Application note: Process Analytical Technology employed in the Freeze Drying Process to determine the End of Primary drying and Cycle Optimisation

Process Analytical Technologies (PAT) are analytical methods that can help to monitor a process in real time, enabling measurement of its effectiveness and assess how well the process achieves its end goal. They are employed in the manufacturing of various drug forms including solid dose, liquid dose, semi-solids, and freeze drying (lyophilisation). Freeze drying is a low temperature process in which a solvent, typically water, is removed from a frozen material by sublimation under vacuum, leaving the freeze concentrated material behind, which is then referred to as a freeze dried cake or lyophile.

Freeze drying is employed to preserve and extend the shelf life of heat-labile drugs which when in solution degrade too rapidly, to stabilise bio-pharmaceutical molecules or to make the material more convenient for transport at ambient conditions rather than be refrigerated.

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