技術(shù)規(guī)格
TECHNICAL SPECIFICATIONS
Lyophilizer Technical Parameters凍干機技術(shù)參數(shù)表
1、XY-FD-S0.5E真空冷凍干燥機
General Detail 總述 | ||
Sr. No. | Description 描述 | Specifications 規(guī)格 |
1 | Mode 型號 | XY-FD-S0.5E |
2 | Output (approx.) 產(chǎn)量（大約） | 2.160 units of vials 16mm diameter 外徑16毫米凍干瓶2.160瓶 |
1.130units of vials 22mm diameter 外徑22毫米凍干瓶1.130瓶 | ||
3 | Maximum ice capacity Z大捕冰力 | 10kg |
4 | Stoppering 壓塞 | Hydraulic stoppering 液壓壓塞(sw) |
5 | Control 控制方式 | Microprocessor 微機處理【無菌窒增加一套扳層升降操作系統(tǒng)】 |
6 | Dimension of unit (approx.) (L × W × H) (mm) (with hydraulic cylinder) 外型尺寸（大約）（長×寬×高）（帶液壓缸） | 1,900 × 850 × 2,200 (Final dimension based on design) （以Z終設(shè)計尺寸為準） |
7 | Weight (approx.) 重量（大約） | 900kg |
Chamber 凍干箱 | ||
1 | Chamber type 凍干箱外型 | Rectangular 長方體 |
3 | Finish 內(nèi)部拋光度 | Ra≤0.4um (0.4Mircon) |
4 | Corner 箱內(nèi)角 | Coping 圓弧角 |
5 | Viewing port 視鏡 | Illuminated 帶遠射燈【廣角】 |
Number 數(shù)量 | 1 | |
Location 位置 | Side 側(cè)面 | |
Dimension 尺寸 | DN150 (mm) | |
Material 材質(zhì) | ||
Internal 內(nèi)部 | AISI 316L | |
Insulation 保溫 | Aluminum silicate and polyisocyanurate foam 硅酸鋁和聚氨酯發(fā)泡材料 | |
External cover 外部 | 304 | |
Door 箱門 | ||
1 | Finish 拋光度 | Ra≤0.4um (0.4Mircon) |
2 | Viewing port 視鏡 | Included 有 |
Number 數(shù)量 | 1 | |
3 | Open direction 開門方向 | left (face to door, hinge on left side) 左開（面對箱門，鉸鏈在左） |
4 | Open angle 開門角度 | More than 110o 大于110度 |
5 | Gasket 密封圈 | O-shaped silicone rubber single gasket O-型硅橡膠單密封 |
6 | Locking arrangement 門鎖方式 | Manual handle 手柄 |
7 | Material 材質(zhì) | |
Internal 內(nèi)部 | AISI 316L | |
Insulation 保溫 | Aluminum silicate and polyisocyanurate foam 硅酸鋁和聚氨酯發(fā)泡材料 | |
External cover 外部 | 304 | |
Sterile wall flange 無菌隔離圍板 | 304 | |
Shelves 板層 (帶西林瓶防護條) | ||
1 | Temperature range 溫度范圍 | -58°C to + 80°C |
2 | Temperature sensors (shelves) 板層溫度探頭 | 2 |
Silicone oil inlet 導(dǎo)熱油進口 | ||
Silicone oil outlet 導(dǎo)熱油出口 | ||
3 | Product sensors 產(chǎn)品溫度探頭 | 4 |
4 | Number of shelves 板層數(shù) | 4+ 1(upper radiant shelf) （溫度補償板） |
5 | Dimension (L × W × T) (mm) 板層尺寸 | 450 × 300 × 12 |
6 | Total usable area (sq. m) 總使用面積 | 0.54 m2 |
7 | Spacing (mm) 板間距 | 95 |
8 | Hose of flexible connection 軟管連接 | Welding 焊接 |
9 | Finish 拋光度 | Ra≤0.4um (0.4Micron) |
10 | Level 平整度 | ≤±0.5mm/m |
11 | Material 材質(zhì) | AISI 316L |
Stoppering Device 液壓裝置 | ||
1 | Stoppering condition 運行環(huán)境 | Under vacuum or under inert gas 真空或惰性氣體保護 |
2 | Stoppering direction 壓塞方向 | Top to bottom 從上到下或從下到上 |
Power motor 電機功率 | 0.88kW | |
Oil packing 裝油量 | 15L | |
Stoppering force 液壓力 | 0~1bar (adjustable) 可調(diào) | |
Condenser 冷凝器 | ||
1 | Condenser type 冷凝器外型 | Rectangular 長方體 |
2 | Final temperature J限溫度 | ≤-80°C |
3 | Cooling time (+20 to -40°C) 制冷速度(空載) | ≤30 minutes (empty) |
4 | Finish 拋光度 | Ra≤0.5um (0.5Mircon) |
5 | Coiled pipe welding 盤管焊接 | Orbitally welded 自動焊接 |
6 | Isolation valve 中隔閥 | |
Type 外型 | Mushroom 蘑菇閥 | |
Size 尺寸 | DN 70 (mm) | |
7 | Coiled pipe material 盤管材質(zhì) | |
Internal 內(nèi)部 | AISI 304 | |
Insulation 保溫 | Aluminum silicate ａnd polyisocyanurate foam 硅酸鋁和聚氨酯發(fā)泡材料 | |
External cover 外部 | 304 | |
Shelf Heating / Cooling 板層升溫/降溫 | ||
1 | Circulation pump 循環(huán)泵 | |
Brand 品牌 | 德Gwilo | |
Model 型號 | TOP S25/7 | |
Type 形式 | Shielding method 屏蔽式 | |
Number 數(shù)量 | 1 | |
Motor power 電機功率 | 0.28kW | |
2 | Plate heat exchanger 板式熱交換器 | |
Brand 品牌 | Alfa Laval 阿法拉伐 | |
Type 方式 | Sealed brazed stainless steel 不銹鋼封蜂窩式 | |
Number 數(shù)量 | 1 | |
3 | Heater 電加熱 | PID control PID 控制（雙組電加熱系統(tǒng)） |
4 | Maximum heating power Z大加熱功率 | 1.0kW |
5 | Thermal fluid 導(dǎo)熱介質(zhì) | Silicone oil 5 cst 粘度5 cst硅油 |
6 | Shelf cooling time (+25°C to -40°C) 板層制冷速度(空載) | ≤60 minutes (empty) |
7 | Heating rate 加熱速度(大約) | 1°C/min (approx.) |
8 | Shelves temperature uniformity 板層溫度均勻性(空載平衡后) | ≤±1°C (soak stage) |
9 | Compressor 壓縮機 | |
Brand 品牌 | 泰康 （法G原裝） | |
Model 型號 | THF-2511Z | |
Type 方式 | 1臺 | |
Number 數(shù)量 | 風(fēng)冷 | |
Motor power 電機功率 | 2.25KW | |
10 | Refrigerant 制冷劑 | CFC-free R404A |
Brand 品牌 | 泰康 （法G原裝） | |
Model 型號 | THF-2480Z | |
Number 數(shù)量 | 1臺 | |
Type 方式 | 復(fù)疊 | |
Motor power 電機功率 | 1.5KW | |
11 | Refrigerant 制冷劑 | CFC-free R-23 |
Thermostatic expansion valve 熱力膨脹閥 | Danfoss 丹佛斯 | |
Solenoid valve 電磁閥 | Danfoss 丹佛斯 | |
Sight glass 視液鏡 | Danfoss 丹佛斯 | |
Liquid filter core 液體過濾芯 | Danfoss 丹佛斯 | |
Pressure meter 壓力表 | Refco | |
Pressure controller 壓力控制器 | Danfoss | |
Vacuum System 真空系統(tǒng) | ||
1 | Final vacuum J限真空 | ≤2.6×10 -2mbar |
2 | Evacuation time 抽氣速度 | ≤30minutes (1×103 mbar to 1×10-1 mbar) |
3 | Leakage rate 泄露率 | ≤5×10-2 mbar?lit/sec |
4 | pump 真空泵 | |
Brand 品牌 | BAOSI | |
Model 型號 | BSV-24 | |
Type 方式 | Bipolar vane 雙J旋片 | |
Number 數(shù)量 | 1 | |
Flow rate 排氣速度 | 20m3/hr (×1) | |
Motor power 電機功率 | 1.1Kw (×1) | |
5 | Pump isolation valve 泵閥隔離閥 | |
Type 方式 | Ball valve 球閥 | |
Size 尺寸 | DN 25 (mm) | |
6 | 摻氣閥 | 控制真空度微調(diào) |
Venting Filter 放氣過濾器 | ||
Number 數(shù)量 | 1 | |
Aperture 孔徑
| 0.22um | |
Control System 控制系統(tǒng) | ||
1 | Software 軟件 | XY – 5000(SCADA滿足數(shù)據(jù)采集及監(jiān)控) |
Automatic 自動 | Included 有 | |
Manual 手動 | Included 有 | |
2 | PLC 可編程控制器 | Omron |
3 | Computer 電腦 | 工控機電腦 |
可鏈接PC電腦，也可以手機下載欣諭專用APP軟件進行監(jiān)控操控設(shè)備（有無線情況下） | ||
4 | Vacuum gauge 真空探頭 | Edwards 愛德華 |
5 | Temperature probe 溫度探頭 | Pt100 |
6 | Breaker 空開 | schneider |
7 | Contactor 接觸器 | schneider |
8
| Relay 繼電器 | Schneider |
9 | 共晶點測試裝置 | 選配欣諭開發(fā)的共晶點測試功能 |
Safety System 安全系統(tǒng) | ||
1 | Vacuum failure protection 真空失敗保護 | Included 有 |
2 | Temperature failure protection 溫度失敗保護 | Included 有 |
3 | Compressor protection 壓縮機保護 | Included 有 |
4 | Other motors protection 其它電機保護 | Included 有 |
5 | Interlock protection 連鎖保護 | Included 有 |
Utility Requirement (approx.) 共用工程消耗(大約) | ||
1 | Electricity - total electrical load 總裝機功率 | 6kW (380V, 50Hz, 3Phase, 5Wire) |
軟件功能 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歐盟標準，電子簽名，多組密碼； It accords with European standard FDA. There are electronic signatures and multiple passwords. | ||
2 | 自動、手動在任何節(jié)點任意切換； Switch the type between manual and automatic at any point randomly. | ||
3 | 系統(tǒng)操作可在無菌室、機房、凍干控制室進行，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 | 無菌室裝有液壓控制按鈕，可在緊急情況下強制停止板層運行； 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”可實現(xiàn)：低溫進箱、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、自動放氣和壓塞、低溫出箱等個性功能； 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 | “冷凍干燥”自動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. | ||
9 | “冷凍干燥”過程中可對配方進行隨時調(diào)整； The recipe can be adjusted momentarily in the “freeze drying ”process. | ||
10 | 操作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 | 具有數(shù)據(jù)、曲線兩種記錄功能，可根據(jù)批號隨時調(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 | 可存儲無數(shù)條數(shù)據(jù)、曲線記錄； It can save countless data and curves records. | ||
13 | 各個真空度、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”、“報警記錄”等原始記錄一起打印，可作為批產(chǎn)品的詳細批記錄進行保存； 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，三級用戶權(quán)限管理，曲線報表不可修改； There are electronic signatures and three stage authorization managements. The curve charts can not be modified. | ||
以上數(shù)據(jù)僅供參考，以實際設(shè)計圖紙為準 | |||
L、驗證文件系統(tǒng)（電子光盤1份） 詳細驗證文件系統(tǒng) Verification documents system(one set of CD) The details of verification documents system | |||
序號SN | 名稱 Name | 數(shù)量 Number | |
1 | 安裝確認 Installation qualitation（IQ） | 1套 | |
2 | 操作確認 Operation qualitation（OQ） | 1套 | |
3 | 性能確認 Performance qualitation（PQ） | 1套 | |
4 | 工廠驗收測試 Factory acceptance test（FAT） | 1套 | |
5 | 客戶現(xiàn)場驗收測試 Site acceptance test（SAT） | 1套 | |
6 | 操作手冊 Operation manual (OM) | 1套 | |
7 | 維護手冊 Maintenance manual (MM) | 1套 | |
8 | 安裝手冊 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 | 材質(zhì)報告 Material report | 1套 | |
14 | 校驗報告 Verification report | 1套 | |
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