https://www.avient.com/sites/default/files/2025-03/ISO 13485 2025.pdf
Validity Avient Switzerland GmbH Hauptstrasse 30 4127 Birsfelden Switzerland Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market. Ltd. 30, Hsing Pang Road 33068 Taoyuan Taiwan Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market. Lewiston, ME, 04240 United States of America Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market.
https://www.avient.com/sites/default/files/2022-04/Sustainable Material Answers_ Recycled PET 2022_0.pdf
These pellets are sent to manufacturers who reheat the pellets, then form the material into the size and shape needed for their products. Energy Efficient PET takes less energy to manufacture than alternative materials like glass. Also, the more rPET used in manufacturing, the higher the acetaldehyde levels, which can lead to odor and taste issues.
https://www.avient.com/sites/default/files/2024-07/TPE Whitepaper_0.pdf
These sweeping trends have applied intense pressure on manufacturers to produce greater quantities of products in shorter periods of time. Manufacturing steps for vulcanized rubber— pre-mixing the formulation, subsequent mixing on a two-roll mill, parts molding and secondary operations, including washing off unreacted surplus materials—present manufacturers with a costly, protracted and outdated process. Notable advantages include streamlined manufacturing, resealing performance and coring resistance.
https://www.avient.com/sites/default/files/2020-09/case-study-one-pager-hybrid-5g-cable.pdf
OFC MANUFACTURER 5 G H Y B R I D C A B L E J A C K E T I N G & I N S U L A T I O N • Fire performance: reduce smoke and fume production, high flame and char resistance • Reduce development time • Meet required standards: UL 1581 (Class XL) mechanical properties , UL 1685 (flame test/smoke parameters), FT2 & FV2 (VW1) • Accelerated speed to market, reducing development time to three months • Instilled confidence and proved material expertise as solutions passed extensive testing ahead of competition • Optimized cable manufacture process and line speed following trials at customers facility ECCOH 5549/1 LDD & Syncure™ S100FH KEY REQUIREMENTS WHY AVIENT? https://www.avient.com/products/engineered-polymer-formulations/eco-conscious-formulations/eccoh-low-smoke-and-fume-non-halogen-formulations OFC Manufacturer
https://www.avient.com/sites/default/files/2022-04/Ext Building Products OEM Application Snapshot.pdf
Ext Building Products OEM Application Snapshot E X T E R I O R BU I L D I N G P RO D U C T S O E M S H E E T / P R O F I L E E X T R U S I O N • Source a cost competitive and effective chemical foaming additive (CFA) with prompt availability • Incorporate a CFA lightweighting solution with consistent cell structure and density for better overall operational performance • Improve material usage while manufacturing on both single and twin screw processing equipment • Met customer needs and timing with effective and efficient CFA solutions • Provided formulations that improved the dispersion and efficacy for optimized performance and control in manufacturing • Offered application and processing expertise focused on specific customer manufacturing assets and operations, allowing improved material usage and reduced operational costs Hydrocerol™ and Excelite™ CFAs KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2022-10/5_PolyOne GMP Certificate%5B97%5D.pdf
Pune, Maharashtra - 412 220 India Hold this Opinion Statement No. 770146 / 2022 The Organization has demonstrated that they have followed the Good Manufacturing Practices with reference to IPEC -PQG-GMP requirements applicable to Excipients used in pharma products for the following Business activity: “Research and Development, Manufacture of Color additives, Concentrates and Specialty Formulations for intended use in pharma and other industries”. For and on behalf of BSI Theuns Kotze, Managing Director – IMETA Assurance Last Assessment Date: 2022/06/25 Latest issue Date: 2022/08/24 Expiry Date: 2023/08/17 BSI Group India Private Limited T: +91 11 2692 9000 (CIN U74899DL1999PTC101381 info.in@bsigroup.com The Mira Corporate Suites bsigroup.com/en-IN Plot 1&2, Ishwar Nagar, Mathura Road New Delhi-110065, India Good Manufacturing Practices mailto:info.in@bsigroup.com
https://www.avient.com/sites/default/files/2020-12/portable-speakers-bulletin-selector-guide-2020.pdf
Versaflex™ TPE PORTABLE SPEAKER SOLUTIONS WATER AND DUST PROTECTION, DURABLE LOOK AND FEEL Versaflex™ CE 3120-40 Versaflex™ CE 3620 Versaflex™ CE 3115 Versaflex™ CE 3120-80 Application Gaskets Skins Skins Skins Product Aesthetics Tacky Translucent 42A Silky feel Natural 65A Silky feel Natural 65A Silky feel Natural 80A Special Characteristics Low compression set Low compression set High flow Abrasion resistance High strength Improved scratch/ mar, UV and abrasion Overmolding Polycarbonate ABS Copolyester Polycarbonate ABS Copolyester Polycarbonate ABS Copolyester Polycarbonate ABS Copolyester HOW VERSAFLEX TPEs MAKE THE DIFFERENCE IN PORTABLE SPEAKERS APPLICATIONS GASKETS Water and Dust Protection - Tight housing seals with no leakage over time Reduced Manufacturing Costs - Eliminates sourcing and assembly steps required of O-rings by overmolding directly onto the substrate; strong adhesion to PC & ABS - Faster cycle times than silicone or TPU Design Freedom - Injection molding TPEs in gaskets enables complex designs in which simple O-rings would be challenging to assemble SPEAKER SKINS Durable Look and Feel - Silky feel soft touch - Long lasting aesthetics with abrasion and UV resistance Reduced Manufacturing Costs - Eliminates sourcing and assembly steps required of silicone skins by overmolding directly onto the substrate; strong adhesion to PC & ABS - Faster cycle times than silicone or TPU Design Freedom - Overmolding TPE removes the need for mechanical interlocks and primers to get silicone materials to adhere to substrates To learn more about Versaflex TPEs for portable speakers, contact Avient at +1.844.4AVIENT. Today’s portable speaker manufacturers are searching for materials they can count on to protect against water and dust, but they also need durability and expanded design possibilities. Versaflex TPEs safely deliver on all of these requirements, while also accelerating production speed and reducing manufacturing cost.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Bio-based Polymer Solutions Application Bulletin.pdf
Mevopur™ Healthcare Bio-based Polymer Solutions for Medical Devices and Pharmaceutical Packaging Manufacturers of medical devices and pharmaceutical packaging are increasingly faced with the challenge of integrating sustainability into the design of their products. KEY CHARACTERISTICS • Available for polyethylene, polypropylene, ABS, polycarbonate and styrenics • Bio-content of resin carrier varies from 70% to 100% depending on polymer—calculated to ASTM D6866 standard • Manufactured at four ISO 13485 certified sites, providing global consistency and security of supply • Documented change control beyond CAS number, reducing risk of change • Drop-in solutions that can be processed like fossil-based grades on common injection molding and extrusion machines • Can be provided as ready-to-use pre-colored or additive formulation 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 US FDA and APPLICATION BULLETIN Sustainability Spotlight Bio-polymers 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.
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
The nucleating agents also foster constant process settings throughout part manufacturing with a higher crystallization temperature for improved crystallization speed. REGULATORY SUPPORT • Drug delivery devices • Pharmaceutical packaging • Medical equipment KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing the risk of change • Allows crystallization in semi-crystalline polymers to begin faster and complete earlier REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request 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.
https://www.avient.com/sites/default/files/2023-05/Cesa Light Diffusion Additives for Automotive - Product Overview.pdf
Cesa™ Light Diffusion Additives enable manufacturers to develop consumer-pleasing automotive lighting systems that also meet OEM’s demands for manufacturability and cost management. Our expertise is in understanding a designer’s idea and developing the appropriate formulation to turn it into a manufacturing reality. Information we may require includes: • Which material will be used to manufacture the lens?