Real-Time Characterization of Lyophilized Products
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.
GEA LYOSENSE® STATION for Mobile Testing
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.
Functions and Features
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:
- fast measurement and evaluation (5 ms)
- no required consumables
- simple and easy user interface and operation
- single person operation
- accurate analysis of residual moisture (0.2–5.0% water content)
- 100% vial inspection (from 16.25–33.00 mm) at a rate of up to 100 per minute
- rejection of out-of-specification vials.
Documentation and Testing
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.
Real-Time Residual Moisture Determinationin in Freeze Drying Process with GEA LYOSENSE®
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Produtos relacionados
LYOVAC® Pharma Freeze Dryer
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® Load & Unload of Lyophilizers
ALUS® Automatic Load & Unload Systems minimize the risk of operator/product contamination while loading and unloading a freeze dryer.
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