Operational Qualification of Freeze Dryers is traditionally performed using empty chambers. Secondly, scaling up or transferring Freeze Drying cycles is often empirical, and not necessarily science based. In order to better understand performance characteristics of the freeze dryer and to apply a science based approach to cycle development, scale up and/or transfer, it would be advised that various heat and mass transfer studies should be conducted at lab scale and manufacturing scale during operational qualification or prior to product transfer, in the even OQ has been performed. This presentation will first present the basic principles around heat and mass transfer related to freeze drying and secondly an industry case study at lab and manufacturing scale, demonstrating the approach and application of the model to scale up. Presented by Timothy R. McCoy, MSc, Principle Scientist at Genzyme, a Sanofi Company
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