Modelling Inter-Vial Intra-Batch Variation of Primary Drying Time from the Natural Variation in Freeze-Drying Process Variables

The product temperature during primary drying can vary from vial to vial within a single batch. Several sources of the heterogeneity of product temperature and drying time have been well characterized. For example, the increase in the vial heat transfer coefficient of edge vials is well known, but now we also consider outer and inner edge vials separately. Other nuances that influence the heterogeneity of the vial heat transfer coefficient will also be discussed. Perhaps the least well understood source of batch heterogeneity is the product resistance. Without annealing or ControLyo, the product resistance varies across the batch. Findings on the variation in this important parameter will be discussed in this webinar. Finally, results of the heterogeneity on stability will be presented. Presented by Dr. Robin Bogner, PhD Associate Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut