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/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.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
• 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
Anti-inflammatory,
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/products/polymer-colorants/healthcare-colorants
Based on polysulfone resins and tested to ISO 10993, this line of opaque and transparent colorants is specifically formulated to achieve high heat resistance in healthcare applications.
Formulated with raw materials tested to ISO, USP, EP, and ICH Q3D protocols, the portfolio includes standard color ranges to speed up time to market and custom color solutions tailored to customer requirements.
https://www.avient.com/sites/default/files/2021-11/avient-material-solutions-uk-cert-of-incorporation-name-change-nov-9-2021.pdf
CERTIFICATE OF INCORPORATION
ON CHANGE OF NAME
Company Number 3141094
The Registrar of Companies for England and Wales hereby certifies that under the
Companies Act 2006:
POLYONE CORPORATION UK LIMITED
a company incorporated as private limited by shares, havingits registered office
situated in England and Wales, has changed its name to:
AVIENT MATERIAL SOLUTIONS UK LIMITED
Given at Companies House on9th November 2021.
https://www.avient.com/sites/default/files/resources/TRA%2520-%25202016%2520Annual%2520Report%2520for%252015%2520Tideman.pdf
No Amount
Progress on TRA Plan Amendments
CAS RN
Substance
Name
Were any amendments made to
the toxic substance reduction
plan during the reporting period
Description any amendments that
were made to the toxic substance
reduction plan during the reporting
period
Provide a public summary of the description of any
amendments that were made to the toxic
substance reduction plan during the reporting
period
117817
Bis(2
ethylhexyl)
phthalate
No
85449
Phthalic
anhydride
No
Report Submission and Electronic Certification
NPRI Electronic Statement of Certification
Specify the language of correspondence
English
Comments (optional)
I hereby certify that I have exercised due diligence to ensure that the submitted information is true and complete.
ON MOE TRA Electronic Certification Statement
Annual Report Certification Statement
As of 30/04/2018, I, Robert Greenop, certify that I have read the reports on the toxic substance reduction plans for the toxic substances referred
to below and am familiar with their contents, and to my knowledge the information contained in the reports is factually accurate and the reports
comply with the Toxics Reduction Act, 2009 and Ontario Regulation 455/09 (General) made under that Act.
Highest Ranking Employee
Robert Greenop
Report Submitted by
Najat Kamal
Website address
I, the highest ranking employee, agree with the certification statement(s) above and acknowledge that by checking the box I am electronically
signing the statement(s).
https://www.avient.com/sites/default/files/2021-07/eccoh-optical-cable-sheath-case-study-one-pager.pdf
WIRE &CABLE
COMPANY
O P T I C A L C A B L E S H E A T H
• Excellent resistance to fungi and mildew
• Good UV resistance
• Meet flame retardant standard IEC 60332-3C
• Provided an anti-fungi solution with an ISO
846 rating of 0, showing no growth under
microscope
• Formulated solution to meet flammability
performance demands for IEC60332-2 or
GBT 18380.22-2008 compliance
• Complied with Biocidal Product Regulation
(EU) No528/2012 (BPR)
ECCOH™ Thermoplastic Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/versaflex-cpap-tubing-film.pdf
Versaflex - CPAP tubing film
CPAP TUBING
C O R R U G A T E D T U B I N G F I L M
• Replacement for polyolefins
• Good spring-back
• Bondable cuffs
• Clear & clean look
• Minimize humidity and condensation within the tube
• No noticeable odor
• FDA, ISO 10993 & USP VI compatible
• Provided TPE solution to meet market
expectations for improved user comfort &
aesthetics
• Reduced tube noise and improved drape
compliance with new material solution
versus polyolefins
• Offered solution with improved thermal
properties to combat humidity
Versaflex™ CL2250
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-12/Versaflex OM TPEs for Sealing Ring of Blood Lancet.pdf
BLOOD LANCET
MANUFACTURER
S E A L I N G R I N G
• Compliance with strict regulations for medical materials
• Excellent sealing performance
• Good compression set
• Provided a recycled TPE solutions
compared to silicone without increasing
system cost
• Delivered a TPE that complied with ISO
10993-4 & -5 and USP Class VI
• Supported a change to an injection molded
material to ease production and enhance
assembly capabilities
Versaflex™ HC TPEs – OM1040-1 Grade
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-11/Versaflex HC -Syringe tip cap-Case study snapshot.pdf
PRE-FILLED
SYRINGE COMPANY
S Y R I N G E T I P C A P
• Excellent sealing performance
• No DEHP or natural rubber latex added during processing
• Can be sterilized by EtO
• Compliant with ISO 10993-4&5 and USP Class VI
• Formulated a solution that met rigorous
medical application requirements
• Leveraged global footprint to ensure supply
continuity
• Increased process efficiency by replacing
previous thermoset material with a TPE
Versaflex™ HC Thermoplastic Elastomers
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2022-11/Versaflex CL-Serum collection cartridge-Application Snapshot.pdf
A LIFE SCIENCE
COMPANY
S E R U M C O L L E C T I O N
C A R T R I D G E
• Excellent clarity
• Good bonding and peel strength onto PP
• Heat resistance
• Meet sterilization needs
• Easy processing
• Formulated transparent Shore 50A TPE with
excellent adhesion onto PP and good
sealing performance
• Met regulatory requirements for USP Class
VI and ISO 10993-4,5
• Provided a short lead time and on-site
technical service
Versaflex™ CL Thermoplastic Elastomers
KEY REQUIREMENTS
WHY AVIENT?