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Application Note: In-line Raman spectroscopy for content uniformity
18 January 2016 • Author(s): Kaiser Optical Systems, Inc.
Raman monitoring of blended granule uniformity prior to tablet press
The U.S. FDA’s Quality by Design (QbD) and Process Analytical Technology (PAT) initiatives encourage the pharmaceutical industry to adopt risk-based manufacturing approaches. Real-time PAT monitoring of pharmaceutical unit operations enables Quality by Design and improves process robustness. Raman spectroscopy is uniquely suited as a PAT tool because it can acquire data directly from the process line in real-time and with little or no sample preparation, often without a need for the probe to come into contact with the sample. The utility of Raman for in-line, real-time process monitoring and control is demonstrated for content uniformity. In this application, in-line, noninvasive Raman spectroscopy was used to monitor blended granule uniformity prior to tablet compression.
Raman measurements were obtained during process-validation runs with a RAMANRXNTM analyser utilising PhAT technology from Kaiser Optical Systems. A non-contact Raman PhAT probe (785nm, 6mm spot size, 250mm focal length) mounted onto a Teflon holder was used to monitor the blended granule uniformity just upstream from the tablet press. The Raman probe analysed granule samples of approximately 140mg which correlates closely to the standard dosage unit of 160mg. Raman data were recorded continuously with a 30s exposure time and two accumulations. The mean square of differences (MSD) between two consecutive spectra was used to identify the time required to obtain a homogeneous mixture. The predicted quantitative blend uniformity was determined by Raman analysis of laboratory samples using a two-component partial leastsquares (PLS1) calibration model (RMSEC = 0.43, RMSECV = 0.52). Raman measurements were also collected during tablet compression.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics