FD-P Series Production Pharmaceutical Freeze Dryer, Industry lyophilizer for Vaccines vials, pharmacy, medicines

  • Labfreez® Pharmaceutical freeze dryer lyophilizer Conforms to GMP standard.
  • Design for vaccine vails, pharmaceutical , medicine as well as bulk sample producing in clean room.
  • 2 square meter shelves area, to process 20kg to 30kg sample one batch.
  • Stoppering function for sealing vials under vacuum.
  • CIP, SIP for easy clean and sterilization after freeze drying.
  • FAT, SAT, IQ/PQ/DQ/OQ documents support.
  • 1 square meter to 50 square meter shelves area.
  • CE/ISO 9001 certificated.

FD-P series full function production freeze dryer machine is not only suitable for the freeze-drying of conventional materials in bulk (liquid, paste, solid), but also suitable for the drying of the bottled materials of vials. When preparing for lyophilization, the materials are dispensed into the vials as needed, and the floating cover The bottle cap is lyophilized, and after the drying, the capping mechanism is pressed to press the cap to avoid secondary pollution, re-adsorb moisture, and easy to store for a long time.

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Main Features

  • Shelf pre-freezing function.
  • Can be filled with nitrogen or inert protect machine after working.
  • lyophilized automatic control system: procedural programming, both freeze-dried and defrost control procedures.
  • helf: adopting international advanced welding technology without leak
  • Lyophilized end point test system: automatic lyophilized end testing parsed end of the drying stage, to ensure that the moisture content of the material to reach the standards.
  • Vacuum regulator systems: sublimation and vacuum drying process analytical adjustment, avoid special material to foaming & blowing, accelerate lyophilization efficiency.
  • Pulse backfill system: slow, medium, fast three backfill mode selection, avoiding the issue for the end of the freeze-dried granular material and flocculent inflatable produce effective substances are blown away loss.
  • Large industrial touch screen, human-computer interaction is good, easy to understand, no instructions are also available for easy operation.
  • Monitoring system: real-time monitoring system temperature, vacuum, acquisition frequency 50ms / times.
  • Lyophilization process recipe storage function: can store 2000 group fixed or user-defined lyophilized formulation process.
    PC remote monitoring system: remote monitoring equipment operating conditions, as far as monitoring distance 1.5KM.
  • Eutectic point test function (optional).
  • Process data recording system (Standard).
  • Calibration function: temperature and vacuum calibration ensures long-term accuracy of the measured values.
  • Lyophilized curve inquiry function (available temperature and vacuum degree curve, convenient process optimization and lyophilized effect verification).
  1. Meets with GMP standard;
  2. Meets with CE/ISO standard;
  3. SIP+CIP is optional;
  4. Material made by SS316L to meets with pharmaceutical standards.
  5. Well documented included IQ/PQ/OQ/FAT and etc.

Dry Chamber

  • Vacuum vessel design standards, design pressure -0.1Mpa (SIP model as per Pressure container certificated *)
  • Polish SS304 or SS316L* material
  • Round corner design easy to clean
  • Cabinet vacuum leak rate 5*10-3Pa*m³/S
  • Roughness of chamber and door Ra≤0.4um
  • Insulation made of Polyurethane foam, thickness > 100mm
  • Door with two handle with lock (Extra pneumatic locking mechanism for SIP model)
  • Design as per GMP standard

Shelves

  • Shelves has high intensity and it reaches to 0.3Mpa in the pressure test which can be able to bear the long term usage.
  • Silicone oil circulating heating and cooling, temperature from +20°C  to-40°C within 60min
  • Temperature control accuracy ±0.5°C (adjusted by PID, in balance)
  • Polish SS304 or SS316L* material
  • Roughness of chamber and door Ra≤0.4um
  • All carried out the leak test by helium mass spectrometer.
  • Design as per GMP standard

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Easy to Use

Color touch screen,and PLC as control core ,system is stable and easy to operate; 32 groups of freeze drying date can be stored , every group can be set up 36 segments; with display freeze drying curves function and record data automatically; freeze drying data can be output by USB flash disk.

  • Automatic + manual control mode
  • User management
  • Recipe management
  • Data management
  • Process control
  • SCADA remote control system support computer and mobile
  • Alarm display system
  • Protection system

Auto CIP & SIP System

  • AISI SS316L material
  • Standard and wide -angle type and ball type
  • Everywhere can be cleaned in chamber
  • Intermittent cleaning, to insure cleaning pressure and effect, and save cleaning cost
  • Pulsatile negative pressure steam delivery
  • 121℃ Steam disinfection
  • German GOETZE Valve
  • Pipeline material AISI SS316L
  • Pressure container certificated

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Model & Specifications

MODELUnitFD-P1FD-P2FD-P3FD-P5
dry areaM21.152.163.245.2
Feed amount (material thickness 10mm)L10203050
Number of shelvesQty4+14+16+17+1
shelf sizecm60*4860*9060*9075*100
shelf spacingmm80808080
Temperature control range℃-50°C ~ +70°C-50°C ~ +70°C-50°C ~ +70°C-50°C ~ +70°C
Water vapor condensationKg/B≥20≥40≥60≥100
Catch reservoir temperature℃≤-75≤-75≤-75≤-75
cooling method–Water CoolingWater CoolingWater CoolingWater Cooling
defrosting method–Water soakingWater soakingWater soakingWater soaking
ultimate vacuumpa≤1≤1≤1≤1
Installed powerkw18212425
Dimensions (L*W*H)cm250*110*200250*130*200280*120*250400*150*250
Φ22 vial volumePcs24604608691211648
Φ16 vial volumePcs478889601344022540
Total Weightkg1500260028005000
Pure steam consumptionkgh6080100130
Injection water volume/pure water1/min607590120
ModelUnitFD-P10FD-P15FD-P20FD-P30FD-P50
dry areaM210.51520.229.751.3
Feeding amount (material thickness 10)L100150200300500
Number of shelvesQty7+110+111+111+119+1
shelf sizecm99*15299*152121*152150*180150*180
shelf spacingmm8080808080
Temperature control range℃-50°C ~ +70°C-50°C ~ +70°C-50°C ~ +70°C-50°C ~ +70°C-50°C ~ +70°C
Water vapor condensationkgB≥300≥300≥400≥600≥1000
Catch reservoir temperature℃≤75≤-75≤-7575≤75
cooling method–Water CoolingWater CoolingWater CoolingWater CoolingWater Cooling
defrosting method–Water soakingWater soakingWater soakingWater soakingWater soaking
ultimate vacuumpa≤1≤1≤1≤1≤1
Installed powerkw588096120150
Dimensions (L*W*H)Cm670*180*350650×230×360740*210*370650*240*380750*240*460
Φ22 vial volumePcs22932343984504564449111321
Φ16 vial volumePcs4296664414984843129789224181
Total Weightkg70008000110001500026000
Pure steam consumptionkgh200230280380500
Injection water volume/pure water1min160200230280400

 

Brand of main parts

Compressor

Bitzer (Germany) compressor, more powerful, stable and reliable. CFC-FREE green refrigerant, easy to maintenance.

Vacuum Pump

Leybold (Germany) or Edwards (G.B.) two-stage vane oil vacuum pump, stable & reliable, low noise. Easy to replace oil.

Circulationg Pump

Danish Grundfos circulation pump, Easy, safety, reliable. Silicone oil circulating to shelves make temperature stable at 0.1°C.

Pressure Controller

DANFOSS pressure differential controller, Automatic protection device, Magnetic valve, Refrigerant Expansion valve

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