Migration of plasticizers from PVC medical ...
Type de document :
Article dans une revue scientifique
PMID :
URL permanente :
Titre :
Migration of plasticizers from PVC medical devices: Development of an infusion model
Auteur(s) :
Bernard, L. [Auteur]
Cueff, R. [Auteur]
Chagnon, M. C. [Auteur]
Abdoulouhab, F. [Auteur]
Decaudin, Bertrand [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Breysse, C. [Auteur]
Kauffmann, S. [Auteur]
Cosserant, B. [Auteur]
Souweine, B. [Auteur]
Sautoua, V. [Auteur]
Cueff, R. [Auteur]
Chagnon, M. C. [Auteur]
Abdoulouhab, F. [Auteur]
Decaudin, Bertrand [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Breysse, C. [Auteur]
Kauffmann, S. [Auteur]
Cosserant, B. [Auteur]
Souweine, B. [Auteur]
Sautoua, V. [Auteur]
Titre de la revue :
International journal of pharmaceutics
Nom court de la revue :
Int. J. Pharm.
Numéro :
494
Pagination :
136-145
Date de publication :
2015
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé :
Alternatives to DEHP plasticizers are used in various PVC medical devices (MD) for infusion. As they are able to migrate from these MDs into infused solutions, they may come into contact with patient. Different and specific ...
Lire la suite >Alternatives to DEHP plasticizers are used in various PVC medical devices (MD) for infusion. As they are able to migrate from these MDs into infused solutions, they may come into contact with patient. Different and specific clinical parameters influence their migration in at-risk situations such as infusion. In contrast to the regulations for Food Contact Materials (MCDA), there is currently no acceptable migration limits for the use of these plasticizers in clinical situations. In order to assess their migration, and thus control the risks linked to these MDs, we developed a migration model for the plasticizers in MDs. To this end, we applied a cross-disciplinary methodological process similar to that used in the food-processing industry, taking into account the MDs' conditions of use in clinical practice. The simulation model is simple and includes the following conditions: MD should be tested with a dynamic method that respects our established clinical assumption (2 L of infused solutions via 13 dm(2) of plasticized PVC), at a temperature of 25 °C and during 24 h of contact, using a 50/50 (v/v) ethanol/water simulant. This model could be proposed as a tool for the safety evaluation of the patients' exposure risk to plasticizers from PVC medical devices for infusions.Lire moins >
Lire la suite >Alternatives to DEHP plasticizers are used in various PVC medical devices (MD) for infusion. As they are able to migrate from these MDs into infused solutions, they may come into contact with patient. Different and specific clinical parameters influence their migration in at-risk situations such as infusion. In contrast to the regulations for Food Contact Materials (MCDA), there is currently no acceptable migration limits for the use of these plasticizers in clinical situations. In order to assess their migration, and thus control the risks linked to these MDs, we developed a migration model for the plasticizers in MDs. To this end, we applied a cross-disciplinary methodological process similar to that used in the food-processing industry, taking into account the MDs' conditions of use in clinical practice. The simulation model is simple and includes the following conditions: MD should be tested with a dynamic method that respects our established clinical assumption (2 L of infused solutions via 13 dm(2) of plasticized PVC), at a temperature of 25 °C and during 24 h of contact, using a 50/50 (v/v) ethanol/water simulant. This model could be proposed as a tool for the safety evaluation of the patients' exposure risk to plasticizers from PVC medical devices for infusions.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
CHU Lille
CHU Lille
Collections :
Équipe(s) de recherche :
Innovation/évaluation des dispositifs médicaux de perfusion
Date de dépôt :
2019-02-26T17:15:45Z