Pharmaceutical Freeze Dryers

Address to All Biotech and Pharmaceutical Industries !

The FDL-TP pharmaceutical freeze dryers are large stoppering tray lyophilizers for commercial mass production. The machine can be addressed to all pharmaceutical and biotech industries. Examples include human and veterinary vaccines, antibiotics, serum, penicillin, hormones, reagents and injections. Products can be dried in vials, microplates, semi-sealed bottles and by bulk, the hydraulic stoppering device capable of capping vials or PCR tubes under vacuum environment.

Vikumer’s FDL-TP freeze drying equipment is designed and manufactured modularly which can be configured flexibly to meet user’s specific requirements and industry guidelines, and ensures a right balance between quality and cost. Vikumer provides standard factory models with shelf area up to 40.5m2 and ice condenser capacity up to 400kgs in 24hrs period.

Technical Specifications

Model FD-1L-TP FD-2L-TP FD-3L-TP FD-5L-TP FD-10L-TP
Shelf Area 0.96m2 2.16m2 3.24m2 5.4m2 9.72m2
No. of Shelves 4+1 4+1 6+1 5+1 9+1
Shelf Size 400*600mm 600*900mm 600*900mm 900*1200mm 900*1200mm
Shelves Spacing 100mm 100mm 100mm 100mm 100mm
Shelf Temp. Range -55C~+70C -55C~+70C -55C~+70C -55C~+70C -55C~+70C
Condenser Capacity (24Hrs) 10Kgs 20Kgs 30Kgs 50Kgs 100Kgs
Condenser Capacity (Max) 20Kgs 40Kgs 60Kgs 100Kgs 200Kgs
Condenser Temp. -85C -85C -85C -85C -85C
Vacuum Final 1Pa 1Pa 1Pa 1Pa 1Pa
Power Install 15Kw 18Kw 25Kw 28Kw 60Kw
Electric 380V/50Hz/3P 380V/50Hz/3P 380V/50Hz/3P 380V/50Hz/3P 380V/50Hz/3P
Size (W*L*H) (mm) 1450*3100*2200 1600*3600*2300 1600*4000*2500 1700*4300*2700 2000*6200*2800
Approx. Weight 1500Kgs 2500Kgs 2800Kgs 4000Kgs 6000Kgs
Vials (2R/4R) 3700 8288 12432 21000 37800
Vials (6R/8R) 1944 4320 6480 10800 19440
Model FD-15L-TP FD-20L-TP FD-25L-TP FD-30L-TP FD-40L-TP
Shelf Area 14.4m2 19.8m2 24.7m2 29.7m2 40.5m2
No. of Shelves 10+1 11+1 11+1 11+1 15+1
Shelf Size 1200*1200mm 1200*1500mm 1500*1500mm 1500*1800mm 1500*1800mm
Shelves Spacing 100mm 100mm 100mm 100mm 100mm
Shelf Temp. Range -55C~+70C -55C~+70C -55C~+70C -55C~+70C -55C~+70C
Condenser Capacity (24Hrs) 150Kgs 200Kgs 250Kgs 300Kgs 400Kgs
Condenser Capacity (Max) 300Kgs 400Kgs 500Kgs 600Kgs 800Kgs
Condenser Temp. -85C -85C -85C -85C -85C
Vacuum Final 1Pa 1Pa 1Pa 1Pa 1Pa
Power Install 75Kw 82Kw 102Kw 125Kw 140Kw
Electric 380V/50Hz/3P 380V/50Hz/3P 380V/50Hz/3P 380V/50Hz/3P 380V/50Hz/3P
Size (W*L*H) (mm) 2300*6500*3200 2300*6800*3500 2500*7200*3500 2500*7500*4000 2500*8200*4000
Approx. Weight 8500Kgs 11000Kgs 13000Kgs 16000Kgs 18000Kgs
Vials (2R/4R) 56250 76725 95139 114576 156240
Vials (6R/8R) 29160 40392 50864 60588 82620

Design Highlights

The FDL-TP freeze drying systems can be configured fully meet guidelines of GMP and FDA.  Vikumer offers standard models with CIP, and cGMP compliant models with CIP&SIP.

  • FDL-TP Series Pharmaceutical Freeze Dryer
  • FDL-TP Series Pharmaceutical Freeze Dryer
  • FDL-TP Series Pharmaceutical Freeze Dryer
  • FDL-TP Series Pharmaceutical Freeze Dryer
  • FDL-TP Series Pharmaceutical Freeze Dryer

GMP Compliant Equipment

Vikumer’s FDL-TP industrial pharmaceutical freeze dryers are designed and manufactured meet concepts of GMP. Stainless steel 316L throughout the drying chamber and ice condenser, mirror polished surface, rounded corners, sloped bottom, sanitary pipelines and valves. CIP and SIP to ensure aseptic production.

Configurable Systems

The FDL-TP freeze drying equipment were designed and manufactured modularly, which can be configured flexibly as per needs. Sub-systems are standardized and are international level and a wide range of options can be selected to match the particular needs of customers, which has been proved maximum reliability and cost effectivity.

Solutions from Lab to Production

Vikumer manufactures a comprehensive range of pharmaceutical freeze dryers to accommodate various production capacities requirement. Which including: laboratory freeze dryers, pilot scale unit for R&D and small batch trials, and industrial freeze dryers.

  • Standard units with CIP
  • GMP units with CIP&SIP

High Performance and Delicate Craftsmanship

  • Entirely S/S316L fabricated.
  • Chamber wall mirror polished Ra<0.6um.
  • Shelves Temp. -55C ~ +70C.
  • Shelves cooling +20C ~ -40C <60min.
  • Shelves heating -40C to +20C <60min.
  • Shelves temperature variance <+/-1C.
  • Shelves both surface Ra<0.4um.
  • Shelves flatness <+/-0.5mm/m.
  • Condenser final -85C.
  • Condenser cooling +20C to -40C <10min.
  • System final vacuum <1Pa.
  • Chamber vacuumize to 100Pa <30min.
  • Chamber leakage ≤5Pa L/s.

FDA Compliant Control System

PC, PLC and user-friendly HMI based control system is applied to FDL-TP freeze dryer, to perform interlock checks, monitoring system working status, execute freeze drying processes and generate alarms. Which has the following functions.

  • Interlock checks and sound-light alarms.
  • Graphic displays system working status and key parameters.
  • Freeze drying recipes management.
  • Real-time freeze drying curve and historical trend review.
  • Drying data-logging and can be exported via USB.
    Automatic and semi-automatic working.
  • Users and authorizations.
  • Sensors calibration

Layout as per Request

The drying chamber and ice condenser can be rectangular or cylindrical shape, horizontal layout or vertical layout. System can be fully integrated design or two storey unit. Vikumer create solutions as per user’s situation.

General Features

Structure

  • All-include design, horizontal layout, condenser behind drying chamber.
  • Modular subsystems beneath and behind drying chamber.
  • Fully assembled, quality and performance tested before shipment.

  • Design and produce as per pressure vessel directive.
  • Rectangular product chamber.
  • Internal corners are rounded for easy cleaning.
  • Sloped bottom towards to drain.
  • S/S316L fabricated, surface polish Ra<0.6um.
  • PUF insulation.

  • Heavy duty hinged door with sight glass.
  • Lubricate free D type door gasket.
  • Door position sensor.

  • S/S316L fabricated.
  • With braided bellows, flexible move up or down.
  • Temperature controllable from -55C to +70C.
  • Surface polish Ra<0.4um.
  • Flatness <+/-0.5mm/m.

  • S/S316L cylinder and protect bellow.
  • Shelf positioning system to prevent shelves drifting by gravity.
  • Top to bottom stoppering.

  • Rectangular ice condenser behind drying chamber.
  • S/S316L fabricated wall and coils.
  • Condenser coil surface is designed 1:1 comparing to the shelf area.
  • Butterfly valve for isolation.
    Vapor distribute plates for evenly icing.
  • Hot water defrost.

  • 2-stage oil sealed rotary vane vacuum pumps.
  • Roots pump for larger models.
  • Ball valves for pumps isolate.
  • Pirani type vacuum gauge.
  • Vacuum auto regulate to set range.

  • 2-stage reciprocating compressor system.
  • R404a or R507 HFC refrigerant.
  • Each compressor has individually circuit to ice condenser.
  • Renowned brand parts.

  • 5cst Silicone oil based heat transfer fluid.
  • Grundfos fluid pump.
  • Multi-element type electric boiler.
  • PID control.

  • PLC + HMI based.
  • CE standard electric cabinet.
    LYO-MEGA HMI interface.
  • netSCADA PC package and FDA compliant option.

  • Several groups of fixed and rotary spray nozzles are installed in drying chamber and ice condenser, to distribute water and steam.
  • S/316L fabricated nozzles, pipes and manifolds.
  • Safety interlock functions to ensure the safety CIP and SIP.
  • Diaphragm valves, bypass valves, pressure gauges and temperature sensors for safety sterilize.

  • Chamber door hinge left or right locate.
  • Door lock sensor.
  • Pneumatically door lock.
  • Auto loading/unloading and sub door.
  • Internal ice condenser.
  • Variable shelf spacing.
  • SIP steam in place.
  • Chamber jacket cooling system after SIP.
  • Remote compressor system.
  • Backup compressors, vacuum pumps and fluid pump.
  • HEPA filter on vacuum pipe.
  • Capacitive vacuum gauge.
  • Documents package FAT, IQ, O/PQ.
  • PC control software and authorization.
  • SCADA package.

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