The benefits of using a mass spectrometer and how it is implemented for contaminant detection.

Freeze drying processes are sometimes subject to contamination that jeopardise product quality. Process monitoring is a means improving sterility assurance and as the FDA also stresses the need to monitor leak rates, we have conducted several experiments using mass spectrometers to detect contaminants.

Testing under vacuum conditions inside the freeze-dryer provided valuable answers as we continue to collaborate with industry leaders to develop best practices for leak detection. We discuss the benefits of using a mass spectrometer and how it is implemented for contaminant detection.