https://www.avient.com/news/polyone-collaborates-help-celebriducks-offer-safe-water-toys-children
PolyOne developed an ultra-soft version of its GLS™ TPE (thermoplastic elastomer) approved for food contact and medical applications, and included non-toxic PolyOne colorants.
https://www.avient.com/resource-center/knowledge-base/article/bringing-global-vision-2020-s-usee-life?ind%5B0%5D=6598
Avient’s design team assisted with the design, process analysis and production of the injection-molded plastic USee™ device, which includes a copolyester frame, medical-grade polycarbonate lenses, and acetal for the dials and gears.
https://www.avient.com/sites/default/files/2020-07/versaflex-hc-syringe-plunger-english.pdf
Versaflex HC - Syringe Plunger - English SYRINGE MANUFACTURER D I S P O S A B L E S Y R I N G E P L U N G E R • USP VI and ISO 10993-4,5 compliant • Sterilize by gamma & EtO • Long-term sealing performance • Low coefficient of friction (COF) • Consistent performance across barrel sizes • Provided a formulated solution that met rigorous medical application requirements • Improved global supply continuity • Increased process efficiency by replacing previous thermoset material with TPE Versaflex™ HC 2110-57B KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/trilliant-xr-ct-and-mri-scanners.pdf
Trilliant XR - CT and MRI Scanners MEDICAL DEVICE MANUFACTURER M R I A N D C T S C A N N E R S • Uniform shielding with no “hot spots” • X-ray shielding up to 140 KeV • Meet European Union’s Restriction of Hazardous Substances (RoHS) future compliance requirements • Provided a lead alternative solution that delivered improved geometric flexibility for more uniform radiation shielding • Lowered shielding component costs 30-50% by eliminating machining and assembly steps Trilliant™ XR Lead Replacement Thermoplastics KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2022-01/Dynaflex-Disposable syringe tip cap-Application snapshot.pdf
• Formulated a solution that met rigorous medical application requirements • Leveraged global footprint to ensure supply continuity • Increased process efficiency by replacing previous thermoset material with TPE LEARN MORE https://www.avient.com/products/thermoplastic-elastomers/dynaflex-thermoplastic-elastomers
https://www.avient.com/sites/default/files/2023-10/ISO 13485-2016 cert_expire 28Feb2025_Avient%5B28%5D.pdf
_2 /Ju n- 20 19 /V er si on 1 .0 Certificate Avient Colorants Singapore Pte Ltd 8 Third Chin Bee Road Jurong Industrial Estate 618684 Singapore Singapore Scope Administration, Site management, Manufacture, Laboratory, Procurement, Maintenance, infrastructure, Warehouse and Transport Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45483 Validity 01. 03. 2022 – 28. 02. 2025 Issue 01. 03. 2022 A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2022-05/Glucose Monitoring App Snapshot.pdf
Glucose Monitoring App Snapshot draft MEDICAL DEVICE OEM C O N T I N U O U S G L U C O S E M O N I T O R I N G S Y S T E M • Adapt to strict processing requirements of a secondary operation put in place to manufacture a new device model • Meet material size and thickness requirements while achieving desired color target • Overcome material unpredictability and sensitivity to heat, light and moisture • Minimize impact of supply chain instability and changes • Offered support for processing under low pressure conditions and at every stage of manufacturing • Performed extensive R&D work to consistently deliver the customer’s color target of a hard-to-achieve light gray • Effectively addressed all material challenges and sensitivities • Provided regular ‘summaries of understanding’ to keep up with changing forecasts and ordering patterns Mevopur™ Pre-color Formulation KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2021-07/mevopur-needle-hub-1-page-case-study.pdf
NEEDLE HUB MANUFACTURER N E E D L E H U B C O L O R S • RAL and Pantone® colors available in palette to align with ISO 6009 color standard • Opaque and transparent polypropylene selections available in both masterbatch and ready-to-use precolors • Raw materials pre-tested to ISO 10993 and USP Class VI medical device guidelines • Certified formulations available globally • Provided RAL and Pantone colors as required • Developed custom polypropylene formulations to meet specific opacities • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the value chain • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Colors KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2023-09/65567-Certificate-08SEP2023.pdf
MANUFACTURE OF COLORANTS FOR PLASTICS FOR THE MEDICAL DEVICE INDUSTRY Certificate Of Conformance
https://www.avient.com/sites/default/files/resources/NEU%2520ISO%25209001-2015%2520Exp%25201-22%2520%25281%2529.pdf
COMPOUND AND SUPPLY OF THERMOPLASTICS FOR THE MEDICAL DEVICE INDUSTRY.