Determination of residual moisture

Rubrik: Analytik

(Treffer aus pharmind, Nr. 09, Seite 726 (2026))

Bartels O | Mangold A

Determination of residual moisture / At the end of the primary drying of freeze-drying using a combined AI- and model-based approach · Bartels O, Mangold A · Bartels Forschung und Entwicklung und Tempris
Freeze Drying Lyophilization Process Control Design Space Artificial Intelligence Lyophilization is the method of choice to remove water from sensible pharmaceutical products by sublimation without excessive heat, which would destruct the chemical structure of the active substances. In industrial processing this takes place in the individual vials, contained within large freeze dryers. The process uses 3 phases: Freezing the filled vials, sublimation under vacuum conditions, which is the primary drying phase, secondary drying often above room temperature levels and then tracing back the temperature back to room temperature conditions, finally terminated by the mechanical stoppering. The primary drying phase under vacuum ...