In a recent paper published by IMA Life, the “Commercial applications of a residual gas analyzer for Lyophilization” was studied with a specific focus on 5cSt silicone oil contamination testing in an IMA Life Lyofast3 and Lyomax40 freeze drier. The IMA Quantum mass spectrometry solution was used to address the FDA’s guideline (UCM074909), which necessitates the monitoring for system leak rates, including possible leaks from silicone oil used as a thermal transfer medium.
Referenced in this article is the 2018 paper jointly authored by IMA and Atonarp: “Mass spectrometry in freeze-drying: Motivations for using a bespoke PAT for laboratory and production environment”.