Home // Medical Hose Manufacturer Boosts Productivity With Specialized Material The Avient team assessed the application’s technical and operational requirements, and recommended a GLS™ Versalloy™ alloy in 45 Shore A durometer, an FDA-compliant medical TPV grade designed for overmolding onto PP. With Avient’s assistance and experience in medical device applications, the manufacturer immediately realized the following lifts:

Home // Medical Hose Manufacturer Boosts Productivity With Specialized Material The Avient team assessed the application’s technical and operational requirements, and recommended a GLS™ Versalloy™ alloy in 45 Shore A durometer, an FDA-compliant medical TPV grade designed for overmolding onto PP. With Avient’s assistance and experience in medical device applications, the manufacturer immediately realized the following lifts:

Mevopur™ Healthcare Functional Additives Chemical Foaming Agents (CFA) for Medical Devices and Pharmaceutical Packaging As the need to integrate sustainability in the design of healthcare products is growing, manufacturers of medical devices and pharmaceutical packaging are looking for materials with a more environmentally-friendly profile. KEY CHARACTERISTICS • Manufactured under ISO 13485 procedures • Documented change control beyond CAS number, reducing risk of change • Can be used on common injection molding and extrusion machines—set-up support by a technical assistance team • Available for use in polyolefins, styrenics and copolymers • Can be combined with colorants REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to USA FDA and EU norms APPLICATION BULLETIN Sustainability Spotlight Healthcare use limitations apply—see below. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

Avient products have not been designed for nor are they promoted or intended for use in: (a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under US Pharmacopoeia (USP) or ISO standards; or (b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or (c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended. Without limiting the generality of this statement, Avient products shall not be used in any medical device application intended for: (1) exposure to human tissue or body fluids for 30 days or greater; (2) “plastic” (cosmetic or reconstructive) surgery use; (3) reproductive implants or any birth control device; or (4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device, including the suitability of all raw materials and components used for its manufacture, and with all applicable laws and regulations. 1.844.4AVIENT www.avient.com

Mevopur Healthcare Bio-based Polymer Solutions are drop-in solutions that can be used the same way as conventional concentrates in the injection molding, blow molding, and extrusion of medical devices and pharmaceutical packaging. Mevopur™ Healthcare Colorants and Formulations: color concentrates and ready-to-use formulations to add color and enhance the performance of medical plastics, developed with raw materials pre-tested to ISO, USP, EP, and ICH Q3D protocols

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Disinfectant Resistance for Medical Device Housings - Case Study Manufacturer boosts disinfectant resistance for medical device housings using Trilliant HC High Performance Formulations ColorMatrix™ Excelite™ helped PVC processors optimize performance, control and efficiency in the extrusion process