Pharmaceutical Stoppering Tray 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.
Introduction
The Vikumer FDL-TP pharmaceutical freeze dryers are commercial stoppering tray dryers. Capable of lyophilize a large number of vials and bottles, and stopper them under vacuum environment. These machines can address to all pharmaceutical industries such as human and veterinary vaccines production, serum and injections freeze drying.
Designed and manufactured modularly, the FDL-TP equipment enable flexible configure as per needs. All its sub-systems are standardized, components are finished meet with the strictest international standards. Entire system accordance with guidelines of cGMP, GB150, CE and FDA 21CFR PART11, and with highest technical performance.
Vikumer’s pharmaceutical freeze dryers ensure your safe and cost-effective freeze drying, while guarantee the high product quaity. The FDL-TP freeze dry systems available in shelf size from 5.4m2 to 29.7m2, with a condenser capacity up to 600kgs.
FDL-TP Freeze Dryer Models
Useable trays area from 5.4m2 to 29.7m2, condenser capacity up to 600kgs.
All Vikumer’s pharmaceutical freeze dryers are modular equipment, enable flexible configuration.
And 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.
