Mass spectrometer LYOPLUS™

processmeasurementpharmaceutical

The LYOPLUS® mass spectrometer provides essential data from within the freeze dryer itself, including the ability to detect very small silicone oil leaks and monitor the moisture content. By analyzing the gas mix situated inside the freeze dryer the system is able to distinguish substances that are common in the freeze drying environment, such as water or other solvents, nitrogen, oxygen and helium. The comprehensible data representation allows easy implementations of primary and secondary drying endpoint detection and convenient chamber leak testing. The purity of pharmaceutical products such as parenterals is an absolute prerequisite. Production processes such as freeze drying pose an inherent risk of contamination with process fluids. This should not happen during routine production; but, in the event of a malfunction, small amounts of these fluids may contaminate the drug product and invalidate the safety of an entire batch. The GEA LYOPLUS® mass spectrometer improves the safety, quality and productivity of freeze-drying applications. Being able to prevent product contamination by detecting trace concentrations of silicone oil or other known contamination sources, the multipurpose device can also be used to monitor the moisture content in the product chamber during freeze drying cycles. As a result of the monitoring, recipe-dependent moisture profiles can be derived, making it possible to define endpoints for primary and secondary drying.