https://www.avient.com/sites/default/files/2022-07/Lewiston 308872_en_13485_21%5B43%5D.pdf
Lewiston, ME, 04240
United States of America
Scope
Avient CAI
Design and manufacture of colour and additive
concentrates and specialty compounds for
the Healthcare and Medical device market.
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 45484 Validity 01.03.2022 – 28.02.2025
Issue 01.03.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.
https://www.avient.com/sites/default/files/2023-10/308659_en_46154.pdf
Ltd.
30, Hsing Pang Road
33068 Taoyuan Taiwan
Scope
Design and manufacture of colour and additive
concentrates and specialty compounds for the
Healthcare and Medical device market.
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 46154 Validity 12.01.2022 – 11.01.2025
Issue 12.01.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
F.
https://www.avient.com/sites/default/files/2020-10/tpe-injection-molding-guide.pdf
A material is shear
dependent when its viscosity is higher at low shear rates (such as extrusion) and lower
at high shear rates (as in injection molding).
To aid in release, the cavity or core may be
coated with a release coating such as PTFE impregnated nickel after it has been
given a sandblast or EDM finish.
8
Sprue and Sprue Puller Design
The sprue should have sufficient draft, from 1º to 3º to minimize drag and sprue sticking.
Hot Runner System Gates
Valve Gates
Valve gates offer the best solution for high production parts where surface quality is
critical, such as medical and cosmetic products.
https://www.avient.com/sites/default/files/2022-11/WPC Sheet Decking Application Snapshot.pdf
WOOD PLASTIC
COMPOSITE (WPC) MFG
S H E E T A N D D E C K I N G
• Lightweighting solution offering energy savings and manufacturing
efficiencies
• Reduced downtime associated with poor quality rejections
• Consistent and uniform cell structure in decking material
• Compatibility with mono-core extrusion formula (rice hull bio-filler
and virgin PVC) when used with a chemical foaming additive
• Density control of 0.60-0.65 g/cc in production
• Provided a CFA solution that offered energy
savings, process optimization, and extended
manufacturing run times
• Enabled improved performance results and
enhanced process control
• Allowed tighter tolerance control with uniform cell
structure, eliminating voids and surpassing
density target ($100K savings)
• Increased productivity and aesthetic finish with
secondary operations (sanding)
KEY REQUIREMENTS
Excelite™ Chemical Foaming Additives (CFA)
WHY AVIENT?
https://www.avient.com/sites/default/files/2024-12/ISO 22000-2024. Avient Sta. Clara 308865_en_46389 %2811%29.pdf
Plasticos 28, int B102
Santa Clara Coatitla
55540 Ecatepec de Morelos, Estado de México
Mexico
Scope
Category I
Production of customer specific Masterbatches for
Food packaging materials on the dedicated extrusion
lines.
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-bt218-biopharmaceutical-tubing-case-study.pdf
MEDICAL TUBING
EXTRUDER
B I O P H A R M A C E U T I C A L
T U B I N G
• Low leachables & extractables
• Great tensile performance and kink resistance
• Good thermal weldability
• Excellent clarity and medical blue tint
• ISO 10993-4 & 5, USP Class VI & Animal Derivative Free
(ADF)
• Supplied drop-in material replacement to
overcome supply constraints of incumbent TPE
• Offered a lower extractable profile than
comparable materials in the market
• Enabled easy material transition without changes
in tooling or thermal welding machine settings
• Formulated solution with proprietary additives to
provide clarity and prevent yellowing after
sterilization
Versaflex™ HC BT218 Thermoplastic
Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2025-01/Stethoscope Dispersions Case Study Snapshot.pdf
MEDICAL DEVICE
MANUFACTURER
S T E T H O S C O P E S
• Provide a silicone paste colorant dispersion for liquid silicone
rubber (LSR) to use in stethoscope ear tips
• Create a custom-colored vinyl plastisol formulation for
stethoscope tubing
• Harmonize color across materials to meet specific process
and performance requirements
• Deliver effective communication and cross-functional
collaboration
• Offered dependable silicone paste colorants
that allowed for comfort and easy sterilization
• Provided a colored vinyl plastisol to reduce
tackiness and support product longevity
• Collaborated internally to align all materials and
provide color consistency across components
• Supported fast color changes and met quality
specifications through constant communication
and technical expertise
Silcopas Silicone Paste Colorants and
CORE Vinyl Plastisols for Healthcare
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/vinyl-formulations/vinyl-plastisols-organosols/core-vinyl-plastisols-healthcare
https://www.avient.com/products/polymer-colorants/colorant-dispersions/colorants-liquid-silicone-rubber
Slide 1: Medical device manufacturer
https://www.avient.com/sites/default/files/2025-01/ISO 13485 Shanghai %28ZhangJiang%29%2C China.pdf
240625-2017-AQ-RGC-NA-PS
Initial certification date:
14 September 2017
Valid:
08 February 2025 – 07 February 2028
This is to certify that the management system of
PolyOne-Shanghai, China
88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode:
91310000607342402D)
has been found to conform to the Quality Management System standard:
ISO 13485:2016
This certificate is valid for the following scope:
Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates
Used for the Plastic Parts of Medical Devices
http://www.dnv.com
https://www.avient.com/sites/default/files/resources/PolyOne%2520IR%2520Presentation%2520-%2520Seaport%2520Global%2520Transports%2520%2526%2520Industrials%2520Confer....pdf
T H E N E W P O L Y O N E : A S P E C I A L T Y G R O W T H C O M P A N Y
Growing leadership position in attractive markets
Innovation, technology and service are differentiators
Capital management is a strength: Record-setting cash generation
to continue for years
Expand ROIC while increasing invested capital
Proven acquisition strategy with robust pipeline
Commercial investments are fueling momentum and generating
organic growth
SEGMENT
HIGHLIGHTS
PolyOne Corporation 17
C O L O R , A D D I T I V E S & I N K S
PolyOne Corporation 18
Solid
Colorants
Performance
Additives
Screen
Printing Inks
Liquid
Colorants
27%
14%
Textiles
Building &
Electrical &
Operating Income & MarginRevenue by Region
C O L O R , A D D I T I V E S & I N K S
2 0 1 7 R E V E N U E | $ 8 9 3 M I L L I O N
$4
$25
$104
$139
0.9%
5.5%
12.2%
15.5%
16.0%
18.0%
100
110
120
130
140
150
PolyOne Corporation 19
32%
46%
1%
Mexico
Brazil
S P E C I A L T Y E N G I N E E R E D M A T E R I A L S
PolyOne Corporation 20
Engineered
Formulations
Advanced
Composites
Thermoplastic
Elastomers
20%
19%
Electrical &
13%
Building &
S P E C I A L T Y E N G I N E E R E D M A T E R I A L S
Revenue by Region Operating Income & Margin
2 0 1 7 R E V E N U E | $ 6 2 4 M I L L I O N
PolyOne Corporation 21
$21
$57
$78
0.1%
5.1%
9.3%
12.5%
28%
48%
22%
P E R F O R M A N C E P R O D U C T S & S O L U T I O N S
PolyOne Corporation 22
Specialty Vinyl
Solutions
Healthcare
Formulations
Smart Device
Materials
Flame Retardant
Polymers
Building &
30%
15%Appliance
Electrical &
1%
Mexico
77%
Latin
America
P E R F O R M A N C E P R O D U C T S & S O L U T I O N S
Operating Income & MarginRevenue by Region
2 0 1 7 R E V E N U E | $ 7 2 1 M I L L I O N
$40
$33
$56
$77
4.6%
3.6%
7.2%
10.7%
16.0%
0
100
PolyOne Corporation 23
D I S T R I B U T I O N
E N D M A R K E T S & S U P P L I E R S
PolyOne Corporation 24
23% Healthcare
22%
Electrical &
Building &
$20
$25
$63
$73
2.9%
5.9%
6.3%
1.0%
3.0%
5.0%
7.0%
15
25
35
45
55
65
75
Operating Income & Margin
2017 Revenue | $1.2 Billion
http://www.avient.com/Pages/VariationRoot.aspx
http://www.avient.com/Pages/VariationRoot.aspx
T A R G E T E N D M A R K E T S &
A P P L I C A T I O N E X A M P L E S
PolyOne Corporation 25
Thermally Conductive
Chemical Resistant
Polymer Colorants
Elastomeric Grips and
Handles
Structural Composites
Antimicrobial Technologies
Anti-Counterfeiting
Target End Markets… Healthcare
Catheter Technologies
Under-hood Components
Target End Markets… Automotive
Interior Structural
Sound & Vibration
Management
Roof Systems
Air Management
Electronics and Cameras
Lighting
Exterior / Interior Trim
Braces & Brackets
Fasteners
Seals & Flaps
Target End Markets… Consumer
Thermally Conductive
Polymer Colorants
Elastomeric Grips and
Handles
Structural Composite
Oxygen Scavenger
Laser Marking Additives
Antistatic Technologies
UV Light Barrier Technologies
Cap & Closure Colorants
Process Optimization
Antioxidant Technologies
Density Modified
Target End Markets… Packaging
Impart weight, sound and
metallic finish to caps and
closures for cosmetics and
spirits applications
Elevate quality and
prestige perceptions
among high-end
consumers
Eliminate time and cost
associated with secondary
operations and assembly
Luxury Packaging
GravitechTM Density Modified Polymers
Eliminate costs by
increasing pigment density
Enhance color
performance without
altering form and
formulation
Increase design
capabilities by reducing
weight and layer thickness
Optimize Color Usage
OnColorTM Super Concentrates
Inhibit microbial growth
on polymer surfaces
Enhance value or products
and devices
Highly versatile
concentrate with the
ability to be incorporated
into a wide variety of
products
Combat Bacteria Formation
WithStandTM Antimicrobial Technology
Durable, long-lasting products
stand up to the most aggressive
disinfectants
Minimize environmental stress
cracking and discoloration
One of the broadest medically
approved polymer and colorant
portfolios
Medical Device Housings
Chemically Resistant Engineered Polymers
Color & Design Services
Greater control of color
development and supply chain
Work across entire design
process from concept to
commercialization
Inspire creativity in the use of
polymer materials, colors, and
effects
Innovative brand differentiation
Faster development timelines
Outdoor Applications
Leading provider of high
performance specialty materials
for the recreational and sports &
leisure industry
Well positioned across all
segments to address market
needs
Metal to Polymer Conversion
Lightweighting
Thermal Management
Impact Performance
ColorMatrix Fiber Colorant
Solutions
Proprietary advanced liquid color
formulations and equipment
enable greater efficiency and
productivity
Eliminates aqueous dyeing and its
associated wastewater treatment
Solid Color Concentrates
Extrusion-spun fibers colored via
solid masterbatch
Fiber Colorants
High flame retardancy to
meet strict UL standards
Greater processing and
design flexibility
Specialized additives
provide long term color
stability
Diffusive lens materials
improve light dispersion
Smart Home Devices
ResilienceTM Vinyl Solutions
1
Reconciliation of Non-GAAP Financial Measures (Unaudited)
(Dollars in millions, except per share data)
Senior management uses comparisons of adjusted net income from continuing operations attributable to PolyOne common shareholders, adjusted earnings per share (EPS)
attributable to PolyOne common shareholders and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) to assess performance and allocate resources
because senior management believes that these measures are useful in understanding current profitability levels and that current levels may serve as a base for future performance.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
Fast, accurate and reliable results
aid medical professionals to understand the
illness and develop the strategy for an effective
treatment.
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.