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
منتجات ذات صلة
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.
رؤى GEA
Innovating for impact: صياغة حلول أفضل للعملاء
يُطلب من قطاع الإنتاج الصناعي أن يقلل من استهلاك الموارد، وأن يصبح أكثر ذكاءً، وأن يحافظ على إنتاجية المعدات لفترة أطول. في شركة GEA، يتغير أسلوب الابتكار؛ إذ تتضافر جهود الهندسة، ورؤى العملاء، والخبرة الرقمية، والخدمات في مرحلة مبكرة، أي في الوقت الذي لا يزال فيه بالإمكان تشكيل الحل من جوهره.
