https://www.avient.com/sites/default/files/2020-07/tpes-for-healthcare-industry-bulletin.pdf
VERSAFLEX™
HC MEDICAL
TUBING SERIES
• Improve extrusion
rates, achieve high
service temperature
performance or
increase clarity
in medical tubing
• Meet
biopharmaceutical
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, made
with Santoprene™
TPV
• 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
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 MT Series
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
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 ✔ ✔
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/2025-03/65536-Certificate-05MAR2024.pdf
Leadership, EHS&S-PS,
Facility Services, Design & Development, Information Technology, Sourcing,
Logistics, Legal, and Human Resources
33587 Walker Road Avon Lake OH
44012 United States
Avon Lake, OH (SEM)
Design and Manufacture of Specialty Engineered Thermoplastics 554 Moore Road Avon Lake OH
44012 United States
Kornkamp 50 Ahrensburg Schleswig-
Holstein 22926 Germany
Avient Corporation - Albany Design and Manufacture of Colorants and Additives for Plastics 4 Rothwell Ave, PO Box 300-009
Auckland 0632 New Zealand
Avon Lake Color
Design and Manufacture of Specialty Engineered Thermoplastics 33587 Walker Road, Building 416
Avon Lake OH 44012 United States
Avient Corporation Design and Manufacture of Specialty Engineered Thermoplastics Pol.
Water Street North Baltimore
OH 45872 United States
NEU Specialty Engineered Materials,
LLC
Compound, Supply, and Prototyping Services of Thermoplastics 15 Corporate Drive North Haven CT
06473 United States
Avient Corporation Design and Manufacture of Colorants and Additives for Plastics 80 North West Street Norwalk OH
44857 United States
Page 3 of 5
Avient Corporation Manufacture of Masterbatches, Additives, ECCOH, and Compounds for
Pigmenting Thermoplastic
Pol.
https://www.avient.com/sites/default/files/2025-02/31307-Certificate-17JUL2024.pdf
Certificate Avient Corporation
S
E
s
Certificate Of Conformance
This is to certify that the Quality Management System of:
Avient Corporation
33587 Walker Road, Building 428
Avon Lake OH
44012
United States
has been assessed by ABS Quality Evaluations, Inc. and found to be in
conformance with the requirements set forth by:
ISO 9001:2015
The Quality Management System is applicable to:
Manufacture of plastic compounds, color and performance additives, engineered
thermoplastics, vinyl resins, custom mixed plastic materials, custom and commodity colorants
for plastics, polyurethane systems, and plasticizers with design and sampling support at
Suwanee, GA, and purchasing, customer service, logistics, quality, design and sampling
support at PolyOne Corporate Headquarters at Avon Lake, OH, and distribution of resins
Certificate No: 31307
Certification Date: 12 OCT 1995
Effective Date: 11 JUL 2024
Expiration Date 07 OCT 2025
Revision Date: 17 JUL 2024
Dominic Townsend, President
Page 1 of 4
S
E
s
ISO 9001:2015
Certificate Of Conformance
ANNEX
Certificate No.: 31307
Avient Corporation
At the below facilities
The Manufacture of Pultruded and Filament wound components Pultrusion and CRTM 3943, Valley East Industrial
Drive, Buildings 1,2,3,4
Birmingham - AL 35217 United
The Manufacture of Pultruded and Filament wound components Pultrusion and Filament Wound
Tubing
3968, Valley East Industrial
Drive, Building 5 Birmingham -
AL 35217 United States
The Manufacture of Pultruded and Filament wound components Pultrusion 3950, Valley East Industrial
Drive, Building 6 Birmingham -
AL 3517 United States
Corporation
Management of QMS.
Purchasing, Customer Service, Logistics, Quality, Design and Sampling;
Corporate HQ, Management of QMS
33587, Walker Road, Building
428 Avon Lake - OH 44012
United States
Avon Lake, OH
(SEM)
Manufacture of Engineered Thermoplastics , 554 Moore Road Avon Lake -
OH 44012 United States
Aland (Odkarby),
Finland
Manufacture of colorants and compounds for fluoropolymer and high temperature polymers Kroklundsvagen 346 AX-22320
Ödkarby Finland
Alicante (Ibi -
IQAP), Spain
Design, development and production of color concentrates and additives for plastic and synthetic
fibers
Guadalajara 6, Poligono
Industrial L'Alfalç 03440 Ibi
Assesse,
Belgium (CAI &
SEM)
"Design of color concentrates, precolors, and compounds for fluoropolymer and high temperature
polymers, LSFOH (low smoke and fume, zero halogen compounds), and Specialty Compounds
Manufacture of Color and Additive Concentrates and Specialty Compounds"
2 Rue Melville Wilson 5330
Assesse Belgium
Barbastro
Design and Manufacture of Specialty Engineered Thermoplastics Pol.
https://www.avient.com/sites/default/files/2023-10/31307-Certificate-20SEP2023.pdf
This is to certify that the Quality Management System of:
Avient Corporation - HQ
33587 Walker Road
The Quality Management System is applicable to:
Certificate No: 31307
Certification Date: 12 October 1995
Effective Date: 20 September 2023
Expiration Date: 07 October 2025
Revision Date: 20 September 2023 Dominic Townsend, President
MANUFACTURE AND SUPPLY OF PLASTIC COMPOUNDS, COLOR AND PERFORMANCE ADDITIVES, ENGINEERED
THERMOPLASTICS, VINYL RESINS, CUSTOM MIXED PLASTIC MATERIALS, CUSTOM AND COMMODITY
COLORANTS FOR PLASTICS, POLYURETHANE SYSTEMS, AND PLASTICIZERS WITH DESIGN AND SAMPLING
SUPPORT AT SUWANEE, GA, AND PURCHASING, CUSTOMER SERVICE, LOGISTICS, QUALITY, DESIGN AND
SAMPLING SUPPORT AT AVIENT CORPORATE HEADQUARTERS AT AVON LAKE, OH, AND DISTRIBUTION OF
RESINS
This certificate may be found on the ABS QE Website (www.abs-qe.com).
Purchasing, Customer Service, Logistics,
Quality, Design and Sampling; Corporate HQ, Management of QMS
Activity: Manufacture of Engineered Thermoplastics
Page 3 of 7
Facility: Avient Corporation - Massillon, OH
1675 Navarre Road
Massillon, OH 44646
833 Ridgeview Drive
Activity: Manufacture of Color and Performance Additives Activity: Design, Manufacture and Distribution of Thermoplastic Elastomer
831 Ridgeview Drive
921 Ridgeview Drive
Activity: Design, Manufacture and Distribution of Thermoplastic Elastomer
Activity: Design, Manufacture and Distribution of Thermoplastic Elastomer
Facility: Avient Corporation - Lehigh Valley, PA
2513 Highland Avenue
Bethlehem, PA 18017
Facility: Avient Corporation - Lockport, NY
4921 I D A Drive
Lockport, NY 14094
Activity: Manufacture of Colorants for Plastics Activity: Manufacture of thermoplastic compounds
Page 4 of 7
Facility: Avient Corporation- Suwanee, GA
2900 Shawnee Industrial Way
Suwanee, GA 30024
Facility: Avient Corporation - Toluca, Mexico
AV.
https://www.avient.com/sites/default/files/2022-02/Sustainability ESG Disclosures_Titanium Dioxide.pdf
The most common use—coatings and plastics—accounts for more than 80 percent of global consumption.
https://www.avient.com/sites/default/files/2024-01/ColorMatrix AAnchor Brochure_A4.pdf
GLOBAL REGULATORY
APPROVALS
ColorMatrix AAnchor is approved
for use in Europe, with regulatory
approval by FDA expected in 2024.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Colorants and Formulations Special Effects Application Bulletin_0.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified
manufacturing sites, providing global
consistency and increased security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Non-phthalate and formulated without
animal-derived substances
• Available as pre-colored formulation or
concentrate and for use in different polymers
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
* Design note: Effect colors require careful consideration of part design and
polymer flow paths to minimize visible flow lines.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations for Needle Hubs 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, reducing risk of change
• Non-phthalate and formulated without
animal-derived substances
• Color can be combined with additives to
enhance performance and protection
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 Device Master File
• Food contact established with FDA/EU*
NOMINAL
OUTSIDE
DIAMETER OF
NEEDLE (MM)
COLOR
DESCRIPTION RAL PANTONE TRANSPARENT
PRODUCT CODE
OPAQUE
PRODUCT
CODE
0.4 Medium Grey 7035 423 C PP7M665125 PP7M665127
0.45 Brown 8017 7588 C PP8M665294 PP8M665296
0.5 Orange 2003 173 C PP2M665298 PP2M665300
0.55 Medium Purple 4005 7676 C PP4M665290 PP4M665292
0.6 Deep Blue 5010 288 C PP5M665894 PP5M665896
0.7 Black 9005 Black C PP9M664950 PP9M664952
0.8 Deep Green 6001 7483 C PP6M665687 PP6M665689
0.9 Yellow 1021 115 C PP1M665211 PP1M665213
1.1 Cream 1015 7401 C PP0M665290 PP0M665292
1.2 Pink 3015 502 C PE3M665725 PP3M665727
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-10/Cesa Unify A4R Product Bulletin.pdf
Cesa™ Unify™ A4R
Polyolefin Compatibilizer for Enhanced Recycling
RECYCLED MATERIAL IN A CHANGING
MARKET
Legislation globally is driving change towards
increased quantities of post-consumer recycled
(PCR) materials, further encouraged by the
implementation of usage targets and new tariffs.
https://www.avient.com/sites/default/files/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified
manufacturing sites, providing global
consistency and increased security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Non-phthalate and formulated without animal-
derived substances
• Standard concentrates in a PE carrier and
on request in PP
• Pre-colored formulations can be supplied in
specific resins selected for the application
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)
• Food contact established with FDA/EU*
APPLICATION BULLETIN
DRUG TYPE COLOR
DESCRIPTION
PANTONE
REFERENCE
AVIENT PRODUCT
CODE PE BASED
Adrenergic agonist
combinations Light Green 373 C PE6M176349
Adrenergic agonists Purple 2583 C PE4M176057
Anti-infectives Tan 467 C PE8M176130
Anti-inflammatory,
nonsteroidal Grey Cool Grey 4 C PE7M176184
steroids Pink 197 C PE3M176237
Anti-inflammatory,
immunomodulators Olive Green 5763 C On request
Beta-blockers Yellow Yellow C PE1M176160
Beta-blocker combinations Dark Blue 281 C PE5M176272
Carbonic anhydrase inhibitors Orange 1585 C PE2M176089
Cytotoxic Black 6 C PL9M176008
Miotics Dark Green 348 C PE6M176267
Mydriatics and cycloplegics Red 1797 C PE3M176236
Prostaglandin analogues Turquoise 326 C PE5M176273
Healthcare use limitations apply—see below.