LYOVAC® Small-scale Freeze Dryers

LYOVAC® Small-scale Freeze Dryers

Designed to comply with the most stringent good manufacturing practice (GMP) standards, the LYOVAC® FCM 25-I, FCM 75-I and FCM 150-I freeze dryers are a unique and efficient combination of proven technology and individual solutions that are customized to meet specific user requirements.

LYOVAC® Small-scale Freeze Dryers

GEA.com

For flexible product development and small-scale production.

LYOVAC® SMALL-SCALE FREEZE DRYERS.

Designed to comply with the most stringent good manufacturing practice (GMP) standards, the LYOVAC® FCM 25-I, FCM 75-I and FCM 150-I freeze dryers are a unique and efficient combination of proven technology and individual solutions that are customized to meet specific user requirements.

Integrated VARIOSYS® Isolator Built with operator safety in mind, full isolator protection for processes involving potent or toxic substances is available,

and each unit is supplied with an integrated L-flange for a modular isolator system.

Supplied in three sizes (1.5 m², 4.5 m² and 9.9 m²) with nominal condenser capacities of 25 kg, 75 kg and 150 kg, the smaller FCM 25-I machine can process up to 6500 vials (2 mL) per batch, whereas the larger FCM 75-I and FCM 150-I units are capable of handling more than 20,000 and 42,000 similarly sized vials, respectively. An automatic loading and unloading system (ALUS®) is available.

VarioSys® Since its launch, more than 70 modular VARIOSYS® systems — jointly developed by SKAN AG, Bausch+Ströbel GmbH + Co. KG, GEA, Harro Höfliger Verpackungsmaschinen GmbH and ATEC — have been installed and are currently being used by 30+ biopharmaceutical companies.

Including the use of nests and tubs, the FCM-I range of LYOVAC® Freeze Dryers from GEA provides reliable, safe and cost-effective productivity and price/performance excellence.

Fully automatic cleaning for vials.

Sterilizing tunnel.

H2O2 decontamination airlock.

Vial filling and stoppering.

Freeze drying section.

Finished product

Capping station.

LYOVAC® FCM-75-I with ALUS® for integration in Isolator.

SMALL BATCH FREEZE DRYERS.

Typical layout.

2 Small Batch Freeze Dryers.

The LYOVAC® freeze dryer offer the following features and benefits: • compact footprint with a belly condenser design • suitable for Grad C environments • LYOSPARK® controlled nucleation • LYOPLUS® silicone oil detection • Fast turnaround through defrost/CIP/SIP • alternative end-point detection is also available.

Plus, fully compatible with toxic, potent and volatile products, the FCM units are ATEX-compliant and designed for easy scale-up. Partial loading is also possible for variable batch sizes.

Operating in a Grade C environment, other modules, such as filling and capping systems, can be quickly and easily interchanged, resulting in both a dramatic reduction in footprint and equipment costs.

Available for rapid delivery — with low infrastructure requirements — for multiple product and/or delivery device lines, the modules offer an ideal solution for vial, ampoule, syringe and cartridge processing, as well as liquid, powder or lyophilized form applications.

FCM 25-I FCM 75-I FCM 150-I

Capacity Shelf area 1.5 m² 4.5 m² 9.9 m² Shelves 5 5 7 Kg ice/24 h 25 kg 75 kg 150 kg

Possible Load 2R vials 6523 20,039 42,406 6R vials 3388 10,506 22,295 20R vials 1778 5583 11,900

Further information GEA Pharma & Healthcare lyophil@gea.com gea.com/contact

FCM-I RANGE OF LYOVAC® FREEZE DRYERS.

3 Small Batch Freeze Dryers.

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© GEA Lyophil GmbH 06/2026. All rights reserved. Subject to modifications. ALUS®, LYOPLUS®, LYOSPARK®, LYOVAC® & VARIOSYS® are registered as trademarks in several countries worldwide.

GEA Lyophil GmbH Siemensstrasse 9, 50189 Elsdorf, Germany

Tel +49 2274 93 80 99-0 lyophil@gea.com gea.com/contact

GEA.com


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