Commercial Application of Residual Gas Analyzers for Freeze Drying

A recent paper published by IMA Life, "On the Commercial Use of Residual Gas Analyzers for Lyophilization," focuses specifically on contamination testing of 5cSt silicone oil in the IMA Life Lyofast3 and Lyomax40 lyophilizers. The IMA Quantum mass spectrometry solution was used to meet FDA guidelines (UCM074909). This guideline requires that the leakage rate of the system be monitored, including possible leakage from silicone oil used as a heat transfer medium.

‍Referenced in this article is a 2018 paper co-authored by IMA and Atonarp: "Mass Spectrometry in Freeze Drying. Motivation to use custom-made PATs tailored to the laboratory and production environment.