Volume: 4, 2025
4th International PhD Student’s Conference at the University of Life Sciences in Lublin, Poland:
ENVIRONMENT – PLANT – ANIMAL – PRODUCT
Abstract number: H013
DOI: https://doi.org/10.24326/ICDSUPL4.H013
Published online: 9 April 2025
ICDSUPL, 4, H013 (2025)
A new approach to the validation of sterility testing
Konrad Niedźwiadek1*, Klaudia Gustaw1, Magdalena Polak-Berecka1
1 Department of Biotechnology, Microbiology and Human Nutrition, University of Life Sciences in Lublin, Skromna 8, 20-704 Lublin, Poland
* Corresponding author: konrad.niedzwiadek@up.lublin.pl
Abstract
With the growing use of plastics in medical devices, concerns about possible inhibitory effects on microbial growth persist. This study assesses the impact of extracts from acrylonitrile butadiene styrene (ABS), styrene-butadiene copolymer (SBC), polypropylene (PP), polyvinyl chloride (PVC), polyethylene (PE) and polyurethane (PU) on selected microorganisms — Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, and Candida albicans — under standard sterility testing conditions. Polymer extracts were prepared following PN-EN ISO 10993-12. Test microorganisms (ATCC 6538 S. aureus; ATCC 6633 B. subtilis; ATCC 9027 P. aeruginosa; ATCC 10231 C. albicans) were cultivated in media containing these extracts. Optical densities (OD600) and percentage differences compared to controls were evaluated. The Student’s t-test was used for statistical significance (p < 0.05). ABS and PP extracts significantly promoted S. aureus growth by 29.1% and 28.2%, respectively, while ABS and PU extracts notably inhibited C. albicans growth by up to 47.0%. SBC, PVC and PE did not show significant inhibitory effects. The findings indicate that certain polymers can induce false-negative results in sterility testing if their influence on microbial growth is overlooked. This work highlights the importance of examining polymer-specific impacts on standard sterility tests. While PP, SBC and PE showed no inhibitory effects on most test strains, PU inhibited C. albicans, and ABS had contrasting effects. The study underlines the need for refining testing methodologies and revisiting current standards to ensure reliable sterility assessments, especially for devices involving plastics. Further research is warranted to develop mitigation strategies and enhance the accuracy of sterility testing in medical device contexts.
Keywords: sterility testing, microbial inhibition, plastic materials, pharmacopoeial methodology, antimicrobiological effect
How to cite
K. Niedźwiadek, K. Gustaw, M. Polak-Berecka, 2025. A new approach to the validation of sterility testing. In: 4th International PhD Student’s Conference at the University of Life Sciences in Lublin, Poland: Environment – Plant – Animal – Product. https://doi.org/10.24326/ICDSUPL4.H013