Small-scale pharmaceutical freeze dryer

Enhance precision in biopharmaceutical preparation with this versatile freeze dryer, specifically designed for small-scale and pilot production, ensuring optimal temperature control and reliable endpoint detection for sensitive formulations.

Freeze Dries Small-Scale Pharmaceutical Batches

The LYOVAC® FCM 10-P from GEA is a versatile pilot-scale freeze dryer designed specifically for the pharmaceutical and biotech industries. It facilitates small-scale production and research with a keen focus on precision control throughout the lyophilization process, essential for developing injectables and biologics. Using a GLP/GMP-compliant FALCO control system, it offers seamless recipe transfer from trial to production. The FCM 10-P accommodates up to 10 kg of product over a 0.63 m² shelf area. It supports customization with options such as IQ/OQ documentation, wireless temperature sensors, and sterilization alternatives using VHP or steam, aligning with available utilities. Additionally, it integrates process development services and advanced end-point detection via LYOPLUS® mass spectrometer. Ideal for R&D and process development, this equipment ensures precise drying necessary for sensitive biopharmaceutical applications.

Benefits

  • Enhances process development with precision temperature and moisture control.
  • Facilitates seamless scale-up with direct recipe transfer capability.
  • Reduces contamination risks through optional VHP or steam sterilization.
  • Offers flexible configuration with wireless monitoring and advanced end-point detection.
  • Ensures GMP compliance for pharmaceutical research and production.

General


Applications
Biopharmaceuticals,Pharmaceutical powder,Liquid formulations,Lyophilized products
End products
Drug apis,Lyophilized vials for pharmaceuticals,Peptide drugs,Vaccines,Blood plasma products,Antibiotics,Monoclonal antibodies,Biological suspensions,Sterile injectable solutions,Protein therapeutics,Nucleic acid-based medications
Steps before
Formulation development,Batch preparation,Solution mixing
Steps after
Sterilization,Packaging,Capping,Lyophilized product handling
Input ingredients
small-scale batches,formulation,process development,vials,ampules,syringes,cartridges,liquid,powder
Output ingredients
lyophilized product,freeze-dried product
Market info
GEA is known for its expertise in engineering innovative and sustainable equipment and solutions, focusing on sectors such as food, beverages, pharmaceuticals, and energy, with a reputation for quality, efficiency, and advanced technological applications in industrial processing.

Technical Specifications


Capacity
10 kg in 24 h
Shelf Area
0.63 m²
Number of Shelves
4 shelves
Possible Load
2608 of 2R vials,1352 of 6R vials,708 of 20R vials
Compliance
GLP/GMP-compliant
Control System
FALCO control system
Sterilization
VHP (VAPOVAC™) or steam
Documentation
IQ/OQ documentation

Operating Characteristics


Batch size
10 kg in 24 h
Shelf area
0.63 m²
Compliance level
GLP/GMP-compliant
Process Scale-Up
Direct recipe transfer
Flexibility
Standalone / wall-mounted
Validation Access
Easy-access doors and spare flanges

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm
Cleanability
GLP/GMP-compliant


GMP Compliance
GLP/GMP-compliant

Physical Characteristics


Unit Configuration
Two-chamber unit
Installation Type
Standalone or Wall-mounted
Door Type
Easy-access doors

Custom Options


Sterilization Options
VHP / Steam
Temperature Sensor Type
Wireless
Control System
FALCO Control System
Integration Type
Wall-mounted Option
Process Development Service
LYOSPARK© Controlled Nucleation