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A methodological inter-comparison study on the detection of surface contaminant sodium dodecyl sulfate applying ambient- and vacuum-based techniques

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Abstract

Biomedical devices are complex products requiring numerous assembly steps along the industrial process chain, which can carry the potential of surface contamination. Cleanliness has to be analytically assessed with respect to ensuring safety and efficacy. Although several analytical techniques are routinely employed for such evaluation, a reliable analysis chain that guarantees metrological traceability and quantification capability is desirable. This calls for analytical tools that are cascaded in a sensible way to immediately identify and localize possible contamination, both qualitatively and quantitatively. In this systematic inter-comparative approach, we produced and characterized sodium dodecyl sulfate (SDS) films mimicking contamination on inorganic and organic substrates, with potential use as reference materials for ambient techniques, i.e., ambient mass spectrometry (AMS), infrared and Raman spectroscopy, to reliably determine amounts of contamination. Non-invasive and complementary vibrational spectroscopy techniques offer a priori chemical identification with integrated chemical imaging tools to follow the contaminant distribution, even on devices with complex geometry. AMS also provides fingerprint outputs for a fast qualitative identification of surface contaminations to be used at the end of the traceability chain due to its ablative effect on the sample. To absolutely determine the mass of SDS, the vacuum-based reference-free technique X-ray fluorescence was employed for calibration. Convex hip liners were deliberately contaminated with SDS to emulate real biomedical devices with an industrially relevant substance. Implementation of the aforementioned analytical techniques is discussed with respect to combining multimodal technical setups to decrease uncertainties that may arise if a single technique approach is adopted.

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Acknowledgements

We would like to acknowledge Jean-Luc Vorng for the technical support on AMS results interpretation.

Funding

We acknowledge financial support by the European Metrology Research Programme (EMRP). This work was funded through the EMRP Project IND56 Q-AIMDS. The EMRP is jointly funded by the EMRP participating countries within EURAMET and the European Union.

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Authors and Affiliations

  1. Quality of Life Division, INRIM, Strada delle Cacce 91, 10135, Turin, Italy

    Andrea M. Giovannozzi, Chiara Portesi & Andrea Mario Rossi

  2. Physikalisch-Technische Bundesanstalt Berlin (PTB), Abbestr. 2-12, 10587, Berlin, Germany

    Andrea Hornemann, Beatrix Pollakowski-Herrmann & Burkhard Beckhoff

  3. National Centre of Excellence in Mass Spectrometry Imaging (NiCE-MSI), National Physical Laboratory, Hampton Road, Middlesex, Teddington, TW11 0LW, UK

    Felicia M. Green, Tara L. Salter, Rory T. Steven & Josephine Bunch

  4. Smith & Nephew Advanced Wound Management, 101 Hessle Road, Hull, HU3 2BN, UK

    Paul Gunning

  5. Department of Chemistry, School of Life Sciences, University of Sussex, Falmer, Brighton, BN1 9QJ, UK

    Tara L. Salter

  6. Department of Surgery & Cancer, Computational and Systems Medicine, Imperial College London, London, SW7 2AZ, UK

    Josephine Bunch

  7. University of Münster, 48149, Münster, Germany

    Bonnie J. Tyler

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  1. Andrea M. Giovannozzi
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  2. Andrea Hornemann
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  3. Beatrix Pollakowski-Herrmann
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  8. Josephine Bunch
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  9. Chiara Portesi
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  11. Burkhard Beckhoff
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  12. Andrea Mario Rossi
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Correspondence to Andrea M. Giovannozzi.

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Giovannozzi, A.M., Hornemann, A., Pollakowski-Herrmann, B. et al. A methodological inter-comparison study on the detection of surface contaminant sodium dodecyl sulfate applying ambient- and vacuum-based techniques. Anal Bioanal Chem 411, 217–229 (2019). https://doi.org/10.1007/s00216-018-1431-x

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  • DOI: https://doi.org/10.1007/s00216-018-1431-x

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