ResourceSpectroscopy

The NanoRam Hand-held Raman Spectrometer: Full Regulatory Compliance for the Inspection of Raw Materials and Chemicals Used in the Pharmaceutical Industry

21 Sept 2014

This application note describes the NanoRam as a state-of-the-art, handheld Raman spectrometer for the rapid identification of various chemicals used in the pharmaceutical manufacturing process.

NanoRam® Handheld Raman Spectrometer

B&W Tek, Inc.

The NanoRam® is the state-of-the-art compact handheld Raman analyzer designed for use by non-specialists, and easily operates single-handedly.It allows rapid development of libraries and methods for material identification and verification within cGMP compliant facilities, whether in the lab, the warehouse, the loading dock or the field. Raman spectroscopy is an approved method by US Pharmacopeia, European Pharmacopeia, Pharmacopeia of the People’s Republic of China and is a well-recognized method for compliance with the PICS GMP guide to provide 100% assurance of the identity of each container of starting material.The NanoRam is fully compliant with all governing regulations including 21 CFR Part 11 and Part 1040.10. B&W Tek offers a wide variety of services including assistance with method and/or new library development and other services such as support with IQ/OQ/PQ validation.NanoRam® Handheld Raman Spectrometer Features: Intuitive Software – a user-friendly tool for both technical & non-technical users to make their job easier Versatility – measure a variety of samples in a variety of environments and packaging with just one unit Data Reproducibility – superior hardware ensures that results are consistent and reliable Performance – robust multivariate algorithms guarantee accuracy when testing and identifying materials

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Raman SpectroscopyRaman spectroscopy is used to discern the vibrational and rotational states of molecules and hence the chemical composition of a sample by measuring the inelastic scattering of monochromatic light. Explore a range of Raman spectrometers, including handheld/portable Raman spectrometers for QC/QA labs and in situ spectrometers for processes. Conduct Raman imaging for microanalysis of mixed samples using a Raman microscope. Raman spectrographs are also available. Find the best Raman spectroscopy products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.Compound Identification
The NanoRam Hand-held Raman Spectrometer: Full Regulatory Compliance for the Inspection of Raw Materials and Chemicals Used in the Pharmaceutical Industry