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.