Thermo Electron Announces FT-NIR Analyzer For Rapid QC Analysis of Lyophilized Materials
Thermo Electron Announces FT-NIR Analyzer For Rapid QC Analysis of Lyophilized Materials
June 20, 2005
MADISON, Wis. - Thermo Electron Corporation (NYSE:TMO) announces the LyoCheck solution - a rugged, easy-to-use package that provides a rapid method for the analysis of lyophilized (freeze-dried) materials using the Nicolet Antaris FT-NIR (Fourier transform near-infrared) analyzer. It is the ideal tool for quality control technicians and scientists in industries from biopharmaceutical to food manufacturing who need to perform repeated analyses of lyophilized 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 analyze the sample non-destructively saving time and making 100% QC checking a possibility. This technique is also extremely efficient; typical scan times per sample by FT-NIR are 15-30 seconds, compared to 30-60 minutes necessary for a Karl Fischer titration. Techniques such as GC and LOD are operator-dependent and require carrier gases and specialty equipment while Karl Fischer titration requires solvents and solvent disposal. Another key advantage of FT-NIR is that multiple parameters can be measured from a single spectrum providing more information about your sample in less time.
LyoCheck is a turnkey package including all the components necessary for robust quality testing in a regulated setting - FT-NIR analyzer, software, ValPro System Qualification, a Lyophilization Method kit, procedures, IQ, calibration, training, and set-up services. Based on the 2001 R&D award-winner, the Nicolet Antaris FT-NIR, LyoCheck is ensured to provide rapid return and vastly improved efficiency and precision in the quality assurance for lyophilized products.
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