- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
Whitepaper: Enhanced Raman reflection spectroscopy for process analytical technology
1 December 2015 • Author(s): Kaiser Optical Systems, Inc
The Process Analytical Technology (PAT) initiative from the U.S. Food and Drug Administration (FDA) encourages pharmaceutical manufacturers to employ real-time analytical tools for detailed understanding of their processes.
This serves two purposes: to enable real-time process control and to promote detailed process understanding for flexible quality control during the course of the process rather than only by analyzing the end product.
The development of techniques for real-time process analysis is a significant focus of recent work in pharmaceutical technology and analytical chemistry. Vibrational spectroscopic methods such as nearinfrared (NIR) spectroscopy and Raman spectroscopy have gained favor because they can be deployed in a non-contact mode, and they give detailed chemical information with great potential for robust modeling. Raman has proven to be especially useful in pharmaceutical process monitoring because it is not obstructed by the presence of water, which is a significant problem for infrared spectroscopies, and because it usually requires little to no sample preparation.
Of particular utility in pharmaceutical processing is the ability to analyze the entire depth of a complex layered solid simultaneously. This note describes the use of enhanced Raman reflection spectroscopy to accomplish this analysis on multi-layered samples similar to many pharmaceutical tablets. This work underpins current applications in the pharmaceutical industry.
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