欣諭XY-FD-S10E真空冷凍干燥機(jī)（冰凍干燥機(jī)） 制造標(biāo)準(zhǔn) Manufacture Standards | cGMP | |||||||
A、干燥箱（含1.08m2板層） Chamber (with1.08m2 shelves) | ||||||||
序號(hào)SN | 名稱 Name | 型號(hào)/規(guī)格/材質(zhì) Model/Specifications/Material | 數(shù)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 | |||||
Dimensions：600×450×20mm | ||||||||
3 | 箱門 Door | 部分AISI 316 不銹鋼 Part AISI 316 stainless steel | 1套 | |||||
4 | 干燥箱視鏡 Viewing port (chamber) | DN-200 mm 帶延時(shí)照明燈 DN-200 mm With time delay head lamp | 1個(gè) | |||||
5 | 箱門視鏡 Viewing port (door) | DN-200 mm | 1個(gè) | |||||
6 | 驗(yàn)證孔 Validation port | 1個(gè) | ||||||
7 | 手動(dòng)門鎖系統(tǒng) Door lock system with safe | 蝶形手柄設(shè)計(jì) The butterfly handles | 1套 | |||||
8 | 制品測(cè)溫探頭 Product sensors | Pt-100 熱電阻 A級(jí) Pt-100 Hot resistance A Level | 3支 | |||||
9 | 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≤0.5μm | ||||||
4 | 平整度 Level | ±1mm/m | ||||||
5 | 板層Z低溫度(導(dǎo)熱油進(jìn)口) Shelves temperature Min | -50℃ | ||||||
6 | 板層Z高溫度(導(dǎo)熱油進(jìn)口) 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 | 100mm | ||||||
9 | 干燥箱外形 Chamber type | 長(zhǎng)方型 Rectangular | ||||||
10 | 保溫層 Insulation | 硅酸鋁和聚氨酯發(fā)泡材料 Aluminum silicate and polyisocyanurate foam | ||||||
11 | 開(kāi)門方向 Open direction | 根據(jù)用戶要求確定 According to user’s requirements | ||||||
12 | 開(kāi)門角度 Open angle | 大于110度 More than 110° | ||||||
13 | 視鏡方向 Position of viewing port | 根據(jù)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(shù)優(yōu)勢(shì) Technical advantages | ||||||||
1 | 不銹鋼板材均采用優(yōu)質(zhì)板材，保證箱體表面光潔度，從而保證無(wú)菌要求； Stainless steel plates are superior. Ensure the finish of chamber surfaces, and then ensure the asepsis requirement. | |||||||
2 | 板層具有很高強(qiáng)度，能夠耐受長(zhǎng)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(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) | |||||||
6 | 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) | ||||||||
序號(hào) SN | 名稱 Name | 型號(hào)/規(guī)格/材質(zhì) Model/Specifications/Material | 數(shù)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 | DN-150mm 帶延時(shí)照明燈 DN-150 mm With time delay head lamp | 1個(gè) | |||||
5 | 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 | 2支 | |||||
6 | 化霜噴球 Spray ball for de-icing | AISI 316L 不銹鋼 | 2個(gè) | |||||
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≤0.5um | ||||||
4 | 盤管Z低溫度 Coiled temperature Min | ≤-70℃ | ||||||
5 | 冷凝器捕冰能力 Condenser frosting capacity | 60Kg/批 60Kg/batch | ||||||
6 | 冷凝器外型 Condenser type | 長(zhǎng)方型 Rectangular | ||||||
技術(shù)優(yōu)勢(shì) Technical advantages | ||||||||
1 | 不銹鋼板材均采用優(yōu)質(zhì)板材，保證箱體表面光潔度，從而保證無(wú)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(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、蘑菇閥 Mushroom valve | ||||||||
序號(hào) SN | 名稱 Name | 型號(hào)/規(guī)格/材質(zhì) Model/Specifications/Material | 數(shù)量 Number | |||||
1 | 蘑菇閥mushroom valve | AISI 316 不銹鋼 AISI 316 stainless steel | 1套 | |||||
2 | 蘑菇閥油缸 mushroom valve cylinder | 上海“晶盛”30/80 Shanghai“jingsheng” 30/80 | 1個(gè) | |||||
性能參數(shù) Performance parameters | ||||||||
1 | 工作動(dòng)力 Motivation | 液壓驅(qū)動(dòng) Hydraulic driven | ||||||
2 | 蘑菇閥尺寸 Mushroom valve dimension | DN-250mm | ||||||
技術(shù)優(yōu)勢(shì) 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(guò)減壓閥進(jìn)行調(diào)整，防止關(guān)閉壓力過(guò)大； Mushroom valve can be adjusted by reducing valve to prevent the over closing pressure. | |||||||
3 | 蘑菇閥的“打開(kāi)”或“關(guān)閉”具有反饋信號(hào)，能夠真實(shí)的了解工作狀態(tài)； When mushroom valve is ON or OFF there is a feedback signal which can be in favor of knowing the working state truly. | |||||||
4 | 新型蘑菇閥板法蘭采用二次加工，具有很高的密封性和準(zhǔn)確性，可完全防止內(nèi)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(tǒng) Refrigeration system | ||||||||
序號(hào) SN | 名稱 Name | 型號(hào)/規(guī)格/材質(zhì) Model/Specifications/Material | 數(shù)量 Number | |||||
1 | Compressor model and number | BITZER“比澤爾”S4G-5.2Y | 1臺(tái) | |||||
2 | Refrigerant | R404a Environment Friendly | 適量 Right quantity | |||||
3 | Emerson | 1個(gè) | ||||||
4 | 回氣過(guò)濾器 Filter for return air | Emerson | 1個(gè) | |||||
5 | Oil differential pressure controller | 1個(gè) | ||||||
6 | Viewing port (oil level) | 丹麥 DANFOSS | 1個(gè) | |||||
7 | Automatic protective device for pressure | FNC KOREA | 1個(gè) | |||||
8 | Automatic liquid recycling device | FNC KOREA | 1個(gè) | |||||
9 | Gas-liquid separator | DANHUA | 1個(gè) | |||||
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(gè) | |||||
12 | 頂蓋閥 Tectum valve | 意大利 CASTEL | 1個(gè) | |||||
13 | ARRON | 1個(gè) | ||||||
14 | 3個(gè) | |||||||
15 | 丹麥 Danfoss | 5個(gè) | ||||||
16 | Low-pressure vibration absorber | 1套 | ||||||
17 | 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 | ||||||||
序號(hào) SN | 名稱 Name | 型號(hào)/規(guī)格/材質(zhì) Model/Specifications/Material | 數(shù)量 Number | |||||
1 | 真空泵Vacuum pump | ULVAC VDN401 | 1臺(tái) | |||||
2 | 泵阱隔離閥Isolation valve of pump well | DN-50mm | 1個(gè) | |||||
3 | 泵頭閥Pump head valve | 西瑪特 SIEGV | 2個(gè) | |||||
4 | 真空探頭Vacuum gauge | 英G“愛(ài)德華”EDWARDS APG | 2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(kāi)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 | ||||||||
序號(hào) SN | 名稱 Name | 型號(hào)/規(guī)格/材質(zhì) Model/Specifications/Material | 數(shù)量 Number | |||||
1 | 過(guò)濾器Filter | 0.22μm | 1個(gè) | |||||
2 | 摻氣閥Aeration valve | 西瑪特 SIEGV | 1個(gè) | |||||
4 | 管道Pipeline | AISI 316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. | |||||||
2 | 復(fù)壓系統(tǒng)預(yù)留了可進(jìn)行充氮?dú)饨涌冢?/span> A interface by which it can inject nitrogen reserves in the repressing system. | |||||||
G、循環(huán)系統(tǒng) Circulation system | ||||||||
序號(hào) SN | 名稱 Name | 型號(hào)/規(guī)格/材質(zhì) Model/Specifications/Material | 數(shù)量 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 | 2Kw | 1支 | |||||
4 | 板式熱交換器Plate heat exchanger | 瑞典“阿法拉伐” ALFALAVAL 技術(shù) | 2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) | |||||
7 | 壓力控制器 Pressure 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 | 5cSt 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 | |||||||
