1 SECTION NAME
44 SPECTROSCOPY
Compliance to NEW STANDARD aids pharmaceutical industry I
n 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
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
polystyrene, paracetamol and cyclohexane, appropriate calibration and system performance tests have also been outlined. Designed to seamlessly integrate into
any work environment, Progeny delivers a wide and comprehensive range of material identification in a handheld, sealed platform. Unlike some 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/
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manufacturing processes and lower costs per analysis without compromising quality and now is a great time to upgrade outdated Raman systems to achieve a streamlined workflow.”
For more information visit
www.rigakuanalytical.com
Spectrophotometers for new teaching labs D
eNovix, a manufacturer of instrumentation and assays for the life sciences sector has announced that Queensland University of Technology (QUT) in Australia has adopted the DS- 11 UV-Vis spectrophotometer as a key undergraduate teaching tool. QUT is globally recognised for
excellence in teaching and state-of-the-art laboratory facilities. “To equip students for the world of
advanced research, we see access to cutting-edge instrumentation as vital to providing first-class training,” says associate professor Terry Walsh, head of the School of Biomedical Sciences at QUT. “As part of a large-scale refurbishment
of our teaching labs in the Faculty of Health, we identified a UV-Vis spectrophotomer as a fundamentally important instrument for students to access.” Fred Kielhorn, CEO of DeNovix says:
“In order to fill their demands for 81 spectrophotometers in their labs, the
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DS-11+ had to meet the demand for a high-performance, compact, standalone instrument that works in both microvolume and cuvette applications. During evaluation, it was clear that our custom Android platform allowed easy access to the data via USB or Wi-Fi and provided a familiar interface for students.” The DS-11 rapidly quantifies 0.5-1.5 uL samples of nucleic acids and proteins. The standalone unit includes an Android- based operating system that does not require a PC. The system features a
glove compatible, high-resolution, 7in touchscreen. Measurements are made using intuitive EasyApps designed for the most common life science applications. The DS-11 is a full spectrum (190-840nm) UV-Vis spectrophotometer and measures the broadest concentration range of any microvolume spectrophotometer. The DS-11 Series is also available as a combined spectrophotometer/fluorometer.
For more information visit
www.denovix.com
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