Portable capillary electrophoresis coupled with swab-based extraction device for cleaning validation in pharmaceutical facilities.

J Chromatogr A

Australian Centre for Research on Separation Science (ACROSS), Chemistry, School of Natural Science, University of Tasmania, Private Bag 75, Hobart, Tasmania 7001, Australia. Electronic address:

Published: January 2023

All pharmaceutical manufacturers are required to verify that their production equipment is free from contaminants. Here, we report the capability of a fully automated portable capillary electrophoresis instrument with an integrated sample swab extraction - the Grey Scan ETD-100 - for the detection of pharmaceutical residues on surfaces of manufacturing equipment. Lidocaine was used as a model compound and could be recovered from a surface by swabbing, extracted from the swab, and analysed within 1 min. The recovery of lidocaine from a stainless-steel coupon was 81.3 %, with a LOD of 0.13 µg/swab. This fast, sensitive, and simple method implemented on a user-friendly portable CE instrument without the need for manual sample pre-treatment provides the possibility for on-site rapid determination of equipment cleanliness in the pharmaceutical industry.

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http://dx.doi.org/10.1016/j.chroma.2022.463666DOI Listing

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