Journal
DRYING TECHNOLOGY
Volume 29, Issue 14, Pages 1673-1684Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/07373937.2011.597059
Keywords
Freeze-drying; Heat and mass transfer; Mathematical modeling; Pharmaceuticals; Process transfer; Scale-up
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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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