LYOSENSE® for Online Moisture Control

The lyophilization of pharmaceutical products such as vaccines enhances their stability and shelf-life. However, these properties can only be maintained when the resulting cake has a residual water level of 0.2–5.0%.

For this reason, regulatory guidance indicates that this parameter must be controlled and determined. Until now, however, techniques to measure such properties have been both destructive and time-consuming, and therefore uneconomical.

Our GEA LYOSENSE^® sensor uses multipoint NIR measurements to comprehensively and non-destructively evaluate freeze-dried product cakes in real-time. This easy-to-install and use online measuring device is a fast and a non-invasive solution to moisture determination, enabling the effortless detection of residual moisture.

The LYOSENSE^® and LYOSENSE^® STATION automatically measure the residual moisture content in lyophilized glass vials, which are manually loaded via a tray on the infeed turntable. Process parameters such as vial speed can be controlled using an integrated touchscreen and residual moisture limits can be controlled by a laptop via an interface. Checked vials are stored on the outfeed table and can be collected manually on the infeed tray.

The NIR sensors measure the vials from the side and/or from below. The results are sent to an external computer, which is isolated from the process area and reports any out-of-specification data. Rejected vials are collected in a container adjacent to the conveyor.

Our LYOSENSE^® products are verified before delivery in a factory acceptance test (FAT). The results comprise part of the documentation package. Designed to comply with the European Union’s CE Guidelines, they are supplied with a manual, safety instructions and wiring diagram.