https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Bio-based Polymer Solutions Application Bulletin.pdf
KEY CHARACTERISTICS
• Available for polyethylene, polypropylene, ABS,
polycarbonate and styrenics
• Bio-content of resin carrier varies from 70% to
100% depending on polymer—calculated to
ASTM D6866 standard
• Manufactured at four ISO 13485 certified sites,
providing global consistency and security of
supply
• Documented change control beyond CAS
number, reducing risk of change
• Drop-in solutions that can be processed like
fossil-based grades on common injection
molding and extrusion machines
• Can be provided as ready-to-use pre-colored
or additive formulation
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP and (incl. class VI)
- European Pharmacopeia, monograph 3.1.3/
3.1.5 (polyolefin packaging materials)
- USP (polyethylene)
- Elemental impurities as per ICH Q3D
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact according to US FDA and
APPLICATION BULLETIN
Sustainability Spotlight
Bio-polymers
Healthcare use limitations apply—see below.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication
of performance or properties obtained or obtainable on larger-scale equipment.
Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent
implants, birth control devices, or plastic surgery.
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.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication
of performance or properties obtained or obtainable on larger-scale equipment.
Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent
implants, birth control devices, or plastic surgery.
https://www.avient.com/sites/default/files/2023-05/Mevopur Healthcare Colorants and Formulations Amber for Pharma 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 level, reducing risk of change
• Non-phthalate and formulated without
animal-derived substances
• Different tones of amber available on request
—more or less red or yellow and/or lighter
or darker
• Also available in liquid form
REGULATORY SUPPORT
• Pre-tested raw materials:
- ISO 10993-1 and USP parts
(Class VI)
- European Pharmacopeia, monograph
3.1.15, USP and elemental analysis
as per ICH Q3D
- USP criteria appearance of solution,
color
• Registered Drug Master File (Type III) by
the FDA
• Food contact compliance established with
FDA/EU*
• YBB00102002-2015 (oral liquid pharmaceutical
PET bottles) compliance support
APPLICATION BULLETIN
* FDA/EU compliance
information available
upon request
Healthcare use limitations apply—see below.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication
of performance or properties obtained or obtainable on larger-scale equipment.
Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent
implants, birth control devices, or plastic surgery.
https://www.avient.com/sites/default/files/2020-09/oncap-anti-fog-product-bulletin.pdf
Prevents condensation: Controlling the
distribution, and so effectiveness, of anti-fog
additives is easier than controlling the efficacy of
a coating.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable
indication of performance or properties obtained or obtainable on larger-scale equipment.
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.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication
of performance or properties obtained or obtainable on larger-scale equipment.
Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent
implants, birth control devices, or plastic surgery.
https://www.avient.com/sites/default/files/2022-05/OnColor Non-Phtalate Color Concentrates for PVC Formulations Product Bulletin.pdf
Strict
regulations control the use of plasticizers containing
phthalates and some users are now switching to
non-phthalate* formulations for the preparation of
soft PVC.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication
of performance or properties obtained or obtainable on larger-scale equipment.
https://www.avient.com/products/engineered-polymer-formulations/general-engineered-formulations/artisan-pre-colored-thermoplastics-premium-finishes
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https://www.avient.com/products/polymer-additives/uv-and-light-blocking-additives/cesa-light-additives
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https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/oncolor-bio-colorants
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https://www.avient.com/products/polymer-additives/antioxidant-additives/cesa-nox-a4r-additive-enhanced-recycling
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