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
https://www.avient.com/company/policies-and-governance-0/avients-human-rights-policy
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance/avients-position-water-stewardship
Global ISO Certificate Library
https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-biocompatible-peek-pre-colored-compounds
Biocompatibility: Our PEEK solutions have passed ISO 10993 biocompatibility testing, ensuring safety and reliability for medical applications.
Passed ISO 10993 biocompatibility testing, suitable for medical use
https://www.avient.com/news/avient-launches-new-bio-based-polymer-solutions-medical-and-pharmaceutical-applications-during-pharmapack-europe-2022
Like other Mevopur formulations, they are produced in dedicated facilities according to ISO 13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.
https://www.avient.com/news/avient-attains-acc-responsible-care-14001-global-certification-environmental-health-safety-and-security-excellence
Obtaining the RC14001® certification is unique as it encompasses security, product safety, and transportation elements, setting itself apart from the individual ISO 14001 and ISO 45001 certifications.”
https://www.avient.com/news/polyone-specialty-tpe-material-enables-oems-meet-skin-sensitivity-testing-requirements
– June 24, 2014 – PolyOne GLS Thermoplastic Elastomers, a global leader in high-performance, custom-formulated thermoplastic elastomer (TPE) solutions, today announced that its Versaflex™ CE 3620 material meets all ISO 10993-10:2010 testing requirements with no signs of irritation.
Several Versaflex CE materials have been used in wearable electronics applications without irritation for a number of years, and the recent ISO testing results underscore this track record.
https://www.avient.com/company/policies-and-governance/cpsia-information
PDI is accredited under ISO 17025 by A2LA (the American Association for Laboratory Accreditation) to perform testing as an independent laboratory body.
Global ISO Certificate Library
https://www.avient.com/news/bio-based-tpe-biopharmaceutical-tubing-added-avient-s-sustainable-healthcare-solutions
Avient’s PCF calculation method follows the ISO 14067:2018 standard and is certified by TÜV Rheinland.
Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is manufactured in the United States with global commercial availability.
