Lyophilization Services at GRAM

May 6, 2022

The Bells & Whistles

The bottom integrated condenser on GRAM’s lyophilizer allows for a natural flow of vapor from the top down. This helps create a more uniform and consistent ice formation on the condensers and greatly reduces the overall footprint of the lyophilizer. The footprint gives available space if a second lyophilizer is desired in the future.

Unique Attributes

GRAM’s lyo has an IMA CLU automatic load and unload unit all in an isolator Grade A environment. This reduces the need for operator intervention or dealing with a HEPA cart. The lyo has multiple Pirani gauges that could be used to monitor the point of nucleation and may help develop or even improve the lyo cycle long term. Additionally, our capper is installed with a camera system to monitor stopper presence and raised stopper detection for 100% of vials that come from the lyophilizer. Rejects are rejected before being capped and crimped.

OEM Support

IMA provides both US support and remote support from branches in New York and Italy. GRAM has plenty of support from IMA during equipment onboarding and counts on partners that are quick to respond. As the second IMA lyophilizer at GRAM, we have established a strong relationship with IMA over the years.

The Lyophilizer: IMA LyoMax 17

  • 7 shelves
  • Shelf area: 16.7 m2 (54.79 m2)
  • Automated loading/unloading
  • Capacity:
    • 2R: ~68,500 vials
    • 6R: ~36,000 vials
    • 10R: ~31,000 vials
    • 20R: ~19,000 vials
    • 50R: ~9500 vials
  • Integrated condenser
  • Shelf cooling to -55/70°C and condenser cooling to -75/120°C
  • HFC/LN2 refrigerants
  • Frozen shelf loading with screw loading mechanism that reduces vial sticking
  • Vacuum measurements with capacitance manometers