The LyoStar 4.0 from SP represents a substantial development in freeze dryer engineering and is devised and constructed to improve biopharmaceutical products’ speed to market.

LyoStar 4.0 is a pilot-scale lyophilizer providing greater swift shelf freezing, shelf mapping, unparalleled process accuracy and reliability and is based on a complete-scale production freeze dryer to enable quick scale-up.

LyoStar 4.0 also consists of a state-of-the-art suite of Process Analytical Technology (PAT) tools augmenting SP’s Line of Sight™ suite of technologies, which master crucial lyophilization challenges at the time of development, scale-up and manufacturing of a biologic. Moreover, SP’s novel freeze dryer employs an eco-friendlier refrigerant gas, which decreases the carbon footprint of lyophilization.

SP Hull LyoStar 4.0.

SP Hull LyoStar 4.0.

Image Credit: SP Scientific Products

LyoStar 4.0 door open.

LyoStar 4.0 door open.

Image Credit: SP Scientific Products

LyoStar 4.0 close-up.

LyoStar 4.0 close-up.

Image Credit: SP Scientific Products

LyoStar 4.0 loading vials.

LyoStar 4.0 loading vials.

Image Credit: SP Scientific Products

Thermocouple.

Thermocouple.

Image Credit: SP Scientific Products

The LyoStar 4.0 encompasses more sophisticated innovations in freeze-drying technology to safeguard important products by assuring accurate process control and strong reliability. The system is perfect for quick lyophilization cycle development, optimization and scale-up.

The LyoStar 4.0 has numerous advanced, upgradeable PAT tools including AutoMTM/SMART™ Freeze Dryer Technology, a primary drying cycle optimization tool and LyoFlux® TDLAS Sensors for vapor mass flow measurement.

It also includes a 3D modeling package for computational fluid dynamics and process monitoring, ControLyo® Nucleation Technology providing pinpoint control of freezing point and Tempris® Wireless Sensors for immediate product temperature measurement.

Key features and benefits

Key features

  • Advanced instrumentation set
  • Unparalleled process reliability and accuracy
  • Cleanroom or isolator integrable
  • Innovative cycle development and optimization features
  • 4-Shelf configuration provided
  • Availability of solvent package
  • Tools of Advanced Process Analytical Technology (PAT)
    • ControLyo® Controlled Nucleation Technology ready
    • Optional LyoFlux® TDLAS and Tempris® Wireless Sensors
    • SMART™ Freeze Dryer technology

Key benefits

  • Reduces cycle development time and preserves useful API: Employing SMART and AutoMTM tools
  • Readily scalable: Employing Line of Sight™ technologies, PAT tools and software promotes scale-up
  • Offers additional process and product information: In particular, heat flow, dried layer resistance, mass transfer and how various freezing protocols affect cake resistance
  • Increases process control and repeatability: Line of Sight™ PAT tools allow process accuracy and reliability, as well as batch consistency

Application examples

  • Lyophilization of product with organic solvents besides water
  • Laboratory research and development and/or small production freeze-drying
  • Formulation development and stability studies
  • Cycle optimization and scale-up
  • Diagnostic kits
  • Serum bottles and vials
  • 96 well plates

Optional components and accessories

  • MVP Freeze Drying Probes
  • SMART™ Freeze Drying Technology
  • ControLyo™ Nucleation Technology