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.
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