https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
HYPODERMIC NEEDLE MANUFACTURER N E E D L E H U B , C O V E R A N D S H I E L D • Compliance to ISO 6009 color coding for single use hypodermic needle • Biocompatibility of all component materials • Good mechanical and visual properties after sterilization (e.g.
ETO / Gamma radiation) • Facilitated 510(k) submission with formulations registered under Device Master File MAF 1833 • Pre-tested raw materials to biocompatibility ISO10993, US and Eu Pharmacopeia, ICH-Q3D extractable metals • Enhanced stability with gamma stabilizing package • Minimized risk of change with change control beyond CAS number level • Ensured uninterrupted supply from multiple ISO 13485-2016 certified sites • MEVOPURTM ISO 6009 Standard / Customized Solutions KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/resources/Polyolefins%2520Product%2520Selection%2520Guide.pdf
This product selection guide provides detailed information to help you select the Maxxam product that’s right for your application. 4 INJECTION MOLDING POLYPROPYLENE Product Code - - - PP5113 B44 F5134T2-4 PP5130 B63 F5134T4-1 Filler Percentage - % - 13 20 30 40 Tensile Strength Yield psi ASTM D638 5000 4800 4600 4500 MPa ISO 527 33 33 32 31 Tensile Elongation Yield % ASTM D638 6 4 3 2 ISO 527 Break % ASTM D638 60 30 15 10 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 300,000 360,000 400,000 460,000 MPa ISO 178 2300 2450 2900 3300 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 0.65 0.60 0.55 0.50 kJ/m2 ISO 180 3.50 3.3 3.00 2.75 Heat Deflection 66 psi °F ASTM D648 230 240 260 275 °C ISO 75 110 116 127 135 264 psi °F ASTM D648 130 140 150 175 °C ISO 75 54 60 66 79 Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.04 1.15 1.25 ISO 1183 Linear Shrinkage Range 1/8 in wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0 3.2 mm wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0 Product Code - - - PP6113 A77-SM PP6120 B16-2 PP6130 B11 PP6135 B40-UV Filler Percentage - % - 13 20 30 35 Tensile Strength Yield psi ASTM D638 4350 3500 2600 3700 MPa ISO 527 30 24 18 26 Tensile Elongation Yield % ASTM D638 5 4 7 6 ISO 527 Break % ASTM D638 35 70 150 70 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 290,000 280,000 280,000 390,000 MPa ISO 178 2000 1950 1750 2700 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 0.7 2.7 4.5 0.65 kJ/m2 ISO 180 4.0 14 24 3.5 Heat Deflection 66 psi °F ASTM D648 239 215 225 250 °C ISO 75 115 102 107 123 264 psi °F ASTM D648 140 125 130 150 °C ISO 75 60 52 54 60 Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.05 1.15 1.18 ISO 1183 Linear Shrinkage Range 1/8 in wall % - 1.1–1.5 .9–1.3 0.7–1.1 0.5–0.9 3.2 mm wall % - 1.1–1.5 .9–1.3 0.7–1.1 0.5–0.9 Maxxam™ Talc-Filled Copolymer Polypropylene • Scratch & mar resistant • UL approved • FDA certifiable • Natural, black or colors • High flow grades • UV stabilized • UL approved • FDA certifiable • Natural, black or colors • High flow grades • UV stabilized • Recycled content Maxxam™ Talc-Filled Homopolymer Polypropylene Offers a moderate level of impact strength and improved stiffness and heat deflection performance.
PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES 51.866.POLYONE www.polyone.com INJECTION MOLDING POLYPROPYLENE Product Code - - - PP5210 A111 PP5220F A1 PP5230F B1 PP5240 A111 Filler Percentage - % - 10 20 30 40 Tensile Strength Yield psi ASTM D638 4600 4300 3900 3500 MPa ISO 527 32 30 27 24 Tensile Elongation Yield % ASTM D638 7.0 6.0 5.5 5.0 ISO 527 Break % ASTM D638 125 115 100 70 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 250,000 285,000 310,000 340,000 MPa ISO 180 1600 1900 2100 2300 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 0.70 0.70 0.70 0.70 kJ/m2 ISO 180 3.85 3.85 3.85 3.85 Heat Deflection 66 psi °F ASTM D648 190 210 225 240 °C ISO 75 88 99 107 116 264 psi °F ASTM D648 120 125 130 133 °C ISO 75 49 52 54 56 Specific Gravity 73°F (23°C) - ASTM D792 0.96 1.04 1.15 1.25 Linear Shrinkage Range 1/8 in wall % - 1.3–1.7 1.1–1.5 0.9–1.3 0.7–1.1 3.2 mm wall % - 1.3–1.7 1.1–1.5 0.9–1.3 0.7–1.1 Product Code - - - PP6210 A11 PP7220 A614 PP6230F A1 PP6240 A44 Filler Percentage - % - 10 20 30 40 Tensile Strength Yield psi ASTM D638 3200 3400 2800 2550 MPa ISO 527 22 24 19 18 Tensile Elongation Yield % ASTM D638 14.0 10.0 8.0 7.0 ISO 527 Break % ASTM D638 >400 >400 >400 200 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 160,000 185,000 250,000 225,000 MPa ISO 178 1100 1300 1750 1550 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 >10.0 >10.0 8 8.0 kJ/m2 ISO 180 55.0 55.0 44.0 14.0 Heat Deflection 66 psi °F ASTM D648 160 170 198 200 °C ISO 75 71 77 92 93 264 psi °F ASTM D648 100 105 108 112 °C ISO 75 38 41 42 44 Specific Gravity 73°F (23°C) - ASTM D792 0.96 1.04 1.15 1.25 ISO 1183 Linear Shrinkage Range 1/8 in wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0 3.2 mm wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0 Maxxam™ Calcium Carbonate Filled Homopolymer Polypropylene Maxxam™ Calcium Carbonate Filled Copolymer Polypropylene Offers improved stiffness over unfilled materials as well as substantial improvement in drop weight impact and notched izod impact.
These materials offer an excellent balance of stiffness, impact resistance and dimensional stability. • FDA certifiable • Natural, black or colors • UV stabilized Product Code - - - PE4125 B1 Reinforcement Type - - - Talc Reinforcement % - % - 25 Specific Gravity 73°F (23°C) - ASTM D792 1.15 ISO 1183 Tensile Strength Yield psi ASTM D638 4050 MPa ISO 527 28 Tensile Elongation Yield % ASTM D638 10 ISO 527 Break % ASTM D638 40 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 270,000 MPa ISO 178 1850 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 3.5 kJ/m2 ISO 180 20.0 Heat Deflection 66 psi °F ASTM D648 190 °C ISO 75 88 264 psi °F ASTM D648 115 °C ISO 75 46 PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES 12 www.polyone.com Copyright © 2019, PolyOne Corporation.
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/2023-03/Onflex-Cell Pack Cooling Tube-Application Snapshot.pdf
AVIENT SOLUTION VEHICLE BATTERY MANUFACTURER C E L L P A C K C O O L I N G T U B E • Comply with ISO 3384-1:2011 for TPE compression set • Comply with ISO 11359-2:1999 standard for linear thermal expansion • Good ethanediol resistance • Good sealing performance • Customized a Shore 60A hardness TPE formulation with good physical property retention • Achieved good compression set and bonding performance with PA12 • Qualified thermal expansion by customer • Provided excellent ethanediol resistance under both low and high temperature conditions KEY REQUIREMENTS CHEMICAL RESISTANCE + SEALING LEARN MORE OnFlex™ TPE Custom Formulation Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2023-02/PH - 15701960 AVIENT ASSESSE ISO 14001.pdf
AVIENT BELGIUM 2, RUE MELVILLE WILSON 5330 ASSESSE- BELGIUM Bureau Veritas Certification France certify that the Management System of the above organization has been audited and found to be in accordance with the requirements of the management system standard detailed below: Standard ISO 14001 : 2015 Scope of certification DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE CONCENTRATES, THERMOPLASTIC RESINS AND SPECIALITY COMPOUNDS.
https://www.avient.com/sites/default/files/2020-07/PH -AVIENT LUXEMBOURG - 15608678 - ISO 14001.pdf
POLYONE FRANCE TOSSIAT 43, PLACE DE LA GARE 01250 TOSSIAT FRANCE Bureau Veritas Certification France certify that the Management System of the above organization has been audited and found to be in accordance with the requirements of the management system standard detailed below: Standard ISO 14001:2015 Scope of certification THE DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE CONCENTRATES FOR THERMOPLASTICS Certification/Recertification Cycle Start Date: 03 May 2023 Subject to the continued satisfactory operation of the organization’s Management System, this certificate expires on: 02 May 2026 Expiry date of previous cycle: NA Certification/Recertification Audit date: 08 March 2023 Original Cycle Start Date: 15 July 2011 Certificate n°: FR081968-1 File n°:15608678 Revision date:24 April 2023 Laurent CROGUENNEC - President Local Office: Bureau Veritas Certification France Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense Further clarifications regarding the scope of this certificate the applicability of the management system requirements may be obtained by consulting the organization.
https://www.avient.com/sites/default/files/2020-07/ISO 14001 - 14 March 2026.pdf
F-27, MIDC, Ranjangaon, Shirur, Pune, Maharashtra 412 220 India ISO 14001:2015 The Environmental Management System is applicable to: Certificate No: 55688 Certification Date: 15 March 2017 Effective Date: 09 March 2023 Expiration Date: 14 March 2026 Revision Date: 21 March 2023 Dominic Townsend, President DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY COMPOUNDS This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/sites/default/files/2020-07/ISO 45001 14 March 2026.pdf
F-27, MIDC, Ranjangaon, Shirur, Pune, Maharashtra 412 220 India ISO 45001:2018 The Occupational Health and Safety Management is applicable to: Certificate No: 55689 Certification Date: 15 March 2017 Effective Date: 09 March 2023 Expiration Date: 14 March 2026 Revision Date: 15 March 2023 Dominic Townsend, President DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY COMPOUNDS.
https://www.avient.com/sites/default/files/2023-12/Jeddah%2C Saudia Arabia ISO 14001.pdf
Limited PO Box 2137, Jeddah 22758 Saudi Arabia Has been assessed and found to meet the requirements of ISO 14001:2015 This certificate is valid for the following scope of operations: Production and Supply of Color and Additive Master Batches Authorised by: Stan Wright Director Date of Certificate Issue: 20 December 2022 Certificate Valid Until: 19 December 2025 Recertification audit before 20 November 2025.
https://www.avient.com/sites/default/files/2024-12/ISO-14001_English_Shanghai Zhangjiang.pdf
Park, China (Shanghai) Pilot Free Trade Zone, Shanghai, China 201203 has been found to conform to the Environmental Management System standard: ISO 14001:2015 This certificate is valid for the following scope: Design and Manufacture of Colour and Additive Concentrates http://www.dnv.com/assurance