Lyophilizer Technical Parameters凍干機(jī)技術(shù)參數(shù)表欣諭
XY-FD-S40 (SIP、CIP)真空冷凍干燥機(jī) Lyophilizer-40 (SIP、CIP)
制造標(biāo)準(zhǔn)Manufacture Standards | cGMP | ||||||
A、干燥箱(含41.86m2板層)Chamber (with41.86m2 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 | ||||
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(shí)照明燈 DN150 mm With time delay head lamp | 1個(gè) | ||||
5 | 箱門視鏡 Viewing port (door) | DN150 mm | 1個(gè) | ||||
6 | 驗(yàn)證孔Validation port | 3D設(shè)計(jì) 3D design | 1個(gè) | ||||
7 | 安全插銷門鎖系統(tǒng) Door lock system with safe bolt | “XY”D特設(shè)計(jì) Unique design by XINYU | 1套 | ||||
8 | 制品測溫探頭 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 | 0.15Mpa(壓力0.25MPa) | |||||
2 | 設(shè)計(jì)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(dǎo)熱油進(jìn)口) Shelves temperature Min | -55℃ | |||||
6 | 板層Z高溫度(導(dǎo)熱油進(jìn)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(fā)泡材料 Aluminum silicate and polyisocyanurate foam | |||||
11 | 開門方向Open direction | 根據(jù)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(jù)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(shù)優(yōu)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(shè)計(jì),更符合滅菌要求; International advanced nozzle design of 3D more accords with the requirements of thorough sterilization. | ||||||
3 | **設(shè)計(jì)的安全插銷門鎖系統(tǒng),D立監(jiān)控,聯(lián)鎖運(yùn)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(qiáng)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(jī)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(kuò)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(diào)節(jié)); 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(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 | DN150mm 帶延時(shí)照明燈 DN150 mm With time delay head lamp | 1個(gè) | ||||
5 | 冷凝器測溫探頭 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 | 0.15Mpa(壓力0.25MPa) | |||||
2 | 設(shè)計(jì)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(shù)優(yōu)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(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 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(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 | DN900mm | |||||
技術(shù)優(yōu)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(jìn)行調(diào)整,防止關(guān)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(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 | 新型蘑菇閥具有很高的密封性和準(zhǔn)確性,可防止內(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 | 壓縮機(jī)型號(hào)及數(shù)量 Compressor model and number | KEBELCO“日本神戶制鋼”KS10LTH | 2臺(tái) | ||||
2 | 制冷劑 Refrigerant | R404a 綠色環(huán)保型 R404a Environment Friendly | 適量 Right quantity | ||||
3 | 油分離器 Oil separator | “法斯克”(天津) | 2個(gè) | ||||
4 | 冷卻水流量開關(guān) Flow switch for cooling water | 韓G HFS | 1個(gè) | ||||
6 | 電磁閥 Solenoid valve | 丹麥 DANFOSS | 10個(gè) | ||||
7 | 膨脹閥 Expansion valve | 丹麥 DANFOSS | 10個(gè) | ||||
8 | 頂蓋閥 Tectum valve | 意大利 CASTEL | 10個(gè) | ||||
9 | 黃銅絲口閘閥 Brake valve with screwed brass | 寧波 永享 | 2個(gè) | ||||
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(gè) | ||||
12 | 儲(chǔ)液罐角閥 Angle valve for fluid reserve tank | 中國臺(tái)灣 SY | 4個(gè) | ||||
13 | 視液鏡 Viewing port | 丹麥 DANFOSS | 2個(gè) | ||||
14 | 手動(dòng)球閥 Manual globe valve | 意大利 CASTEL | 4個(gè) | ||||
15 | 單向閥 Check valve | HELDON或ARROW | 2個(gè) | ||||
16 | 油冷卻器 Oil condenser | “法斯克”(天津) | 2個(gè) | ||||
17 | 油壓差繼電器 Oil differential pressure relay | 丹麥“丹佛斯”DANFOSS | 2個(gè) | ||||
18 | 壓力表 Pressure meter | 日本 KOBELCO | 4個(gè) | ||||
19 | 高低壓壓力繼電器 Pressure relay (high/low pressure) | 丹麥“丹佛斯”DANFOSS | 2個(gè) | ||||
20 | 溫度指示計(jì) Temperature indicator | 日本 NESS | 2個(gè) | ||||
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Technical advantages | |||||||
1 | 壓縮機(jī)采用日本神戶制鋼螺桿機(jī)組,性能非常穩(wěn)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(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. | ||||||
4 | 回氣溫度能夠進(jìn)行控制;Back temperature can be controlled. | ||||||
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 | 英G“愛德華”EDWARDS E2M175 | 2臺(tái) | ||||
2 | 羅茨泵Roots pump | 英G“愛德華”EDWARDS EH1200 | 1臺(tái) | ||||
3 | 泵阱隔離閥Isolation valve of pump well | 德G“蓋米”GEMU DN150mm | 1個(gè) | ||||
4 | 泵頭閥Pump head valve | 西瑪特SIEGV | 2個(gè) | ||||
5 | 閥門反饋信號(hào)Feedback signal of valve | 德GROTECH | 1套 | ||||
6 | 真空探頭Vacuum gauge | 英G“愛德華”EDWARDS APG | 2個(gè) | ||||
性能參數(shù)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(shù)優(yōu)勢Technical advantages | |||||||
1 | 真空系統(tǒng)閥門具有反饋信號(hào),可了解開關(guān)的真實(shí)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(shí)打開和關(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. | ||||||
3 | 羅茨泵可與真空泵同時(shí)啟動(dòng); The roots pump and vacuum pump can be started simultaneously. | ||||||
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 | 過濾器Filter | 0.22µm | 1個(gè) | ||||
2 | 摻氣閥Aeration valve | 西瑪特SIEGV | 1個(gè) | ||||
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(shù)優(yōu)勢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 | 過濾器可進(jìn)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(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“海密梯克” CNF 50-160 | 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 | 60Kw | 1支 | ||||
4 | 板式熱交換器Plate heat exchanger | 瑞典“阿法拉伐”ALFALAVAL | 4個(gè) | ||||
5 | 導(dǎo)熱油測溫探頭 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 controled by PID which can use the heating energy most effectively. | ||||||
H、液壓系統(tǒng)Hydraulic 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 | 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(shù)Performance parameters | |||||||
1 | 壓塞壓力 Stoppering force | 0~1.0bar(可調(diào)) 0~1.0bar(adjustable) | |||||
技術(shù)優(yōu)勢Technical advantages | |||||||
1 | 液壓系統(tǒng)設(shè)置有“背壓閥”,在蒸汽滅菌時(shí)可對(duì)油缸腔室進(jìn)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(shí)現(xiàn)動(dòng)態(tài)清洗 Dynamic washing for shelves is achieved. | ||||||
4 | 能準(zhǔn)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(dòng)系統(tǒng)Pneumatic 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 | 氣動(dòng)元件Pneumatic Units | 中國臺(tái)灣“AIRTAC”亞德客 | 1套 | ||||
技術(shù)優(yōu)勢Technical advantages | |||||||
1 | 帶潤滑的氣動(dòng)系統(tǒng)可以保證閥門有效開關(guān); Pneumatic system with lubrication device can ensure that valves turn ON or OFF effectively. | ||||||
2 | 帶過濾器的氣動(dòng)系統(tǒng)可以保證閥門穩(wěn)定性; Pneumatic system with filter can ensure stability of valves. | ||||||
J、在線清洗、在線滅菌系統(tǒng) (SIP、CIP) CIP and SIP system (SIP、CIP) | |||||||
序號(hào) SN | 名稱 Name | 型號(hào)/規(guī)格/材質(zhì) Model/Specifications/Material | 數(shù)量 Number | ||||
1 | 噴嘴Nozzle | 美G“噴霧”SSC | 1套 | ||||
2 | 管道Pipeline | AISI 316L | 1套 | ||||
3 | 進(jìn)水進(jìn)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(gè) | ||||
6 | 疏水器Steam trap | 日本MIYAWAKA | 2個(gè) | ||||
7 | 電接點(diǎn)壓力表 Electronic contactor | 德GWIKA | 1個(gè) | ||||
8 | 壓力變送器 Pressure transmitter | 英GGEMS | 2個(gè) | ||||
9 | 水環(huán)泵Water-ring pump | 山東“納西姆”2BV-5110 或“斯特林”LEM150或者SIHI斯赫 | 1臺(tái) | ||||
技術(shù)優(yōu)勢Technical advantages | |||||||
1 | 與箱體連接管道全部采用符合衛(wèi)生標(biāo)準(zhǔn)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(dòng)焊接,內(nèi)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(duì)箱體進(jìn)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(tǒng)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(shè)置有過濾網(wǎng); A filter screen set near the outfall. | ||||||
6 | 排水系統(tǒng)設(shè)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(tǒng)Electric control 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 | 電氣標(biāo)準(zhǔn)Electric standard | IEC60204-1 | / | ||||
2 | PLC | 日本OMRON | 1套 | ||||
3 | 計(jì)算機(jī)Computer | 聯(lián)想LENOVO | 1臺(tái) | ||||
4 | 觸摸屏Touch screen | 日本OMRON | 1個(gè) | ||||
5 | 空氣開關(guān)Breaker | 德G SIEMENS | / | ||||
6 | 交流接觸器AC contactor | 德G SIEMENS | / | ||||
7 | 電氣保護(hù)等級(jí) Protection class | IP22 | / | ||||
8 | UPS電源 UPS power | SANTAK | 1臺(tái) | ||||
9 | 軟件系統(tǒng)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(dòng)及自動(dòng)控制Manual and automatic | ||||||
軟件功能Software function | |||||||
1 | 冷凍干燥(手動(dòng)、自動(dòng),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(dòng)、自動(dòng))Cleaning in place (manual, automatic) | ||||||
4 | 在線滅菌(手動(dòng)、自動(dòng))Sterilization in place (manual, automatic) | ||||||
5 | 工藝設(shè)定(配方管理)Technique setting (recipe management) | ||||||
技術(shù)優(yōu)勢Technical advantages | |||||||
1 | 符合FDA歐盟標(biāo)準(zhǔn),電子簽名,多組密碼; It accords with European standard FDA. There are electronic signatures and multiple passwords. | ||||||
2 | 自動(dòng)、手動(dòng)在任何節(jié)點(diǎn)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(jī)的健康提供數(shù)據(jù)保障; One touch function for examination provides data protection for the health of lyophilizer. | ||||||
4 | 系統(tǒng)操作可在無菌室、機(jī)房、凍干控制室進(jìn)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(qiáng)制停止板層運(yùn)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(jī)界面具有各種部件、閥門工作狀態(tài)及溫度、真空度參數(shù)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(shè)置無數(shù)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(shí)現(xiàn):低溫進(jìn)箱、二次回凍(反復(fù)預(yù)凍)、壓力升測試、摻氣閥或者小碟閥選擇性摻氣控制、自動(dòng)放氣和壓塞、低溫出箱等個(gè)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(dòng)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(duì)配方進(jìn)行隨時(shí)調(diào)整; The recipe can be adjusted momentarily in the “freeze drying ”process. | ||||||
11 | 操作畫面具有各個(gè)故障點(diǎn)顯示功能; There is a function for displaying various trouble points on the operation interface. | ||||||
12 | 具有數(shù)據(jù)、曲線兩種記錄功能,可根據(jù)批號(hào)隨時(shí)調(diào)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(chǔ)無數(shù)條數(shù)據(jù)、曲線記錄; It can save countless data and curves records. | ||||||
14 | 各個(gè)真空度、溫度曲線由多種顏色顯示,并可任意設(shè)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(shù)據(jù)曲線”、“歷史記錄”、“操作記錄”、“報(bào)警記錄”等原始記錄一起打印,可作為批產(chǎn)品的詳細(xì)批記錄進(jìn)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(shí)現(xiàn)自動(dòng)控制; “Cleaning in place”can be automatically controled. | ||||||
17 | “在線消毒”功能具有安全連鎖保護(hù);脈動(dòng)預(yù)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(jù)用戶實(shí)際使用需要增加相應(yīng)軟件功能; It can increase corresponding software function according to actual requirements of customer. | ||||||
19 | 軟件系統(tǒng)符合FDA 21CFR PART II; Software system accords with FDA 21CFR PART II. | ||||||
20 | 電子簽名,三級(jí)用戶權(quán)限管理,曲線報(bào)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(nèi)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(jī)功率Total power | 186Kw (380V, 50Hz, 3Phase, 5Wire) | |||||
2 | 用于制冷系統(tǒng)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(dòng)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(shù)據(jù)僅供參考,以實(shí)際設(shè)計(jì)圖紙為準(zhǔn) | |||||||
M、設(shè)備主要參數(shù)The equipment’s main technique parameter | |||||||
1 | 整機(jī)結(jié)構(gòu) Machine construction | 分體式 Split | |||||
2 | 外型尺寸 Dimension of unit | 約10100*2850*3600mm | |||||
3 | 整機(jī)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(shù)據(jù)僅供參考,以實(shí)際設(shè)計(jì)圖紙為準(zhǔn) | |||||||
O、驗(yàn)證文件系統(tǒng)(電子光盤1份) 詳細(xì)驗(yàn)證文件系統(tǒng)Verification documents system(one set of CD) The details of verification documents system | |||||||
序號(hào) SN | 名稱 Name | 數(shù)量 Number | |||||
1 | 安裝確認(rèn) Installation qualitation(IQ) | 1套 | |||||
2 | 操作確認(rèn) Operation qualitation(OQ) | 1套 | |||||
3 | 性能確認(rèn) Performance qualitation(PQ) | 1套 | |||||
4 | 工廠驗(yàn)收測試 Factory acceptance test(FAT) | 1套 | |||||
5 | 客戶現(xiàn)場驗(yàn)收測試 Site acceptance test(SAT) | 1套 | |||||
6 | 操作手冊(cè) Operation manual (OM) | 1套 | |||||
7 | 維護(hù)手冊(cè) Maintenance manual (MM) | 1套 | |||||
8 | 安裝手冊(cè) 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(zhì)量證書 Quality certificate for pressure vessel | 1套 | |||||
14 | 材質(zhì)報(bào)告 Material report | 1套 | |||||
15 | 校驗(yàn)報(bào)告 Verification report | 1套 |