https://www.avient.com/knowledge-base/article/quality-design?ind[]=6598
To help customers manage their risk potential, dedicated facilities and systems govern the production of our medical colorants and performance masterbatches.
Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals).
https://www.avient.com/knowledge-base/article/quality-design?rtype[]=1164
To help customers manage their risk potential, dedicated facilities and systems govern the production of our medical colorants and performance masterbatches.
Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals).
https://www.avient.com/products/polymer-colorants/fiber-colorants/remafin-fiber-colorants
Explore the power of polymer solutions for hygiene & medical nonwovens
Discover how Avient's polymer colorants and additives can help increase the performance and appeal of nonwovens used in hygiene and medical applications
https://www.avient.com/products/polymer-colorants/colorant-dispersions/stan-tone-hc-plus-silicone-dispersions-healthcare
They are suitable for specialty medical devices, surgical devices, and other vital healthcare applications.
Portfolio of available dispersion colorants and additives for medical applications
https://www.avient.com/sites/default/files/resources/HIGH_PERFORMANCE_CLEAR_THERMOPLASTICS_ELASTOMER.pdf
Silicone/PVC/TPV replacement for medical
tubing
The plasticizer used in PVC compound
restricts PVC in many medical applications.
Special grade of TPV can be used for various
medical application, however is opaque.
Medical grade
SBC compounds have transparent or translucent
appearance and are suitable for medical tubing
applications.
https://www.avient.com/sites/default/files/2023-01/Mevopur Colorants _ Additives Brochure.pdf
Mevopur color and performance concentrates as
well as ready-to-use formulations add value to a
wide range of applications:
MEDICAL DEVICES
• Drug delivery
• Catheters
• Renal care/dialysis
• Surgical instruments
• Dental instruments
• Medical device packaging
• Electronic instruments and accessories
for monitoring
PHARMACEUTICAL PACKAGING
• Vials, ampoules
• Bottles for pills, liquid medicines
• Blister packaging
IN VITRO DIAGNOSTICS (IVD)
• Blood analysis
• IVD devices
• IVD disposables (e.g., pipette tips)
• Point-of-Care
To meet various manufacturing processes,
colorants and functional additives are provided
as concentrates for dilution into the polymer or
as ready-to-use formulations.
Mevopur products
cover the wide range of polymers and thermoplastic
elastomers (TPEs) used in the medical and
pharmaceutical sectors.
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/sitemap
Medical Stoppers, Improved
Medical Tubing
Medical Packaging
https://www.avient.com/sites/default/files/2023-01/Disinfectant Resistant Trilliant and Versaflex HC Materials Program Bulletin_0.pdf
When designing a medical device, selecting a material that will last and perform well under harsh conditions
has never been tougher.
Currently, concerns over healthcare-associated infections (HAIs) have led many
medical facilities to respond by disinfecting equipment surfaces more frequently using harsher disinfectants.
Versaflex™ HC thermoplastic elastomers can
enhance ergonomics in medical devices by adding
a soft touch and improved grip.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Colorants and Formulations Special Effects Application Bulletin_0.pdf
Mevopur™ Healthcare Colorants and Formulations
Special Effect Colorants for Healthcare Devices and
Pharmaceutical Packaging
Self-administered medication, for example via
pen devices and inhalers, has been the norm for
many years.
Ingredients used in the
Mevopur™ portfolio have been tested to industry
standards that support applications in both
medical devices and pharmaceutical packaging.*
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.
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/2022-12/Mevopur Laser Marking Additives Application Bulletin.pdf
Mevopur™ Healthcare Functional Additives
Laser Marking Additives for Medical Devices and Pharmaceutical Packaging
Laser marking offers several advantages compared
to other marking technologies.
Potential applications include
graduation markings for dose-dials, syringes and
droppers, and serialization/coding (e.g., UDI) for
medical devices and pharmaceutical packaging.
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.