Affinity and Inactivation of Bacterial Endotoxins for Medical Device Materials
Open accessAbstract
Endotoxins are high-molecular-weight complexes that contain lipopolysaccharide, protein, and phospholipid originating from the outer membrane of gram-negative bacteria. As gram-negative bacteria are naturally present in a variety of sources, endotoxins are commonly identified as contaminants in manufacturing environments. In industrial applications, endotoxin often is considered difficult to inactivate and to have a strong affinity with surfaces resulting from its hydrophobic chemical structure. This article describes the investigation of the true affinity of endotoxin, from various microbial sources in solution, for medical device material surfaces. In addition, endotoxin reduction was investigated with commonly used sterilization methods such as those based on ionizing radiation, dry and moist heat, and ethylene oxide sterilization. Endotoxin activity was found to be reduced following exposure to a range of sterilization modalities with the degree of activity reduction related to the source of endotoxin and the substrate material upon which it was present.
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Residual microbial components, particularly endotoxins such as LPS, are among the most potent inducers of innate immune activation; even trace amounts can activate TLR4 signaling in APCs, leading to pro-inflammatory cytokines and M1-like macrophage polarization.
“Residual microbial components introduced or not properly removed during processing, particularly endotoxins such as lipopolysaccharides (LPS), are among the most potent inducers of innate immune activation [145].Even trace amounts of LPS can activate TLR4 signaling in APCs, leading to robust secretion of pro-inflammatory cytokines and skewing macrophage polarization toward an M1-like phenotype.”
From Immune Response to Extracellular Matrix Bioscaffolds: A Comprehensive Review (2025) · cites this paper as [145]
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- Authors
- Kimble, A., Hauschild, J., & McDonnell, G.
- Affiliations
- Johnson & Johnson (United States) (US)
- ORCID
- McDonnell, Gerald
- Venue
- Biomedical Instrumentation & Technology
- Published
- 2023-10
- Volume
- 57
- Issue
- 4
- Pages
- 153-162
- ISSN
- 0899-8205 (ISSN-L)
- 1943-5967
- PMC
- PMC10764065
- OpenAlex
- W4390552906
- Cited by
- 10
- References
- 25
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 3
- FWCI
- 1.82
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Biomedical Instrumentation & Technology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Immunology and Microbiology › Microbiology › Medical Device Sterilization and Disinfection
- Health Sciences › Medicine › Infectious Diseases › Infection Control in Healthcare
- Physical Sciences › Chemistry › Organic Chemistry › Antimicrobial agents and applications
- Keywords
- bacterial endotoxin, lipopolysaccharide, medical device materials, surface adsorption, endotoxin inactivation, sterilization, ionizing radiation sterilization, dry heat sterilization, autoclaving, ethylene oxide sterilization, Gram-negative bacteria, microbial contamination
- MeSH terms
- Endotoxins, Hot Temperature, Sterilization
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