Praxair’s ControLyo™ technology is a critical, quality driven, cost-saving tool that is becoming the cornerstone of pharmaceutical freeze drying applications. It is a novel and scalable method for controlling nucleation during the freezing step in commercial lyophilization. By introducing a carefully timed depressurization event during the freezing cycle, nucleation will occur simultaneously in all vials. Relying on pressure control, the ControLyo technology is highly adaptable and can be retrofitted to most freeze dryers with minimal impact on established lyophilization protocols. And ControLyo technology does not require any changes to existing drug formulations.
By inducing simultaneous nucleation at a specific temperature set point, manufacturers better control the entire freeze drying process — avoiding the time delays and temperature variations associated with stochastic or uncontrolled nucleation. Nucleating at warmer temperatures results in larger ice crystal formation and consequently shorter drying times. ControLyo technology users have reported up to 40% reduction in cycle times. In addition to supporting the FDA’s Quality by Design (QbD) initiative, ControLyo technology delivers immediate and measurable benefits to customers. While results are formulation dependent, users have reported improved cake appearance, reduced protein aggregation, shorter drying times, reduced vial cracking and faster reconstitution times.