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 plasticizersVersaflex™ 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 aestheticsVersalloy™ 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/2024-07/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/2024-12/Avient Norwalk A2LA ISO17025-17.pdf
No. 0962.01) 09/05/2023 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 AVIENT CORPORATION 80 North West Street Norwalk, OH 44857 Craig Polta Phone: 419 660 4278 MECHANICAL Valid To: September 30, 2025 Certificate Number: 0962.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following tests on plastics: Test Method(s) Test Name ASTM D256; ISO 180 Notched Izod ISO 179 (1eA) Determination of Charpy Impact ASTM D523 Gloss ASTM D618 (Method A) Conditioning of Test Specimens ASTM D792 (Method A) Specific Gravity ASTM D1238 (Method B) Melt Flow Rate ASTM D3012 Thermal Oxidative Stability ASTM D3641 Injection Molding Test Specimens FMVSS 302 Flammability ASTM E1331; SAE J1545 Spectrophotometric Color Difference SAE J1885 (Rev.
Accredited Laboratory A2LA has accredited AVIENT CORPORATION Norwalk, OH for technical competence in the field of Mechanical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories.
This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
https://www.avient.com/sites/default/files/2024-07/31307-Certificate-17JUL2024.pdf
Certificate - ISO 9001 - Avient Corporation - 337726 - 23521667 (1).pdf
https://www.avient.com/sites/default/files/2023-01/45324-Certificate-13JAN2023.pdf
ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 45324 Certification Date: 24 February 2014 Effective Date: 13 January 2023 Expiration Date: 23 January 2026 Revision Date: 13 January 2023 Dominic Townsend, President DESIGN, MANUFACTURE AND DISTRIBUTION OF THERMOPLASTIC ELASTOMER RESINS & PELLETS FOR THE MEDICAL DEVICE INDUSTRY This certificate may be found on the ABS QE Website (www.abs-qe.com).
WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations Avient Corporation ISO 13485:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2023-10/LubriOne Product Selection Guide.pdf
Steel – Static 0.25 0.46 0.18 0.15 0.12 0.19 0.11 0.14 0.13 0.24 0.17 0.17 Impact Notched Izod Impact (23°C, 3.18 mm, Injection Molded) J/m ASTM D256A 41 64(6) 110 107 107 70 80 37 37 75 – 69 Thermal Properties Heat Deflection Temperature ASTM D648 0.45 MPa °C 215(6) – 250 215 216 184 152 151(6) 153(6) 218(6) – – 1.8 MPa °C 65(6) 239(7) 244(6) 210 210 75 94 81.1(6) 88 197(6) – 135(5) Electrical Properties Surface Resistivity ohms/sq ASTM D254 – – – 1.30x1012 1.9x1012 5.2x1012 – – – – – 1.0x109 Dielectric Strength (Short Time) kV/mm – – 8.5 – – – – – – – – – Flammability Flame Rating Class UL 94 HB – – HB HB HB – HB – – – – LubriOne™ Internally Lubricated Formulations NOTES (1) Type I, 5.1mm/min (2) Type I, 21.3 mm/min (3) Type I, 50 mm/min (4) Type I, 5.1mm/min, Break (5) 3.2 mm thick, Unannealed (6) 6.35 mm thick, Unannealed (7) 3.2 mm thick, Annealed PRODUCT DESCRIPTION UNITS TEST METHOD LB6000- 5024 RS HI Natural LB6000- 5021 RS S1 Black LB6000- 5021 RS X2 Black LB6000- 5019 X1 Black LB6700- 5001 RS AF Black NN- 000/01M Black SO REC LB6600- 5030 RS Grey LB3300- 5010 RS Natural LB3300- 5005 RS Natural REC LB3220- 5001 RS C Natural X1 LB8900- 5010 GP Grey LB8900- 5006 RS PE Natural LB8900- 5004 RS PE Natural LB4200- 5022 Black LB4200- 5023 Natural Base Polymer PA 6 PA6/PA66 PA66 PBT PC PKE POM Lubricant UHMWPE1 UHMWPE UHMWPE UHMWPE UHMWPE MoS22 Graphite UHMWPE UHMWPE UHMWPE Graphite UHMWPE UHMWPE MoS2 UHMWPE Filler type GF10 GF30 GF30 GF50 GF50 Unfilled GF33 GF20 MI20 GF10 Unfilled GF20 GF30 Unfilled Unfilled General Properties Specific Gravity g/cm3 ISO 1183 1.18 1.35 1.39 1.55 1.58 1.14 1.44 1.42 1.46 1.23 1.26 1.34 1.43 1.4 1.35 Mechanical Properties Tensile Modulus (23°C) MPa ISO 527-1 4250 9500 9000 15500 16600 3500 10600 6300 3330 4000 1630 5300 9250 2470 2150 Tensile Strength (Yield, 23°C) MPa ISO-527-2 97 150 160 205 200 85 164 102 55 60 60 108 99.1 55 50 Tensile Elongation (Break, 23°C) % ISO-527-2 12 2.5 3 2.7 2.4 3.4 2.0 4.2 8 2.5 46 3.7 1.5 11 11 Flexural Strength (23°C) MPa ISO 178 103 – – 285 265 108 215 127 78 85 38 155 117 73 68 Flexural Modulus (23°C) MPa ISO 178 3250 – – 12400 11100 2690 9000 4700 3000 3100 1380 4600 5450 2210 2070 Impact Charpy Notched Impact Strength (23°C, Injection Molded) kJ/m^2 ISO 179 14 12 10 15 10 3 6 7.7 4.3 12 15 10 7.6 8 5 Charpy Unnotched Impact Strength (23°C, Injection Molded) kJ/m^2 ISO 179 82 55 61 75 60 65 50 47 69 - NB 63 36 NB NB Thermal Properties Deflection Temperature Under Load 1.8 Mpa, Unannealed °C ISO 75-2/A 107 – – 204 – 73 235 – – – 90 210 204 86 80 Cofficient of Friction (CoF) & Wear Rate CoF vs.
https://www.avient.com/sites/default/files/2021-11/0514-02-dec2021.pdf
Avon Lake, OH for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories.
This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Presented this 28th day of February 2020. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.02 Valid to December 31, 2021 Revised September 21, 2021 0514-02s SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 Test Method or Standard: Test Description: 0514-02c
https://www.avient.com/sites/default/files/resources/PolyOne%2520Standard%2520Quality%2520Response_2016_6_9.pdf
ISO certificates can be found at www.polyone.com under Quick Links > ISO List.
What certifications exist, or what certifications is the supplier in the process of achieving Plants are ISO 9001or ISO/TS 16949.
Yes, as part of the ISO 9001 documentation. 8.
https://www.avient.com/sites/default/files/2023-11/ISO14001 Global Cert_Avient.pdf
Activity: Design and Manufacture of Colorants and Additives for Plastics Page 6 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Compound, Supply, and Prototyping Services of Thermoplastics Activity: Design and Manufacture of Colorants and Additives for Plastics Page 8 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Design and Manufacture of Plastics Compounding Material and Thermoplastic Elastomers Page 10 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2024-05/ISO14001 Global Cert_Avient_2024.pdf
Activity: Design and Manufacture of Colorants and Additives for Plastics Page 6 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Compound, Supply, and Prototyping Services of Thermoplastics Activity: Design and Manufacture of Colorants and Additives for Plastics Page 8 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Design and Manufacture of Plastics Compounding Material and Thermoplastic Elastomers Page 10 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.