欣諭XY-FD-S10E真空(kong)冷凍干(gan)燥機（冰凍干(gan)燥機） 制造標準 Manufacture Standards | cGMP | |||||||
A、干(gan)燥箱（含(han)1.08m2板層） Chamber (with1.08m2 shelves) | ||||||||
序(xu)號SN | 名稱 Name | 型(xing)號(hao)/規格(ge)/材質 Model/Specifications/Material | 數量(liang) Number | |||||
1 | 干燥箱 Chamber | AISI 316L 不銹鋼 | 1套 | |||||
2 | 板層 Shelves | AISI 316L 不(bu)銹(xiu)鋼 | 1套 | |||||
Dimensions：600×450×20mm | ||||||||
3 | 箱門 Door | 部分(fen)AISI 316 不銹鋼 Part AISI 316 stainless steel | 1套(tao) | |||||
4 | 干燥箱(xiang)視鏡 Viewing port (chamber) | DN-200 mm 帶延時照明燈 DN-200 mm With time delay head lamp | 1個 | |||||
5 | 箱(xiang)門(men)視鏡 Viewing port (door) | DN-200 mm | 1個 | |||||
6 | 驗證孔 Validation port | 1個(ge) | ||||||
7 | 手(shou)動門鎖系統 Door lock system with safe | 蝶(die)形手柄設計 The butterfly handles | 1套 | |||||
8 | 制品測溫(wen)探頭 Product sensors | Pt-100 熱(re)電阻(zu) A級 Pt-100 Hot resistance A Level | 3支 | |||||
9 | 導熱油溫度探(tan)頭 Temperature sensors (thermal fluid) | Pt-100 熱電阻(zu) A級(ji) Pt-100 Hot resistance A Level | 2支 | |||||
性能參數 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(du) Finish | Ra≤0.5μm | ||||||
4 | 平(ping)整度 Level | ±1mm/m | ||||||
5 | 板層Z低溫度(導熱油(you)進口) Shelves temperature Min | -50℃ | ||||||
6 | 板層Z高溫度(導熱油進口) Shelves temperature Max | +70℃ | ||||||
7 | 板(ban)層溫(wen)度均勻性 Shelves temperature uniformity | ±1°C（空載平衡后） ±1°C（soak stage） | ||||||
8 | 擱板間距 Spacing | 100mm | ||||||
9 | 干燥箱外形(xing) Chamber type | 長方型 Rectangular | ||||||
10 | 保溫層 Insulation | 硅酸鋁和聚(ju)氨酯發(fa)泡材料 Aluminum silicate and polyisocyanurate foam | ||||||
11 | 開門方向(xiang) 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(gui)橡膠 O-shaped silicone rubber | ||||||
技術(shu)優(you)勢 Technical advantages | ||||||||
1 | 不(bu)銹(xiu)鋼(gang)板(ban)材(cai)均(jun)采用優(you)質板(ban)材(cai)，保(bao)(bao)證箱體(ti)(ti)表(biao)面光潔(jie)度，從而(er)保(bao)(bao)證無(wu)菌要求； Stainless steel plates are superior. Ensure the finish of chamber surfaces, and then ensure the asepsis requirement. | |||||||
2 | 板(ban)層(ceng)具有很(hen)高強度，能夠耐(nai)受長(chang)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(ji)械(xie)加工，可保證高(gao)要求(qiu)平(ping)整度； Shelves are processed by machining which can ensure the demanding level. | |||||||
4 | 板層控溫精度(du)±0.5℃（PID調節）； Temperature control accuracy±0.5℃ (adjusted by PID) | |||||||
6 | 箱(xiang)體、板層(ceng)、軟管均采用(yong)氦質譜儀進(jin)行泄漏(lou)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) | ||||||||
序號 SN | 名稱 Name | 型(xing)號/規格/材質 Model/Specifications/Material | 數量(liang) Number | |||||
1 | 冷凝器 Condenser | AISI 316L不銹鋼 | 1套 | |||||
2 | 冷凝盤管(guan) Condenser coiled pipe | AISI 316L 不(bu)銹鋼(gang) | 1套 | |||||
4 | 視鏡 Viewing port | DN-150mm 帶延時(shi)照明燈 DN-150 mm With time delay head lamp | 1個 | |||||
5 | 冷凝器測溫探頭(tou) Temperature sensors (condenser) | Pt-100 熱電(dian)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(she)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(pan)管Z低溫度 Coiled temperature Min | ≤-70℃ | ||||||
5 | 冷凝器(qi)捕冰(bing)能力(li) Condenser frosting capacity | 60Kg/批(pi) 60Kg/batch | ||||||
6 | 冷凝器外(wai)型 Condenser type | 長方(fang)型(xing) Rectangular | ||||||
技術優勢 Technical advantages | ||||||||
1 | 不銹鋼板材均采用優質板(ban)材，保(bao)證箱(xiang)體表面光潔度，從而保(bao)證無菌要求； Stainless steel plates are 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、蘑菇閥(fa) Mushroom valve | ||||||||
序號 SN | 名稱 Name | 型(xing)號(hao)/規(gui)格/材(cai)質 Model/Specifications/Material | 數(shu)量 Number | |||||
1 | 蘑菇閥mushroom valve | AISI 316 不銹鋼 AISI 316 stainless steel | 1套(tao) | |||||
2 | 蘑菇閥油缸(gang) mushroom valve cylinder | 上(shang)海“晶盛”30/80 Shanghai“jingsheng” 30/80 | 1個 | |||||
性能(neng)參數 Performance parameters | ||||||||
1 | 工(gong)作動力 Motivation | 液壓驅動 Hydraulic driven | ||||||
2 | 蘑菇閥(fa)尺寸(cun) Mushroom valve dimension | DN-250mm | ||||||
技術優勢(shi) Technical advantages | ||||||||
1 | 蘑菇閥球頭采(cai)用模壓(ya)制(zhi)造，球頭表面光潔易清(qing)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(da)； Mushroom valve can be adjusted by reducing valve to prevent the over closing pressure. | |||||||
3 | 蘑菇閥的(de)“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 | 新型蘑菇閥板法(fa)蘭(lan)采用二次加工(gong)，具有很(hen)高的(de)密封(feng)性和準確(que)性，可完全防止內泄漏； 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 | ||||||||
序(xu)號 SN | 名稱(cheng) Name | 型號/規(gui)格/材質 Model/Specifications/Material | 數量(liang) Number | |||||
1 | Compressor model and number | BITZER“比澤(ze)爾”S4G-5.2Y | 1臺(tai) | |||||
2 | Refrigerant | R404a Environment Friendly | 適量 Right quantity | |||||
3 | Emerson | 1個 | ||||||
4 | 回氣過濾(lv)器 Filter for return air | Emerson | 1個 | |||||
5 | Oil differential pressure controller | 1個(ge) | ||||||
6 | Viewing port (oil level) | 丹麥 DANFOSS | 1個 | |||||
7 | Automatic protective device for pressure | FNC KOREA | 1個 | |||||
8 | Automatic liquid recycling device | FNC KOREA | 1個 | |||||
9 | Gas-liquid separator | DANHUA | 1個 | |||||
10 | Filter for disacidifying and drying | 外殼Emerson，濾芯Emerson Shell Emerson，Filter Core Emerson | 1套 | |||||
11 | 壓力表 Pressure meter | ARRON | 4個 | |||||
12 | 頂蓋閥 Tectum valve | 意(yi)大利 CASTEL | 1個 | |||||
13 | ARRON | 1個(ge) | ||||||
14 | 3個 | |||||||
15 | 丹麥(mai) Danfoss | 5個 | ||||||
16 | Low-pressure vibration absorber | 1套(tao) | ||||||
17 | 高壓避震管(guan) High-pressure vibration absorber | 航天“晨光(guang)” | 1套 | |||||
性(xing)能參數 Performance parameters | ||||||||
1 | 板層(ceng)制(zhi)冷速度（空載(zai)） （擱板進(jin)口） Shelf cooling time (empty) | +20 ～ -40°C ≤ 60 minutes | ||||||
2 | 冷凝器制冷速度（空(kong)載） Condenser cooling time (empty) | +20 ～ -40°C ≤ 30 minutes | ||||||
技術優勢 Technical advantages | ||||||||
1 | 壓縮機采用“比(bi)澤爾(er)”機組，性能更加穩(wen)定、可(ke)靠； Adopting the BITZER compressor makes the performance be more stable and relibale. | |||||||
2 | 采用符合蒙(meng)特利爾(er)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(xi)統具有各項保護(hu)(hu)功能，連(lian)鎖保護(hu)(hu)； The refrigeration system has all kinds of protection functions and interlock protection. | |||||||
① | 凍干后(hou)期(qi)低負荷條件下的壓力(li)自動調整功能(neng)； The automatic adjustment function of pressure under the condition of low load in the late of freeze drying period. | |||||||
② | 制(zhi)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(ji)電機(ji)多重保護功能； The poly-protection function of compressor motor | |||||||
E、真空系統(tong) 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 | ULVAC VDN401 | 1臺 | |||||
2 | 泵阱隔離閥Isolation valve of pump well | DN-50mm | 1個 | |||||
3 | 泵頭閥(fa)Pump head valve | 西瑪特(te) SIEGV | 2個(ge) | |||||
4 | 真空(kong)探頭Vacuum gauge | 英G“愛德(de)華”EDWARDS APG | 2個 | |||||
性能參數 Performance parameters | ||||||||
1 | J限真空Final vacuum | ≤5Pa | ||||||
2 | 抽氣速度Evacuation time | 從(cong)大氣壓抽至(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(beng)頭閥與真空泵(beng)同時打開和關(guan)閉，可大(da)大(da)防止真空泵(beng)油(you)逆向擴(kuo)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(chan)氣系(xi)統 Aeration system for repressing | ||||||||
序(xu)號(hao) SN | 名稱(cheng) 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(xi)瑪特 SIEGV | 1個 | |||||
4 | 管道Pipeline | AISI 316不銹(xiu)鋼 | 1套 | |||||
技術(shu)優(you)勢 Technical advantages | ||||||||
1 | 管道全部采用(yong)自動焊接，保證內外壁光(guang)潔(jie)； All the pipelines use the automatic welding which will ensure the finish of inner and outer surface. | |||||||
2 | 復(fu)壓系統預留了可進行(xing)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 | ||||||||
序號 SN | 名稱 Name | 型號/規格/材質 Model/Specifications/Material | 數(shu)量 Number | |||||
1 | 循環泵(beng) Circulation pump | 德G“威樂” WILO TOP-SD32-7 | 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 | 2Kw | 1支 | |||||
4 | 板式熱(re)交換器Plate heat exchanger | 瑞典“阿法拉伐” ALFALAVAL 技術 | 2個 | |||||
5 | 導熱油(you)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(mai)“丹佛斯”DANFOSS | 1個 | |||||
性(xing)能(neng)參數 Performance parameters | ||||||||
1 | 加熱速度(du)Heating rate | 1°C/min | ||||||
2 | 硅油粘(zhan)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(yuan)； Electric heating is | |||||||
