https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
REGULATORY SUPPORT
• Drug delivery devices
• Pharmaceutical packaging
• Medical equipment
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number level, reducing the risk of change
• Allows crystallization in semi-crystalline
polymers to begin faster and complete earlier
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
* FDA/EU compliance information available upon request
Healthcare use limitations apply—see below.
Avient is committed to the needs of our healthcare customers.
As part of our commitment, we publish Avient’s Mevopur™ product policy and use limitations to assist customers in their product selection.
https://www.avient.com/sites/default/files/2023-05/Mevopur Healthcare Colorants and Formulations Amber for Pharma 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 level, reducing risk of change
• Non-phthalate and formulated without
animal-derived substances
• Different tones of amber available on request
—more or less red or yellow and/or lighter
or darker
• Also available in liquid form
REGULATORY SUPPORT
• Pre-tested raw materials:
- ISO 10993-1 and USP parts
(Class VI)
- European Pharmacopeia, monograph
3.1.15, USP and elemental analysis
as per ICH Q3D
- USP criteria appearance of solution,
color
• Registered Drug Master File (Type III) by
the FDA
• Food contact compliance established with
FDA/EU*
• YBB00102002-2015 (oral liquid pharmaceutical
PET bottles) compliance support
APPLICATION BULLETIN
* FDA/EU compliance
information available
upon request
Healthcare use limitations apply—see below.
Avient is committed to the needs of our healthcare customers.
As part of our commitment, we publish Avient’s Mevopur™ product policy and use limitations to assist customers in their product selection.
https://www.avient.com/idea/andwin-scientific-innovation-improves-dosing-accuracy
They ultimately selected a solution that utilized two custom formulations, both of which would meet FDA requirements.
The membrane would be made from a custom-engineered GLS™ Dynaflex™ TPE overmolded onto the shell.
When the product went into full production in the United States, Andwin Scientific realized a number of key gains:
https://www.avient.com/knowledge-base/article/overmolding-tpe-selection
There are a variety of GLS™ soft touch TPEs designed to have excellent adhesion to a number of rigid plastic substrates.
If you do not see your substrate in this table, please contact GLS directly; we can develop a custom TPE that is optimized to bond to your specific substrate.
https://www.avient.com/knowledge-base/article/overmolding-tpe-selection?rtype[]=1164
There are a variety of GLS™ soft touch TPEs designed to have excellent adhesion to a number of rigid plastic substrates.
If you do not see your substrate in this table, please contact GLS directly; we can develop a custom TPE that is optimized to bond to your specific substrate.
https://www.avient.com/sites/default/files/2021-04/gravi-tech-pipe-system-valve-case-study.pdf
They
are difficult and time-consuming to install, require a number
of different par ts, and wear out rapidly.
Avient’s experts customized a Gravi-Tech formulation
that met our exact requirements.”
High performance = customer satisfaction: The
PolyChek valve gives API’s customers the ability to create
all-plastic piping systems that eliminate leakage and
weak spots
https://www.avient.com/sites/default/files/2021-06/avient-design-versaflex-wet-grip-tpe-fishing-tool-grip-case-study-one-pager.pdf
OUTDOOR GEAR
MAKER
F I S H I N G T O O L G R I P
• Aesthetically differentiate new products while optimizing
user functionality and safety
• Meet weatherability performance required by industry
standard UV and Salt Water Exposure tests
• Resist fish oils, sunscreens, and cleaners
• Comply with FDA food contact requirements
• Provided product development support from
concept to production, including visual brand
integration, part design, and material selection
• Customized grip design and TPE formulation to
retain grip and tactile feel in wet and oily
environments
• Expedited lead time with advanced design and 3D
modeling services to enable product launch at key
industry tradeshow
• Offered global supply continuity with local technical
and manufacturing support
Custom Versaflex™ Wet Grip TPE and Avient
Design Services
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/resource-center/services/avient-design
https://www.avient.com/news/dyneema-showcase-latest-law-enforcement-and-defense-armor-material-innovations-enforce-tac-2025-european-made-material-solutions-enable-lightweight-ballistic-protection
Additionally, the Dyneema® Technical Service Center in Heerlen supports body armor manufacturers in next-generation product development.
Experience the future of personal protection firsthand by visiting the Dyneema® team in Hall 9, booth number 9–650, during Enforce Tac 2025, February 24–26 in Nurnberg, Germany.
Our local touch and customer engagement, combined with our global presence, allows us to serve customers with agility.
https://www.avient.com/company/sustainability/sustainability-report/products/markets/protective-materials
Improving safety for those that protect us—law enforcement, first responders, and military service personnel—while they keep communities around the world safe.
Through innovation and collaboration the portfolio has expanded not only in the number of applications but also in the different forms that are available.
International Sustainability & Carbon Certification (ISCC certified), Bio-based Dyneema® fiber enables our partners and downstream customers to reduce their carbon footprint while maintaining the same trusted performance of the world’s strongest fiber™.
https://www.avient.com/sites/default/files/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.pdf
Custom
pre-colored formulations can be developed in other
resins upon customer request.
Avient is committed to the needs of our healthcare customers.
As part of our commitment, we publish Avient’s Mevopur™ product policy and use limitations to assist customers in their product selection.