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A new approach to verification of incoming raw materials through packaging in pharmaceutical manufacturing is proposed and demonstrated. The method is based around Spatially Offset Raman Spectroscopy (SORS) and permits a rapid chemical identity analysis of incoming materials to satisfy regulatory requirements but without the need to open the packaging. This dramatically increases the throughput of incoming raw materials into the pharmaceutical manufacturing chain and eliminates the need for a chemically safe sampling environment required for invasive inspection methods. Since the inspection is non-invasive the safety of the operators is ensured and the integrity of inspected material is not compromised by preventing exposure to the ambient atmosphere and cross contamination. The experiments presented here demonstrate the ability to accurately identify common pharmaceutical materials, typically in under 10s acquisition time, through a range of frequently used packaging, including translucent plastic and paper sacks and coloured glass bottles, which can be challenging for conventional Raman spectroscopy as well as other optical spectroscopy methods. With the exception of metallic containers and cardboard drums all the tested packaging materials proved to be amenable to this technique. This demonstrates the viability of this new rapid verification method for non-invasive materials identification in pharmaceutical manufacture.

Original publication

DOI

10.1016/j.jpba.2012.11.046

Type

Journal

Journal of pharmaceutical and biomedical analysis

Publication Date

03/2013

Volume

76

Pages

65 - 69

Addresses

Cobalt Light Systems Limited, The Electron Building, Fermi Avenue, Harwell, Oxford OX11 0QR, United Kingdom. Matthew.Bloomfield@cobaltlight.com

Keywords

Pharmaceutical Preparations, Spectrum Analysis, Raman, Drug Packaging, Drug Contamination, Time Factors, Drug Industry