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Open AccessArticle

The Ubiquitous Issue of Cross-Mass Transfer: Applications to Single-Use Systems

1
LNE, 29 Avenue Roger Hennequin, 78197 Trappes CEDEX, France
2
Sartorius Stedim FMT S.A.S., avenue de Jouques, CS91051, ZI des Paluds, 13781 Aubagne CEDEX, France
3
Ingénierie Procédés Aliments, AgroParisTech, INRA, Université Paris-Saclay, 91300 Massy, France
*
Authors to whom correspondence should be addressed.
Academic Editors: Roland Franz and Frank Welle
Molecules 2019, 24(19), 3467; https://doi.org/10.3390/molecules24193467
Received: 21 August 2019 / Revised: 13 September 2019 / Accepted: 19 September 2019 / Published: 24 September 2019
(This article belongs to the Special Issue Food Packaging Materials)
The leaching of chemicals by materials has been integrated into risk management procedures of many sectors where hygiene and safety are important, including food, medical, pharmaceutical, and biotechnological applications. The approaches focus on direct contact and do not usually address the risk of cross-mass transfer of chemicals from one item or object to another and finally to the contacting phase (e.g., culture medium, biological fluids). Overpackaging systems, as well as secondary or ternary containers, are potentially large reservoirs of non-intentionally added substances (NIAS), which can affect the final risk of contamination. This study provides a comprehensive description of the cross-mass transfer phenomena for single-use bags along the chain of value and the methodology to evaluate them numerically on laminated and assembled systems. The methodology is validated on the risk of migration i) of ϵ-caprolactam originating from the polyamide 6 internal layer of the overpackaging and ii) of nine surrogate migrants with various volatilities and polarities. The effects of imperfect contacts between items and of an air gap between them are particularly discussed and interpreted as a cutoff distance depending on the considered substance. A probabilistic description is suggested to define conservative safety-margins required to manage cross-contamination and NIAS in routine. View Full-Text
Keywords: migration; non-intentionally added substances (NIAS); cross-mass transfer; modeling; risk assessment; single-use; extractables; laminates migration; non-intentionally added substances (NIAS); cross-mass transfer; modeling; risk assessment; single-use; extractables; laminates
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MDPI and ACS Style

Nguyen, P.-M.; Dorey, S.; Vitrac, O. The Ubiquitous Issue of Cross-Mass Transfer: Applications to Single-Use Systems. Molecules 2019, 24, 3467. https://doi.org/10.3390/molecules24193467

AMA Style

Nguyen P-M, Dorey S, Vitrac O. The Ubiquitous Issue of Cross-Mass Transfer: Applications to Single-Use Systems. Molecules. 2019; 24(19):3467. https://doi.org/10.3390/molecules24193467

Chicago/Turabian Style

Nguyen, Phuong-Mai; Dorey, Samuel; Vitrac, Olivier. 2019. "The Ubiquitous Issue of Cross-Mass Transfer: Applications to Single-Use Systems" Molecules 24, no. 19: 3467. https://doi.org/10.3390/molecules24193467

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Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

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