Minimization of radiation coming from the chamber wall during lyophilization has the potential to reduce the edge-vial-effect. The edge-vial-effect is a phenomenon in which vials positioned at the shelf edges and corners tend to run warmer compared to center vials. A higher product temperature may result in product collapse in these vials. Consequently, more conservative and time-consuming freeze-drying cycles with lower shelf temperatures and pressures are chosen to ensure a product temperature below the collapse temperature in all vials. The edge-vial-effect is of even higher impact in small batches, where the ratio of corner and edge to center vials is higher compared to large scale manufacturing. The chamber wall is often discussed as the primary source of radiation impacting corner and edge vials. A radiation cage was set at different low temperatures to determine the impact of chamber wall temperatures below 0 °C on product temperature. At the end of primary drying, product temperature of corner vials could be reduced by 6 °C through the radiation cage but primary drying was elongated. Compared to vials in a tray, the chamber wall temperature had less impact on vials nested in a rack system due to a shielding effect of the rack itself. Corner and center vials ran more homogeneous with radiation cage since the edge and corner vials were slowed down. The difference in primary drying time between corner and center vials in the tray could be significantly reduced by 18% by means of 7 h when the radiation cage was controlled at product temperature and combined with a higher shelf temperature. In summary, the radiation cage is a useful tool for a more homogeneous batch with the potential to reduce primary drying time. Nevertheless, the drying difference between corner and center vials could only be reduced and was not completely eliminated.
Keywords: Chamber wall; Edge-vial-effect; Freeze drying; Heat transfer; Lyophilization; Radiation; Radiation cage.
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