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LYOSENSE® A fast and effective sensor for online moisture control.

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 thereby uneconomical.

Real-Time Characterization of Lyophilized Products LYOSENSE® from GEA, based on multipoint NIR measurements, provides the comprehensive and non-destructive evaluation of freeze dried product cakes in real-time. This easy-to-install and use online measuring device is a fast and non-invasive solution to moisture control, enabling the effortless detection of • residual moisture • cake homogeneity • API concentration.

Other critical process parameters, such porosity, melt and glass particles, can also be assessed.

For 100% vial inspection, machine communication capabilities and easy integration into both lab and production environments, this miniaturized probe is simple to calibrate and enhances product development by facilitating Quality by Design.

Fully GMP and 21 CFR Part 11 compliant and supplied with IQ/OQ/PQ support, the LYOSENSE® provides the following benefits: • whole cake assessment with multipoint measurement • fast measurement and evaluation (5 ms) • no required consumables • simple and easy user interface and operation.

LYOSENSE® is compatible with other GEA innovations such as LYODATA® for continuous monitoring and full traceability, and the ALUS® automatic loading and unloading system.

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%.

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Difference between

Residual Residual LYOSENSE® Weighted Filling Layer Moisture Moisture and sample

Product volume height LYOSENSE® Karl-Fischer Karl-Fischer Karl-Fischer

Mannitol (3%) 5,5 ml 15 mm 0,9655% 0,94% 0,03% 0,06691g Mannitol (3%) 5,5 ml 15 mm 0,9660% 0,96% 0,01% 0,06862g Mannitol (3%) 5,5 ml 15 mm 0,8112% 0,91% -0,10% 0,08897g Mannitol (3%) 5,5 ml 15 mm 1,0332% 1,00% 0,03% 0,05580g Mannitol (3%) 5,5 ml 15 mm 0,8970% 0,99% -0,09% 0,03957g Mannitol (3%) 5,5 ml 15 mm 1,0040% 0,95% 0,05% 0,04799g Mannitol (3%) 5,5 ml 15 mm 0,8499% 0,99% -0,14% 0,02641g Mannitol (3%) 5,5 ml 15 mm 0,9502% 1,04% -0,09% 0,04898g Mannitol (3%) 5,5 ml 15 mm 0,9645% 0,98% -0,02% 0,07598g

Table I: LYOSENSE® versus a Karl Fischer sensor.

Technical data In an experiment to compare the LYOSENSE® with a Karl Fischer sensor, the data in Table I was obtained.

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Similarly, predicted versus recorded measurements were compared for mannitol and sucrose, using the LYOSENSE®, and are shown in Figure 1.

Figure I: Predicted and observed residual moisture content.

Further information GEA Pharma & Healthcare lyophil@gea.com gea.com/contact

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© GEA Lyophil GmbH 06/2026. All rights reserved. Subject to modifications. LYODATA® & LYOSENSE® are registered as trademarks in several countries worldwide.

GEA Lyophil GmbH Siemensstrasse 9, 50189 Elsdorf, Germany

Tel +49 2274 93 80 99-0 lyophil@gea.com gea.com/contact