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The freezing stage is the only portion of the freeze-drying process that normally remains largely uncontrolled. Ice nucleation is a stochastic process, so the degree of super-cooling varies both inter- and intra-batch. However, ice nucleation can be controlled, with the “ice-fog” techniques and the recently developed “ControLyo”. This presentation will give an overview of different controlled nucleation methods and their importance in attaining inter- and intra- batch homogeneity, uniformity of specific surface area, dry layer resistance, impact on process time and product quality. Presented by Vamsi K. Mudhivarthi, PhD Researcher at Department of Pharmaceutics, University of Connecticut

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