Lyophilisation or freeze-drying involves removal of solvent, typically water, from a frozen solution by sublimation, resulting in a porous (cake like) structure. The process is inefficient and expensive due to the slow drying rates and the operating expenses associated with the use of chillers and other equipment needed for the process. The bulk of the water vapor is removed during primary drying (sublimation) and the remaining during secondary drying (desorption) at controlled temperatures to avoid irreversible damages to the active ingredient.
Coupled with the value of the products manufactured in each batch of a freeze-drying cycle, testing product integrity is of paramount importance.
Real time in-situ monitoring of the drying process, both during primary and secondary drying at laboratory scale and production scale provides unprecedented process quantitation and control capability through:
Guaranteeing quality assurance by reducing rejects and maximizing confidence.
Maximising the return of investment (ROI) by accurately detecting process end point and identifying procence of trace contaminants prior to failure events.
Ready to use, anytime, anywhere, QUANTUM is the only miniaturised mass spectrometer developed to monitor the freeze-drying process in real time and to detect the presence of any leaks or contaminants. Water vapor can be quantified giving the exact end point of the lyophilisation process.
Compact, small and light, this device can be easily integrated in new or existing freeze dryers, both pilot and production scale.