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P. 43-47 /

Rational approaches and transfer strategies for the scale-up of freeze-drying cycles

 

STEFAN C. SCHNEID1,2*, HENNING GIESELER1

*Corresponding authorUniversity of Erlangen, Division of Pharmaceutics, Cauerstr. 4, Erlangen, 91058, GermanySyntacoll GmbH, Donaustr. 24, 93342 Saal, Germany
 

Abstract

The rational development and optimization of freezedrying cycles in the laboratory should be based on knowledgeof the critical formulation properties, such as the collapsetemperature. Once a recipe has been finalized that ensuresacceptable quality of the final product, the transfer to manufacturingscale can be initiated. When scaling a freeze drying cycle fromthe laboratory to pilot or production scale, identical producttemperature profiles over time must be established to assure thesame quality defined in the lab. To achieve this, several importantfactors have to be taken into consideration. The most importantparameters such as nucleation behaviour, differences in heatand mass transfer, freeze dryer design and performance and theirimpact on product quality will be surveyed. Additionally, methodsto evaluate and compensate differences between freeze dryers are presented.


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