QC analysis of lyophilised materials

The Thermo Electron LyoCheck solution is a rugged, easy-to-use package that provides a rapid method for the analysis of lyophilised (freeze-dried) materials using the Nicolet Antaris FT-NIR (Fourier transform near-infrared) analyser.

It is suitable for quality control technicians and scientists in industries from biopharmaceutical to food manufacturing who need to perform repeated analyses of lyophilised products for quality assurance and regulatory compliance. This technique offers a modern, fast, and non-destructive method compared to traditional analysis techniques, such as loss-on drying (LOD), gas chromatography (GC), and Karl Fischer titration.

The system is capable of scanning through glass or plastic containers to analyse the sample non-destructively saving time and making 100% QC checking a possibility. This technique is also efficient; typical scan times per sample by FT-NIR are 15-30 s, compared to 30-60 min necessary for a Karl Fischer titration.

Another advantage of FT-NIR is that multiple parameters can be measured from a single spectrum providing more information about a sample in less time.

LyoCheck is a turnkey package including all the components necessary for robust quality testing in a regulated setting - FT-NIR analyser, software, ValPro System Qualification, a Lyophilisation Method kit, procedures, IQ, calibration, training, and set-up services.