Pharmaceutical Freeze Dryers

Address To All Pharmaceutical And Biological Industries

The Vikumer FDL-TP pharmaceutical freeze dryers are large stoppering tray lyophilizers for commercial and industrial mass production. These machines can be addressed to all pharmaceutical and biological industries, such as human and veterinary vaccines, serum and injections freeze drying. Products can be dried in trays, vials, bottles or other glass containers, lyophilizing and stoppering under vacuum environment.

FDL-TP freeze drying equipment were designed and manufactured modularly, which can be configured flexibly as per needs. All its sub-systems are standardized, international level and components are finished meet the strictest international standards. This solution has been proved maximum reliability and cost effective, entire system is in accordance with guidelines of cGMP, GB150, CE and FDA 21CFR PART11.

Vikumer’s FDL-TP pharmaceutical freeze dryers offer highest technical performance, to ensure your high quality and cost-effective freeze drying. The freeze dry system available in shelf area from 5.4m2 to 29.7m2, condenser capacity up to 600kgs.

Meet GMP

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, no dead corners, easy clean and hygienic. CIP&SIP version machine also ensures an aseptic processing environment.

Meet FDA

The control system of FDL-TP pharmaceutical lyophilizers are based on PC, PLC and user-friendly HMI, software functions fully meet FDA. Provide real-time drying trend; historical drying curve review; data-logging and can be exported via USB; batch drying curve and data print functions. Users management system pre-set 3 groups/privileges of administrator, parameter manager and operator.

Pharmaceutical Freeze Dryer

Pharmaceutical Freeze Dryer

Freeze drying and lyophilization is a widely used technique for pharmaceuticals and biologicals preservation. The process starts with raw material freezing, and then reduces the drying chamber pressure, gradually apply heat to the frozen materials to allow the ice to sublime. Sublimation technology not involve liquid phase, which means it doesn’t need high temperature to vaporize the water. In another word, freeze drying is a low temperature dehydration method. Products are dried gently and without being degraded, well preserve their physical structure and biological activities. Typically, freeze dried drugs contain minimum moisture (<1%) and maximum shelf life (>5 years) at room temperature.

Models and Technical Spec.

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

Technical Features

  • All in one structure, easy to transport and install.
  • Standardized modular sub-systems, international standard parts, easy to maintain and replace.
  • CE marked and GMP compliant.
  • Entirely stainless steel fabricated.
  • 2 chambers system, ice condenser is install behind drying chamber.
  • Rectangular drying chamber with PUF insulation.
  • Hinged door with observation window.
  • Sandwich type heat-plates, silicone oil based, shelves capable of heating and chilling.
  • Shelves flexible move up or down for vials capping, by hydraulic stoppering system.
  • 2-stage reciprocating compressor system, water cooling method.
  • 2-stage oil sealed vacuum pumps and roots pump combination for vacuum system.
  • Pirani vacuum sensor.
  • Vacuum adjustable.
  • PLC and touch screen HMI based control system meet FDA 21CFR PART11.
  • CIP clean in place.

System Performance

  • Shelves Temp. -55C ~ +70C.
  • Shelves cooling >1C/min (+20C ~ -40C <60min).
  • Shelves heating >1C/min (-40C to +20C <60min).
  • Shelves temperature variance <+/-1C.
  • Shelves roughness Ra<0.6um.
  • Shelves flatness <+/-0.5mm/m.
  • Condenser Temp. final -85C.
  • Condenser cooling +20C to -40C <30min.
  • System final vacuum <1Pa.
  • Chamber vacuumize to 100Pa <30min.
  • Chamber vacuum leakage ≤5Pa L/s.
  • Vacuum adjustable.

Accessories Options

  • 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.

Applications

  • Human Vaccines
  • Veterinary Vaccines
  • Antibiotics
  • Serum
  • Penicillin
  • Biologicals
  • Hormones
  • Reactives
  • Injections

FDL-TP Freeze Dryer Models

Useable trays area from 5.4m2 to 29.7m2, condenser capacity up to 600kgs.
Vikumer’s pharmaceutical freeze dryers are affordable price and are configured with world class parts, that can compare with any brands.
The machines meet guidelines of cGMP and FDA 21CRF PART11.

FD-5L-TP Pharmaceutical Freeze Dryer

FD-5L-TP Freeze Dryer

5.4m2 trays area, 100kgs ice condenser. Vials Capacity 2R*21000pcs, or 6R*10800pcs, or 10R*9250pcs.

FD-10L-TP Pharmaceutical Freeze Dryer

FD-10L-TP Freeze Dryer

9.7m2 trays area, 200kgs ice condenser. Vials Capacity 2R*37800pcs, or 6R*19440pcs, or 10R*16650pcs.

FD-20L-TP Pharmaceutical Freeze Dryer

FD-20L-TP Freeze Dryer

19.8m2 trays area, 400kgs ice condenser. Vials Capacity 2R*76725pcs, or 6R*40392pcs, or 10R*34100pcs.

FD-30L-TP Pharmaceutical Freeze Dryer

FD-30L-TP Freeze Dryer

29.7m2 trays area, 600kgs ice condenser. Vials Capacity 2R*114576pcs, or 6R*60588pcs, or 10R*51150pcs.

FD-40L-TP Pharmaceutical Freeze Dryer

FD-40L-TP Freeze Dryer

40.5m2 trays area, 800kgs ice condenser. Vials Capacity 2R*156240pcs, or 6R*82620pcs, or 10R*69750pcs.

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