INDUSTRIAL- SCALE FREEZE DRYERS BUILT TO CUSTOMER SPECIFICATIONS. Meet your specific manufacturing requirements with a bespoke lyophilizer from GEA.

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GEA provides standard or customized solutions based on proven technology and a thorough understanding of the individual requirements for specific applications.

FREEZE DRYING

LYOVAC® FCM 600-D shelf package.

LYOVAC® FCM 600-D.

Application support.

Plant configuration extends from specialized solutions for highly potent products and layout requirements, and from two story units up to fully integrated systems with multiple freeze dryers and loading systems.

Our extensive experience in interface design guarantees the smooth integration of a perfectly harmonized production line. Based on your containment requirements and product details, we can help you to determine whether your specific application requires an ALUS® with open or closed RABS (Restricted Access Barrier Systems) or isolators.

Offering a variety of both standard and highly customized options, as well as the cost-effective SMART LYO® range, GEA’s modular equipment extends from R&D to standalone production plants and high-capacity systems for bulk product applications.

Sustainability GEA has developed an innovative air cycle solution for freeze dryers that uses natural refrigerants. The ATEX- compatible LYOAIR® system offers high levels of throughput and reliability with less vibration and quieter functionality. In addition, a carbon dioxide booster reduces energy consumption and eliminates the need to use explosive or toxic gases.

Production LYOVAC® customized industrial freeze dryers designed in accordance with the latest cGMP regulationns. Ranging from 5-60 m² up to 1000 kg ice condenser capacity. The layout can be arranged on one or multiple floors in the building. Industrial freeze dryers (shelf size 5–60 m2) for large-scale production plants are also available and can be built to customer specifications. Small scale production including high potent materials. Variosys FCM 75i and FCM 150i.

LYOSPARK® Nucleation Technology LYOSPARK® controlled nucleation technology from GEA facilitates uniform ice crystal formation in laboratory and production-scale freeze dryers with a minimum degree of supercooling. This is reflected in more consistent and larger ice crystal sizes with a more open product structure. As a result, faster drying and reconstitution times can be achieved. In addition, LYOSPARK® ensures inter-batch homogeneity, improves process repeatability and enhances both the presentation and quality of the final product.

2 LYOVAC – Industrial-Scale Freeze Dryers.

Technical Data – Standard LYOVAC® Models

Units FCM 200 FCM 400 FCM 600 FCM 800

Chamber Geometry Form Rectangular Rectangular Rectangular Rectangular

Shelves Shelf area m² 10 20.4 30.2 41.22 No. of shelves Quantity 9 + 1 11 + 1 13 + 1 15+1 Shelf size mm 914 x 1219 1219 x 1524 1524 x 1524 1524 x 1803 Clearance mm 125 125 125 125 No. of vials (Ø 16mm) Batch size 42,759 87,527 129,662 177,000 No. of vials (Ø 22mm) Batch size 22,464 46,057 68,302 93,240 No. of vials (Ø 30mm) Batch size 11,970 24,607 36,530 49,875 Shelf temperature °C -55 … +70 -55 … +70 -55 … +70 -55 … +70

Condenser Geometry Form Cylindrical Cylindrical Cylindrical Cylindrical

Position Laterally / behind Laterally / behind Laterally / behind Laterally / behind Type Tube Tube Tube Tube

Nominal ice capacity kg 200 400 600 800

Chamber \ Condenser Valve Type Mushroom Mushroom Mushroom Mushroom Clear diameter mm 500 700 900 1000

Weights Chamber and condenser (empty) t 12.5 15 17.5 20

3 LYOVAC – Industrial-Scale Freeze Dryers.

Technical Data – Utility Consumption Units FCM 200 FCM 400 FCM 600 FCM 800

Utilities Pure steam barg 1,5 1,5 1,5 1,5

°C 127 127 127 127 Consumption for sterilization* kg 240 385 460 560 Consumption for defrosting kg 80 110 240 320 CIP water barg 3-4 3-4 3-4 3-4 Temperature °C 80 80 80 80 Consumption* m3 2,6 3,4 4,2 5 Cooling water (Compressor) °C < 25 < 25 < 25 < 25 Peak flow m3/h 9 12 15 19 Consumption m3 138 175 212 267 Electrical power supply kW 105 140 175 210

Power Consumption per Cycle* With compressors KWh 650 900 1250 1700 With liquid nitrogen KWh 140 185 270 305 LN2 consumption kg 1610 2040 3460 4030

* Standard cycle

4 LYOVAC – Industrial-Scale Freeze Dryers.

Technical Data – Base Values Units FCM 200 FCM 400 FCM 600 FCM 800

Chamber

Surface finish µm 0,8 0,8 0,8 0,8 System leak rate mbar x l /s 0,008 0,008 0,008 0,008

Shelves Flatness in the usable area mm / m 1 1 1 1 Surface finish on top side Ra µm 0,8 0,8 0,8 0,8 Surface finish on bottom side Ra µm 1,6 - 2,2 1,6 - 2,2 1,6 - 2,2 1,6 - 2,2 Temperature distribution on one shelf K < 1 < 1 < 1 < 1 Temperature distribution shelf stack K < 1,5 < 1,5 < 1,5 < 1,5 Difference between in- and outlet K < 1 < 1 < 1 < 1

Condenser Inner surface of the condenser Finish Pearl blasted Pearl blasted Pearl blasted Pearl blasted Surface finish of the condenser coils Finish Cold drawn Cold drawn Cold drawn Cold drawn Defrosting of ice Min 40 50 60 60 Ratio evaporator area/shelf area m² / m² 1 1 1 1

Vacuum Final vacuum of the vacuum pump set mbar 0.005 0.005 0.005 0.005 Final vacuum of the freeze dryer mbar 0.01 0.01 0.01 0.01 Pump time from 1000 to 0.1 mbar min 30 30 30 30

Cooling and Heating Shelf cooling rate from +20 to -40°C K/min 1.5 1.5 1.5 1.5 Shelf heating rate K/min 1.5 1.5 1.5 1.5 Temperature range during drying °C -50 - + 60 -50 - + 60 -50 - + 60 -50 - + 60 Condenser cooling rate +20 to -40 K/min 1.5 1.5 1.5 1.5 Final temperature °C -75 -75 -75 -75

Performing Data Sublimation rate kg/h 8.33 16.67 25 33.33 Turnaround (CIP, SIP, Drying, Recooling) h 8 8.5 9 9

5 LYOVAC – Industrial-Scale Freeze Dryers.

Standard and Optional Features – Freeze Dryer Chamber

Rectangular chamber • Pressureless vessel ◦ Material 316 L • Ports 3d •

Layout 1 Floor • 2 Floor ◦ Passthrough ◦

Door Full size door • Automatic locking • Pizza door (constant loading level) ◦ Door in door ◦

Condenser Rectangular Rear ◦ Side ◦ Underneath ◦ Hydraulic ram coverage with bellow •

CIP CIP chamber + condenser • Recirculation including heating ◦ Multiple cleaning media ◦

SIP

PED • ASME ◦ GB-150 ◦ Chamber recooling after SIP •

Hydraulic Lift / lower + stoppering •

Shelf Package With rails and fully collapsible • Hydraulic ram coverage with bellow • Interface for ALUS® ◦

Refrigeration Piston compressors • Screw compressors ◦ Liquid nitrogen ◦ Cascades (propene + ethylene) ◦

Vacuum Oil sealed vacuum pumps + blower • Redundancy (second pump set) ◦ Dry pumps + blower ◦

Pressure Regulation On/Off • Flow controller •

Process Sensors MKS • Pirani ◦

Venting System incl. Filter

Sterilizable • Ports for I-Test • Second venting media ◦ Second venting filter ◦ Automatic WIT test ◦

Control System and Documentation PLC Siemens • PLC Rockwell automation ◦ SCADA - WIN CC • iFix ◦ Recorder ◦ GAMP • Audit trail • 21 CFR Part 11 • FAT / SAT • IQ/OQ Documents and tests ◦ Material certificates ◦ Welding documentation ◦

Technology ALUS® ◦ ATEX (alcoholic solvent treatment) ◦ Cold shelf loading > +5°C • Frozen shelf loading < +5°C - -40°C ◦ LYOPLUS® ◦ LYOSPARK® ◦

• Included ◦ Option

6 LYOVAC – Industrial-Scale Freeze Dryers.

Standard and Optional Features – ALUS® Loading

Pusher with transfer table • Vial handling • Tray / nest handling ◦ Single row loading ◦ Multiple row loading ◦ Loading speed 200 V/min • Loading speed 400 V/min ◦ Loading speed 600 V/min ◦ Loading on precooled shelves • Transfer cart (automatic) ◦ Transfer cart (semi-automatic) ◦ Transfer cart (manual) ◦ Conveyor belts to the filling machine •

Containment oRABS ◦ cRABS ◦ Isolator ◦

Unloading

Puller with transfer table • Back pusher ◦ Vial handling • Tray / nest handling ◦ Single row unloading ◦ Multiple row unloading • Unloading speed 200 V/min • Unloading speed 400 V/min ◦ Unloading speed 600 V/min ◦ Transfer cart (automatic) • Transfer cart (semi-automatic) ◦ Transfer cart (manual) ◦ Conveyor belts to the capping machine ◦

Cleaning Wipe down • Wet cleaning with spray guns and static rots ◦ Inclination of the base plate ◦

Technology LYODATA® ◦ LYOSENSE® ◦ ATEX ◦ Cold shelf loading > +5°C • Frozen shelf loading < +5°C - -40°C ◦

• Included ◦ Option

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

7 LYOVAC – Industrial-Scale Freeze Dryers.

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© GEA Lyophil GmbH 06/2026. All rights reserved. Subject to modifications. ALUS®, LYODATA®, LYOPLUS®, LYOSENSE®, LYOSPARK®, LYOVAC® & SMART LYO® 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