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J Pharm Biomed Anal. 2018 Feb 20;150:308-317. doi: 10.1016/j.jpba.2017.12.007. Epub 2017 Dec 7.

A calibration procedure for a traceable contamination analysis on medical devices by combined X-ray spectrometry and ambient spectroscopic techniques.

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Physikalisch-Technische Bundesanstalt (PTB), Abbestr. 2-12, 10587 Berlin, Germany. Electronic address:
Physikalisch-Technische Bundesanstalt (PTB), Abbestr. 2-12, 10587 Berlin, Germany.
Quality of Life Division, INRIM, Strada delle Cacce 91, 10135 Torino, Italy.
National Physical Laboratory, Hampton Road, Teddington TW11 0LW, United Kingdom.
Smith & Nephew, 101 Hessle Road, Hull, HU3 2BN, United Kingdom.


There is a strong need in the medical device industry to decrease failure rates of biomedical devices by reducing the incidence of defect structures and contaminants during the production process. The detection and identification of defect structures and contaminants is crucial for many industrial applications. The present study exploits reference-free X-ray fluorescence (XRF) analysis as an analytical tool for the traceable characterization of surface contaminants of medical devices, in particular N,N'-ethylene-bis (stearamide), an ubiquitous compound used in many industrial applications as a release agent or friction reduction additive. Reference-free XRF analysis as primary method has been proven to be capable of underpinning all other applied methods since it yields the absolute mass deposition of the selected N,N'-ethylene-bis (stearamide) contaminant whilst X-ray absorption fine structure analysis determines the chemical species. Ambient vibrational spectroscopy and mass spectroscopy methodologies such as Fourier transform infrared, Raman, and secondary ion mass spectroscopy have been used in this systematic procedure providing an extensive range of complementary analyses. The calibration procedure described in this paper was developed using specially designed and fabricated model systems varying in thickness and substrate material. Furthermore, typical real medical devices such as both a polyethylene hip liner and a silver-coated wound dressing have been contaminated and investigated by these diverse methods, enabling testing of this developed procedure. These well-characterized samples may be used as calibration standards for bench top instrumentation from the perspective of providing traceable analysis of biomaterials and surface treatments. These findings demonstrate the potential importance and usefulness of combining complementary methods for a better understanding of the relevant organic materials.


Medical device; N,N’-ethylene-bis (stearamide); Reference-free; Vibrational spectroscopy; XRF

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