Pharmaceutical Freeze Dryers

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 biology 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, for long term storage.

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.

• 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.

• 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 ≤5×10-2mbarL/s.
• Vacuum adjustable.

• 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.

• Human vaccines
• Veterinary vaccines
• Serum
• Penicillin
• Injections