https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
Mevopur™ Healthcare Functional Additives
Chemical Foaming Agents (CFA) for Medical Devices
and Pharmaceutical Packaging
As the need to integrate sustainability in the design
of healthcare products is growing, manufacturers
of medical devices and pharmaceutical
packaging are looking for materials with a more
environmentally-friendly profile.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including
the suitability of all raw materials and components used for its manufacture.
https://www.avient.com/sites/default/files/2023-10/Nonwoven Colorants and Additives Brochure_A4.pdf
COLORANTS &
ADDITIVES
FOR NONWOVENS
NONWOVENS ARE USED IN A VARIETY OF INDUSTRIES, from hygiene and medical to
building and construction.
At higher addition
levels they also have a hydrophilic effect,
which is particulary recommended for
medical gowns.
COLOR
Color can be added for application
identification (e.g., blue and green for
medical) or for differentiation.
https://www.avient.com/sites/default/files/2024-11/Dispersions Healthcare Leave-Behind.pdf
Suitable for a variety of healthcare
applications including medical tubing, devices, and
equipment.
Rubber Colorant Dispersions
Provide optimal dispersion and lot-to-lot consistency
to promote durability and ease of handling for medical
devices and tools.
Surface Modification Additives for Silicone
Reduce tackiness and enhance smoothness of the cured
silicone compound for healthcare applications such as
medical tubing, catheters, and medical equipment.
https://www.avient.com/knowledge-base/article/chemically-resistant-polymers-next-generation-devices?ind[]=6596
Various materials and their resistnace to common disinfectants used in consumer, industrial, and medical applications
https://www.avient.com/knowledge-base/article/chemically-resistant-polymers-next-generation-devices?ind[]=6598
Various materials and their resistnace to common disinfectants used in consumer, industrial, and medical applications
https://www.avient.com/sites/default/files/2024-07/TPE Whitepaper_0.pdf
Ergonomic Enhancements
TPE soft grips can also optimize medical practitioners’ control of surgical instruments during procedures
and protect expensive handheld diagnostic devices.
In addition, when used to produce easy-open
pill bottles in various colors that can be clearly identified, TPEs aid arthritic patients while they self-
administer medications at home.
4.
In addition, the formulation
meets ISO 15759 requirements for medical infusion equipment and is
manufactured in an ISO 13485 facility.
https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-versalloy-infusion-adapter-port.pdf
MEDICAL EQUIPMENT
MANUFACTURER
C L O S E D S Y S T E M D R U G
T R A N S F E R D E V I C E
• A new material for a seal inside the next generation of
closed system drug transfer device
• Compliance with stringent regulatory standards:
• Biocompatibility to ISO10993
• USP VI compliance
• Provided regulatory support services and
expertise throughout extensive medical
approval process
• Provided a custom formulation compliant with
the highest healthcare regulatory standards
• Enabled material to be manufactured and
shipped globally
Custom Versalloy™ HC 9220-90 Formulation
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
REGULATORY COMPLIANCE
LEARN MORE
© 2020, All Right Reserved
Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012
https://www.avient.com/products/thermoplastic-elastomers/versalloy-thermoplastic-elastomers
Medical equipment Manufacturer
https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
Avient products have not been designed for nor are they promoted or intended for use in:
(a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under
US Pharmacopoeia (USP) or ISO standards; or
(b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or
(c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.
Without limiting the generality of this statement, Avient products shall not be used in any medical device application intended for:
(1) exposure to human tissue or body fluids for 30 days or greater;
(2) “plastic” (cosmetic or reconstructive) surgery use;
(3) reproductive implants or any birth control device; or
(4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device, including the suitability of all raw materials and
components used for its manufacture, and with all applicable laws and regulations.
1.844.4AVIENT
www.avient.com
https://www.avient.com/sites/default/files/2021-05/avnt-tpe-beginner-guide-fin.pdf
What are medical
grade TPEs?
What are medical grade
TPEs?
Medical tubing made from
TPE is likewise formulated from a medical grade that withstands various
fluids without degrading.
https://www.avient.com/sitemap
Medical Stoppers, Improved
Medical Tubing
Medical Packaging