The SP Hull LyoStar 4.0 R&D and Process Development Freeze Dryer is designed and built to speed your biologic to market, with significant advancements in freeze dryer engineering. Based on a full-scale production freeze dryer to support rapid-scale-up, the SP Hull LyoStar 4.0 is a pilot-scale lyophilizer offering superior shelf mapping and rapid shelf freezing for unmatched process accuracy and reliability.
Including a cutting-edge suite of Process Analytical Technology (PAT) tools, SP's Line of Sight™ suite of technologies helps you overcome critical lyophilization challenges during development, scale up and manufacture of a biologic. These technologies include:
• LyoFlux® TDLAS Sensors for vapor mass flow measurement
• AutoMTM/SMART™ Freeze Dryer Technology, a primary drying cycle optimization tool
• ControLyo® Nucleation Technology giving pinpoint control of freezing point
• Tempris ® Wireless Sensors for real-time product temperature measurement
Features & Benefits
• Get to market faster - sophisticated instrumentation set, advanced cycle development and optimization features decrease cycle development time and conserve valuable API
• You can never be too informed - LyoStar 4.0 provides more product and process information such as dried layer resistance, heat flow, mass transfer, and how different freezing protocols impact cake resistance
• Easily scalable - advanced, reliable, and scalable lyophilization technologies, along with Process Analytical Technology (PAT) tools, support smooth scale-up from process development through to manufacturing
• Cleanroom or isolator integrable - with optional 21 CFR Part 11 compatible software