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

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,...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Journal of pharmaceutical sciences 2021-03, Vol.110 (3), p.1219-1226
Hauptverfasser: Ehlers, Sarah, Schroeder, Rudolf, Friess, Wolfgang
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung: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.
ISSN:0022-3549
1520-6017
DOI:10.1016/j.xphs.2020.10.024