Lyophilization Technology LYOVAC™ Pharma Freeze Dryer

This proprietary technology can control the nucleation temperature of a solution to within 1 ºC of its freezing point, providing exceptional control and vial-to-vial uniformity. Historically, owing to the random nature of nucleation in the freeze dryer, lyophilization has been difficult to control. Vial contents for a typical pharmaceutical formulation would nucleate across a broad range of temperatures (5–20 °C below the freezing point) and, as nucleation temperature directly affects ice structure formation and crystal size, as well as cake structure and appearance, it can adversely influence final product CQAs (Critical Quality Attributes) such as product humidity or dissolution behaviour. Now, a patent pending process technology, implemented on GEA freeze dryers, offers a novel and scalable method to control nucleation without having to reformulate the drug.

This state-of-the-art nucleation control technology allows users to select the temperature at which the product is nucleated. ControLyo™ then ensures that every vial in the freeze dryer chamber, regardless of location, experiences the same process conditions at exactly the same time, resulting in simultaneous nucleation. Implementing the ControLyo™ process step in a conventional freeze drying cycle is very straightforward. The vials are loaded into the freeze dryer and cooled to a target nucleation temperature. During the cooling step, the chamber is pressurized with an inert gas and, once the desired nucleation temperature is reached, the chamber is rapidly depressurized, which triggers the sub-cooled solutions in the vials to nucleate and begin freezing instantaneously and homogeneously. ControLyo™ offers a higher initial pressure and a faster pressure drop than conventional systems, resulting in optimized performance and productivity.