LyoCheck from Thermo speeds up biopharma QC
lyophilised (freeze-dried) materials using ts Nicolet Antaris
FT-NIR (Fourier transform near-infrared) analyser.
LyoCheck is being billed as 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, according to the company.
The system is capable of scanning through glass or plastic containers to analyse the sample non-destructively, saving time and making it feasible to test 100 per cent of the units in a production run.
The technique is also extremely efficient, claims Thermo. Typical scan times per sample by FT-NIR are 15-30 seconds, compared to 30-60 minutes necessary for a Karl Fischer titration.
Meanwhile, 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 a sample.
LyoCheck is a turnkey package including all the components necessary to set up the system: the FT-NIR analyser, software, ValPro System Qualification, a Lyophilisation Method kit, procedures, IQ, calibration, training, and set-up services.
A seminar tour on this topic will take place in select locations throughout the US and Europe in 2005. More information is available at www.thermo.com/nir.
