https://www.avient.com/sites/default/files/2023-05/Mevopur Healthcare Colorants and Formulations Amber for Pharma Application Bulletin.pdf
Mevopur™ Healthcare Colorants and Formulations
Amber Colorants for Pharmaceutical Packaging
Avient constantly monitors the evolution of
regulations in the healthcare industry, and
develops compliant products well before those
regulations go into effect.
Mevopur Healthcare
Colorants and Formulations in amber tones
provide the safety of pre-tested raw materials
while protecting and prolonging the shelf life of
pharmaceuticals and nutraceuticals in amber PET
packaging products.
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.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Colorants and Formulations Special Effects Application Bulletin_0.pdf
Mevopur™ Healthcare Colorants and Formulations
Special Effect Colorants for Healthcare Devices and
Pharmaceutical Packaging
Self-administered medication, for example via
pen devices and inhalers, has been the norm for
many years.
Ingredients used in the
Mevopur™ portfolio have been tested to industry
standards that support applications in both
medical devices and pharmaceutical packaging.*
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
• Available as pre-colored formulation or
concentrate and for use in 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
* Design note: Effect colors require careful consideration of part design and
polymer flow paths to minimize visible flow lines.
https://www.avient.com/resources/safety-data-sheets?page=5194
LIQUID COLOR AMBAR 489-10122-3
LIQUID COLOR AMBAR 489-10438-1
LIQUID COLOR HERSHEY BROWN 489-20141-1
https://www.avient.com/resources/safety-data-sheets?page=4750
LIQUID COLOR SILVER
LIQUID COLOR GOLD
LIQUID COLOR YELLOW
https://www.avient.com/resources/safety-data-sheets?page=5146
LIQUID COLOR WHITE
LIQUID COLOR AMBER
LIQUID COLOR BLUE
https://www.avient.com/resources/safety-data-sheets?page=4773
LIQUID COLOR PEARL PINK
LIQUID COLOR AMARILLO
LIQUID COLOR BLUE
https://www.avient.com/resources/safety-data-sheets?page=5279
LIQUID COLOR YELLOW 486-33492-3
LIQUID COLOR YELLOW 486-33593-1
LIQUID COLOR YELLOW 486-33615-1
https://www.avient.com/resources/safety-data-sheets?page=4774
LIQUID COLOR BLUE 485-90237-1
LIQUID COLOR CYPRESS GREEN
LIQUID COLOR BLUE
https://www.avient.com/resources/safety-data-sheets?page=3681
WT PE COLOR CONCENTRATE
WT PE COLOR CONCENTRATE
WT PE COLOR CONCENTRATE
https://www.avient.com/resources/safety-data-sheets?page=6638
LIQUID COLOR BRIGHT RED 483-32322-3
LIQUID COLOR GREEN 348C 484-20424-1
LIQUID COLOR AQUA 16-5127 TPX