https://www.avient.com/sites/default/files/2024-08/LATAM CAI Certifications Bulletin _Portuguese_.pdf
ISO 9001:2015 Cert. No. 65799 ISO 9001:2015 Cert. © 2024, All Rights Reserved Avient Corporation https://www.avient.com/company/policies-and-governance-0/global-iso-certificate-library
https://www.avient.com/sites/default/files/2022-04/MEVOPUR LQ for Silicone Elastomers.pdf
Customized color solutions are available on request • Production under ISO 13485 / GMP quality system with change control management • Fingerprinting of raw materials and routine batch testing • Extractability evaluated in hexane, isopropanol, and water according to ISO 10993 part 18 REGULATORY SUPPORT • Raw materials are pre-tested to biologically- evaluated raw materials using ISO 10993-1 and USP chapters , Class VI • DMF/MAF documentation filed with the FDA for all standard colors APPLICATIONS MEVOPUR LQ formulations can be applied in demanding applications including: • Medical devices such as catheter tubing & connectors, syringe tips, and needleless connectors • Skin contact devices such as wearables or soft-touch surfaces of medical devices PRODUCT BULLETIN MEVOPUR™-LQ YELLOW (PMS1205C) Product Code FZ1M415005 MEVOPUR™-LQ TRANS YELLOW Product Code FZ1M415006 MEVOPUR™-LQ BLUE (PMS292C) Product Code FZ5M415008 MEVOPUR™-LQ TRANS BLUE Product Code FZ5M415009 MEVOPUR™-LQ RED (PMS198C) Product Code FZ3M415008 MEVOPUR™-LQ TRANS RED Product Code FZ3M415009 MEVOPUR™-LQ GREEN (PMS346C) Product Code FZ6M415008 MEVOPUR™-LQ TRANS GREEN Product Code FZ6M415009 MEVOPUR™-LQ VIOLET (PMS2655C) Product Code FZ4M415003 MEVOPUR™-LQ TRANS VIOLET Product Code FZ4M415004 CUSTOM-MADE Individual options Customized colors are also available to meet your needs, please contact us. 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.
https://www.avient.com/sites/default/files/2023-11/ISO 9001 2015_Hickory NC.pdf
This is to certify that Fiber-Line, LLC 280 Performance Drive SE, Hickory, North Carolina 28602 USA Quality Management System ISO 9001:2015 Manufacture of textile components to cable manufacturers. Certificate No.: CERT-0116814 Original Certification Date: 2010年11月24日 File No.: 1616267 Certification Effective Date: 2021年4月1日 Issue Date: 2021年3月30日 Certificate Expiry Date: 2024年3月31日 ________________________________________________________________________________ ISO 9001 Registered by: QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada. This registration is subject to the SAI Global Terms and Conditions for Certification.
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-3810-covid-19-containment-tube-screw-caps-case-study.pdf
DIAGNOSTICS MANUFACTURER C O V I D - 1 9 C O N T A I N M E N T T U B E S C R E W C A P S • Wide range of durometers with consistent raw materials • Processing consistencies across the durometer ranges for an easy transition between materials • Materials formulated without animal derivatives at a competitive cost • Offered a comprehensive range of solutions to accommodate specific application demands such as barrier, flexibility, and sealing performance • Provided materials manufactured in an ISO 13485 certified facility • Delivered a series of medical-grade TPEs that could be extruded and injection molded Versaflex™ HC 3810 Thermoplastic Elastomers KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2024-01/16824-8%23ISO 9001 Certificaat Fiber-Line International B.V. %28PDF%29.pdf
16824-8#ISO 9001 Certificaat Fiber-Line International B.V. Franken Managing Director Registration number 1682418.1 Start date certificate 2910112024 Certificate valid until 2910112027 Date of first certificate 2910112009 Certificate for the quality management system according to NENNENNENNEN1111ENENENEN1111ISOISOISOISO 9001:9001:9001:9001:2015201520152015 The certification body TÜV NORD Nederland hereby confirms that the certification 1682418.12910112024 took place in accordance with its certification regulations for the organisations 29101120272910112009 FiberFiberFiberFiber1111Line International B.V.Line International B.V.Line International B.V.Line International B.V. The certification is subject to annual evaluation by TÜV NORD Nederland.
https://www.avient.com/sites/default/files/2020-10/auto-injector-application-study.pdf
Pigments and eye-catching special effects • Prompt, precise and custom color matching • Biocompatible functional additives • FDA CFR 21, USP VI, ISO 10993-X, and/or USP 661-X • ISO 13485 facilities Avient Corporation 5 4. Requirements: Skin contact colorant certified for ISO 10993 biocompatibility Solution: OnColor™ HC Plus, MEVOPUR® 5.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Bio-based Polymer Solutions Application Bulletin.pdf
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.
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
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.
https://www.avient.com/sites/default/files/2023-05/Mevopur Healthcare Colorants and Formulations Amber for Pharma Application Bulletin.pdf
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 risk of change • Non-phthalate and formulated without animal-derived substances • Different tones of amber available on request —more or less red or yellow and/or lighter or darker • Also available in liquid form REGULATORY SUPPORT • Pre-tested raw materials: - ISO 10993-1 and USP parts (Class VI) - European Pharmacopeia, monograph 3.1.15, USP and elemental analysis as per ICH Q3D - USP criteria appearance of solution, color • Registered Drug Master File (Type III) by the FDA • Food contact compliance established with FDA/EU* • YBB00102002-2015 (oral liquid pharmaceutical PET bottles) compliance support APPLICATION BULLETIN * FDA/EU compliance information available upon request Healthcare use limitations apply—see below.
https://www.avient.com/products/vivo-formulations-healthcare/neusoft-thermoplastic-polyurethanes
USP Class VI and ISO 10993-4/5 compliant ASTM ISO Shore A/D ASTM/ISO %