https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
ETO / Gamma radiation)
• Facilitated 510(k) submission with formulations
registered under Device Master File MAF 1833
• Pre-tested raw materials to biocompatibility
ISO10993, US and Eu Pharmacopeia, ICH-Q3D
extractable metals
• Enhanced stability with gamma stabilizing
package
• Minimized risk of change with change control
beyond CAS number level
• Ensured uninterrupted supply from multiple ISO
13485-2016 certified sites
• MEVOPURTM ISO 6009 Standard / Customized
Solutions
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/polymer-additives/performance-enhancement-additives/mevopur-functional-additives
https://www.avient.com/investor-center/news/polyone-announces-first-quarter-2018-results
Color, Additives and Inks
Color, Additives and Inks
Color, Additives and Inks
https://www.avient.com/investor-center/news/polyone-announces-record-first-quarter-2016-results
In addition, a weaker euro impacted Color, Additives and Inks and Engineered Materials.
Color, Additives and Inks
Color, Additives and Inks
https://www.avient.com/sites/default/files/2021-01/mevopur-laser-welding-for-ivd-case-study-brief.pdf
GENOMIC DIAGNOSTIC
DEVICE MANUFACTURER
I N - V I T R O D I AG N O S T I C ( I V D ) D E V I C E
MEVOPURTM Laser-Transmitting and Laser-Absorbing
Pre-color Solution
AVIENT SOLUTION
• Customized solutions - Quality-by-Design (QdB) approach
• Optimized pigment / additive selection – good distribution in
final part minimizes welding failure
• Mitigated contamination and extractable risk on incoming raw
material with control based on fingerprinting
• Ensured uninterrupted supply from multiple ISO13485-2016
certified sites
• Minimized risk of change with change control agreements
WHY AVIENT
KEY REQUIREM ENTS
P R O D U C T I V I T Y & Q UA L I T Y
• Good weldability, low rejection rate
• Solutions in wide range of polymers, colors and
transparency
• Pre-tested ingredients to biocompatibility and
extractable metals
LEARN MORE
https://www.avient.com/products/polymer-additives/performance-enhancement-additives/mevopur-functional-additives
https://www.avient.com/knowledge-base/article/making-plastic-parts-more-sustainable
Biopolymers and recycled materials can be colored using sustainable colorants and additives.
Customizing the material may include incorporating functional additives and modifiers such as fibers, foaming agents, oxygen scavengers, flame retardants, and UV blockers.
In what application will the final product be used?
https://www.avient.com/news/polyone-acquires-specialty-assets-accella-performance-materials
The acquired business joins PolyOne’s Global Color, Additives and Inks segment, and provides specialty coatings solutions and value-added services in a wide range of applications, including consumer products, interior and under-the-hood automotive parts, outdoor recreational equipment and food packaging.
Van Hulle, president, Global Color, Additives and Inks, PolyOne Corporation.
https://www.avient.com/sites/default/files/2020-09/oncolor-hc-product-bulletin-1.pdf
These customizable color solutions enhance
brand value and promote product differentiation
for medical device, cosmetic, or pharmaceutical
polymer applications.
OnColor
HC Plus Colorants have been tested across a
wide range of medical polymers to provide
added confidence in meeting these critical bio-
compatibility standards.
KEY CHARACTERISTICS
• Polymer colorants formulated specifically for
healthcare product applications
• Meets and exceeds various material
performance requirements including
FDA 21 CFR, ISO 10993 and USP Class VI
• HC Plus colorants certified for bio-compatibility
• Available as pre-color, concentrate,
masterbatch or Smartbatch™ combined
colorant/additive solution
• Wide range of colors, striking special effects
and custom color matching
MARKETS AND APPLICATIONS
OnColor™ HC and HC Plus Colorants are an
excellent choice for medical devices and parts,
pharmaceutical or cosmetic packaging, and many
other healthcare related polymer applications.
https://www.avient.com/sites/default/files/resources/PDI_Case_Study_-_Medical_Device_0.pdf
PDICaseStudy.indd
8.5 in
11.6875 in
8 .75 in
11.9375 in
8 .25 in
11 in
PDI Solution Boosts Long-Term
Medical Device Performance
Spinal disc replacement manufacturer relies on quality
analysis and manufacturing solutions from Polymer
Diagnostics to help its breakthrough product reach far
beyond durability requirements.
Developed specifically for this application, the prediction
method was recognized by the U.S.
This
device exemplifies the next generation in disc replacement and offers mobility
equal to the body’s natural components.
https://www.avient.com/sites/default/files/2020-08/silcosperse-lm-product-bulletin-v2.pdf
PRODUCT BULLETIN
Silcosperse™ LM Laser Marking
Additive Dispersions
Silcosperse™ Laser Marking additives are laser
absorbing silicone dispersions that use UV, YAG or
fiber laser technologies.
KEY CHARACTERISTICS
• Provides laser marking options
of silicone materials
• Eliminates the needs for etching
and embossing
• Faster and cleaner than pad printing
• High contrast, permanent markings
• Mechanical properties of the silicone matrix
are maintained
• Compatible with various types of lasers
• Chemically resistant
• Available in pre-colored or natural
MARKETS AND APPLICATIONS
Silcosperse LM Laser Marking additive dispersions
are suitable for a variety of applications within
industries such as:
• Consumer Goods
• Electronics
• Healthcare
• Industrial
• Transportation
• Wire & Cable
Typical applications and purposes include:
• Traceability, UPC bar-coding, branding
• Unique Device Identification (UDI),
medical device ID’s
• Serialization for pharmaceutical packaging
• Safety taggants & equipment
• Automotive components
• Wire & cable part numbers or gauge size
www.avient.com
Copyright © 2020, Avient Corporation.
Avient makes no warranties or
guarantees respecting suitability of either Avient’s products or the information for your process or end-use application.
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=45
Application Overview
How TPEs Can Help Medical and Pharmaceutical Manufacturers Meet Growing Global Demand
Application Overview