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Analysis of plasticizers in poly(vinyl chloride) medical devices for infusion and artificial nutrition: comparison and optimization of the extraction procedures, a pre-migration test step

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Abstract

Medical devices (MDs) for infusion and enteral and parenteral nutrition are essentially made of plasticized polyvinyl chloride (PVC). The first step in assessing patient exposure to these plasticizers, as well as ensuring that the MDs are free from di(2-ethylhexyl) phthalate (DEHP), consists of identifying and quantifying the plasticizers present and, consequently, determining which ones are likely to migrate into the patient’s body. We compared three different extraction methods using 0.1 g of plasticized PVC: Soxhlet extraction in diethyl ether and ethyl acetate, polymer dissolution, and room temperature extraction in different solvents. It was found that simple room temperature chloroform extraction under optimized conditions (30 min, 50 mL) gave the best separation of plasticizers from the PVC matrix, with extraction yields ranging from 92 to 100 % for all plasticizers. This result was confirmed by supplemented Fourier transform infrared spectroscopy-attenuated total reflection (FTIR-ATR) and gravimetric analyses. The technique was used on eight marketed medical devices and showed that they contained different amounts of plasticizers, ranging from 25 to 36 % of the PVC weight. These yields, associated with the individual physicochemical properties of each plasticizer, highlight the need for further migration studies.

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Acknowledgments

This study is a part of the project Assessment and Risk Management of Medical Devices in Plasticized Polyvinylchloride (ARMED) which has received the financial support of the French Medicine Agency (ANSM, Agence Nationale de Sécurité du Médicament et des Produits de Santé).

The authors wish to also thank the collaborators of the ARMED study group in its task 1 “Characterization of plasticizers in medical devices”: Lise Bernard, Daniel Bourdeaux, Philip Chennell, Damien Richard, Bruno Pereira, and Valérie Sautou (University Hospital, Clermont-Ferrand, France); Nathalie Azaroual, Christine Barthelémy, Bertrand Décaudin, Thierry Dine; Frédéric Feutry, Stéphanie Genay, Nicolas Kambia, Marie Lecoeur, Pascal Odou, Nicolas Simon, and Claude Vaccher (EA 4481, University of Lille 2, France); Régis Cueff and Emmanuelle Feschet (EA 4676 C-Biosenss, Auvergne University, France); and Colette Breysse (Technology Research Centre CASIMIR, Aubière).

Conflict of interest

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Authors and Affiliations

  1. CHU Clermont-Ferrand, Pôle Pharmacie, rue Montalembert, 63003, Clermont-Ferrand, France

    Lise Bernard, Daniel Bourdeaux & Valérie Sautou

  2. Clermont Université, Université d’Auvergne, EA 4676 C-BIOSENSS, BP 10448, 63000, Clermont-Ferrand, France

    Lise Bernard, Régis Cueff, Daniel Bourdeaux & Valérie Sautou

  3. Centre de Ressources Technologiques CASIMIR, 63173, Aubiere cedex, France

    Colette Breysse

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  1. Lise Bernard
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  2. Régis Cueff
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  3. Daniel Bourdeaux
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  4. Colette Breysse
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  5. Valérie Sautou
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Correspondence to Lise Bernard.

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Bernard, L., Cueff, R., Bourdeaux, D. et al. Analysis of plasticizers in poly(vinyl chloride) medical devices for infusion and artificial nutrition: comparison and optimization of the extraction procedures, a pre-migration test step. Anal Bioanal Chem 407, 1651–1659 (2015). https://doi.org/10.1007/s00216-014-8426-z

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  • DOI: https://doi.org/10.1007/s00216-014-8426-z

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