Institut Galien Paris-Sud, CNRS, Univ. Paris-Sud, University Paris-Saclay, Châtenay-Malabry, France, University Grenoble Alpes, Grenoble, France, CEA, LETI, MINATEC Campus, Grenoble, France, Univ Paris-Sud, Faculty of Pharmacy, Châtenay-Malabry, France, INSERM UMR 1153, Epidemiology and Biostatistics Sorbonne Paris Cité Center (CRESS), Team « Early Origin of the Child's Health and Development » (ORCHAD), University Paris Descartes, Villejuif, France, Amatsigroup (site Idron), Idron, France, Nanobiotix, Paris, France, Onxeo, Paris, France

Quality control analysis of nanomaterials has been identified as a major issue to pursue their development in different industrial fields including nanomedicine. One difficulty is the lack of standardized and validated protocols suitable to achieve their characterization. In a previous work, we have developed standardized protocols for the evaluation of the size and zeta potential of nanomaterials based on methods described in the ISO standard and have performed validation of each one. The present work was aimed to transfer these protocols in three independent receiving laboratories. No official guideline was described in the literature to achieve such a transfer. A comparative study for receiving laboratories equipped with the same instrument as the sending laboratory was designed based on the Code of Federal Regulation edited by the Food and Drug Administration. For the receiving laboratory equipped with an instrument working at a different wavelength, a new validation was designed and applied. Corresponding statistical methods were used for the analysis of the results. A successful transfer of the protocols in all receiving laboratories was achieved. All laboratories recorded consistent results applying in blind the protocol of size measurements on two samples of nanomaterials from which included one reference. © 2017 Elsevier B.V.

Metrology, Nanomaterials, Size, Standardized protocol, Surface charge, Transfer

nanomaterial, Article, comparative study, electrophoretic light scattering, electrophoretic mobility, light scattering, measurement, measurement accuracy, particle size, photon correlation spectroscopy, priority journal, quality control, standardization, surface charge, validation process, zeta potential