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Pharmaceutical Freeze Dryers

FDL-TP Freeze Dryers

Vikumer FDL-TP pharmaceutical freeze dryers are stoppering tray dryers, mainly to lyophilize injectable formulations in pharmaceutical industry. Human and veterinary vaccines for example. Vaccine vials are placed on shelves in freeze drying chamber, lyophilization and later capping under vacuum environment, to guarantee the drugs stability and extend its shelf life.

Meet GMP is the essential requirement of pharmaceutical lyophilizers, and so does the FDL-TP. Whatever machine design, control functions and document packages. The Vikumer FDL-TP fully meet GMP and 21CFR PART11 directives.

FDL-TP Pharmaceutical Stoppering Lyophilizer

FD-5L-TP Freeze Dryer

5.4m2 Trays Area, 100L Condenser. Vials Capacity 2R*21000Pcs, or 6R*10800Pcs, or 10R*9250Pcs.

FD-10L-TP Freeze Dryer

9.7m2 Trays Area, 200L Condenser. Vials Capacity 2R*37800Pcs, or 6R*19440Pcs, or 10R*16650Pcs.

FD-20L-TP Freeze Dryer

19.8m2 Trays Area, 400L Condenser. Vials Capacity 2R*76725Pcs, or 6R*40392Pcs, or 10R*34100Pcs.

FD-30L-TP Freeze Dryer

29.7m2 Trays Area, 600L Condenser. Vials Capacity 2R*114576Pcs, or 6R*60588Pcs, or 10R*51150Pcs.

Machine Design Meet GMP and FDA

Vikumer FDL-TP Lyophilizers Meet FDA and GMP

Strict follow GMP concepts, the Vikumer pharmaceutical freeze dryers drying chamber is entirely stainless steel made, pressure vessel rated. Inner corners rounded, easy cleaning, CIP and SIP. Control system meet FDA 21CFR PART 11, and is PLC and user-friendly HMI based, which has the following functions.

  • Graphic display system working status.
  • Freeze drying recipes management.
  • Real-time freeze drying curve.
  • Freeze drying data & curve review, print and download.
  • Automatic and semi-automatic working select.
  • Users and authorization management.
  • Alarms and debug model.

Configurations

Luxury But Affordable Price

Modular sub-systems offer tons of benefits and enable flexible configuration. Components installed are under international standard, which is easy replace and maintain. Connect of components use clamp connection, quick assembly & disassembly.

Vacuum Pumps Installed In FDL-TP Lyophilizer

Functions Built as Per Needs

FDL-TP Lyophilizer Machine Layout

FDL-TP pharmaceutical lyophilizers come with all include structure, plug and play send. Components like hydraulic cylinder and vacuum pipe that installed on roof of drying chamber are dismountable, easy enter workshop door. We also accept customization service, which include:

  • CIP, SIP
  • PC control
  • Clean room config.
  • Variable shelves spacing
  • Combination of drying chamber and condenser: Separated, Integrated, Horizontal or Vertical arrangement.
  • Single system or more reliable dual system.

Flexible of Use

By use of FDL-TP, you can freeze dry bulk material as a tray freeze dryer. Or use the hydraulic device for vials capping, as a stoppering lyophilizer for vaccines production.

FDL-TP Freeze Dryer Shelves
Freeze Dryers Documents

Documents and Validation Packages

Provide complete files package, include:

  • User manual.
  • Drawings of Electric, Pneumatic, Fluid Circulates, Refrigeration.
  • CIP, SIP, Flow Chart.
  • IQ, O/PQ.
  • FAT.
  • Software Authorization.

Low Cost Lyophilizers

Thanks to our creative/unique cost control system. The FDL-TP freeze dryers’ price up to 20% lower than other brands (Same configurations, same performance).

Keep in mind that Vikumer aim to offer cost-effective freeze dryers, and We Are Vikumer!

Economic Price and High Quality Freeze Dryer

Outstanding 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 0.1mbar < 30min.
  • Chamber vacuum leakage ≤5x10-2mbarL/s.
  • Vacuum adjustable between 1Pa and 100Pa.