Pilot Freeze Dryer LYOVAC® FCM 10-P
The highly flexible standalone FCM 10-P freeze dryer from GEA has been designed for the production of small-scale batches and formulation/process development. Also available as a wall-mounted option, this two-chamber unit is configured to industry standards.
With a capacity of 10 kg and shelf space of 0.63 m², the FCM 10-P also benefits from easy-access doors and spare flanges for validation and/or additional equipment.
Using the same FALCO control system as the production unit, allowing direct recipe transfer during scale-up, the FCM 10-P is GLP/GMP-compliant.
Available options:
- IQ/OQ documentation and test performance
- Wireless temperature sensors
- Sterilization by VHP (VAPOVAC™) or steam depending on the availability of utilities
- Process development service
- LYOSPARK© controlled nucleation
- LYOPLUS© mass spectrometer for silicone oil detection or alternative end-point detection
| FCM10-P | |
| Capacity | 0,63m² shelf area |
| 4 shelves | |
| 10 kg in in 24 h | |
| Possible Load | 2608 of 2R vials |
| 1352 of 6R vials | |
| 708 of 20R vials |
VarioSys®
A combination of isolator and machine modules, VarioSys® provides a quick and flexible way to process liquid, powder or lyophilized product in vials, ampules, syringes or cartridges. Operating in a Grade C environment, filling and capping systems can be quickly and easily interchanged, reducing in both footprint and equipment costs.
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Prodotti correlati
LYOVAC® Pharma Freeze Dryer
GEA’s LYOVAC® industrial-scale freeze dryers are built to customer specifications and are available with production areas of 1–60 m² and condenser capacities of more than 1000 kg.
SMART LYO® Pharma Freeze Dryer
SMART LYO™ Freeze Dryers help reduce the cost of freeze drying while maintaining quality and performance, making validation and documentation easier and reducing delivery times.
Process Analytical Technology (PAT) for Lyophilization: LYOPLUS®
LYOPLUS™ mass spectrometer is a multi-purpose measurement device for pharmaceutical freeze dryers.
ALUS® Load & Unload of Lyophilizers
ALUS® Automatic Load & Unload Systems minimize the risk of operator/product contamination while loading and unloading a freeze dryer.
Approfondimenti GEA
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Al settore manifatturiero viene richiesto di utilizzare meno risorse, puntare su tecnologie avanzate e mantenere le attrezzature in piena efficienza più a lungo. In GEA, questo sta cambiando il modo in cui nasce l’innovazione: ingegneria, comprensione delle esigenze dei clienti, competenze digitali e assistenza si integrano sin dalle prime fasi, quando una soluzione può ancora essere plasmata nella sua essenza.
