LYOSENSE® for Online Moisture Control
LYOSENSE® from GEA, based on multipoint NIR measurements, provides the comprehensive and non-destructive evaluation of freeze-dried product cakes in real-time.
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® STATION was designed for the quick, accurate and mobile testing of pharmaceutical glass vials for residual moisture. Mounted on wheels for easy maneuverability, the LYOSENSE® STATION is 900 mm wide and can readily pass through the doors and corridors of most pharmaceutical production areas.
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.
This miniaturized probe is simple to calibrate and enhances product development by facilitating Quality by Design. It also offers the following benefits:
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.
GEA’s LYOVAC® industrial-scale freeze dryers are built to customer specifications and are available with production areas of 1–60 m² and condenser capacities of more than 1000 kg.
ALUS® Automatic Load & Unload Systems minimize the risk of operator/product contamination while loading and unloading a freeze dryer.
地球温暖化の影響は世界中でますます明らかになっています。あらゆる地域の町や都市が同じ課題に直面しています。それは、信頼性が高く、手頃な価格で、持続可能な供給源からの熱を地域社会に供給することです。GEAは、この分野の専門家であるGEA Heating & Refrigeration TechnologiesのヒートポンプマネージャーであるKenneth Hoffmannに、地球温暖化への迅速な対応について話を聞きました。
酪農家のトムの目に留まったもの。従来の製品デモの代わりに、GEAはAR(拡張現実)によるイノベーションを紹介しました。これはGEAのインタラクティブなデジタル酪農場始まりにすぎません。