制造標準 Manufacture Standards

cGMP

A、干燥箱（含0.2m²板層） Chamber (with 0.2m² shelves)

序號SN

名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

干燥箱 

Chamber

進口AISI 316L 不銹鋼

1套

2

板層 

Shelves

進口AISI 316L 不銹鋼

1套

尺寸：400×300×12mm

Dimensions：400×300×12mm

2 +1層

3

箱門 Door

透明樹脂

colophony

1套

4

驗證孔  

Validation port

1個

5

制品測溫探頭

Product sensors

Pt-100 熱電阻 A級

Pt-100 Hot resistance  A Level

2支

6

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

常壓 Normal pressure

2

設計溫度

Design temperature

常溫 Normal temperature

3

光潔度 Finish

Ra≤0.5µm

4

平整度 Level

±0.5mm/m

5

板層溫度

（擱板進口）

Shelves temperature Min

-60℃

6

板層溫度

Shelves temperature Max

+70℃

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

矩形 Rectangle

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

O型硅橡膠 O-shaped silicone rubber

技術優勢 Technical advantages

1

不銹鋼板材均采用優質板材，保證箱體表面光潔度，從而保證無菌要求；

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

2

板層具有很高強度，能夠耐受長期使用；

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.

4

板層控溫精度±0.5℃（PID調節）；

Temperature control accuracy±0.5℃ (adjusted by PID)

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

序號

SN

名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

冷凝器  

Condenser

進口AISI 304 不銹鋼

1套

2

冷凝盤管

Condenser coiled pipe

AISI 304 不銹鋼

1套

3

冷凝器測溫探頭

Temperature sensors

(condenser)

Pt-100 熱電阻 A級

Pt-100 Hot resistance A Level

1支

性能參數 Performance parameters

1

設計壓力 

Design pressure

常壓Normal pressure

2

設計溫度

Design temperature

常溫Normal temperature

3

光潔度 Finish

Ra≤0.5um

4

盤管溫度

Coiled temperature Min

-85℃

5

冷凝器捕冰能力

Condenser frosting

capacity

4Kg/批

4Kg/batch

6

冷凝器外型

Condenser type

矩形 rectangle

技術優勢 Technical advantages

1

不銹鋼板材均采用優質板材，保證箱體表面光潔度，從而保證無菌要求；

Stainless steel plates are all superior. 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、中隔閥 Big Isolation valve

序號

SN

名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

電動碟閥Electric valve

DN-100

1套

D、制冷系統 Refrigeration system

序號

SN

名稱

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

法國泰康CAJ2464

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

美國  EMERSON

1個

4

過濾器

Filter

丹麥 DANFOSS

2個

5

壓力表 Pressure meter

HONGSENG

4個

6

膨脹閥 Expansion valve

丹麥 Danfoss

3個

7

電磁閥 Solenoid valve

卡士妥 CASTEL

3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“泰康”機組，性能更加穩定、可靠；

Adopting the Tesumsh 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.

E、真空系統 Vacuum system

序號

SN

名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

真空泵

Vacuum pump

德國萊寶D16C

1臺

2

泵阱隔離閥Isolation valve of pump well

DN-25mm

1個

3

泵頭閥

Pump head valve

西瑪特 SIEGV

1個

4

真空探頭Vacuum gauge

英國“愛德華”EDWARDS APG

1個

性能參數 Performance parameters

1

極限真空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

技術優勢 Technical advantages

1

高效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.

F、復壓摻氣系統 Aeration system for repressing

序號

SN

名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

過濾器Filter

0.22µm

1個

2

摻氣閥Aeration valve

西瑪特 SIEGV

1個

3

管道Pipeline

AISI 304L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.

G、循環系統 Circulation system

序號

SN

名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

循環泵 

Circulation pump

德國“威樂”WILO

RS25/8

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

1Kw

1支

4

板式熱交換器

Plate heat exchanger

瑞典“阿法拉伐”

ALFALAVAL技術

1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

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

序號

SN

名稱

Name

型號/規格/材質

Model/Specifications/Material

數量

Number

1

液壓元件Hydraulic units

Dorteck

2

液壓泵Hydraulic pump

Dorteck

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

6L

1套

5

壓塞油缸

Stop cylinder

上海“SW”

1個

性能參數 Performance parameters

1

壓塞壓力

Stoppering force

0~1.0bar（可調）

0~1.0bar（adjustable）

I、電氣控制系統 Electric control system

序號

SN

名稱

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

空氣開關  

Breaker

施耐德

／

5

交流接觸器

AC contactor

施耐德

／

6

電氣保護等級

Protection class

IP22

／

7

UPS電源 UPS power

SANTAK

1臺

8

軟件系統 Software system

HOS-V2

1套

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

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

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.

4

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.

5

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.

6

“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”.

7

“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”.

8

“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.

9

“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.

10

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.

11

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.

12

可存儲無數條數據、曲線記錄；

It can save countless data and curves records.

13

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.

14

“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.

15

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.

16

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.

17

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.

J、公用工程清單 Utility list

1

總裝機功率 

Electricity-total electrical load

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

以上數據僅供參考，以實際設計圖紙為準

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

1

整機結構

Machine construction

一體式

Union

2

外型尺寸 

Dimension of unit

約1800×900×1780mm

3

整機重量 

Weight of unit

約1.0T  (About )1.0T

4

凍干原料裝量（建議值）

Capacity of raw material for freeze drying

(suggestive value)

4Kg/批

4kg/batch (Max)

以上數據僅供參考，以實際設計圖紙為準