal fluid)

Pt-100 熱電阻 A級

Pt-100 Hot resistance  A Level

2支

性能參數Performance parameters

1

設計壓力Design pressure

0.15Mpa(壓力0.25MPa)

2

設計溫度

Design temperature

128℃

3

光潔度Finish

Ra≤0.4µm

4

平整度Level

±0.5mm/m

5

板層Z低溫度(導熱油進口)

Shelves temperature Min

-55℃

6

板層Z高溫度(導熱油進口)

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

120mm

9

干燥箱外形Chamber type

長方型 Rectangular

10

保溫層Insulation

硅酸鋁和聚氨酯發泡材料

Aluminum silicate and polyisocyanurate foam

11

開門方向Open direction

根據用戶要求確定 According to user’s requirements

12

開門角度Open angle

大于110度 More than 110°

13

視鏡方向 

Position of viewing port

根據用戶要求確定 According to user’s requirements

14

門密封條

Sealing strips for doors

T型硅橡膠 T-shaped silicone rubber

技術優勢Technical advantages

1

保證箱體表面光潔度，從而保證無菌要求；

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

2

G際的3D管口設計，更符合滅菌要求；

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

3

**設計的安全插銷門鎖系統，D立監控，聯鎖運行，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

板層具有很高強度，能夠耐受長期使用； 

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

5

板層通過機械加工，可保證高要求平整度；

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

6

板層油缸裝有AISI 316L不銹鋼波紋管，可防止液壓油擴散，并且具有在線檢測完整性功能；

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

板層控溫精度±0.5℃（PID調節）；

Temperature control accuracy±0.5℃ (adjusted by PID)

8

特殊T型門密封條，可防止積水，更加符合無菌要求；

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

9

箱體、板層、軟管均采用氦質譜儀進行泄漏檢驗；

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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名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

冷凝器Condenser

AISI 316L 不銹鋼

1套

2

冷凝盤管

Condenser coiled pipe

AISI 316L 不銹鋼

1套

4

視鏡

Viewing port

DN150mm 帶延時照明燈

DN150 mm With time delay head lamp

1個

5

冷凝器測溫探頭

Temperature sensors

(condenser)

Pt-100 熱電阻 A級

Pt-100 Hot resistance A Level

2支

6

化霜噴球

Spray ball for de-icing

AISI 316L 不銹鋼

2個

性能參數Performance parameters

1

設計壓力Design pressure

0.15Mpa(壓力0.25MPa)

2

設計溫度

Design temperature

128℃

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

800Kg/批

800Kg/batch

6

冷凝器外型

Condenser type

臥式圓桶體

Horizontal cylinder

技術優勢Technical advantages

1

保證箱體表面光潔度，從而保證無菌要求；

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

2

冷凝器、盤管采用氦質譜儀進行泄漏檢驗；

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

C、蘑菇閥Mushroom valve

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名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

蘑菇閥Mushroom valve

AISI 316L 不銹鋼

AISI 316L stainless steel

1套

2

蘑菇閥油缸

Mushroom valve cylinder

上海“SW”70/125

1個

性能參數Performance parameters

1

工作動力Motivation

液壓驅動Hydraulic driven

2

蘑菇閥尺寸

Mushroom valve dimension

DN900mm

技術優勢Technical advantages

1

蘑菇閥球頭采用模壓制造，球頭表面光潔易清洗；

The head of mushroom valve is manufactured by molding, the head surface is glabrous and easy clean.

2

蘑菇閥可通過減壓閥進行調整，防止關閉壓力過大；

Mushroom valve can be adjusted by reducing valve to prevent the over closing pressure.

3

蘑菇閥的“打開”或“關閉”具有反饋信號，能夠真實的了解工作狀態；

When mushroom valve is ON or OFF there is a feedback signal which can be in favor of knowing the working state truly.

4

新型蘑菇閥具有很高的密封性和準確性，可防止內泄漏；

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、制冷系統Refrigeration system

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Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

壓縮機型號及數量

Compressor model and

number

KEBELCO“日本神戶制鋼”KS10LTH

2臺

2

制冷劑 Refrigerant

R404a 綠色環保型

R404a Environment Friendly

適量

Right quantity

3

油分離器 Oil separator

“法斯克”（天津）

2個

4

冷卻水流量開關 Flow switch for cooling water

韓G HFS

1個

6

電磁閥 Solenoid valve

丹麥 DANFOSS

10個

7

膨脹閥 Expansion valve

丹麥 DANFOSS

10個

8

頂蓋閥 Tectum valve

意大利 CASTEL

10個

9

黃銅絲口閘閥 Brake valve with screwed brass

寧波 永享

2個

10

除酸干燥過濾器

Filter for disacidifying and drying

外殼EMERSON，濾芯EMERSON

Shell EMERSON，Filter Core EMERSON

2套

11

安全閥 Safety valve

意大利 CASTEL

2個

12

儲液罐角閥 Angle valve for fluid reserve tank

中國臺灣 SY

4個

13

視液鏡 Viewing port

丹麥 DANFOSS

2個

14

手動球閥

Manual globe valve

意大利 CASTEL

4個

15

單向閥 Check valve

HELDON或ARROW

2個

16

油冷卻器  Oil condenser

“法斯克”（天津）

2個

17

油壓差繼電器 Oil differential pressure relay

丹麥“丹佛斯”DANFOSS

2個

18

壓力表 Pressure meter

日本 KOBELCO

4個

19

高低壓壓力繼電器

Pressure relay (high/low pressure)

丹麥“丹佛斯”DANFOSS

2個

20

溫度指示計

Temperature indicator

日本 NESS

2個

性能參數Performance parameters

1

板層制冷速度（空載）

(擱板進口)

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

技術優勢Technical advantages

1

壓縮機采用日本神戶制鋼螺桿機組，性能非常穩定、可靠；

Adopting the KEBELCO KS10STH compressor makes the performance be more stable and relibale.

2

采用符合蒙特利爾公約的環保型制冷劑；

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

3

制冷系統具有各項保護功能，連鎖保護；

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

4

回氣溫度能夠進行控制；Back temperature can be controlled.

①

凍干后期低負荷條件下的壓力自動調整功能；

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

②

制冷系統油壓壓力多重保護功能；

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

③

壓縮機電機多重保護功能；

The poly-protection function of compressor motor.

E、真空系統Vacuum system

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型號/規格/材質

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Number

1

真空泵Vacuum pump

英G“愛德華”EDWARDS E2M175

2臺

2

羅茨泵Roots pump

英G“愛德華”EDWARDS EH1200

1臺

3

泵阱隔離閥Isolation valve of pump well

德G“蓋米”GEMU DN150mm

1個

4

泵頭閥Pump head valve

西瑪特SIEGV

2個

5

閥門反饋信號Feedback signal of valve

德GROTECH

1套

6

真空探頭Vacuum gauge

英G“愛德華”EDWARDS APG

2個

性能參數Performance parameters

1

J限真空Final vacuum

1Pa

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

技術優勢Technical advantages

1

真空系統閥門具有反饋信號，可了解開關的真實性；

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

2

GX泵頭閥與真空泵同時打開和關閉，可大大防止真空泵油逆向擴散；

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

羅茨泵可與真空泵同時啟動；

The roots pump and vacuum pump can be started simultaneously.

F、復壓摻氣系統Aeration system for repressing

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型號/規格/材質

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1

過濾器Filter

0.22µm

1個

2

摻氣閥Aeration valve

西瑪特SIEGV

1個

3

隔膜閥Diaphragm valve

德GGEMU或BURKERT

1套

4

管道Pipeline

AISI 316L不銹鋼

1套

技術優勢Technical advantages

1

管道全部采用自動焊接，保證內外壁光潔；

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

2

過濾器可進行在位蒸汽滅菌，操作更換方便；

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

3

復壓系統預留了可進行充氮氣接口；

A interface by which it can inject nitrogen reserves in the repressing system.

G、循環系統Circulation system

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名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

循環泵 Circulation pump

德G“海密梯克” CNF 50-160

1臺

2

導熱油 Thermal fluid

低粘度硅油

Silicon oil (low viscosity)

適量

Right quantity

3

電加熱 Heater

60Kw

1支

4

板式熱交換器Plate heat exchanger

瑞典“阿法拉伐”ALFALAVAL

4個

5

導熱油測溫探頭

Temperature sensors(thermal fluid)

Pt-100 熱電阻 A級

Pt-100 Hot resistance A Level

2支

6

溫度控制器

Temperature controller

丹麥“丹佛斯”DANFOSS

1個

7

壓力控制器

Pressure controller

丹麥“丹佛斯”DANFOSS

1個

性能參數Performance parameters

1

加熱速度Heating rate

1°C/min

2

硅油粘度

Silicon oil viscosity

5cSt 25℃

技術優勢Technical advantages

1

電加熱采用PID能量調節控制，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Hydraulic system

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名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

液壓元件Hydraulic units

意大利“海普液壓” HYDR-APP

2

液壓泵Hydraulic pump

意大利“海普液壓” HYDR-APP

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

60L

1套

5

性能參數Performance parameters

1

壓塞壓力

Stoppering force

0~1.0bar（可調）

0~1.0bar（adjustable）

技術優勢Technical advantages

1

液壓系統設置有“背壓閥”，在蒸汽滅菌時可對油缸腔室進行泄壓，避免損壞；

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

壓塞液壓缸具有防滑落裝置

Stoppering hydraulic cylinder has the antiskid device.

3

板層實現動態清洗

Dynamic washing for shelves is achieved.

4

能準確判斷板層是否全部升起和板層是否全部落下

It is sure whether all the shelves rise or fall.

I、氣動系統Pneumatic system

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型號/規格/材質

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1

氣動元件Pneumatic Units

中國臺灣“AIRTAC”亞德客

1套

技術優勢Technical advantages

1

帶潤滑的氣動系統可以保證閥門有效開關；

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

2

帶過濾器的氣動系統可以保證閥門穩定性；

Pneumatic system with filter can ensure stability of valves.

J、在線清洗、在線滅菌系統 （SIP、CIP）  CIP and SIP system (SIP、CIP)

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型號/規格/材質

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1

噴嘴Nozzle

美G“噴霧”SSC

1套

2

管道Pipeline

AISI 316L

1套

3

進水進汽閥門Inlet Vavle

德G“蓋米”GEMU或“寶帝”

1套

4

排水閥門 Drain Valve

新萊“King Lai”& 意大利“AT”

1套

5

安全閥Safety vavle

英G GRESSWELL

2個

6

疏水器Steam trap

日本MIYAWAKA 

2個

7

電接點壓力表

Electronic contactor

德GWIKA

1個

8

壓力變送器

Pressure transmitter

英GGEMS

2個

9

水環泵Water-ring pump

山東“納西姆”2BV-5110 或“斯特林”LEM150或者SIHI斯赫

1臺

技術優勢Technical advantages

1

與箱體連接管道全部采用符合衛生標準管材，更符合無菌要求；

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

2

管道全部采用自動焊接，內窺鏡檢查；

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

3

箱體帶有冷卻夾套，可以在蒸汽滅菌后迅速對箱體進行冷卻；

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

4

排蒸汽冷卻裝置，避免地漏系統受到蒸汽影響；

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

5

排水口設置有過濾網；

A filter screen set near the outfall.

6

排水系統設置有單向閥及壓差控制功能，避免倒吸；

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

K、電氣控制系統Electric control system

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Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

電氣標準Electric standard

IEC60204-1

／

2

PLC

日本OMRON

1套

3

計算機Computer

聯想LENOVO

1臺

4

觸摸屏Touch screen

日本OMRON

1個

5

空氣開關Breaker

德G SIEMENS

／

6

交流接觸器AC contactor

德G SIEMENS

／

7

電氣保護等級

Protection class

IP22

／

8

UPS電源  

UPS power

SANTAK

1臺

9

軟件系統Software system

TF-HOS-V2

1套

10

軟件備份光盤

CD for sofrware backup

1份

控制方式Control type

手動及自動控制Manual and automatic

軟件功能Software function

1

冷凍干燥（手動、自動，可任意切換）

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

2

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

3

在線清洗（手動、自動）Cleaning in place (manual, automatic)

4

在線滅菌（手動、自動）Sterilization in place (manual, automatic)

5

工藝設定（配方管理）Technique setting (recipe management)

技術優勢Technical advantages

1

符合FDA歐盟標準，電子簽名，多組密碼；

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

2

自動、手動在任何節點任意切換；

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

3

一鍵式體檢功能，為凍干機的健康提供數據保障；

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

4

系統操作可在無菌室、機房、凍干控制室進行，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.

5

無菌室裝有液壓急停按鈕，可在緊急情況下強制停止板層運行；

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

6

友善的人機界面具有各種部件、閥門工作狀態及溫度、真空度參數顯示；

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.

7

“配方管理”可設置無數條凍干工藝曲線；

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

8

“配方管理”可實現：低溫進箱、二次回凍（反復預凍）、壓力升測試、摻氣閥或者小碟閥選擇性摻氣控制、自動放氣和壓塞、低溫出箱等個性功能；

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

“冷凍干燥”自動過程有階段顯示功能，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.

10

“冷凍干燥”過程中可對配方進行隨時調整；

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

11

操作畫面具有各個故障點顯示功能；

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

12

具有數據、曲線兩種記錄功能，可根據批號隨時調用或打印；

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

13

可存儲無數條數據、曲線記錄；

It can save countless data and curves records.

14

各個真空度、溫度曲線由多種顏色顯示，并可任意設置“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.

15

“冷凍干燥”完成后，可將“工藝配方”、“數據曲線”、“歷史記錄”、“操作記錄”、“報警記錄”等原始記錄一起打印，可作為批產品的詳細批記錄進行保存；

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

“在線清洗”可實現自動控制；

“Cleaning in place”can be automatically controled.

17

“在線消毒”功能具有安全連鎖保護；脈動預熱消毒

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

18

可根據用戶實際使用需要增加相應軟件功能；

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

19

軟件系統符合FDA 21CFR PART II；

Software system accords with FDA 21CFR PART II.

20

電子簽名，三級用戶權限管理，曲線報表不可修改；

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

21

UPS不間斷電源可在緊急停電后20分鐘內給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.

L、公用工程清單Utility list

1

總裝機功率Total power

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

2

用于制冷系統的冷卻水

Cooling water for refrigerant cooling

45m³/hr (1.5≤P≤2bar, T≤25°C)

3

凍干箱清洗用水Water for chamber cleaning

380L/min (P≥5bar, T=80°C)

4

用于氣動閥的壓縮空氣

Compressed air for pneumatic valve

100L/min (5≤P≤8bar)

5

SIP純蒸汽用量 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)

以上數據僅供參考，以實際設計圖紙為準

M、設備主要參數The equipment’s main technique parameter

1

整機結構

Machine construction

分體式

Split

2

外型尺寸 Dimension of unit

約10100*2850*3600mm

3

整機重量 Weight of unit

約30T  (About )30T

4

西林瓶裝量

Filling volume of vial

Ф22mm  87600支

Ф16mm  172000支

5

凍干原料裝量（建議值）

Capacity of raw material for freeze drying

(suggestive value)

Z大640Kg/批

640kg/batch (Max)

以上數據僅供參考，以實際設計圖紙為準

O、驗證文件系統（電子光盤1份） 詳細驗證文件系統Verification documents system(one set of CD)

The details of verification documents system

序號

SN

名稱

Name

數量

Number

1

安裝確認  Installation qualitation（IQ）

1套

2

操作確認  Operation qualitation（OQ）

1套

3

性能確認  Performance qualitation（PQ）

1套

4

工廠驗收測試  Factory acceptance test（FAT）

1套

5

客戶現場驗收測試  Site acceptance test（SAT）

1套

6

操作手冊   Operation manual (OM)

1套

7

維護手冊   Maintenance manual (MM)

1套

8

安裝手冊   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

主要部件說明書  Instruction for the main parts

1套

13

壓力容器質量證書  Quality certificate for pressure vessel

1套

14

材質報告  Material report

1套

15

校驗報告  Verification report

1套