SP Hull LyoStar® 4.0 – R&D & Process Development Freeze Dryer

The SP Hull LyoStar 4.0 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. 

 

Click the image to zoom in

  • SP Hull LyoStar 4.0

    SP Hull LyoStar 4.0

  • LyoStar 4.0 Door Open

    LyoStar 4.0 Door Open

  • LyoStar 4.0 Close-Up

    LyoStar 4.0 Close-Up

  • LyoStar 4.0 Loading Vials

    LyoStar 4.0 Loading Vials

  • Thermocouple

    Thermocouple

Get More Information

Key Features

  • Unmatched process accuracy and reliability
  • Sophisticated instrumentation set
  • Advanced cycle development and optimization features
  • Clean room or isolator integrable
  • Solvent package available
  • 4-Shelf configuration available
  • Advanced Process Analytical Technology (PAT) tools:
    • ControLyo® Controlled Nucleation Technology ready
    • SMARTTM Freeze Dryer technology
    • Optional LyoFlux® TDLAS and Tempris® Wireless Sensors
     

    Key Benefits

    • Decreases cycle development time and conserves valuable API: Using SMART 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
      • Formulation development and stability studies
      • Cycle optimization and scale-up
      • Lyophilization of product with organic solvents in addition to water
      • Laboratory research and development and/or small production freeze drying
      • Diagnostic kits
      • 96 well plates
      • Serum bottles and vials