Lyophilizer Technical Parameters凍干機(jī)技術(shù)參數(shù)表
1、XY-FD-S5E真空冷凍干燥機(jī)
制造標(biāo)準(zhǔn) Manufacture Standards | cGMP | ||
A、干燥箱（含0.54m2板層） Chamber (with 0.54m2 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 | 316L 不銹鋼 | 1套 |
2 | 板層 Shelves | 316L 不銹鋼 | 1套 |
尺寸：450×300×12mm Dimensions：450×300×12mm | 4 +1層 | ||
3 | 箱門 Door | 透明樹脂 colophony | 1套 |
4 | 驗(yàn)證孔 Validation port | 1個(gè) | |
5 | 制品測(cè)溫探頭 Product sensors | Pt-100 熱電阻 A級(jí) Pt-100 Hot resistance A Level | 2支 |
6 | 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≤0.4µm | |
4 | 平整度 Level | ±0.5mm/m | |
5 | 板層Z低溫度 （擱板進(jìn)口） Shelves temperature Min | -55℃ | |
6 | 板層Z高溫度 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 | 80mm | |
9 | 干燥箱外形 Chamber type | 圓桶體cylinder | |
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 | 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 | 不銹鋼板材均采用衛(wèi)生級(jí)不銹鋼板材，保證箱體表面光潔度，從而保證無(wú)菌要求； Stainless steel plates are all sanitary stainless steel plates. 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) | |||||
5 | 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 | 304 不銹鋼 | 1套 | |||
2 | 冷凝盤管 Condenser coiled pipe | 304 不銹鋼 | 1套 | |||
3 | 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 | 1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≤0.4um | ||||
4 | 盤管Z低溫度 Coiled temperature Min | -75℃ | ||||
5 | 冷凝器捕冰能力 Condenser frosting capacity | 10Kg/批 10Kg/batch | ||||
6 | 冷凝器外型 Condenser type | 圓桶體 cylinder | ||||
技術(shù)優(yōu)勢(shì) Technical advantages | ||||||
1 | 不銹鋼板材均采用衛(wèi)生級(jí)不銹鋼板材，保證箱體表面光潔度，從而保證無(wú)菌要求； Stainless steel plates are all sanitary stainless steel plates. 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、中隔閥 Big Isolation 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 | 電動(dòng)碟閥Electric valve | DN-100 | 1套 | |||
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 | BITZER“比澤爾”S4T-5.2Y | 1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 | 美G EMERSON | 1個(gè) | |||
4 | 回氣過(guò)濾器 Filter for return air | 外殼EMERSON，濾芯EMERSON Shell EMERSON，Filter Core EMERSON | 1個(gè) | |||
5 | 油壓差控制器 Oil differential pressure controller | 丹麥 DANFOSS | 1個(gè) | |||
6 | 油平面視鏡 Viewing port (oil level) | 丹麥 DANFOSS | 1個(gè) | |||
7 | 壓力自動(dòng)保護(hù)裝置 Automatic protective device for pressure | 丹麥 DANFOSS | 1個(gè) | |||
8 | 自動(dòng)收液裝置 Automatic liquid recycling device | 丹麥 DANFOSS | 1個(gè) | |||
9 | 氣液分離器 Gas-liquid separator | DANHUA | 1個(gè) | |||
10 | 除酸干燥過(guò)濾器 Filter for disacidifying and drying | 外殼EMERSON，濾芯EMERSON Shell EMERSON，Filter Core EMERSON | 1套 | |||
11 | 壓力表 Pressure meter | 瑞士 REFCO | 1個(gè) | |||
12 | 頂蓋閥 Tectum valve | 意大利 CASTEL | 1個(gè) | |||
13 | 繼電器 Relay | 丹麥 DANFOSS | 3個(gè) | |||
14 | 安全閥 Safety valve | 意大利 CASTEL | 1個(gè) | |||
15 | 膨脹閥 Expansion valve | 丹麥 Danfoss | 3個(gè) | |||
16 | 電磁閥 Solenoid valve | 丹麥 Danfoss | 2個(gè) | |||
17 | 低壓避震管 Low-pressure vibration absorber | 美G YORK PA | 1套 | |||
18 | 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 | 優(yōu)成 TRP-24 | 1臺(tái) | |||
2 | 泵阱隔離閥Isolation valve of pump well | DN-25mm | 1個(gè) | |||
3 | 泵頭閥 Pump head valve | 西瑪特 SIEGV | 1個(gè) | |||
4 | 真空探頭Vacuum gauge | 英G“愛(ài)德華”EDWARDS APG | 1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) | |||
3 | 管道Pipeline | 316L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. | |||||
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 | 1Kw | 1支 | |||
4 | 板式熱交換器 Plate heat exchanger | 瑞典“阿法拉伐”ALFALAVAL | 1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) | |||
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 | 2cSt 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 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 | 柔肯ROKEN | ||||
2 | 液壓泵Hydraulic pump | 柔肯ROKEN | 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 | 14L | 1套 | |||
性能參數(shù) Performance parameters | ||||||
1 | 壓塞壓力 Stoppering force | 0~1.0bar（可調(diào)） 0~1.0bar（adjustable） | ||||
I、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 | 正泰 | ／ | |||
6 | 交流接觸器 AC contactor | 施耐德 | ／ | |||
7 | 電氣保護(hù)等級(jí) Protection class | IP22 | ／ | |||
9 | 軟件系統(tǒng) Software system | XY-HMI-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 | 工藝設(shè)定（配方管理） Technique setting (recipe management) | |||||
技術(shù)優(yōu)勢(shì) 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 | 系統(tǒng)操作可在無(wú)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. | |||||
4 | 無(wú)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. | |||||
5 | 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. | |||||
6 | “配方管理”可設(shè)置無(wú)數(shù)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(shí)現(xiàn)：低溫進(jìn)箱、二次回凍（反復(fù)預(yù)凍）、壓力升測(cè)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”. | |||||
8 | “冷凍干燥”自動(dòng)過(guò)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(guò)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. | |||||
10 | 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. | |||||
11 | 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??； 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(chǔ)無(wú)數(shù)條數(shù)據(jù)、曲線記錄； It can save countless data and curves records. | |||||
13 | 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. | |||||
14 | “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. | |||||
15 | 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. | ||||
16 | 軟件系統(tǒng)符合FDA 21CFR PART II； Software system accords with FDA 21CFR PART II. | ||||
17 | 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. | ||||
18 | 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. | ||||
J、公用工程清單 Utility list | |||||
1 | 總裝機(jī)功率 Electricity-total electrical load | 8Kw (380V, 50Hz, 3Phase, 5Wire) | |||
2 | 用于制冷系統(tǒng)的冷卻水 Cooling water for refrigerant cooling | 4m3/hr (1.5≤P≤2bar, 15℃≤T≤30℃) | |||
以上數(shù)據(jù)僅供參考，以實(shí)際設(shè)計(jì)圖紙為準(zhǔn) | |||||
K、設(shè)備主要參數(shù) The equipment’s main technique parameter | |||||
1 | 整機(jī)結(jié)構(gòu) Machine construction | 一體式 Union | |||
2 | 外型尺寸 Dimension of unit | 約1815×900×1780mm | |||
3 | 整機(jī)重量 Weight of unit | 約1.5T (About )1.5T | |||
4 | 西林瓶裝量 Filling volume of vial | Ф22mm 1160支 Ф16mm 2260支 | |||
5 | 凍干原料裝量（建議值） Capacity of raw material for freeze drying (suggestive value) | Z大8Kg/批 8kg/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) | |||||
L、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(cè)試 Factory acceptance test（FAT） | 1套 | |||
5 | 客戶現(xiàn)場(chǎng)驗(yàn)收測(cè)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(shuō)明書 Instruction for the main parts | 1套 | |||
13 | 材質(zhì)報(bào)告 Material report | 1套 | |||
14 | 校驗(yàn)報(bào)告 Verification report | 1套 | |||
M、備品備件 | |||
序號(hào) Serial number | 名稱 Name | 型號(hào)/規(guī)格/材質(zhì) Model/Specifications/Material | 數(shù)量 Number |
1 | 氟利昂Freon | R404A | 10.9kg |
2 | 冷凍機(jī)油 Refrigeration oil | BITZER專用 | 5.0L |
3 | 電磁閥 Solenoid valve | DANFOSS | 1 |
4 | 電磁閥線圈 Solenoid valve coil | DANFOSS | 2 |
5 | 測(cè)溫探頭 Temperature probe | PT-100單支 | 5 |
6 | 高壓壓力表 High-pressure gage | REFCO | 1 |
7 | 低壓壓力表 Low-pressure gage | REFCO | 1 |
8 | 干燥過(guò)濾器 Dry filter core | DANFOSS | 2 |
9 | 真空泵油 Vacuum pump oil | 優(yōu)成 | 4L |
10 | 制冷專用板手 Special wrench for cooling | COOLMAX | 1把 |
11 | 制冷專用加液管 Special liquid inlet tube for cooling | HONGSEN | 1根 |
12 | 制冷劑加液表 Dosing table for refrigerant | HONGSEN | 1套 |
