Process analytical technology for lyophilization
Ensure product integrity by detecting trace contaminants and optimizing lyophilization cycles with a high-sensitivity solution designed for contamination prevention in biopharmaceutical freeze-drying processes.
Monitors Contamination and Moisture in Freeze Drying
The LYOPLUS® Mass Spectrometer from GEA is an essential tool for pharmaceutical and biotech manufacturers focused on ensuring the integrity and quality of their freeze-drying processes. Specially designed to detect trace contamination and moisture within freeze dryers, the system provides a crucial safeguard against silicone oil leaks and helps optimize drying cycles. Its quadrupole mass spectrometer design integrates seamlessly with existing automation environments or operates as a standalone unit, offering high sensitivity down to 1 ppm. With applications ranging from the production of monoclonal antibodies to lyophilized tablets, LYOPLUS® supports both pilot and production-scale operations, providing compliance with GMP requirements. Equipped with SCADA applications and multilingual interfaces, the system enhances process control while minimizing downtime and ensuring product purity.
Benefits
- Enhances product safety by detecting silicone oil leaks early, preventing contamination.
- Optimizes drying cycles, reducing unnecessary process time and energy consumption.
- Integrates smoothly with existing control systems, ensuring swift adoption and minimal disruption.
- Complies with GMP standards, supporting stringent regulatory requirements.
- Increases operational efficiency with real-time monitoring and data analysis.
- Applications
- Parenterals,Biopharmaceuticals,Liquid formulations,Pharmaceutical products
- End products
- Gene therapy medications,Hormone therapies,Cell therapy products,Vaccines,Lyophilized tablets,Chemotherapeutic drugs,Insulin,Monoclonal antibodies,Biological drug substances,Enzymes,Injectable drugs,Eye drops,Protein therapeutics
- Steps before
- Formulation,Loading of Vials,Evacuation of Dryer,Cooling Shelves and Ice Condenser
- Steps after
- Quality Control Testing,Product Removal,Post-Production Cleaning,Shelf Heating
- Input ingredients
- water vapor,solvents,nitrogen,oxygen,helium,silicone oil
- Output ingredients
- lyophilized product,reduced moisture content
- 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.
- Detection limit
- Down to 1 ppm
- Automation
- SCADA application compliant to 21 CFR Part 11
- Interfaces
- Industrial standard interfaces
- Inlet system
- High-conductance
- Measurement
- Quadrupole mass spectrometer
- Sensitivity
- 1 ppm of non-interfering species
- Software
- Advanced data collection and control
- Automation level
- Manual / PLC / SCADA
- Batch vs. continuous operation
- Batch
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- CIP / Manual
- Energy efficiency
- 0.5–2 kWh/kg moisture
- Leak detection
- Silicone oil and helium leak tests
- Moisture content monitoring
- Recipe-dependent moisture profiles
- Process monitoring
- Mass spectrometry
- System integration
- Standalone or full integration
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Contamination risk
- Silicone oil,process fluids
- Machine footprint
- Customizable
- Control panel type
- Multilingual graphical user interface
- Compact footprint
- Fits existing automation environments
- Discharge method
- Integrated with freeze drying process
- System's connection type
- Tri-clamp connection
- Integration with existing systems
- Compatible with legacy and modern systems
- Control system
- Standalone or integrated with automation
- Interface type
- Standard industrial interfaces
- Installation options
- Retrofit into existing setups
- Data representation
- Comprehensible,real-time monitoring
- System adaptability
- Adaptable to different freeze dryer models
- User interface
- Multilingual graphical user interface