https://www.avient.com/sites/default/files/2021-04/versaflex-hc-3810-covid-19-containment-tube-screw-caps-case-study.pdf
DIAGNOSTICS
MANUFACTURER
C O V I D - 1 9 C O N T A I N M E N T
T U B E S C R E W C A P S
• Wide range of durometers with consistent raw materials
• Processing consistencies across the durometer ranges for
an easy transition between materials
• Materials formulated without animal derivatives at a
competitive cost
• Offered a comprehensive range of solutions
to accommodate specific application
demands such as barrier, flexibility, and
sealing performance
• Provided materials manufactured in an ISO
13485 certified facility
• Delivered a series of medical-grade TPEs
that could be extruded and injection molded
Versaflex™ HC 3810 Thermoplastic
Elastomers
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-bt218-biopharmaceutical-tubing-case-study.pdf
MEDICAL TUBING
EXTRUDER
B I O P H A R M A C E U T I C A L
T U B I N G
• Low leachables & extractables
• Great tensile performance and kink resistance
• Good thermal weldability
• Excellent clarity and medical blue tint
• ISO 10993-4 & 5, USP Class VI & Animal Derivative Free
(ADF)
• Supplied drop-in material replacement to
overcome supply constraints of incumbent TPE
• Offered a lower extractable profile than
comparable materials in the market
• Enabled easy material transition without changes
in tooling or thermal welding machine settings
• Formulated solution with proprietary additives to
provide clarity and prevent yellowing after
sterilization
Versaflex™ HC BT218 Thermoplastic
Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2024-02/Santa Clara_ISO22000.pdf
Plasticos 28
Santa Clara Coatitla
55540 Ecatepec de Morelos, Estado de México
Mexico
Scope
Category I
Production of customer specific Masterbatches
for Food packaging materials on the dedicated
extrusion lines
Normative base
ISO 22000:2018 Food Safety Management Systems
Requirements for any organization in the food chain
Reg. no. 46389 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Made
sqs.ch
F.
https://www.avient.com/sites/default/files/2024-07/Versaflex TPE for Orthopedic Sole Insert - Application Snapshot.pdf
O RT H O P E D I C PA RT S
M A N U FAC T U R E R
O R T H O P E D I C S O L E I N S E R T
• A super soft TPE (
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.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 concentrates or ready-to-use
formulations in a wide range of polymers
• Functionality and color can be combined in
one product for convenience
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
• Documentation support for approval or
transition to comply with (new) regulations
such as IVDR
APPLICATION BULLETIN
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2020-08/willowwood-prosthetics-case-study.pdf
After extensive testing, including mechanical testing to
ISO 10328 standards and a six-month participant clinical
trial, WillowWood introduced DuraWalk™, their most
advanced low-activity foot.
https://www.avient.com/sites/default/files/2022-12/Cesa Fiber Additives Antimicrobials Product Bulletin.pdf
PRODUCT BULLETIN
KEY BENEFITS
Avient’s antimicrobial concentrates for fiber
applications provide the following benefits:
• High active-ingredient loading which translates
to excellent efficacy at low let-down ratios
• Easily withstand 50 washings in ISO 20743
standard tests
• Also applicable for bi-component technology
• Low levels of abrasiveness means higher
process performance—reducing cost in the
spinning phase
• Can be combined with colors and with other
additives (e.g., flame retardants) into a single
combination concentrate for convenience
• Product guidance and technical assistance from
our experts
Copyright © 2022, Avient Corporation.
https://www.avient.com/sites/default/files/2023-12/Cesa Light Additives for Injection Molding Product Bulletin.pdf
The white ABS
plastic samples, produced with and without Cesa
Light Additives, were exposed to simulated sunlight
conditions using the weathering test ISO 4892-
2:2013.
https://www.avient.com/sites/default/files/2025-01/NEUSoft Product Selection Guide.pdf
Whether your application demands can be supported
by the NEUSoft Express color palette or require
customization, all our NEUSoft TPUs are designed with
patient safety and regulatory specifications in mind,
complying with ISO 10993 and USP Class VI standards.
https://www.avient.com/sites/default/files/2021-08/avient-cdp-climate-change-questionnaire-2021.pdf
In addition, Avient has externally
certified EHS&S management systems, including ISO 9001 worldwide.
ISO 14001,
Responsible Care 14001, ISO 45001, ISO 50001, and OHSAS 18001, certification at 74% of
facilities.
In addition, Avient has ISO 9001
worldwide and ISO 14001 and ISO 50001 certification at many facilities.