| | Product structure | Technical parameters | Remarks |
| Design standard:GMP |
| ※ Public distribution |
| | Power (Single-phase ) | 220V/50HZ | |
| | Power consumption | 2.5kw | |
| | Cooling water qty | (T≤25℃,P=0.2-0.3Mpa) | |
| | Appearance size | 910mm×670mm×1700mm | (According to design standard) |
| | Structure | Rectangular monolithic / movable | (According to design standard) |
| | Total weight | 500kg | |
| ※ Drying body |
| | Performance parameters |
| | | Design and manufacturing standards | Vacuum vessel design standards |
| | | Chamber design pressure | -0.1Mpa |
| | | Chamber design temperature | -60℃-+90℃ |
| | | Chamber Vacuum leak rate | 5×10-3 Pa.m3/sec |
| | main components |
| | Chamber material | SUS304/δ4mm | |
| | Geometry Box | Rectangular monolithic | |
| | Lock method | Rotate and locking type by handle | |
| | Direction of opening door | open right (the user can choose) | |
| | Door materials | SUS304 | |
| | Box external decoration | SUS304 SUS304 | |
| | The roughness of chamber and door | Ra≤0.4μm | |
| | Insulation material | Rubber insulation board/δ70mm | |
| | Door sealing | medical silicone rubber seal O-sectional | 1 pair |
| | Technical Features |
| | 1 | Stainless steel is polished with excellent brand to ensure surface roughness to ensure sterility requirements |
| | 2 | 3D design, consistent with CGMP requirements of complete sterilization. |
| | 3 | Cabinet, board level, and hose are tested after multiple procedures to ensure without leakage |
| ※ Shelf |
| | Performance parameters |
| | | Total usable area of shelves | 0.2M2 |
| | | Maximum water fishing | 3Kg/batch |
| | | Minimum temperature of lamellar | ≤-50℃ |
| | | Maximum temperature of lamellar | +80℃ |
| | Main components |
| | Lamellar material | SUS304 | |
| | Surface roughness | Ra≤0.4μm | |
| | The number of board layers | 3+1 (Compensation Board) | |
| | Shelf spacing | 100mm | |
| | Shelf dimensions | 300 mm×300mm×15mm | seamless combination with rectangular tube |
| | Bottle / disk protection | Shelf with anti bottles / tray fall protection rack | |
| | Product temperature probe | Import thermocouple (Origin: United | 4 pieces |
| | Technical Features |
| | 1 | Shelf has high strength and can withstand long-term use; |
| | 2 | Shelf through a dedicated machining, can guarantee high demand flatness; |
| | 3 | Lamellar heating Temperature accuracy ± 0.5 ℃ (PID control) |
| ※ Condenser |
| | Performance parameters |
| | | Design Standard | Vacuum vessel design standards |
| | | Cabinet design pressure | -0.1Mpa |
| | | Tank design temperature | -80℃-+90℃ |
| | | Min temperature of condenser | ≤-70℃ |
| | Main components |
| | Condenser shape | Horizontal drum type | |
| | Condenser material | SUS304/δ3mm | |
| | The condenser form | Snake-type coil | |
| | The inner surface roughness | Ra≤0.4μm | |
| | Defrosting Mode | High pressure hot melt frost | |
| | Temperature probe | Import thermocouple (Origin: United | 1 piece |
| | Insulation material | ARMAFLEX | |
| | Eternal decoration of box | SUS304 | |
| | Technical Features |
| | 1 | Stainless steel is polished with excellent brand to ensure surface roughness to ensure sterility requirements |
| | 2 | Argon welding, forming an internal and external, to ensure pipes cleanly and without leak |
| ※ Refrigeration System |
| | Performance parameters |
| | | Lamellar cooling rate (no load) | 20℃→-40℃≤60min |
| | | Condenser cooling rate (no load) | 20℃→-50℃≤20min |
| | Main components |
| | compressor model/quantity | TECUMSEH CAJ-2446Z | 1set |
| | Refrigerant | R404A | 0.56kg |
| | Power | 0.74Kw | |
| | Oil separator | AlCO AW55824 | 1 piece |
| | High pressure protection device | DANFOSS | 2piece |
| | Refrigerant endoscopic | DANFOSS | 1 piece |
| | High /Low pressure gauges | Switzerland REFCO shockproof pressure gauge oil-immersed | 4 pieces |
| | Technical Features |
| | 1 | Screw compressor is used TECUMSEH refrigeration compressor, more stable performance, reliable, easy to maintain |
| | 2 | Temperature and pressure of compressor has multiple protection features |
| | 3 | Compliance with the Montreal Convention, with environmentally friendly refrigerants; |
| ※ Vacuum system |
| | Performance parameters |
| | | Extraction rate | 105Pa→133 Pa≤30min |
| | | System leakage rate | 5×10-3 Pa.m3/sec |
| | | Ultimate vacuum | ≤1.0Pa |
| | Main components |
| | The type and number of vacuum pump | JAPAN ULVAC VDN-902 | 1SETS |
| | Power | 0.4kw | |
| | Technical Features |
| | 1 | The JAPAN ULVAC vacuum pump has been stable operation ensure |
| | 2 | Vacuum pump check valve of high performance and vacuum pump can avoid backing due to the difference of atmospheric when pump stops |
| | 3 | Multi-stage vacuum setting function, you can achieve a degree of vacuum freeze-drying cycle to control of multiple variables |
| ※ Circulatory system |
| | Performance parameters |
| | | Heating rate | -40℃→20℃≤90min |
| | Main components |
| | Circulating pump | Denmark GRUNDFOS / UPS50-180F | 1Unit |
| | Power | 0.1Kw | |
| | Hot and cold fluid | Silicone / 10cst | (machine capacity) |
| | Pipe materials | SUS304/Seamless stainless steel tube | |
| | Heating mode | PID way | |
| | Heating pipe | heating pipe 0.5kw | |
| | Pipe insulation material | ARMAFLEX | |
| | Technical Features |
| | 1 | Electric heating is controlled by PID with the characteristics of energy efficiency and temperature stability; |
| | 2 | Use international brands of GRUNDFOS , leak-free, no noise, stable operation. |
| ※ Control system |
| | Performance parameters |
| | | Software system meet | FDA 21CFR PART II |
| | | Freeze-drying method | Manual and automatic switch |
| | | Process setting method | management |
| | Main components |
| | Control software | PDFD-0.2 | one set |
| | Control mode | Touch screen +PLC (automatic + full manual emergency operation) |
| | PLC | SIEMENS 216-2BD23 | 1 piece |
| | Heating module | SIEMENS | one set |
| | Touch screen | SIEMENS | 1 set |
| | Current protection device | SIEMENS | one set |
| | AC contactor | SIEMENS | one set |
| | Relay | HH54P | one set |
| | Regulated power supply | Taiwan MW companies | Each one |
| | Terminal Blocks | Weidmuller | Machine capacity |
| | Wire and Cable | shanghai Panda Wire Co., Ltd. (China Top Brand) | Machine capacity |
| | (Electrical components of the model and quantity according to the actual date) |
| | Technical Features |
| | 1 | Automatic operation and manual operation can change in any node; |
| | 2 | We can operate in the engine room and freeze-dried control room, which interlock with each other to avoid misuse; |
| | 3 | A variety of components, the main components working condition and temperature, vacuum |
| | 4 | "Process recipe management" are free to set the freeze-drying technology curve; |
| | 5 | Operation screen display with different point of failure; |
| | 6 | It has data, the curve of two records function which can be called at any time or print under the batch. |
| | 7 | Store freeze-dried data , freeze-drying curve of records randomly. |
| | 8 | Each vacuum, temperature curve from a variety of colors can arbitrarily set the "Show" or "hidden"; |
| ※ Verify file |
| | 1 | IQ Installation Qualification |
| | 2 | OQ Installation Qualification |
| | 3 | PQ Performance Qualification |
| | 4 | Factory acceptance test |
| | 5 | Site acceptance test |
| | 6 | Operating Manual |
| | 7 | Maintenance Manual |
| | 8 | Installation Manual |
| | 9 | Floor plan |
| | 10 | P&ID |
| | 11 | Electrical circuit diagram |
| | 12 | Main parts manual |
| | 13 | Material Report |
| ※Spare parts |
| | NO | Name | Model / Specification / Material | Quantity |
| | 1 | Solenoid valve coil | DANFOSS | 2 pieces |
| | 2 | Temperature Sensor | Import thermocouple (Origin: United | 5M |
| | 3 | Vacuum pump oil | R-7 | 2L |
| | 4 | Welding | 1 piece silver electrode with 3MM+Silver solder powder 5 g | 1 set |
