R&d and process development freeze dryer
When developing biologics, achieving precise process control during lyophilization is critical. Challenges such as maintaining uniform shelf temperature and optimizing the primary drying cycle can impact the quality and stability of the end product.
Ensure precise process control and reliability
The Hull LyoStar 4.0 R&D and Process Development Freeze Dryer, from Scientific Products, offers advanced freeze-drying technology designed to accelerate and optimize lyophilization cycles. This pilot-scale freeze dryer ensures superior shelf temperature mapping and rapid shelf freezing, providing unmatched process accuracy. It includes SP’s Line of Sight™ Process Analytical Technology (PAT) tools, such as LyoFlux® TDLAS Sensors for vapor mass flow measurement and AutoMTM/SMART™ Freeze Dryer Technology for primary drying cycle optimization. The ControLyo® Nucleation Technology precisely controls the freezing point, and Tempris® Wireless Sensors offer real-time product temperature measurement. Suitable for diverse applications like formulation development, stability studies, and lyophilization of organic solvents, this equipment supports rapid scale-up from development to manufacturing. Optional software ensures compliance with 21 CFR Part 11, making it ideal for cleanroom or isolator integration.
Benefits
- Accelerates lyophilization cycle development and optimization
- Ensures precise shelf temperature mapping and rapid freezing
- Includes advanced PAT tools for comprehensive process monitoring
- Supports smooth scale-up from R&D to manufacturing
- Integrable with cleanroom or isolator environments