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.
Downloads
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
The breakthrough that changed spray drying
In 1976, NIRO engineers responded to a competitive challenge by rethinking what spray drying could do. Their idea became the multi-stage dryer MSD. Fifty years later, the same fundamental principle helps turn liquids into the powders used in essential nutrition products and important medicines around the world. Refined through decades of engineering expertise, customer insight and continuous development, MSD is a story of innovation with lasting impact.
Oltre le macchine: come migliorare le prestazioni dell’impianto
Una macchina efficiente non garantisce automaticamente l'efficienza di uno stabilimento. Il vero miglioramento spesso inizia guardando oltre le singole attrezzature e comprendendo come i processi, i sistemi energetici e le decisioni operative si influenzino a vicenda. Si tratta di un approccio olistico pensato per individuare opportunità che altrimenti potrebbero sfuggire.
Come una valvola rivoluziona la produzione di alimenti e bevande
Negli impianti di produzione di alimenti e bevande, le valvole vengono solitamente azionate tramite aria compressa. GEA Hydract® Actuation Technology utilizza l'acqua all'interno di un circuito chiuso e controllato digitalmente. Il risultato è una valvola che può essere mantenuta esattamente in posizione e regolata con per piccoli incrementi con grande precisione. Ciò si traduce in un minor consumo energetico e in un maggiore controllo.
