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.

MEVOPUR medical-grade materials are produced according to ISO13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.

Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.

Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.

Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines. They can be customized to meet specific regulatory demands such as USP Class VI, FDA CFR, and ISO 10993.   Versaflex™ HC 2110-57B TPEs comply with ISO 10993-4, ISO 10993-5, and USP Class VI and are suitable for Ethylene Oxide (EtO) sterilization without residue or allergens.

Avient has 102 global manufacturing facilities. 96% of these sites are certified through independent third parties to management system standards including ISO:14001, ISO:50001, ISO:22000, ISO:45001, ISO:9001, and Responsible Care®. For our sensitive applications we have implemented Good Manufacturing Processes (GMP) and ISO 13485. 100% of our facilities producing for the healthcare market are GMP or ISO audited within a 3–year period. Major Non-Conformances at ISO Sites

Like other Mevopur products, the bio-based polymer solutions are formulated with raw materials pre-tested to ISO, USP, EP, and ICH Q3D protocols, supporting their compliance with safety and regulatory requirements for use in healthcare.   In Europe, Mevopur concentrates and ready-to-use formulations are manufactured in the ISO 13485-2016 certified site of Malmö, Sweden.

The materials are produced under a third-party certified ISO 13485:2016 quality management system and backed by comprehensive change control of raw materials, formulation, and manufacturing standards to enable consistent batch-to-batch quality.”

All Mevopur formulations are manufactured across a global network of ISO 13485 facilities, and they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, European Pharmacopeia, and ICH Q3D. They are available in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards.

Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.