Pharmaceutical Freeze Dryers
Vikumer produces a broad line of standard and custom-made pharmaceutical vacuum freeze drying equipment, for industrial production of pharmaceutical and biotech products. And offers technical support like FAT, IQ, O/PQ documentation packages etc.
Address to All Pharmaceutical and Biological Industries
Freeze drying and lyophilization is a widely used technique for pharmaceuticals and biologicals preservation. The process starts with raw material freezing, and then reduce drying chamber pressure, gradually apply heat to frozen materials, to enable the ice to sublimate to gas.
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 less than 1% and maximum shelf life more than 5 years at room temperature.
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, or filled in vials, bottles or other glass containers, lyophilized and later stoppered 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.
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.
Main Features & benefits
- All in one structure, easy to transport and install.
- Sub-systems and modules are standardized, international standard parts, easy to maintain and replace.
- GMP equipment.
- CE marked.
- GB-150 pressure vessel rated drying chamber and condenser.
- S/S316L made drying chamber, shelves and trays.
- Drying chamber PUF insulated.
- Hydraulic stoppering shelves, direction top to bottom.
- Sandwich type heat-plates, heating and cooling through heat transfer fluid circulates inside shelves.
- Heavy duty chamber door.
- External ice condenser.
- Direct expand condenser cooling.
- Ice condenser with isolation valve.
- 2-stage reciprocating compressor system, water cooling method.
- 2-stage oil sealed vacuum pumps and roots pump combination for vacuum system.
- Vacuum adjustable.
- PLC and touch screen HMI based control system meet FDA 21CFR PART11.
- CIP clean in place.
- Internal ice condenser.
- Pneumatically door lock and sensor.
- Auto loading/unloading and sub door.
- Variable shelf spacing.
- SIP steam in place.
- Chamber jacket cooling system after SIP.
- Remote compressor system.
- Backup compressors, vacuum pumps and fluid pump.
- Capacitive vacuum gauge.
- Documents package FAT, IQ, O/PQ.
- PC software and authorization.
- SCADA package.
- Human vaccines
- Veterinary vaccines
- Serum
- Penicillin
- Injections
Model | Shelf Size | Shelf Area | Vials Capacity |
---|---|---|---|
3L-TP | 600*900mm | 3.24m2 | 2R*12432Pcs, 6R*6480Pcs, 10R*5550Pcs. |
5L-TP | 900*1200mm | 5.4m2 | 2R*21000pcs, 6R*10800pcs, 10R*9250pcs. |
10L-TP | 900*1200mm | 9.7m2 | 2R*37800pcs, 6R*19440pcs, 10R*16650pcs. |
15L-TP | 1200*1200mm | 14.4m2 | 2R*56250pcs, 6R*29160pcs, 10R*25000pcs. |
20L-TP | 1200*1500mm | 19.8m2 | 2R*76725pcs, 6R*40392pcs, 10R*34100pcs. |
25L-TP | 1500*1500mm | 24.7m2 | 2R*95139pcs, 6R*50864pcs, 10R*42284pcs. |
30L-TP | 1500*1800mm | 29.7m2 | 2R*114576pcs, 6R*60588pcs, 10R*51150pcs. |
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 ≤5×10-2mbarL/s.
- Vacuum adjustable.