Cost-effective quality control for increased productivity. GEA LYOPLUS™ Process Analytical Technology (PAT) for Lyophilization

Improve your freeze drying 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, the multipurpose device can also be used to monitor the moisture content in the product chamber during freeze drying cycles. As a result of exact monitoring, recipe-dependent moisture profiles can be derived, making it possible to define endpoints for primary and secondary drying. Furthermore the system can be used for efficient chamber leak detection. A mobile GEA...

System details • High-performance quadrupole mass spectrometer system with Faraday and Secondary Electron Multiplier detectors Detection limit down to 1 ppm of non-interfering species High-conductance inlet system Tri-clamp connection by default or customer demand (<3 d) GEA LYOPLUS™ SCADA application compliant to 21 CFR Part 11 with User log, Audit trail and Batch reports Alarms & messages, e.g. for high silicone oil concentration Multilingual graphical user interface Various interfaces and functions to forward or export data Additional advanced data collection and control software for maintenance...

When small leaks occur on the freeze dryer's shelves package, the silicone oil that is used as heat transfer medium can contaminate the product. GEA LYOPLUS™ is able to detect very small traces of silicone oil during the operating cycle, facilitating the identification of a contaminated batch - prior to final quality testing - and ensuring that no additional product is put at risk. Trend diagram from a silicone oil spike test showing the critical masses 71, 73 and 75 for silicone oils and the significant response on mass 73 (red). Spare parts packages (OEM)

Moisture content During the freeze drying process, GEA LYOPLUS™ measures Correlated with average product moisture levels, this data the decreasing amount of product-derived vapor in the can be used to refine recipes, optimize processing times product chamber. and predict product drying curves. Moisture monitoring – Trend diagram Trend diagram from a monitored freeze drying process showing the water vapor concentration (blue) in relation to the venting gas compound nitrogen (purple) and the process pressure (black / grey). Annual preventive maintenance, incl. inspection, cleaning, calibration...

Excellence • Passion • Integrity • Responsibility • GEA-versity GEA is a global technology company with multi-billion euro sales operations in more than 50 countries. Founded in 1881 the company is one of the largest providers of innovative equipment and process technology. GEA is listed in the STOXX® Europe 600 Index. In addition, the company is included in selected MSCI Global Sustainability Indexes. GEA Service GEA Lyophil GmbH Kalscheurener Str. 92 50354 Hürth, Germany The information contained in this brochure merely serves as a non-binding description of our products and is without guarantee....