In the June/July 2013 issue (#3) of European Pharmaceutical Review, Katherine Bakeev, Director of Applications Support at B&W Tek, discusses how handheld Raman spectroscopy is used to meet PIC/S regulations.
The PIC/S guidelines call for procedures to ensure the identity of the contents of each container of starting material used in pharmaceutical manufacturing by performing an identity test on each sample. As a result, companies are seeking rapid, reliable means of testing that won’t cause delays in their acceptance of materials, or create long material quarantine times. Early detection of issues will be more cost-effective in the long run, and in the meantime, companies need to equip themselves with the tools and processes that allow them to fully test their incoming materials and packaging materials so that each process is started with the right material every time. Handheld Raman is considered to be one of the methods of choice since it is a non-destructive technique that doesn’t require any sample preparation.
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