https://www.avient.com/sites/default/files/2022-04/MEVOPUR LQ for Silicone Elastomers.pdf
Customized color solutions are
available on request
• Production under ISO 13485 / GMP quality
system with change control management
• Fingerprinting of raw materials and routine
batch testing
• Extractability evaluated in hexane, isopropanol,
and water according
to ISO 10993 part 18
REGULATORY SUPPORT
• Raw materials are pre-tested to biologically-
evaluated raw materials using ISO 10993-1 and
USP chapters , Class VI
• DMF/MAF documentation filed with the FDA
for all standard colors
APPLICATIONS
MEVOPUR LQ formulations can be applied
in demanding applications including:
• Medical devices such as catheter tubing
& connectors, syringe tips, and needleless
connectors
• Skin contact devices such as wearables
or soft-touch surfaces of medical devices
PRODUCT BULLETIN
MEVOPUR™-LQ YELLOW (PMS1205C)
Product Code FZ1M415005
MEVOPUR™-LQ TRANS YELLOW
Product Code FZ1M415006
MEVOPUR™-LQ BLUE (PMS292C)
Product Code FZ5M415008
MEVOPUR™-LQ TRANS BLUE
Product Code FZ5M415009
MEVOPUR™-LQ RED (PMS198C)
Product Code FZ3M415008
MEVOPUR™-LQ TRANS RED
Product Code FZ3M415009
MEVOPUR™-LQ GREEN (PMS346C)
Product Code FZ6M415008
MEVOPUR™-LQ TRANS GREEN
Product Code FZ6M415009
MEVOPUR™-LQ VIOLET (PMS2655C)
Product Code FZ4M415003
MEVOPUR™-LQ TRANS VIOLET
Product Code FZ4M415004
CUSTOM-MADE Individual options
Customized colors
are also available to
meet your needs,
please contact us.
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.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured under ISO 13485 procedures
• Documented change control beyond
CAS number, reducing risk of change
• Can be used on common injection molding
and extrusion machines—set-up support by
a technical assistance team
• Available for use in polyolefins, styrenics
and copolymers
• Can be combined with colorants
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP and (incl. class VI)
- European Pharmacopeia, monograph 3.1.3/
3.1.5 (polyolefin packaging materials)
- USP (polyethylene)
- Elemental impurities as per ICH Q3D
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact according to USA FDA and
EU norms
APPLICATION BULLETIN
Sustainability Spotlight
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
APPLICATIONS
• Medical devices
• Drug delivery devices
• Labware
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
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*
* FDA/EU compliance information available upon request
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2021-04/colormatrix-optica-specialty-toners-for-pc-product-bulletin.pdf
MARKETS AND APPLICATIONS
ColorMatrix Optica is formulated for
PC resins used in the production of:
• Automotive interiors
• Appliance housings
• Consumer goods
• Food packaging
• Finished materials such as
PC sheet
• Electrical & Electronics
REGULATORY
• No heavy metals or restricted
ingredients
• In-house chemical testing and
verification system compliant with
ISO ISO/IEC 17025:2005
• Dedicated product stewardship
team globally and locally
https://www.avient.com/resource-center?document_type=221&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
https://www.avient.com/resource-center?document_subtype=0&document_type=59&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=28
MEVOPUR™ ISO 6009 Standard/Customized Solutions met compliance requirements and improved quality for needle hub, cover and shield
https://www.avient.com/resource-center?document_subtype=0&document_type=59&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=0
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
https://www.avient.com/resource-center?document_type=59
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
https://www.avient.com/company/sustainability/sustainability-report/products/supplier-collaboration-evaluation
Additionally, Avient’s self-assessments, based on ISO 9001/IATF 16949, are requested of suppliers in order to provide insight into the core components of their Quality Management Systems (QMS) and subsequently used as approval criteria for Avient’s most sensitive end applications.
https://www.avient.com/news/avient-features-specialty-healthcare-material-solutions-services-mdm-west-2022
Mevopur™ Colorants represent a broad range of color concentrates and formulations, developed specifically for use in today’s complex healthcare applications, which meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661 and ICH Q3D.