Near Infrared Spectroscopy In-Depth Focus 2013
In this Near Infrared Spectroscopy In-Depth Focus: Validation methodologies of near infrared spectroscopy methods in pharmaceutical applications; Evaluating the influence of hopper geometry on radial and axial concentration profiles in flowing granular mixtures…
- Validation methodologies of near infrared spectroscopy methods in pharmaceutical applications
Pierre-François Chavez, Charlotte De Bleye, Pierre-Yves Sacré, Eric Rozet, Philippe Hubert and Eric Ziemons – Laboratory of Analytical Chemistry, CIRM, Department of Pharmacy, University of Liege
As in any analytical method, a mandatory step at the end of the development of a near infrared spectroscopy (NIRS) method is the validation. This step ensures that future results coming from the application of the method in routine will be close enough to the true value. However, from the literature, a minority of NIRS methods are thoroughly validated despite the guidelines published by different group and regulatory authorities to help an analyst adequately decide if his method can be considered as valid. In this context, the aim of this review is to offer a critical overview of the different validation methodologies applied to assess the validity of quantitative methods using near infrared spectroscopy used in the field of pharmacy.
- Evaluating the influence of hopper geometry on radial and axial concentration profiles in flowing granular mixtures
Nicolas Abatzoglou, Eddy Castellanos Gil and Ryan Gosselin – Department of Chemical & Biotechnological Engineering, Pfizer Industrial Research Chair on PAT in Pharmaceutical Engineering, University of Sherbrooke
The residence time distribution of a binary powder’s components can be used to predict segregation tendency. A Near Infrared Spectroscopy (NIRS) based method was developed to analyse the composition of flowing powders. The experimental setup consists of a lab-scale hopper equipped with an automated high-speed gate-valve (guillotine). This setup made it possible to evaluate the radial and axial composition profiles of the flowing powder through sampling of multiple thin cylindrical slices. The present work aims to evaluate the influence of hopper geometry on pharmaceutical powder flows.
- Near Infrared Spectroscopy Industry Roundtable
Holger Lutz (NIR & Process Technology / International Manager Chemistry & Pharma, Bruker Optik), Brad Swarbrick (Vice President, Business Development, CAMO), Anders Lofstrand
(Project Manager, FOSS NIRSystems), Claude Robotham (Senior Product Manager, Thermo Scientific), Petter Möree (Director, GPM, Umetrics), moderated by Marcel Blanco Romia
(Department of Chemistry, Universitat Autònoma de Barcelona)
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