Rapid QC analysis of lyophilised materials - Lyophilization Articles & Reports

Rapid QC analysis of lyophilised materials
June 22, 2005
Laboratorytalk
Thermo Electron announces the LyoCheck - 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 the ideal tool 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 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, says Thermo.
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 the 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.
Based on the 2001 R and 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 lyophilised products.