Application of Surface-Enhanced Raman Spectroscopy (SERS) for Cleaning Verification in Pharmaceutical Manufacture

Damion K. Corrigan; Michael Cauchi; Sergey Piletsky; Sean Mccrossen

Abstract

Cleaning verification is the process by which pharmaceutical manufacturing equipment is determined as sufficiently clean to allow manufacture to continue. Surface-enhanced Raman spectroscopy (SERS) is a very sensitive spectroscopic technique capable of detection at levels appropriate for cleaning verification. In this paper, commercially available Klarite™ SERS substrates were employed in order to obtain the necessary enhancement of signal for the identification of chemical species at concentrations of 1 to 10 ng/cm², which are relevant to cleaning verification. The SERS approach was combined with principal component analysis in the identification of drug compounds recovered from a contaminated steel surface.

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