https://www.avient.com/sites/default/files/2020-12/packaging-solution-bulletin-selector-guide.pdf
What’s more, they are FDA and REACH compliant and resist those chemicals particular to cosmetics,
personal care, and household products.
Our FDA and REACH compliant Versaflex™ PKG TPEs provide options for designing aesthetically pleasing
packaging components that withstand aggressive chemicals
Regulatory compliance is offered for consideration only—
limitations apply; please check with product stewardship.
https://www.avient.com/sites/default/files/2024-07/avient-human-rights-position-statement-updated-july-2021 %286%29.pdf
We recognize that there are many different organizations that have set forth international
human rights principles, such as the Universal Declaration of Human Rights and The International Labor
Organization’s (ILO) Declaration on Fundamental Principles and Rights at Work .
To ensure consistent
communication and compliance, all associates globally are expected to complete our Code of Conduct
training on an annual basis on various aspects of our Code, including but not limited to human rights.
Our
suppliers and partners understand that our relationship is based on an expectation of compliance with
applicable laws and regulations and adherence to internationally recognized environmental, social,
corporate governance and management systems standards.
https://www.avient.com/sites/default/files/2023-10/Nonwoven Colorants and Additives Brochure_A4.pdf
The active ingredient is
compliant with FDA/EU regulations*.
Recommended use: nonwoven fabrics used
in construction (e.g., roof underlays) and in
transportation (e.g., seat covers in buses)
* FDA/EU compliance information available upon request
** It is the responsibility of the end article manufacturer to ensure
compliance with flame retardancy standards
LIGHT STABILIZER
Nonwovens exposed to sunlight often
need to incorporate light stabilizers to
protect them from color fading and loss
of mechanical properties.
FDA/EU compliance information available upon request
Colorants and additives can be supplied in a combination concentrate for convenience.
https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
FDA/EU compliance information available upon request
REMAFIN™ EP White Colorants
for Pharmaceutical Packaging
REMAFIN™ EP is a range of PE and PP based
masterbatches designed for protecting oral,
topical, parenteral, ophthalmic and nasal
pharmaceuticals by opacifying primary and
secondarypharmaceutical packaging.
KEY CHARACTERISTICS
• Manufactured under change control principles
beyond CAS number (similar level as MEVOPUR
concentrates), reducing risk of change
• Free from animal-derived substances and
phthalates
• Suitable for blown film, injection molding,
blow molding and extrusion
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP chapters , including Class VI,
a requirement for ophthalmic and nasal drugs
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
- USP and USP light transmission
• Registered Drug Master File (Type III)
• Food contact compliance established with
FDA/EU*
APPLICATION BULLETIN
CARRIER
MATERIAL
PIGMENT
CONTENT/TYPE
LIGHT
FASTNESS
THERMAL
STABILITY
PRODUCT
CODE
HDPE 50% TiO2
8 300°C PH00075525
LLDPE 60% TiO2
8 300°C PL00075542
LLDPE 70% TiO2
8 300°C PL00075545
PP 50% TiO2
8 300°C PP00075717
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, including the suitability of all raw materials and
components used for its manufacture, and with all applicable laws and regulations.
1.844.4AVIENT
www.avient.com
https://www.avient.com/idea/top-five-ways-enhance-ergonomics-healthcare-products
Food and Drug Administration’s (FDA) draft guidance, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” recommends the use of appropriate human factors analysis, testing and validation during the design phase of medical devices to reduce user-related hazards and errors.
While this document is non-binding, it indicates the FDA’s strong interest in this issue.
By emphasizing ergonomic design, manufacturers of healthcare products can provide greater comfort, usability and safety and increase compliance with regulatory requirements.
https://www.avient.com/idea/minimize-fogging-food-packaging
Some suppliers are also able to offer anti-fog solutions with EC and FDA food-contact compliance, enabling film producers to use the same anti-fogging product across multiple geographic regions.
In addition, there is no restriction on the use of anti-fog additives in food contact applications, because no Specific Migration Limit (SML, in EC and FDA regulations) applies to them.
https://www.avient.com/sites/default/files/2021-07/avient-human-rights-position-statement-updated-july-2021.pdf
We recognize that there are many different organizations that have set forth international
human rights principles, such as the Universal Declaration of Human Rights and The International Labor
Organization’s (ILO) Declaration on Fundamental Principles and Rights at Work .
To ensure consistent
communication and compliance, all associates globally are expected to complete our Code of Conduct
training on an annual basis on various aspects of our Code, including but not limited to human rights.
Our
suppliers and partners understand that our relationship is based on an expectation of compliance with
applicable laws and regulations and adherence to internationally recognized environmental, social,
corporate governance and management systems standards.
https://www.avient.com/sites/default/files/2024-10/Avient Human Right Policy - July 2024.pdf
We recognize that there are many different organizations that
have set forth international human rights principles, such as the Universal Declaration of Human
Rights and The International Labor Organization’s (ILO) Declaration on Fundamental Principles and
Rights at Work.
To ensure consistent
communication and compliance, all associates globally are expected to complete our Code of
Conduct training on an annual basis on various aspects of our Code, including but not limited to
human rights.
Our suppliers and partners understand that our relationship is based on an expectation
of compliance with applicable laws and regulations and adherence to internationally recognized
environmental, social, corporate governance and management systems standards.
https://www.avient.com/sites/default/files/2021-08/baby-bottle-one-page-case-study.pdf
BABY BOTTLE
MANUFACTURER
I N F A N T M I L K B O T T L E S
• Compliant with FDA food contact and China National
Standard GB 9685
• Able to withstand repeated steam sterilization
• Transparent for more pleasing appearance and easy
identification of measurement lines
• Good impact resistance
• Developed formulation to comply with both
FDA and GB 9685
• Provided material able to withstand
repeated steam sterilization and maintain
excellent mechanical performance
• Achieved a more pleasing color and clarity
to enhance measurement lines
• Met the need for impact resistance
Colorant Chromatics™ PPSU Precolor
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
COMPLIANCE + HEAT RESISTANCE
LEARN MORE
Copyright © 2021, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives for Bormed Resins Application Bulletin.pdf
Mevopur™ Healthcare Colorants and Formulations
and Mevopur™ Healthcare Functional Additives
for Bormed™ Resins
Mevopur™ Healthcare Colorants and Formulations
and Mevopur™ Healthcare Functional Additives
help medical device, diagnostics and
pharmaceutical packaging sectors meet the
growing challenges of product consistency,
compliance and reliability.
MEVOPUR COLORANTS
• Standard colors in PP and PE to shorten
time-to-market
• Custom colors matched to Pantone, RAL or
other color reference
• White colorants for pharmaceutical packaging
for LDPE, HDPE and PP with opacity to reach
USP chapter
MEVOPUR FUNCTIONAL ADDITIVES
• Antistatic formulation with good flow/impact
for injection molding
• Amide- and amine-free antistatic for film
in contact with API (Active Pharmaceutical
Ingredients)
• UV blocking for transparent PP and PE
packaging to meet USP chapter
• Non-migrating friction reduction/processing
aid for PE and PP
• Laser marking/welding additive for fast,
reliable marking/assembly
• MVTR (Moisture Vapor Transmission Rate)
reduction for HDPE to improve shelf-life
• Thermal protection of the polymer during
processing
• Gamma/e-beam sterilization protection for
PP (up to 50kGy) with color compensation
for reduced yellowing
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
Bormed™ is a registered trademark of Borealis
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.