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.
- 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.
- 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
- 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
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Cleanability
- GLP/GMP-compliant
- GMP Compliance
- GLP/GMP-compliant
- Unit Configuration
- Two-chamber unit
- Installation Type
- Standalone or Wall-mounted
- Door Type
- Easy-access doors
- Sterilization Options
- VHP / Steam
- Temperature Sensor Type
- Wireless
- Control System
- FALCO Control System
- Integration Type
- Wall-mounted Option
- Process Development Service
- LYOSPARK© Controlled Nucleation