Related Experiment Video
Updated: Aug 17, 2025

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
Published on: August 11, 2017
Portable capillary electrophoresis coupled with swab-based extraction device for cleaning validation in
Mostafa A Atia1, Ria Marni Amuno2, Umme Kalsoom3
1Australian Centre for Research on Separation Science (ACROSS), Chemistry, School of Natural Science, University of Tasmania, Private Bag 75, Hobart, Tasmania 7001, Australia; Department of Analytical Chemistry, Faculty of Pharmacy Helwan University, Cairo 11795, Egypt.
Abstract:
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.
Related Concept Videos
Capillary Electrophoresis: Applications
Capillary zone electrophoresis (CZE) separates ionic components based on their electrophoretic mobility. It has been used to separate proteins, amino acids,...
Electrophoresis: Overview
There...
Capillary Electrophoresis: Instrumentation

