https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives 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
• Non-phthalate and formulated without animal-
derived substances
• Available for use in a wide range of polymers
including polyolefins, styrenics, polycarbonate
and alloys, polyester, POM
• Functionality can be combined with colorants
into convenient combination concentrates and
ready-to-use formulations
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
FUNCTIONALITY TARGET APPLICATIONS
DRUG
DELIVERY
DEVICES
SYRINGES &
NEEDLES DIAGNOSTICS CATHETERS
Clarifying PP
Sorbitol-free for transparent
applications with reduced migration
and improved thermal stability
Lubricant—
permanent/
non-migrating
Fast acting reduction in friction
for wide variety of polymers such
as PP, ABS, POM, PC
Protection from
UV in transparent
applications for PP,
PE, PETG, COP
UV blocking in 290-450nm with
no impact on clarity; can be
combined with colors (e.g., amber)
Antistatic ready-to-
use solution for PP,
ABS, PC/ABS
Permanent/non-migrating;
fast decay time independent
of % relative humidity
Gamma/e-beam
sterilization
protection of the
polymer
Preserving the properties of
PP and COC/COP; reduction
in yellowing using Color
Compensation Technology (CCT)
Reduced material
consumption/cycle
time—nucleation
Fast acting new generation
nucleant for PE and PP; improved
thermal and mechanical properties
allows wall thinning; reduction of
tolerance/dimensional problems
between different colors
Laser marking
replacing ink
printing/labels
Solvent-free, high-speed
identification for Nd/YAG laser
for PE,PP, ABS, PC, POM
Antioxidants for
PE, PP, TPE
Thermal protection during
converting/downstream sterilization
Brand protection/
anticounterfeit Covert and non-covert systems
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/2022-12/Mevopur Healthcare Functional Additives Pharma Pkg 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
• Non-phthalate and formulated without animal-
derived substances
• Available for use in a wide range of polymers
including polyolefins, styrenics, polycarbonate
and alloys, polyester, POM
• Functionality can be combined with colorants
into convenient combination concentrates or
formulations
REGULATORY SUPPORT
• Pre-tested raw materials:
- 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
* FDA/EU compliance information available upon request
FUNCTIONALITY TARGET APPLICATIONS EBM/IBM
CONTAINERS CLOSURES FILM COMBINATION
DEVICES
Clarifying PP Sorbitol-free—possibilities in
packaging ocular solutions
Slip/torque reduction Slip for PE, PP films, processing aid,
torque reduction for closures
Protection from UV in
transparent packaging
for PP, PE, PETG, COP
UV blocking in 290–450nm with
no impact on clarity
Antistatic ready-to-use
solution for PE films e.g.
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/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.
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/2024-10/Hydrocerol Chemical Foaming Agents Brochure.pdf
Sustainability Spotlight
Hydrocerol™
Chemical
Foaming
Agents
Reflection electron microscopy (REM)
view of foamed plastic
Hydrocerol Chemical Foaming Agents
are supplied as concentrates
CHEMICAL FOAMING AGENTS (CFAs)
are chemical substances that react under the
influence of heat to release gas into the plastic
matrix during the manufacturing process of
plastic parts.
The portfolio
includes non-hazardous endothermic substances
that require minimum cooling of the plastic parts
after manufacturing.
SUPPORT
Our experts can offer product recommendations
in the chemical foaming of plastics, taking into
consideration:
• Manufacturing process
• Application polymer grades
• Regulatory requirements (e.g., food contact
compliance, toy regulations)
• Targeted performance requirement
(e.g., lightweighting, polymer use reduction,
insulation, improved processing)
They also provide technical assistance and best
practices for using Hydrocerol Chemical Foaming
Agents in the best conditions for a successful
foaming of the plastic parts.
https://www.avient.com/sites/default/files/2020-09/swiss-army-knife-case-study.pdf
Victorinox designed and manufactured
its first knives more than 130 years ago, and their pocket
knives have been officially issued to Swiss Army recruits
since 1891.
Designers conceptualized a new, larger version of the
Soldier’s model, including 10 tools, a lock blade that can
be opened with one hand and, importantly, a non-slip
handle manufactured from a combination of hard and
soft thermoplastics.
THE IMPACT
With our support, Victorinox was enabled to do what it
does best—develop and manufacture high-quality tools
that meet both military and consumer needs.
https://www.avient.com/sites/default/files/2020-12/packaging-solution-bulletin-selector-guide.pdf
Testing is the sole responsibility of the final article manufacturer.
Differentiation – Add color and texture
to stand out from the competition
• Recyclable – TPEs are compatible with most
municipal recycle streams
• Global Support – Avient is a global supplier
with manufacturing and technical support in
Europe, Asia and North America
To learn more about chemical resistant
GLS TPEs for packaging, contact Avient at
+1.844.4AVIENT (+1.844.428.4368).
Testing is the sole responsibility of the final article
manufacturer.
https://www.avient.com/sites/default/files/2022-08/ISO9001-2015 EN -EM.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
Certificate No:
2997-2006-AQ-RGC-RvA
Initial certification date:
08 June, 2006
Valid:
11 April, 2022 – 11 April, 2025
This is to certify that the management system of
Polyone - Suzhou, China
EM Sector, 77 Shenggang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China,
215024
and the sites as mentioned in the appendix accompanying this certificate
has been found to conform to the Quality Management System standard:
GB/T 19001-2016/ISO 9001:2015
This certificate is valid for the following scope:
Design and Manufacture of Plastic Compounding Material
Certificate No: 2997-2006-AQ-RGC-RvA
Place and date: Shanghai, 27 April, 2022
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
Room 201, Building 20, No. 200 JinSu
Road, Shanghai Free Trade Zone, China,
200131
Design of Plastic Compounding Material
Polyone - Suzhou, China EM Sector, 77 Shenggang Street,
Suzhou Industrial Park, Suzhou, Jiangsu,
China, 215024
Manufacture of Plastic Compounding
Material
https://www.avient.com/sites/default/files/2020-10/avient-conflict-minerals-policy-10.2020.pdf
reporting
companies
that
manufacture
products
(or
have
others
manufacture
products)
that
contain
3TG
metals
or
their
derivatives
(tantalum,
tin,
tungsten
and
gold)
that
are
necessary
to
product
functionality
or
production
are
required
to
assess
their
supply
chains
and
report
to
the
SEC
on
whether
those
materials
are
sourced
from
the
Democratic
Republic
of
Congo
and
adjoining
countries.
https://www.avient.com/sites/default/files/resources/ISO9001.2015PolyOneShanghai%25282018-2021%2529.pdf
Park, Pudong, Shanghai, China, 201203
and the sites as mentioned in the appendix accompanying this certificate
has been found to conform to the Quality Management System standard:
ISO 9001:2015/GB/T 19001-2016
This certificate is valid for the following scope:
Design and Manufacture of Masterbatch
C ertificate No: 7071-1998-AQ-RGC-RvA
P lace and date: Shanghai, 30 March, 2018
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
Park, Pudong, Shanghai, China, 201203
Design and Manufacture of Masterbatch
Polyone - Shanghai, China
(Tianjin) Branch
No. 28#C, Jin Bin Hi-Tech Industrial Park,
156 Nan Hai Road, Tianjin
Economic-Technological, Tianjin, China,
300457
Manufacture of Masterbatch
https://www.avient.com/sites/default/files/2022-04/Sustainable Material Answers_ Recycled PET 2022.pdf
Energy Efficient
PET takes less energy to manufacture than alternative materials like glass.
Also, the more rPET used in
manufacturing, the higher the acetaldehyde levels, which can lead to odor and taste
issues.
They should contain at least
25% recycled plastic in their manufacture by 2025 (for PET bottles), and
30% by 2030 (for all bottles).