LyoConstellation Freeze Dryer

LyoConstellation Development & Pilot Freeze Dryers provide the largest process space in their class, allowing development of highly aggressive cycles. Each unit can hold 100mTorr while shelves are at +40⁰C fully loaded. Equipped and controlled as a production system, LyoConstellation offers the same software and technology options as smaller systems for a seamless approach to scale-up while being designed for line integration – including being isolator-ready and suitable for clean room installation.

Available in three shelf sizes: 1m, 2m and 3m, LyoConstellation lyophilizers are configured to order for faster than average market delivery.

LyoConstellation offers a comprehensive range of options for secure, best manufacturing practices for high-value products, including controlled ice nucleation, fluid condenser cooling and large diameter vapor ports for high flow.

Showcasing SP’s Line of Sight technologies, the LyoConstellation is available with ControLyo Technology, Tempris wireless temperature sensors and (SMART) LyoFlux TDLAS mass flow measurement.

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  • LyoConstellationFD

    LyoConstellationFD

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Key Features & Benefits:

  • 3 shelf sizes cover cycle development, stability, pilot and clinical batch production, through full aseptic production
  • S10 – 6 shelves, S20 – 5 shelves, S30 8 shelves
  • Accommodates vials up to 30ml
  • SIP & CIP as standard
  • Full suite of PAT tools and technologies enables a Line of Sight approach in cycle development and scale-up for easiest technology transfer to assure product safety and quality in production
    • LyoFlux TDLAS mass flow measurement and inference of critical data
    • ControLyo ice nucleation
  • Integrates with PennTech filling line and semi-automatic loading system
  • Isolator ready with auto locking doors
  • F Gas compliant
  • Validation ports in chamber and condenser as standard
  • LyoS 2.0 software with 21 CFR part 11 compliant signatures

Chamber

  • Pressure rated (ASME or PED) for SIP/CIP & ControLyo®
  • Constant load height of 43.5” /1105mm (S20 and S30)
  • Pirani and Capacitance Manometer as standard, 2 additional validation ports

Access Doors

  • S10 has an auto locking chamber door to the isolator/cleanroom only
  • S20 and S30 have an auto locking, loading slot door to isolator / cleanroom with powered opening and maintenance door access from machine room.

Large Diameter Vapor Port

  • Cleanable butterfly valve
  • Optional TDLAS spool, pressure rated

Condenser

  • 1:1 shelf to condenser surface area
  • Pressure rated execution (ASME or PED) for SIP/CIP
  • Pirani and Capacitance Manometer as standard, 2 additional validation ports

Controller

  • LyoS – Windows-based; features include Batch Reports, 21 CFR Part 11 compliance capabilities (SEC3) and Uninterruptible Power Supply (UPS)

Cleaning Options

  • Full Steam in Place (SIP) & Clean in Place (CIP) execution with manual / H2O2 option (S10)

Validation Options

  • Full validation documentation package and support available
Recombinant proteins and ADC production for clinical trials and small to medium batch production for compounding pharmacies, and pharma including CMO, CRO
  • LyoFlux TDLAS
  • ControLyo
  • Dry, oil-free vacuum pump