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Specification and Evaluation of Plasticizer Migration Simulants for Human Blood Products: A Delphi Study

Univ. Lille, CHU Lille, ULR 7365 GRITA—Groupe de Recherche sur les Formes Injectables et les Technologies Associées, F-59000 Lille, France
Macopharma, 200 Chaussée Fernand Forest, F-59200 Tourcoing, France
KREADYS, 7000 Mons, Belgium
CHU Lille, Service D’hémostase et Transfusion, Centre de Biologie Pathologie, F-59037 Lille, France
CHU Lille, Department of Anesthesiology and Critical Care, F-59000 Lille, France
CHU UCL, Drug Stability Research Group, Namur, 5530 Yvoir, Belgium
CHU Lille, Institut D’hémato-Transfusion, Unité D’hémovigilance, F-59000 Lille, France
Service du Sang, Croix-Rouge de Belgique, rue du Fond de Maréchal, 8/1, 5020 Suarlée, Belgium
Université de Caen Normandie, Unirouen, ABTE, F-14000 Caen, France
Authors to whom correspondence should be addressed.
Academic Editor: Vladimir N. Uversky
Biomolecules 2021, 11(8), 1081;
Received: 16 June 2021 / Revised: 16 July 2021 / Accepted: 20 July 2021 / Published: 22 July 2021
Potentially toxic plasticizers are commonly added to polyvinyl chloride medical devices for transfusion in order to improve their flexibility and workability. As the plasticizers are not chemically bonded to the PVC, they can be released into labile blood products (LBPs) during storage. Ideally, LBPs would be used in laboratory studies of plasticizer migration from the medical device. However, short supply (i.e., limited stocks of human blood in collection centres) has prompted the development of specific simulants for each type of LBP in the evaluation of new transfusion devices. We performed a Delphi study with a multidisciplinary panel of 24 experts. In the first (qualitative) phase, the panel developed consensus definitions of the specification criteria to be met by each migration simulant. Next, we reviewed the literature on techniques for simulating the migration of plasticizers into LBPs. A questionnaire was elaborated and sent out to the experts, and the replies were synthesized in order to obtain a consensus. The qualitative study established specifications for each biological matrix (whole blood, red blood cell concentrate, plasma, and platelet concentrate) and defined the criteria required for a suitable LBP simulant. Ten criteria were suggested: physical and chemical characteristics, opacity, form, stability, composition, ability to mimic a particular clinical situation, ease and safety of use, a simulant–plastic interaction correlated with blood, and compatibility with analytical methods. The questionnaire data revealed a consensus on the use of natural products (such as pig’s blood) to mimic the four LBPs. Opinions diverged with regard to synthetic products. However, an isotonic solution and a rheological property modifier were considered to be of value in the design of synthetic simulants. Consensus reached by the Delphi group could be used as a database for the development of simulants used to assess the migration of plasticizers from PVC bags into LBPs. View Full-Text
Keywords: labile blood product; migration; plasticizer; simulant labile blood product; migration; plasticizer; simulant
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MDPI and ACS Style

Thelliez, A.; Hénard, G.; Delorme, B.; Chatellier, S.; Danel, C.; Ducoroy, L.; Dupont, A.; Garrigue, D.; Genay, S.; Goossens, J.-F.; Goossens, L.; Havet, C.; Hecq, J.-D.; Maeght, C.; Mendel, I.; Najdovski, T.; Odou, P.; Saint-Lorant, G.; Ung, A.; Lecoeur, M.; Décaudin, B. Specification and Evaluation of Plasticizer Migration Simulants for Human Blood Products: A Delphi Study. Biomolecules 2021, 11, 1081.

AMA Style

Thelliez A, Hénard G, Delorme B, Chatellier S, Danel C, Ducoroy L, Dupont A, Garrigue D, Genay S, Goossens J-F, Goossens L, Havet C, Hecq J-D, Maeght C, Mendel I, Najdovski T, Odou P, Saint-Lorant G, Ung A, Lecoeur M, Décaudin B. Specification and Evaluation of Plasticizer Migration Simulants for Human Blood Products: A Delphi Study. Biomolecules. 2021; 11(8):1081.

Chicago/Turabian Style

Thelliez, Aurélie, Grégory Hénard, Bruno Delorme, Sonia Chatellier, Cécile Danel, Laurent Ducoroy, Annabelle Dupont, Delphine Garrigue, Stéphanie Genay, Jean-François Goossens, Laurence Goossens, Coralie Havet, Jean-Daniel Hecq, Caroline Maeght, Isabelle Mendel, Tomé Najdovski, Pascal Odou, Guillaume Saint-Lorant, Alexandre Ung, Marie Lecoeur, and Bertrand Décaudin. 2021. "Specification and Evaluation of Plasticizer Migration Simulants for Human Blood Products: A Delphi Study" Biomolecules 11, no. 8: 1081.

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