A Novel Automated Approach to Surface Swab Sampling: Poster Presented at PDA Week 2025.

Abstract

Analytical testing and an appropriate sampling method are instrumental in confirming that equipment surfaces have been adequately cleaned during cleaning validation or verification activities. Surface swab sampling is performed manually by directly holding the swab (hand swabbing) or attaching the swab to the end of an extension pole (remote swabbing). This study evaluated the performance of a prototype automated swabbing device constructed from configurable microcontrollers, microelectronics, and electromechanical components against representative manual sampling methodologies. Automated swab sampling of pharmaceutical manufacturing equipment offers several advantages over hand swabbing or remote swabbing, including decreased variability, the necessity for swab qualification of operators, increased accuracy versus remote swabbing, and decreased risk to personnel. To determine if automated swabbing can replace the current state of the art in manual swabbing, The Hyde Analytical Laboratory performed a comparative analysis of manual swabbing methods, hand and remote, and an automated swabbing method using a prototype device developed by Swabbot Solutions. This case study tested the three swabbing methods using multiple replicates, concentrations, representative soils, and controls to gauge the relative recovery performance of the accuracy and variability of each method.