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, 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. (C) 2020 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.

Automated summary

Homogeneity during lyophilization is crucial for product quality. The edge-vial-effect can cause uneven product temperature distribution, due to the impact of neighboring vials. Gas conduction enables cooling effects up to 10 mm distance between vials.