https://www.avient.com/sites/default/files/2022-06/ISO_9001_2015_Cert_PolyOne.pdf
F-27, MIDC, Ranjangaon, Shirur Pune, Maharashtra 412 220 India ISO 9001:2015 The Quality Management System is applicable to: Certificate No: 51482 Certification Date: 08 April 2015 Effective Date: 03 March 2021 Expiration Date: 07 April 2024 Revision Date: 08 March 2021 Dominic Townsend, President THE DESIGN AND MANUFACTURE OF COLOR, ADDITIVE CONCERTRATES AND SPECIALITY 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/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/2024-09/FIBER-LINE HICKORY ISO CERTIFICATION 2024.pdf
SCCertificateRebrandA4Portrait CERTIFICATE OF REGISTRATION This is to certify that the management system of: Fiber-Line, LLC Main Site: 280 Performance Drive SE Hickory North Carolina 28602 United States has been registered by Intertek as conforming to the requirements of: ISO 9001:2015 The management system is applicable to: Manufacture of textile components to cable manufacturers.
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
https://www.avient.com/sites/default/files/2024-12/ISO-9001_English_Shanghai Zhangjiang.pdf
Park, China (Shanghai) Pilot Free Trade Zone, Shanghai, China 201203 and the sites as mentioned in the appendix accompanying this certificate has been found to conform to the Quality Management System standard: GB/T 19001-2016 / ISO 9001:2015 This certificate is valid for the following scope: Design and Manufacture of Colour and Additive Concentrates http://www.dnv.com/assurance Certificate no.: 7071-1998-AQ-RGC-RvA Place and date: Shanghai, 20 March 2024 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/sites/default/files/2024-07/Colorants _ Additives for Appliances Brochure.pdf
SUSTAINABILITY Avient’s color and additive manufacturing sites comply with ISO standards such as ISO 9001:2015 QMS, ISO 14001:2015 Environmental Management System and ISO 45001:2018*. EC) 1907/2006 and amendments) • UL94 file for MB (QMQS.E73454) and formulations (QMQS.E103015) • “Toys declaration” Directive 2009/48/EC • Waste Electrical & Electronic Equipment (WEEE) * Contact us for more detailed information about our ISO certifications.
https://www.avient.com/sites/default/files/2023-07/TPEs for Healthcare Industry Bulletin.pdf
Versaflex™ & Versalloy™ Specialty Engineered Materials Thermoplastic Elastomers for Healthcare Applications Delivering specialized thermoplastic elastomer (TPE) solutions for demanding healthcare applications, Avient has performance-grade materials that are approved for USP VI, ISO 10993-4 and 10993-5. VERSAFLEX™ HC MEDICAL TUBING GRADES • Improve extrusion rates, achieve high service temperature performance or increase clarity in medical tubing • Traditional and bio- based formulations specifically for biopharmaceutical tubing to meet the needs for weldability and minimize extractables during processing VERSALLOY™ HC SERIES • Obtain better flow in long, thin paths and lower shrink rates versus typical TPVs with our alloys • Color easily and obtain a smooth tactile feel VERSAFLEX™ HC GASKETS & STOPPERS SERIES • Achieve no coring, good puncture and resealability in static stoppers • Meet low COF and low stiction requirements in dynamic seals VERSAFLEX™ CL E SERIES • Increase clarity and flexibility in bags, bottles and films • Mitigate risk with plasticizer-free formulations for film extrusion • Deliver excellent odor & O2 barrier performance for film extrusion INDUSTRY BULLETIN TPE HEALTHCARE PRODUCT SELECTOR GUIDE Versaflex™ HC Medical Tubing Grades Versaflex™ HC MT222 Clear 66A 0.88 14 - 334 2.30 629 4.34 898 6.19 430 220 36 ✔ ✔ High clarity, without plasticizers Versaflex™ HC MT224 Clear 75A 0.89 19 - 468 3.23 773 5.33 1360 9.40 530 321 56 ✔ ✔ Versaflex™ HC MT226 Clear 84A 0.88 20 - 606 4.17 885 6.10 1600 11.00 600 433 76 ✔ ✔ Versaflex™ HC MT317 Clear 68A 0.89 17 69 450 3.10 660 4.55 870 6.00 470 221 39 ✔ ✔ Very high service temperature Versaflex™ HC BT218 Natural 67A 0.89 19 69 381 2.60 683 4.70 1186 8.20 608 - - ✔ ✔ Weldable, kink resistant Versalfex™ HC BIO BT218 Natural 70A 0.88 18 58 416 2.87 668 4.60 1190 8.20 630 - - ✔ ✔ Weldable, kink resistant, contains 40% bio-derived content (Gen 1 biomass) Versaflex™ HC Gaskets & Stoppers Series Versaflex™ HC 2110-35N Natural 34A 0.90 19 47 145 1.00 261 1.80 400 2.76 620 97 17 ✔ ✔ Good resealing Versaflex™ HC 2110-43N Natural 43A 0.98 12 46 134 0.92 368 2.54 723 4.98 710 - - ✔ ✔ Good compression set Versaflex™ HC 2110-57B Black 59A 1.01 20 37 369 2.54 558 3.85 537 3.70 350 147 26 ✔ ✔ Low stiction Versaflex™ CL E Series Versaflex™ CL E85 Clear 84A 0.90 20 72 752 5.18 1160 8.00 1550 10.70 450 433 76 ✔ ✔ High clarity, without plasticizers; E95 also offers excellent odor & O2 barrier Versaflex™ CL E90 Clear 90A 0.90 27 73 1000 6.89 1230 8.50 1830 12.60 57 - - ✔ ✔ Versaflex™ CL E95 Clear 95A 0.90 38 71 1680 11.60 1730 11.90 2500 17.20 580 720 126 ✔ ✔ Versaflex™ HC 3810 Series Versaflex™ HC 3810-20N Natural 20A 0.88 16 54 123 0.80 185 1.30 342 2.40 650 - - ✔ - Formulated without animal derivatives, excellent colorability, translucent Versaflex™ HC 3810-30N Natural 30A 0.89 18 58 170 1.20 245 1.70 459 3.20 680 - - ✔ - Versaflex™ HC 3810-40N Natural 40A 0.88 19 59 191 1.30 275 1.90 506 3.50 670 - - ✔ - Versaflex™ HC 3810-50N Natural 50A 0.89 21 61 264 1.80 366 2.50 699 4.80 690 - - ✔ - Versaflex™ HC 3810-60N Natural 60A 0.88 24 65 459 3.20 594 4.10 790 5.40 510 - - ✔ - Versaflex™ HC 3810-70N Natural 70A 0.88 28 67 535 3.70 684 4.70 1000 6.90 570 - - ✔ - Versaflex™ HC 3810-80N Natural 80A 0.88 30 67 689 4.80 869 6.00 1390 9.60 620 - - ✔ - Versaflex™ HC 3810-90N Natural 90A 0.88 27 89 1087 7.50 1350 9.30 1890 13.00 570 - - ✔ - Versalloy™ HC 9210 Series Versalloy™ HC 9210-45N Natural 45A 0.89 19 39 160 1.10 320 2.20 484 3.33 480 100 18 - ✔ Smooth surface aesthetics Versalloy™ HC 9210-55N Natural 53A 0.89 20 44 208 1.44 335 2.31 580 4.00 610 120 21 - ✔ Versalloy™ HC 9210-70N Natural 70A 0.89 23 53 356 2.45 510 3.52 780 5.38 590 180 32 - ✔ Versalloy™ HC 9220 Series Versalloy™ HC 9220-70 Natural 70A 0.95 17 51 453 3.12 - - 643 4.43 265 208 36 ✔ ✔ ExtrudableVersalloy™ HC 9220-80 Natural 80A 0.94 18 59 553 3.67 777 5.36 945 6.52 415 208 36 ✔ ✔ Versalloy™ HC 9220-90 Natural 90A 0.94 25 55 1030 8.13 1350 9.33 1945 13.45 620 400 70 ✔ ✔ Standard Healthcare Grades Versaflex™ G2705N Natural 60A 0.88 - - - - 528 3.64 670 4.62 470 - - ✔ ✔ Natural, high strength Versaflex™ CL 2242 Clear 43A 0.89 23 - 152 1.05 294 2.02 731 5.00 780 124 22 ✔ ✔ High clarity, boilable Versaflex™ CL 2250 Clear 50A 0.89 20 - 220 1.52 337 2.32 827 5.70 770 140 25 ✔ ✔ Versaflex™ OM Series Versaflex™ OM 1040X Natural 42A 0.92 22 - 180 1.24 301 2.08 504 3.47 580 100 18 ✔ ✔ ABS/PC overmoldVersaflex™ OM 3060 Clear 59A 0.90 33 - 420 2.90 360 2.48 500 3.45 480 180 32 ✔ ✔ Versaflex™ OM 8940X-1 Clear 42A 0.91 - - 233 - 311 - 1573 - 1059 - - - - PK, COPE overmold Versaflex™ OM 4052 Natural 56A 1.01 27 - 271 - 557 - 1680 - 670 - - ✔ - Excellent chemical resistance; PK, PC, ABS, PC/ABS overmoldVersaflex™ OM 4063 Natural 54A 1.12 30 - 365 - 580 - 1640 - 670 - - ✔ - Color Hardness Specific Gravity Compression Set @ 23°C Compression Set @ 100°C 100% Modulus 300% Modulus Tensile Strength Elongation Tear Strength ISO 10993 USP VI Special Characteristics ASTM Shore A ASTM/ISO ASTM % ASTM % ASTM psi MPa ASTM psi MPa ASTM psi ISO MPa ASTM % ASTM pll ISO kN/m GENERAL PROPERTIES TENSILE PROPERTIES OTHER For further information on specific grades, review technical data sheets.
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.
https://www.avient.com/sites/default/files/2022-03/Asia SEM Healthcare Product Selection Guide %281%29.pdf
PP OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Dynaflex™ G2706 28A USP Class VI, ISO 10993, Food contact EtO Soft translucent grade, grippy feel Dynaflex™ G2711 43A USP Class VI, ISO 10993, Food contact EtO Highly colorable solution, grippy feel, low compression set Versaflex™ CL2242 & CL2250 42A/ 50A USP Class VI, ISO 10993, US Food contact EtO Clear boilable grades; ABS, PC bondable Versaflex™ G2705 N 60A USP Class VI, ISO 10993, Food contact EtO/Steam High resilience, low compression set Versaflex™ HC3810 20A-90A USP Class VI, ISO 10993 EtO General purpose, unfilled ABS, PC OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Versaflex™ OM1040 40A USP Class VI, ISO 10993 EtO Translucent Versaflex™ OM3060 60A USP Class VI, ISO 10993 EtO Clear VERSAFLEX™ CL AND DYNAFLEX™ TPEs OVERMOLDING FOR ERGONOMICS • Adds good tactile surface with soft-touch feel • Available in a variety of color effects and textures • Improves grip, cushion, and comfort • Enhances functional performance like sealing properties, vibration damping, oxygen barrier, and scratch and abrasion resistance • Reduces assembly costs, good processability • Offers excellent adhesion to a wide range of substrates Applications: • Glucometers • Medical tools overmolds • Injector pens • Analysis devices VERSALLOY™ HC & VERSAFLEX™ HC TPEs SEALING & RESEALING • Rubbery feel and soft touch • No coring, good puncture, and resealability in static stoppers • Meets low coefficient of friction requirements in dynamic seals • Low extractables • Suitable to overmold onto polyolefins Applications: • Sealing and resealing septum • Seals and sanitary gaskets • Syringe plungers and tips MATERIAL DESCRIPTION HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Versalloy™ HC 9210-45N 45A USP Class VI EtO Good processability, smooth surface aesthetics Versalloy™ HC 9210-55N 55A USP Class VI EtO Good processability, smooth surface aesthetics Versalloy™ HC 9210-70N 70A USP Class VI EtO Good processability, smooth surface aesthetics Versalloy™ HC 9220-43N 43A USP Class VI, ISO 10993-4/5 EtO Extrusion grade, high temperature resistance Versaflex™ HC 2110-35N 34A FDA, USP Class VI, ISO 10993 Autoclave EtO radiation Resealing, elevated comp set Versaflex™ HC 2110-57B 57A FDA, USP Class VI, ISO 10993 Autoclave EtO radiation Low stiction VERSAFLEX™ CL AND DYNAFLEX™ TPEs HIGH CLARITY GRADES WITHOUT PLASTICIZERS • Water clear grades formulated without phthalate plasticizers • Meets medical regulatory USP Class VI and ISO 10993-4,5 • Food contact and FDA compliant • Autoclave and radiation stable • Low extractable • High clarity (Haze 50 4.1, 100 4.5, 100 4, 70 6, 70 Tensile Modulus (MPa) 2200 2700 2600 2350 1820 1820 Flexural Strength (MPa) 80 90 104 86 68 68 Flexural Modulus (MPa) 2500 2700 2500 2300 1980 1590 HDT: 0.45, 1.8 (MPa) 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70 UL-94 Rating @ 3.0 mm 5VA V-0 5VA V-0 HB V-0 UL-94 Rating @ 1.5 mm V-0 V-0 5VB V-0 HB V-0 UL-94 Rating @ 0.75 mm V-1 V-2 V-0 None None V-2 COMPETITIVE MATERIAL COMPARISON ENGINEERED POLYMER FORMULATIONS FOR HEALTHCARE TRILLIANT™ HC THERMOPLASTICS The family of Trilliant™ HC high-performance thermoplastics is formulated to meet the growing challenges of medical devices and equipment.