SP Hull LyoStar® 4.0 R&D & Process Development Freeze Dryer
The SP Hull LyoStar 4.0 was designed and built to enhance speed to market of biopharmaceutical products and represents a significant advancement in freeze dryer engineering. Based on a full-scale production freeze dryer to support rapid-scale-up, LyoStar 4.0 is a pilot-scale lyophilizer offering superior shelf mapping, rapid shelf freezing, unmatched process accuracy and reliability. It also includes a cutting-edge suite of Process Analytical Technology (PAT) tools augmenting SP's Line of Sight™ suite of technologies which overcomes critical lyophilization challenges during development, scale‑up and manufacturing of a biologic.
In addition, SP's new freeze dryer uses an eco-friendlier refrigerant gas, which reduces the carbon footprint involved in lyophilization. Ideal for rapid lyophilization cycle development, optimization and scale-up, the LyoStar 4.0 incorporates the very latest innovations in freeze-drying technology to protect valuable product by ensuring precise process control and robust reliability. To enable this, LyoStar 4.0 has a number of sophisticated, upgradeable PAT tools including: 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; a 3D modelling package for computational fluid dynamics and process monitoring; and Tempris® Wireless Sensors for real-time product temperature measurement.
Key Benefits
- Decreases cycle development time and conserves valuable API: Using SMARTTM and AutoMTM tools
- Easily scalable: Using Line of SightTM technologies, PAT tools and software facilitate scale-up
- Provides additional product and process information: Such as dried layer resistance, heat flow, mass transfer and how different freezing protocols impact cake resistance
- Maximizes process control and repeatability: Line of SightTM PAT tools enable process accuracy and reliability, and batch consistency