https://www.avient.com/sites/default/files/2020-11/oncap-denesting-case-study.pdf
Because the trays were regularly handled by consumers
and filled with food, it was very important that any
changes made to the material would not jeopardize the
packaging’s FDA compliance.
Even more importantly,
the additive technology met FDA-compliance, so the
improved packaging was delivered without any service
interruption to the end customer, saving the converter
thousands of dollars in packaging redesign efforts, and
solidifying the sheet producer’s relationship with their
valuable customer.
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.
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.
https://www.avient.com/sites/default/files/2024-11/Remafin_ Fiber Colorants for PP-Hygiene Nonwoven-case study snapshot.pdf
Hygiene fiber manufacturer
HYGIENE FIBER
MANUFACTURER
P P N O N W O V E N M U L T I L A Y E R S
• Meet FDA requirements specified by the customer
• Provide technical support including specific color,
processing and molding recommendations
• Deliver the brighter white colorants to make the final
product look whiter and cleaner
• Developed an FDA colorant to meet
customer regulatory specifications
• Provided technical expertise throughout the
design and manufacturing process
• Offered a brighter white color for the final
product
Remafin Fiber Colorants for PP
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
COMPLIANCE + TECHNICAL SUPPORT
LEARN MORE
Copyright © 2024, Avient Corporation.
https://www.avient.com/sites/default/files/2021-01/case-study-one-pager-gravi-tech-luxury-closures-english-and-spanish_0.pdf
LEADING PRODUCER OF
CLOSURES FOR SPIRITS
L U X U R Y C L O S U R E S
• Replace metal while providing metallic look and feel
• Customization of density and color
• Easy processing
• FDA compliance
• Replaced metal with a weighted polymer
solution to maintain high-quality perception
• Minimized the appearance of chips from
everyday wear better than metal by
matching closure interior and metalized
coating colors
• Enabled the customer to introduce their
luxury closures to a new market segment
Gravi-Tech™ Density Modified Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/engineered-polymer-formulations/eco-conscious-formulations/gravi-tech-density-modified
PRODUCTOR LÍDER DE
TAPONES PARA BEBIDAS
ALCOHÓLICAS
T A P O N E S D E L U J O
• Se sustituye el metal al mismo tiempo que se ofrece
aspecto y sensación metálicos
• Personalización de densidad y color
• Procesamiento sencillo
• Cumplimiento con las normas de la FDA
• El metal se sustituye con un compuesto
plástico de densidad modificada para
mantener una percepción de alta calidad
• Se redujo al mínimo la aparición de
desportilladuras por el desgaste cotidiano,
que supera al metal porque permite hacer
coincidir el interior de la tapa con los
colores de revestimiento metalizado
• Permitió al cliente introducir sus tapones
de lujo en un nuevo segmento del mercado
Formulación de densidad modificada Gravi-
Tech™
REQUERIMIENTOS CLAVE
¿POR QUÉ AVIENT?
https://www.avient.com/sites/default/files/2024-09/Avient_RY 2023 CDP Verification Opinion Declaration.pdf
This verification opinion declaration
applies to the related information included within the scope of work described below.
Cleveland, Ohio Doral, Florida
September 25, 2024
This verification declaration including the opinion expressed herein, is provided to Avient and is solely for the benefit of Avient in
accordance with the terms of our agreement.
We consent to the release of this declaration by you to the public or other
organizations but without accepting or assuming any responsibility or liability on our part to any other party who may have access to
this declaration.
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
REGULATORY SUPPORT
• Drug delivery devices
• Pharmaceutical packaging
• Medical equipment
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 the risk of change
• Allows crystallization in semi-crystalline
polymers to begin faster and complete earlier
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
Healthcare use limitations apply—see below.
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.
https://www.avient.com/sites/default/files/2023-01/Mevopur Standard Colors Product Bulletin _ Color Card.pdf
With
robust raw material testing and a comprehensive
change control policy, these medical-grade
concentrates and pre-colored formulations can
help minimize risk and avoid non-compliance.
KEY CHARACTERISTICS
• Globally harmonized formulations are
manufactured at four ISO 13485 certified
medical sites, providing global consistency
and increased security of supply
• Documented change control available
• A range of standard colors eliminates color
matching to expedite development time
• The portfolio includes compliant colors for
use in:
- Needle hub applications: ISO 6009
- Ophthalmic container closures
(American Academy of Ophthalmology)
REGULATORY SUPPORT
• A library of pre-tested raw materials including:
- 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*
HEALTHCARE APPLICATIONS
• Medical devices such as catheters, surgical and
dental instruments, and drug delivery devices
• Pharmaceutical packaging including vials
and bottles
• Diagnostics for blood analysis or In Vitro
Diagnostics (IVD)
PRODUCT BULLETIN & COLOR CARD
* FDA/EU compliance information available upon request; exceptions may occur
Color Pantone
Reference PE Base PP Base Transparent
PP Base PEBA Base PC Base Transparent
PC Base* ABS Base*
White — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206
Yellow 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958
Orange 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939
Red 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037
Pink 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039
Violet 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978
Light Blue 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402
Mid Blue 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404
Dark Blue 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406
Light Green 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070
Bluish Green 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068
Medium Green 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072
Dark Gray 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297
Mid Gray Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295
Beige 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871
Brown 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869
Black Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896
Colors may vary from actual color shown.
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.
https://www.avient.com/news/avient-showcases-new-sustainable-solutions-and-recent-compliance-certifications-itma-2023
Homepage
//
News Center
//
Avient Showcases New Sustainable Solutions and Recent Compliance Certifications at ITMA 2023
MILAN, Italy – June 7, 2023 – Avient Corporation is debuting a new, sustainable solution for textile dyes and highlighting recently achieved compliance certifications for color & additives for synthetic fibers at the start of ITMA 2023, the world’s largest annual international textile and garment technology exhibition June 8-14 in Milan, Italy.
Avient’s Taoyuan production site in Taiwan recently achieved full compliance with the Global Recycled Standard (GRS) 4.0.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives_Laser Welding Additives for Medical Devices Application Bulletin.pdf
KEY CHARACTERISTICS
• 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
• Available as additive concentrates, ready-to-use
additive formulations or ready-to-use additive/
colorant formulations for different polymers
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; exceptions may occur
Healthcare use limitations apply—see below.
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.
https://www.avient.com/sites/default/files/2023-03/AvientRY 2021 CDP Verification Opinion Declaration_07-26-22r%5B96%5D.pdf
This verification opinion declaration
applies to the related information included within the scope of work described below.
Miami, Florida Santa Ana, California
July 26, 2022
This verification opinion declaration, including the opinion expressed herein, is provided to Avient and is solely for the benefit of
Avient in accordance with the terms of our agreement.
We consent to the release of this declaration by you to CDP in order to
satisfy the terms of CDP disclosure requirements but without accepting or assuming any responsibility or liability on our part to CDP
or to any other party who may have access to this declaration.