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/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/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/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/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/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/polyone-expands-pre-certified-biocompatible-healthcare-portfolio
These expanded offerings add medical-grade LDPE, nylon, PEBA, PS and PVC to the globally available palette of specialty healthcare colorants, and are pre-certified to meet or exceed biocompatibility requirements for ISO 10993 and/or USP Class VI protocols.
All thirteen medical-grade carrier materials in the portfolio are pre-certified to meet or exceed ISO 10993 and/or USP Class VI requirements for applications ranging from medical packaging to device housings.