https://www.avient.com/news/specialty-polymer-solutions-avient-improved-durability-and-sustainability-healthcare-products-pharmapack-2023
All materials in this range are formulated to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS.
All the materials are manufactured in ISO 13485-2016 certified sites and supported by testing to ISO 10993-1, USP, EP, and ICH Q3D protocols.
https://www.avient.com/news/‘future-proof’-pharma-packaging-avient-launches-new-regulatory-compliant-mevopur-amber-masterbatches
Produced under rigorous cGMP and medical manufacturing protocols, the new amber color concentrates are made in three dedicated EN ISO 13485-2016 registered facilities using only medical-grade ingredients.
They are formulated without animal-derived substances and phthalates, and have been pre-tested for compliance with:
• ISO 10993-1 and USP parts , (including class VI)
• European Pharmacopoeia, monograph 3.1.15
• USP and
• elemental analysis, as per ICH Q3D
