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

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 in-strument with an integrated sample swab extraction - the Grey Scan ETD-10 0 - for the detection of pharmaceutical residues on surfaces of manufacturing equipment. Lidocaine was used as a model com-pound 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 mu g/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.(c) 2022 Elsevier B.V. All rights reserved.

Automated summary

This article introduces a fully automated portable capillary electrophoresis instrument for the detection of pharmaceutical residues on surfaces of manufacturing equipment. The instrument has integrated sample swab extraction and can analyze the extracted sample within 1 minute. The method is fast, sensitive, and simple, and provides the possibility for on-site rapid determination of equipment cleanliness in the pharmaceutical industry.