Scale-up and Process Transfer of Freeze-Drying Recipes |
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Authors: | Davide Fissore Antonello A. Barresi |
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Affiliation: | 1. Dipartimento di Scienza dei Materiali e Ingegneria Chimica , Politecnico di Torino , Torino, Italy davide.fissore@polito.it;3. Dipartimento di Scienza dei Materiali e Ingegneria Chimica , Politecnico di Torino , Torino, Italy |
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Abstract: | This paper proposes a simple and effective methodology for the scale-up and process transfer of freeze-drying recipes. Process modeling allows the study of the silico product evolution in a given freeze-dryer, and calculation of the operating conditions that result in the same product dynamics in different equipment. Few experiments are necessary to determine model parameters and to characterize the two freeze-dryers. The problem of the batch non-uniformity and the effect of the parameters' uncertainty are also addressed. The effectiveness of this approach is demonstrated by means of various examples. |
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Keywords: | Freeze-drying Heat and mass transfer Mathematical modeling Pharmaceuticals Process transfer Scale-up |
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