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Updated: Sep 15, 2025

Swabbing the Urban Environment - A Pipeline for Sampling and Detection of SARS-CoV-2 From Environmental Reservoirs

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Automated Surface Swab Sampling: A Statistical Comparison of a Novel Approach to Existing Methods.

Nicole Collier¹, Michael Lund², Keith Bader¹

¹Hyde Engineering+ Consulting, Inc, Louisville, Colorado, USA.

PDA Journal of Pharmaceutical Science and Technology

|July 15, 2025

Summary

Automated swabbing devices offer a reliable alternative for cleaning validation, achieving accuracy comparable to manual hand swabbing with reduced variability. This technology outperforms remote swabbing, enhancing pharmaceutical equipment cleaning verification.

Keywords:

Cleaning Cleaning validation Confined space entry alternatives Direct surface sampling Remote swabbing Swabbing TOC

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Area of Science:

Pharmaceutical manufacturing
Analytical chemistry
Process engineering

Background:

Cleaning validation is crucial for pharmaceutical manufacturing, requiring accurate surface sampling.
Surface swab sampling is a preferred method by regulatory health authorities (RHAs).
Manual methods include hand swabbing and remote swabbing for accessible and inaccessible surfaces, respectively.

Purpose of the Study:

To evaluate the performance of a prototype automated swabbing device.
To compare the automated method against manual hand and remote swabbing techniques.
To determine if automated swabbing is a viable alternative for cleaning validation.

Main Methods:

A prototype automated swabbing device was developed and tested.
Comparative analysis of automated, hand, and remote swabbing methods was conducted.
Multiple replicates, concentrations, soils, and controls were used to assess recovery, accuracy, and variability.

Main Results:

The automated swabbing device demonstrated recovery levels comparable to hand swabbing.
Automated swabbing exhibited significantly lower variability than both hand and remote swabbing.
Remote swabbing showed higher variability and lower recovery, statistically different from the other methods.

Conclusions:

Automated swabbing is an acceptable alternative to manual hand swabbing in cleaning validation.
The automated method outperforms remote swabbing in terms of accuracy and consistency.
This technology can improve the efficiency and reliability of pharmaceutical equipment cleaning verification.