AbbVie Deutschland GmbH & Co. KG, Knollstraße 50, 67061 Ludwigshafen.
AbbVie Deutschland GmbH & Co. KG, Knollstraße 50, 67061 Ludwigshafen.
J Pharm Sci. 2021 Mar;110(3):1219-1226. doi: 10.1016/j.xphs.2020.10.024. Epub 2020 Oct 15.
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.
在冷冻干燥过程中，批处理的均一性对于确保产品的高质量至关重要。众所周知，在主干燥过程中，角落和边缘的小瓶比中心小瓶升温更快，这种现象被称为“瓶缘效应”。这可能会导致由于使用更保守、更长的干燥条件而导致产品温度降低，从而增加成本或导致产品崩溃的风险。瓶缘效应归因于来自腔室壁的辐射。我们可以证明，在冷冻干燥过程中，相邻小瓶对产品温度有显著影响。根据相邻小瓶的数量以及与相邻小瓶的距离，相邻小瓶会产生显著的冷却效果。气体传导的能量传递使得相邻小瓶在 10mm 的距离内产生冷却效果。这不仅导致主干燥时间延长，还会影响干燥饼的外观。因此，为了避免冷冻干燥过程中的问题，您必须注意小瓶的相邻关系。
