Lyophilizer Technical Parameters壓(ya)蓋(gai)型凍干(gan)機技術參(can)數(shu)表(biao)
1、“欣諭”XY-Lyo-0.2壓蓋型真空冷凍干燥機 XY-Lyophilizer-0.2
制造標準 Manufacture Standards | cGMP | ||||||||
A、干燥箱(xiang)（含0.2m2板(ban)層(ceng)） Chamber (with 0.2m2 shelves) | |||||||||
序號SN | 名稱 Name | 型號/規(gui)格/材(cai)質 Model/Specifications/Material | 數量 Number | ||||||
1 | 干燥箱 Chamber | 進口AISI 316L 不銹鋼(gang) | 1套 | ||||||
2 | 板層 Shelves | 進口AISI 316L 不銹鋼(gang) | 1套(tao) | ||||||
尺寸：400×300×12mm Dimensions：400×300×12mm | 2 +1層 | ||||||||
3 | 箱(xiang)門 Door | 透明樹(shu)脂(zhi) colophony | 1套 | ||||||
4 | 驗(yan)證孔 Validation port | 1個(ge) | |||||||
5 | 制品測溫(wen)探頭(tou) Product sensors | Pt-100 熱電阻 A級 Pt-100 Hot resistance A Level | 2支 | ||||||
6 | 導熱油溫(wen)度探頭 Temperature sensors (thermal fluid) | Pt-100 熱電阻 A級 Pt-100 Hot resistance A Level | 2支(zhi) | ||||||
性(xing)能參數 Performance parameters | |||||||||
1 | 設計壓(ya)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(ban)層Z低溫度 （擱板進口(kou)） Shelves temperature Min | -60℃ | |||||||
6 | 板層Z高溫度 Shelves temperature Max | +70℃ | |||||||
7 | 板層(ceng)溫度均勻性 Shelves temperature uniformity | ±1°C（空(kong)載平(ping)衡后） ±1°C（soak stage） | |||||||
8 | 擱(ge)板(ban)間距 Spacing | 80mm | |||||||
9 | 干(gan)燥箱外形(xing) 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(kai)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(ji)術優勢 Technical advantages | |||||||||
1 | 不銹鋼板(ban)材均采用優(you)質板材，保證箱(xiang)體表面(mian)光潔度，從而保證無菌(jun)要(yao)求； Stainless steel plates are all superior. Ensure the finish of chamber surfaces, and then ensure the asepsis requirement. | ||||||||
2 | 板層具有(you)很高(gao)強(qiang)度，能(neng)夠耐受(shou)長期使用(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(ban)層通過機械(xie)加工，可保證高(gao)要求平整度； Shelves are processed by machining which can ensure the demanding level. | ||||||||
4 | 板(ban)層(ceng)控(kong)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(xu)號 SN | 名稱 Name | 型(xing)號/規(gui)格/材質 Model/Specifications/Material | 數(shu)量 Number | ||||||
1 | 冷凝器 Condenser | 進(jin)口AISI 304 不(bu)銹鋼 | 1套 | ||||||
2 | 冷凝盤管 Condenser coiled pipe | AISI 304 不銹(xiu)鋼 | 1套 | ||||||
3 | 冷凝器測溫探頭(tou) Temperature sensors (condenser) | Pt-100 熱(re)電(dian)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(du) Design temperature | 常溫Normal temperature | |||||||
3 | 光潔度 Finish | Ra≤0.5um | |||||||
4 | 盤管Z低溫度 Coiled temperature Min | -85℃ | |||||||
5 | 冷凝(ning)器捕冰能力 Condenser frosting capacity | 4Kg/批 4Kg/batch | |||||||
6 | 冷凝器(qi)外型 Condenser type | 矩形 rectangle | |||||||
技術(shu)優勢 Technical advantages | |||||||||
1 | 不銹鋼板材均采用優(you)質板材，保(bao)證箱體表面光潔度，從而保(bao)證無菌(jun)要求(qiu)； 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(xie)漏檢(jian)驗； Condenser and coiled pipe are all carried out the leak test by helium mass spectrometer. | ||||||||
C、中隔閥(fa) Big Isolation valve
| |||||||||
序號 SN | 名稱 Name | 型(xing)號/規格(ge)/材質 Model/Specifications/Material | 數量 Number | ||||||
1 | 電動碟閥Electric valve | DN-100 | 1套 | ||||||
D、制(zhi)冷(leng)系統 Refrigeration system | |||||||||
序號(hao) SN | 名稱 Name | 型號/規格/材質(zhi) Model/Specifications/Material | 數量 Number | ||||||
1 | 壓(ya)縮機(ji)型號及數量 Compressor model and number | 法G泰康CAJ2464 | 2臺 | ||||||
2 | 制冷(leng)劑 Refrigerant | R404a 綠色環(huan)保型(xing) R404a Environment Friendly | 適量 Right quantity | ||||||
3 | 油分離器 Oil separator | 美G EMERSON | 1個 | ||||||
4 | 過濾(lv)器 Filter | 丹(dan)麥(mai) 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(neng)參數 Performance parameters | |||||||||
1 | 板層制冷(leng)速度（空載） （擱板進口） Shelf cooling time (empty) | +20 ～ -40°C ≤ 60 minutes | |||||||
2 | 冷凝器制冷速(su)度（空載(zai)） Condenser cooling time (empty) | +20 ～ -40°C ≤ 30 minutes | |||||||
技術優勢 Technical advantages | |||||||||
1 | 壓縮(suo)機采用“泰康(kang)”機組，性(xing)能更加穩(wen)定、可靠； Adopting the Tesumsh compressor makes the performance be more stable and relibale. | ||||||||
2 | 采用符合蒙特利(li)爾公約(yue)的(de)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(you)各項保護功(gong)能，連(lian)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(xing)號/規格/材質 Model/Specifications/Material | 數量 Number | ||||||
1 | 真空泵 Vacuum pump | 德G萊寶D16C | 1臺(tai) | ||||||
2 | 泵阱隔離閥Isolation valve of pump well | DN-25mm | 1個 | ||||||
3 | 泵頭閥 Pump head valve | 西(xi)瑪特 SIEGV | 1個 | ||||||
4 | 真空(kong)探頭Vacuum gauge | 英G“愛德(de)華”EDWARDS APG | 1個 | ||||||
性能參(can)數(shu) Performance parameters | |||||||||
1 | J限真空Final vacuum | 5Pa | |||||||
2 | 抽氣速度Evacuation time | 從大氣(qi)壓抽(chou)至(zhi)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 | GX泵頭(tou)閥與真空泵同時打(da)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(fu)壓摻氣系(xi)統 Aeration system for repressing | |||||||||
序號 SN | 名稱 Name | 型號/規格(ge)/材質 Model/Specifications/Material | 數量 Number | ||||||
1 | 過濾器Filter | 0.22μm | 1個(ge) | ||||||
2 | 摻氣閥Aeration valve | 西瑪特 SIEGV | 1個 | ||||||
3 | 管道Pipeline | AISI 304L不銹鋼 | 1套 | ||||||
技(ji)術優(you)勢(shi) Technical advantages | |||||||||
1 | 管(guan)道全(quan)部(bu)采用自(zi)動焊(han)接，保證內(nei)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(tong) Circulation system | |||||||||
序號 SN | 名稱 Name | 型號/規(gui)格/材質 Model/Specifications/Material | 數量 Number | ||||||
1 | 循(xun)環泵(beng) Circulation pump | 德G“威樂”WILO RS25/8 | 1臺 | ||||||
2 | 導熱油 Thermal fluid | 低(di)粘度硅油 Silicon oil (low viscosity) | 適量 Right quantity | ||||||
3 | 電(dian)加(jia)熱 Heater | 1Kw | 1支 | ||||||
4 | 板式熱交換器(qi) Plate heat exchanger | 瑞(rui)典“阿(a)法拉伐” ALFALAVAL技術 | 1個 | ||||||
5 | 導熱油測溫探(tan)頭 Temperature sensors(thermal fluid) | Pt-100 熱電阻 A級 Pt-100 Hot resistance A Level | 2支 | ||||||
6 | 溫度(du)控制(zhi)器 Temperature controller | 丹麥“丹佛(fo)斯”DANFOSS | 1個(ge) | ||||||
性能參數(shu) 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(neng)量調節(jie)控(kong)制，可(ke)以Z有效的利(li)用(yong)加熱(re)能(neng)源； Electric heating is controled by PID which can use the heating energy most effectively. | ||||||||
H、液壓系統 Hydraulic system | |||||||||
序(xu)號 SN | 名(ming)稱 Name | 型號/規格/材(cai)質 Model/Specifications/Material | 數量 Number | ||||||
1 | 液壓元件Hydraulic units | Dorteck | |||||||
2 | 液壓(ya)泵(beng)Hydraulic pump | Dorteck | 1套 | ||||||
3 | 液(ye)壓油(you)Hydraulic oil | 46#抗磨液(ye)壓油 46# anti-wear hydraulic oil | 1套 | ||||||
4 | 油箱(xiang)Tank | 6L | 1套 | ||||||
5 | 壓塞油缸(gang) Stop cylinder | 上海“SW” | 1個(ge) | ||||||
性能參(can)數 Performance parameters | |||||||||
1 | 壓(ya)塞壓(ya)力 Stoppering force | 0~1.0bar（可調） 0~1.0bar（adjustable） | |||||||
I、電氣(qi)控制系統(tong) Electric control system | |||||||||
序號 SN | 名稱 Name | 型(xing)號/規格/材質(zhi) Model/Specifications/Material | 數量 Number | ||||||
1 | 電(dian)氣標(biao)準 Electric standard | IEC60204-1 | ／ | ||||||
2 | PLC | 日本OMRON | 1套(tao) | ||||||
3 | 計(ji)算(suan)機 Computer | 聯想LENOVO | 1臺 | ||||||
4 | 空氣開(kai)關 Breaker | 施耐德 | ／ | ||||||
5 | 交流接觸器 AC contactor | 施耐德 | ／ | ||||||
6 | 電(dian)氣保護(hu)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(neng) 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(gong)藝設(she)定（配方管(guan)理） Technique setting (recipe management) | ||||||||
技術優(you)勢 Technical advantages | |||||||||
1 | 符合FDA歐盟標準，電(dian)子(zi)簽(qian)名(ming)，多組(zu)密碼(ma)； It accords with European standard FDA. There are electronic signatures and multiple passwords. | ||||||||
2 | 自動、手動在(zai)任(ren)何節點任(ren)意切換(huan)； Switch the type between manual and automatic at any point randomly. | ||||||||
3 | 系統操(cao)作可在(zai)無菌室、機房、凍(dong)干控制室進行，并且相互(hu)具(ju)有互(hu)鎖功能，避免誤(wu)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(ya)急停(ting)按(an)鈕，可在緊急情況(kuang)下強制(zhi)停(ting)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(jie)面具有各種部件、閥門工作狀態及(ji)溫度、真(zhen)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(gong)藝(yi)曲線； It can set countless technologies curves for freeze drying in the “recipe management”. | ||||||||
7 | “配方管(guan)理”可(ke)實現(xian)：低溫進箱、二次回凍（反復(fu)預凍）、壓力(li)升測試(shi)、摻氣閥(fa)(fa)或者小碟閥(fa)(fa)選擇性摻氣控制、自動放氣和壓塞、低溫出箱等(deng)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(leng)凍干燥”自動過程(cheng)有階段顯示(shi)功能(neng)，并可任意跳(tiao)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(gan)燥”過程中可對配方進(jin)行隨時調整； The recipe can be adjusted momentarily in the “freeze drying ”process. | ||||||||
10 | 操作(zuo)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(you)數據(ju)、曲線兩(liang)種記(ji)錄功能，可根據(ju)批號(hao)隨時調(diao)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(shu)條(tiao)數(shu)據(ju)、曲線記錄； It can save countless data and curves records. | ||||||||
13 | 各(ge)個真(zhen)空度(du)、溫度(du)曲線由(you)多種(zhong)顏色顯示，并(bing)可任意設(she)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(dong)干燥”完成后，可(ke)將“工藝配方”、“數據曲線”、“歷史記錄(lu)”、“操作記錄(lu)”、“報(bao)警記錄(lu)”等(deng)原始記錄(lu)一起(qi)打印，可(ke)作為批產品的詳細批記錄(lu)進行(xing)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(ji)使用需要增(zeng)加相應軟件功(gong)能； It can increase corresponding software function according to actual requirements of customer. | ||||||||
16 | 電子簽(qian)名，三(san)級用戶(hu)權限(xian)管理，曲線報表不可(ke)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(fen)鐘內(nei)給PLC及各類(lei)傳感器(qi)提(ti)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(yong)工程清(qing)單 Utility list | |||||||||
1 | 總(zong)裝機功率(lv) Electricity-total electrical load | 5Kw (380V, 50Hz, 3Phase, 5Wire) | |||||||
以(yi)上數據僅供參考，以(yi)實際設計(ji)圖紙(zhi)為準(zhun) | |||||||||
K、設備主(zhu)要參數 The equipment’s main technique parameter | |||||||||
1 | 整機結構 Machine construction | 一體(ti)式 Union | |||||||
2 | 外型尺(chi)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(yi)值） Capacity of raw material for freeze drying (suggestive value) | Z大4Kg/批 4kg/batch (Max) | |||||||
以上數據(ju)僅(jin)供(gong)參(can)考，以實際設計圖(tu)紙(zhi)為準 | |||||||||
含稅，含G內(nei)運費安裝調試培訓，保修1年(nian)，終身有償售后。
生產周期：30個工作(zuo)日
