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Compliance to new Raman standards aids pharmaceutical industry

13th June 2016

Posted By Paul Boughton


Rigaku’s Progency analyser fully complies with the new calibration standards

In April 2016, new regulations came into effect that set acceptable Raman wavelength shifts and associated tolerances for benchtop and handheld Raman instruments for pharmaceutical applications.

Rigaku Analytical Devices’ Progeny 1064nm handheld Raman analyser is fully compliant with the new calibration standards, which were published by the European Pharmacopeia (EP) in Supplement 8.7, Chapter 2.2.48 in October 2015.

The need to manufacture pharmaceutical products faster and more safely combined with the pressure to reduce costs and comply with rigorous regulatory requirements has contributed to the increasing adoption of handheld Raman for raw material identification.

The rise in popularity of the technique resulted in the updates to the standards for acceptable tolerances for handheld Raman instrumentation to ensure a set industry standard for instrument performance. In addition to the new tolerances for polystyrene, paracetamol and cyclohexane, appropriate calibration and system performance tests have also been outlined.

Designed to seamlessly integrate into any work environment, Progeny delivers the industry’s widest and most comprehensive range of material identification in a handheld, sealed platform. Unlike other handheld Raman analysers, Progeny successfully overcomes sample-induced fluorescence interference with the use of a 1064nm excitation laser that also enables measurements to be taken through packaging.

The device facilitates regulatory compliance by providing a complete IQ/OQ/PQ protocol package, compliant 21 CFR Part 11 digital signatures and an integrated camera for barcode reading to ensure error free data entry.

“The introduction of the new regulations demonstrate the increased awareness and popularity of handheld Raman as a solution for rapid, accurate and reliable raw material identification,” comments Bree Allen, general manager and vice president of the Molecular business for Rigaku Analytical Devices. “We are committed to supporting our customers in ensuring compliance with the new standards as well as further educating the pharmaceutical industry on the benefits handheld Raman can deliver. Progeny helps customers to achieve leaner manufacturing processes and lower costs per analysis without compromising quality and now is a great time to upgrade outdated Raman systems to achieve a streamlined workflow.”





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