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Swab Sampling Method for the Detection of Human Norovirus on Surfaces

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

Keith Bader¹, Richard Mineo¹, Nicole Coller²

¹Hyde Engineering and Consulting, Louisville CO 80027, USA; and.

PDA Journal of Pharmaceutical Science and Technology

|August 1, 2025

Summary

A new automated swabbing device shows promise for pharmaceutical cleaning validation. This automated method offers decreased variability and increased accuracy compared to manual hand swabbing and remote swabbing techniques.

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Area of Science:

Analytical Chemistry
Pharmaceutical Manufacturing
Process Automation

Background:

Cleaning validation and verification are critical for pharmaceutical manufacturing.
Surface swab sampling is a key method for assessing equipment cleanliness.
Manual methods, including hand and remote swabbing, have limitations in accuracy and variability.

Purpose of the Study:

To evaluate the performance of a prototype automated swabbing device.
To compare the automated swabbing method against manual hand and remote swabbing techniques.
To determine if automated swabbing can replace current manual sampling methods in cleaning validation.

Main Methods:

A prototype automated swabbing device was tested.
Manual hand swabbing and remote swabbing were used as comparative methods.
Multiple replicates, concentrations, representative soils, and controls were employed to assess recovery performance, accuracy, and variability.

Main Results:

The automated swabbing device demonstrated decreased variability compared to manual methods.
The automated method showed increased accuracy, particularly when compared to remote swabbing.
The prototype device offers potential advantages in reducing operator variability and risk to personnel.

Conclusions:

Automated swabbing presents a viable alternative to manual methods for pharmaceutical cleaning validation.
The prototype device has the potential to improve the consistency and accuracy of surface sampling.
Further studies may be warranted to fully integrate automated swabbing into routine pharmaceutical quality control.