Product/Service

SP Hull ControLyo Technology - Controlling Nucleation In Commercial Lyophilization

Source: SP Scientific Products

Freeze All Vials Uniformly and Consistently Every Time
Freezing is a highly variable process, and this variability is one of the most common challenges in freeze-drying scale-up.

Technology offers an effective solution by ensuring instantaneous, controlled ice nucleation at a higher temperature, which minimizes super cooling and yields the largest possible ice crystals. This, in turn, reduces the primary drying time and increases product homogeneity. By tightly controlling the freezing process, ControLyo Technology improves product quality, shortens drying times, and requires no formulation change or introduction of foreign material into the vials.

Improved inter- and intra-batch product quality - QbD approach ensures consistent homogeneity; shorter reconstitution time; better cake appearance
Scalable technology - Easily retrofitted on equipment that is equipped with steam in place (SIP)
Increased productivity and economic benefits - Decreased cycle time by enabling controlled ice nucleation to occur at warmer temperatures
Reduced vial breakage - Inducing nucleation at warmer temperature of -4°C to -6°C with improved and more consistent cake appearance