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 Functional Additives Medical Devices 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
• Available for use in a wide range of polymers
including polyolefins, styrenics, polycarbonate
and alloys, polyester, POM
• Functionality can be combined with colorants
into convenient combination concentrates and
ready-to-use formulations
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
FUNCTIONALITY TARGET APPLICATIONS
DRUG
DELIVERY
DEVICES
SYRINGES &
NEEDLES DIAGNOSTICS CATHETERS
Clarifying PP
Sorbitol-free for transparent
applications with reduced migration
and improved thermal stability
Lubricant—
permanent/
non-migrating
Fast acting reduction in friction
for wide variety of polymers such
as PP, ABS, POM, PC
Protection from
UV in transparent
applications for PP,
PE, PETG, COP
UV blocking in 290-450nm with
no impact on clarity; can be
combined with colors (e.g., amber)
Antistatic ready-to-
use solution for PP,
ABS, PC/ABS
Permanent/non-migrating;
fast decay time independent
of % relative humidity
Gamma/e-beam
sterilization
protection of the
polymer
Preserving the properties of
PP and COC/COP; reduction
in yellowing using Color
Compensation Technology (CCT)
Reduced material
consumption/cycle
time—nucleation
Fast acting new generation
nucleant for PE and PP; improved
thermal and mechanical properties
allows wall thinning; reduction of
tolerance/dimensional problems
between different colors
Laser marking
replacing ink
printing/labels
Solvent-free, high-speed
identification for Nd/YAG laser
for PE,PP, ABS, PC, POM
Antioxidants for
PE, PP, TPE
Thermal protection during
converting/downstream sterilization
Brand protection/
anticounterfeit Covert and non-covert systems
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Pharma Pkg 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
• Available for use in a wide range of polymers
including polyolefins, styrenics, polycarbonate
and alloys, polyester, POM
• Functionality can be combined with colorants
into convenient combination concentrates or
formulations
REGULATORY SUPPORT
• Pre-tested raw materials:
- 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
* FDA/EU compliance information available upon request
FUNCTIONALITY TARGET APPLICATIONS EBM/IBM
CONTAINERS CLOSURES FILM COMBINATION
DEVICES
Clarifying PP Sorbitol-free—possibilities in
packaging ocular solutions
Slip/torque reduction Slip for PE, PP films, processing aid,
torque reduction for closures
Protection from UV in
transparent packaging
for PP, PE, PETG, COP
UV blocking in 290–450nm with
no impact on clarity
Antistatic ready-to-use
solution for PE films e.g.
https://www.avient.com/sites/default/files/2022-12/Mevopur Laser Marking Additives Application Bulletin.pdf
KEY CHARACTERISTICS
• Designed for Nd:YAG lasers operating between
1060-1070 nm
• Available for different polymers including
PP, PE, PC, PBT, POM, ABS, MABS
• 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
• Can be designed for dark marking on natural
or white/light colored background or light
marking on black/dark background
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.
https://www.avient.com/sites/default/files/2023-03/Cergy-AVIENT LUXEMBOURG-2022-Décret 2021-461 Certfificate.pdf
MAIA+
N° rapport :223-2023-000066-FR 10898066 0.5
jour
Date Début / Fin :04/11/2022 /04/11/2022 PolyOne France - site de Saint Ouen l'Aumône 1 /11
ATTESTATION DE RECONNAISSANCE
Attribué à
PolyOne France - site de Saint Ouen l'Aumône
14 avenue de l'Eguillette / ZA du Vert Galant
95310 - SAINT OUEN L'AUMONE - FRANCE
Bureau Veritas Certification certifie que les prestations de l’entreprise susmentionnée
ont été évaluées et jugées conformes aux caractéristiques énoncées dans le décret
en vigueur à la date d’édition du présent certificat :
Décret n°2021-461 du 16 avril 2021 relatif à la
prévention des pertes de granulés de plastiques
industriels dans l’environnement
Sous réserve du respect des caractéristiques vérifiées, cette attestation est
valable jusqu’au : 16/02/2026
Date originale : 17/02/2023
Attestation n°: 223-2023-000066-FR Date : 17/02/2023
Affaire n°: 10898066
Laurent CROGUENNEC - Président
Adresse de l’organisme certificateur : Bureau Veritas Certification France
Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense
Des informations supplémentaires concernant le périmètre de cette attestation ainsi que
l'applicabilité des exigences du décret peuvent être obtenues en consultant l'organisme.
https://www.avient.com/sites/default/files/2022-09/FR Healthy Bldg Codes Application Snapshot.pdf
PROFILE/SHEET EXTRUDER
R A I L S A N D K I C K P L A T E S
• Convert existing PVC profile and sheet rails and kick plates to
polyolefin resin to meet Class A fire safety (ASTM E84)
• Provide a system that meets healthy building certifications
and approvals
• Utilize a more sustainable flame retardant technology,
removing brominated or halogenated flame retardants from
the environment
• Achieve non-compromising performance in aesthetics,
impact, dimensional stability, CLTE, and E84 testing
• Provided broad flame retardant platform, backed by
extensive application and industry expertise, to meet
global flammability standards
• Has largest UL94 recognized Prospector membership
with HB, V-0, V-1, V-2 and 5VA/5VB ratings, and broad
glow wire performance products
• Included in-house UL certified labs and manufacturing
locations to perform UL94 material sampling and testing
• Supported application development to meet fire safety
standards, address current or emerging healthy building
codes, smart home requirements, and LEED credits
• Offered custom formulations in small lot quantities
Cesa™ Flam Non-Halogen Flame Retardants
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
CERTIFICATIONS + QUALITY
LEARN MORECopyright © 2022, Avient Corporation.
https://www.avient.com/products/advanced-composites/continuous-fiber-composite-panels/hammerhead-marine-composite-panels
ISO 845
https://www.avient.com/industries/healthcare/remote-monitoring-wearables/continuous-glucose-monitors-cgm
Color and functional additive masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased appeal and performance
https://www.avient.com/industries/healthcare/catheter-materials-medical-tubing/catheters
Standard colors for needle hubs, cannula hubs, and wings matching ISO 6009 color coding
https://www.avient.com/news/where-sustainability-matters-avient-highlight-its-latest-solutions-support-circular-economy-chinaplas-2023
They are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety.