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Trouble With the Neighbor During Freeze-Drying: Rivalry About Energy

Authors :
Wolfgang Friess
Sarah Ehlers
Rudolf Schroeder
Source :
Journal of Pharmaceutical Sciences. 110:1219-1226
Publication Year :
2021
Publisher :
Elsevier BV, 2021.

Abstract

Batch homogeneity during lyophilization is crucial to ensure products with high quality. Known as edge-vial-effect, vials at the corners and edges tend to run warmer than center vials during primary drying. This is associated with risk of collapse or increased costs due to use of more conservative, longer drying conditions resulting in lower product temperature. The edge-vial-effect has been attributed to radiation coming from the chamber wall. We could show that the neighbor vial has a dominant impact on product temperature during lyophilization. Depending on the number of neighbors as well as the distance to a neighbor vial, the neighbor vial exerts a remarkable cooling effect. Energy transfer by gas conduction enables the cooling effect of a neighboring vial over a distance up to 10 mm. This not only leads to prolonged primary drying but also impacts cake appearance. Thus, to avoid trouble during lyophilization you have to watch out for the neighborhood.

Details

ISSN :
00223549
Volume :
110
Database :
OpenAIRE
Journal :
Journal of Pharmaceutical Sciences
Accession number :
edsair.doi.dedup.....4ea467ede6b049fea24ab75bab2c7082