https://www.avient.com/sites/default/files/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.pdf
FDA/EU compliance information available upon request
Mevopur™ Healthcare Colorants and Formulations
for Ophthalmic Closures
The Mevopur™ range of standard concentrates
for closures used with ocular (ophthalmic)
medicines matches the color standards from the
American Academy of Ophthalmology (AAO).
Custom
pre-colored formulations can be developed in other
resins upon customer request.
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
• Standard concentrates in a PE carrier and
on request in PP
• Pre-colored formulations can be supplied in
specific resins selected for the application
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)
• Food contact established with FDA/EU*
APPLICATION BULLETIN
DRUG TYPE COLOR
DESCRIPTION
PANTONE
REFERENCE
AVIENT PRODUCT
CODE PE BASED
Adrenergic agonist
combinations Light Green 373 C PE6M176349
Adrenergic agonists Purple 2583 C PE4M176057
Anti-infectives Tan 467 C PE8M176130
Anti-inflammatory,
nonsteroidal Grey Cool Grey 4 C PE7M176184
steroids Pink 197 C PE3M176237
Anti-inflammatory,
immunomodulators Olive Green 5763 C On request
Beta-blockers Yellow Yellow C PE1M176160
Beta-blocker combinations Dark Blue 281 C PE5M176272
Carbonic anhydrase inhibitors Orange 1585 C PE2M176089
Cytotoxic Black 6 C PL9M176008
Miotics Dark Green 348 C PE6M176267
Mydriatics and cycloplegics Red 1797 C PE3M176236
Prostaglandin analogues Turquoise 326 C PE5M176273
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2020-08/oncolor-colorants-color-shades-of-nature-product-bulletin-1.pdf
Formulated using a proprietary process, Shades
of Nature special effects colorants deliver a less
industrial effect, appearing more sustainable and
handcrafted to enable products to make a sensory
connection with consumers.
Available in masterbatch solutions, these beautiful
effects are formulated with:
• organic waste materials, such as
almond shells
• glitter flakes
• synthetic fibers
• special effects, such as speckles
and pearlescents
KEY CHARACTERISTICS
• Available in standard or custom finishes
• Cost effective replacement for marble, granite,
and other expensive and heavy materials across
many applications
• No additional production investment required
MARKETS AND APPLICATIONS
Shades of Nature colorants can add depth
and dimension to:
• Packaging – including premium cosmetics
or luxury caps and closures
• Transportation – interior or exterior automotive
trim and components
• Consumer goods – toys, outdoor goods,
furniture
• Small and large household appliances
PRODUCT BULLETIN
NAME COLOR TONE EFFECTS EU FDA TOYS T STABILITY
Fossil Beige Fibers/Speckles YES NO YES 280°C
Lavender Purple Blue Fibers YES NO YES 280°C
Rosewood Light Pink Fibers NO NO NO 280°C
Emerald Creek Green Special Effects YES YES YES 280°C
Mother of Pearl White Pearl Special Effects YES YES YES 280°C
Invigorate Yellow Green Natural Waste NO NO YES < 210°C
Interstellar Brown Special Effects YES YES YES 280°C
Unrefined Grey Glitter NO NO NO 230°C
Reflection Blue Glitter NO NO NO 230°C
Coral Sand Orange Fibers NO NO NO 280°C
REGULATORY INFORMATION
IMPORTANT NOTE
The above technical and regulatory information is based on the formulation of the current 10 colors in the palette.
https://www.avient.com/sites/default/files/resources/PolyOne%2520Standard%2520Quality%2520Response_2016_6_9.pdf
Sincerely,
Brett Warland
Director of Process Improvement
PolyOne Corporate
PolyOne Quality Survey Standard
Response
2015 12 09
Source: Corporate Quality
Page: 2 of 14
Table of Contents
1.0 POLYONE CORPORATE: OVERVIEW ................................................................................................................................... 3
2.0 MANAGEMENT SYSTEM REGISTRATIONS .......................................................................................................................... 3
3.0 AUDIT ................................................................................................................................................................................ 3
4.0 MANAGEMENT RESPONSIBILITY ........................................................................................................................................ 4
5.0 QUALITY OVERVIEW .......................................................................................................................................................... 5
5.1 QUALITY MANAGEMENT SYSTEM ................................................................................................................................................. 7
5.2 SUPPLIER MANAGEMENT ............................................................................................................................................................ 7
5.3 DELIVERY ................................................................................................................................................................................. 8
5.4 SYSTEMS, POLICIES, AND PRACTICES .............................................................................................................................................. 9
5.5 RESPONSIVENESS ....................................................................................................................................................................... 9
5.6 TECHNOLOGY.......................................................................................................................................................................... 10
6.0 INFORMATION TECHNOLOGY DISASTER RECOVERY PRACTICES....................................................................................... 11
7.0 ENVIRONMENTAL MANAGEMENT SYSTEM / ISO 14001 .................................................................................................. 14
8.0 CREDIT REFERENCES ........................................................................................................................................................ 14
9.0 SUSTAINABILITY AND NO SURPRISES PLEDGE .................................................................................................................. 14
PolyOne Quality Survey Standard
Response
2015 12 09
Source: Corporate Quality
Page: 3 of 14
1.0 PolyOne Corporate: Overview
• To view the PolyOne Executive Leadership Team and the PolyOne Business Leadership, please visit the
following URL: http://www.polyone.com/company/about-us/company-officers
Corporate Department of Continuous Improvement (Quality Department)
Brett Warland Director of Process Improvement 440-930-3318
Jake Kucbel Corporate Quality Engineer 440-930-1557
SIC / NAICS Codes and Descriptions for PolyOne Businesses
3087 325991 Customer compounding of purchased resins
2821 325211 Plastic material and resin manufacturing
2851 325510 Paint and coating manufacturing (Specialty Coatings)
5162 422610 Plastic materials wholesalers (POD)
326199 Composites (Glasforms)
DUNS# 84-508-2861 PolyOne Corporate at PolyOne Center
Federal ID# 34-1730488
• Company Longevity: As PolyOne, since 9/1/2000.
The "owner" is the person
or authority who originally developed the
formulation.
6.
https://www.avient.com/sites/default/files/2023-11/LFT for Bicycles Application Graphic.pdf
BATTERY RANGE
EXTENSION
Lightweighting
SOLUTION: Long fiber
reinforced polyketone (PK)
thermoplastics
© 2023, All Rights Reserved
Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012
https://www.avient.com/products/long-fiber-technology/long-fiber-technologies/compl-t-rec-formulations
https://www.avient.com/products/long-fiber-technology/long-fiber-technologies/compl-t-rec-formulations
https://www.avient.com/products/long-fiber-technology/complet-moisture-resistant-nylons
https://www.avient.com/products/long-fiber-technology/complet-moisture-resistant-nylons
https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-versalloy-infusion-adapter-port.pdf
MEDICAL EQUIPMENT
MANUFACTURER
C L O S E D S Y S T E M D R U G
T R A N S F E R D E V I C E
• A new material for a seal inside the next generation of
closed system drug transfer device
• Compliance with stringent regulatory standards:
• Biocompatibility to ISO10993
• USP VI compliance
• Provided regulatory support services and
expertise throughout extensive medical
approval process
• Provided a custom formulation compliant with
the highest healthcare regulatory standards
• Enabled material to be manufactured and
shipped globally
Custom Versalloy™ HC 9220-90 Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2022-01/PREPERM - Body Scanner - Application Snapshot.pdf
SECURITY EQUIPMENT
MANUFACTURER
B O D Y S C A N N E R
• Replace PMMA based radome material
• Consistent dielectric performance across large sheet/surface area
(4mm thick, 2m high)
• Ultra low losses
• No defects across full surface area
• High resolution imaging to show small illegal objects
• Formulated a custom material to match customer
requirements
• Reduced dielectric loss to 0.0009
• Improved image quality of body scanner with
uniform dielectric performance and exceptionally
low losses
• Enabled scan time of 2 seconds and person
throughput of 400 persons per hour, compared to
100 person throughput of conventional devices
PREPERM™ PPE 260 Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/investor-center/news/avient-announces-debt-financing-fund-acquisition-dsm-protective-materials
Factors that could cause actual results to differ materially from those implied by these forward-looking statements include, but are not limited to: disruptions, uncertainty or volatility in the credit markets that could adversely impact the availability of credit already arranged and the availability and cost of credit in the future; the effect on foreign operations of currency fluctuations, tariffs and other political, economic and regulatory risks, including recessionary conditions; the current and potential future impact of the COVID-19 pandemic on our business, results of operations, financial position or cash flows, including without limitation, any supply chain and logistics issues; changes in polymer consumption growth rates and laws and regulations regarding plastics in jurisdictions where we conduct business; fluctuations in raw material prices, quality and supply, and in energy prices and supply; production outages or material costs associated with scheduled or unscheduled maintenance programs; unanticipated developments that could occur with respect to contingencies such as litigation and environmental matters; our ability to pay regular quarterly cash dividends and the amounts and timing of any future dividends; information systems failures and cyberattacks; amounts for cash and non-cash charges related to restructuring plans that may differ from original estimates, including because of timing changes associated with the underlying actions; any material adverse changes in the Dyneema Business; our ability to achieve the strategic and other objectives relating to the Acquisition, and the possible sale of the Distribution business segment; and other factors described in our Annual Report on Form 10-K for the year ended
https://www.avient.com/investor-center/news/avient-announces-tenth-consecutive-annual-increase-quarterly-dividend
Factors that could cause actual results to differ materially from those implied by these forward-looking statements include the impact the COVID-19 pandemic has on our business, results from operations, financial condition and liquidity; our ability to achieve the strategic and other objectives relating to the acquisition of Clariant's Masterbatch business, including any expected synergies; our ability to successfully integrate Clariant's Masterbatch business and achieve the expected results of the acquisition of Clariant's Masterbatch business, including, without limitation, the acquisition being accretive; disruptions, uncertainty or volatility in the credit markets that could adversely impact the availability of credit already arranged and the availability and cost of credit in the future; the effect on foreign operations of currency fluctuations, tariffs and other political, economic and regulatory risks; changes in polymer consumption growth rates and laws and regulations regarding plastics in jurisdictions where we conduct business; changes in global industry capacity or in the rate at which anticipated changes in industry capacity come online; fluctuations in raw material prices, quality and supply, and in energy prices and supply; production outages or material costs associated with scheduled or unscheduled maintenance programs; unanticipated developments that could occur with respect to contingencies such as litigation and environmental matters; our ability to continue to pay cash dividends including at the increased rate; an inability to raise or sustain prices for products or services; an ability to achieve or delays in achieving or achievement of less than the anticipated financial benefit from initiatives related to acquisitions and integration, working capital reductions, costs reductions and employee productivity goals; information systems failures and cyberattacks; and other factors affecting our business beyond our control, including, without limitation, changes in the general economy, changes in interest rates and changes in the rate of inflation.
https://www.avient.com/products/long-fiber-technology/complet-long-carbon-fiber
These fibers reinforce a wide array of resin systems ranging from polyamides to higher-performance engineering polymers such as PEEK.
https://www.avient.com/news/polyone-helps-global-vision-2020-bring-usee-life
PolyOne Corporation, with 2018 revenues of $3.5 billion, is a premier provider of specialized polymer materials, services and solutions.