https://www.avient.com/sites/default/files/2023-10/Value Added Services Brochure.pdf
A RANGE OF WORLD-CLASS SERVICES
COLOR TECHNOLOGY
Custom matching, saturated colors, and special
effects to fill market niches, eliminate secondary
operations, and strengthen your brand
PCR COLOR PREDICTION SERVICE
Digital prediction tool illustrating color possibilities
and limitations of post-consumer recycled (PCR)
content to simplify decision making and shorten
time to launch
PRODUCT CARBON FOOTPRINT (PCF)
CALCULATOR
Methodology that evaluates the carbon footprint of
Avient solutions, contributing a data point to your
overall carbon footprint and supporting credible
reporting
AVIENT DESIGN
A highly specialized group of industrial designers
and project engineers that provides advanced
design and detailed analysis to foster higher levels
of innovation
TESTING AND VALIDATION
Fully accredited and in-house testing capabilities
to generate data for insight into material behavior,
environmental effects, and more
REGULATORY SUPPORT
Dedicated product stewardship team assisting
with new product approvals to reduce regulatory
overhead and minimize risk
COLOR AND ADDITIVE DESIGN SERVICES
Trend and color insights along with product
development assistance from concept through
commercialization to optimize design and gain
speed to market
RESEARCH AND DEVELOPMENT
Long-term strategic solution development that
addresses complex and unmet product innovation
needs
APPLICATION DEVELOPMENT TECHNICAL
SUPPORT
Technical experts specifically trained to work
directly with your team to solve definitive
application challenges with new or existing
approaches
FIELD TECHNICAL SERVICE
Onsite support for tool design, startup, and
production optimization to gain manufacturing
efficiencies and help resolve technical issues
Common compliance categories
where we can assist:
• UL
• USP Class VI
• ISO 10993
• ISO 1345
• REACH
• RoHS
• FDA
• EU 10/2011
• China GB
• MERCOSUR
• USP
• ISP
• CPSIA
• Prop 65
ColorWorks™ Design &
Technology Centers
Our global ColorWorks centers are
focused on design, technology, and
innovation for plastics.
https://www.avient.com/sites/default/files/2021-medical-devices-selection-guide.pdf
Copolyester, Polyester & PC/Polyester Blends
Copolyester Eastman Tritan™
(Copolyester)
High chemical resistance to a wide variety of hospital disinfectants;
excellent toughness and impact resistance after disinfection; retains color and gloss
after sterilization and disinfection; does not contain BPA, BPS or halogens
Polybutylene
Terephthalate
(PBT)
DuPont™ Crastin® & Rynite®
(FR-PBT)
30% glass reinforced; flame retardant; good mold flow and electrical properties;
high strength, stiffness, dimensional stability and heat resistance
Polyester
(PC/PET) &
Polybutylene
Terephthalate
(PC/PBT)
Covestro Makroblend®
(FR-PC/PET) & (FR-PC/PBT) Strength; toughness; chemical resistance; flame retardant
Covestro Makroblend®
(Non-FR PC/PBT) Strength; toughness; chemical resistance; limited biocompatibility
Trinseo EMERGE™
(FR-PC/PET) Chemical resistance; ignition resistance; limited biocompatibility
PA, PVC, PC & PMMA
Polyamide
(Nylon, PA)
Avient Trilliant™ XR
Radiation Shielding (PA)
Radiation shielding; green alternative for lead replacement;
enhanced design freedom vs. lead; available in hard and soft durometers
Arkema Rilsan® MED (PA11) &
Rilsamid® MED (PA12)
Chemical resistance; transparent and opaque; easy processing; creep resistance;
temperature resistance; BPA-free; sterilizable by gamma, EtO and steam
Polyvinyl
Chloride
GEON Performance Solutions
Resilience™ HC (PVC)
Excellent chemical resistance; good strength and stiffness; very good surface quality;
inherently flame resistant; available in all medical colors; excellent solvent bonding to PVC
Polycarbonate
(PC) Trinseo EMERGE™ (PC) Ignition resistant; transparent and opaque; glass-filled also available
PolyMethyl
Methacrylate
(PMMA)
Trinseo Plexiglas® Acrylics
(PMMA) Clarity; easy processing; chemical resistance; BPA free; ideal for light piping and lenses
Styrenics & FR-PC/ABS Blends
Styrenics
Trinseo MAGNUM™ (ABS) Opaque; custom colors; excellent impact and flow; low residuals; full biocompatibility
INEOS Styrolution
Terlux® HD (MABS)
Good clarity; good heat and overall chemical resistance;
good impact strength; good solvent bonding to PVC; outstanding surface quality
INEOS Styrolution
Lustran® & Novodur® HD (ABS)
Opaque appearance; outstanding chemical resistance; high impact strength;
excellent balance of properties; ease of processability; bondable
FR-
Polycarbonate/
ABS
(FR-PC/ABS)
Covestro Bayblend®
(FR-PC/ABS) Flame retardant; good impact resistance; dimensional stability; toughness
Trinseo EMERGE™
(FR-PC/ABS)
Ignition resistant; limited biocompatibility; high flow; easy processing;
glass-filled also available
RIGID COMPONENTS: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY,
Applications include:
• Housings
• Covers
• Monitor bezels
• Body panels
• Handles
• Access panels
• Battery enclosures
• Wands
• Coils
Rigid Component Solution Needs:
• Materials compliant with ISO 10993 & USP Class VI, if required
• UL approved resins to meet flammability requirements
• Housings with toughness & good impact resistance
• Enclosures & components that withstand repeated cleanings
• High-flow materials for components with complex designs
FLEXIBLE COMPONENTS: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY,
Applications include:
• O-rings
• Gaskets
• Wheels
• Soft touch
grips/handles
• Keypads/displays
• Diaphragms
• Seals
Flexible Component Solution Needs:
• Comfortable handles & grips
• Water-tight seals
• Durable feet or casters
• Durable keypads
• Flow control
TPE, TPC-ET, TPU, TPV & Flexible PVC
Thermoplastic
Avient Versaflex™ HC
Overmolding Series
Proven healthcare solutions with hardness ranges 42–65 Shore A; autoclave, radiation
and EtO sterilizable; bondable to many substrates; customizable haptics
Arkema Pebax® MED
Sterilizable by gamma and EtO; low energy return; soft touch;
chemical resistance; overmolding material
Thermoplastic
Polyester
DuPont™ Hytrel®
Wide range of flexibility, stiffness, and processing options; Shore D between 30-82;
BPA-free; excellent flex fatigue and toughness; low temperature flexibility;
good chemical resistance
Thermoplastic
Polyurethane
Covestro Texin®
Biocompatible; soft touch; sterilizable; good chemical resistance;
overmold for grips and handles; excellent bonding to polar substrates like PC; 70A to 95A
Thermoplastic
Vulcanizate
Avient Versalloy™
Proven healthcare solutions with hardness ranges 45–90 Shore A; autoclave, radiation
and EtO sterilizable; natural and colorable; smooth texture; bonds to PP
Exxon Mobil Santoprene™
Durable sealing performance; elastic recovery; excellent chemical resistance;
compliance with medical standards
Flexible
Polyvinyl
Chloride
GEON Performance Solutions
Geon™ Flexible PVC
Engineered exclusively for the healthcare market; transparent and opaque colors; radiopaque
grades available; durometer ranges from 55A to 40D; gamma and EtO sterilizable
Thermoset Silicone Elastomers
Thermoset
Silicone
Elastomers/
Liquid Silicone
Rubber (LSR)
DuPont™ Liveo™
Silicone Elastomers (LSR)
Biocompatible; non-irritating and non-sensitization; sterilizable;
made without plasticizers, phthalates or latex
PVC
Polyvinyl
Chloride
GEON Performance Solutions
Geon™ Flexible PVC
Inherent flame resistance; halogen-free; excellent chemical resistance;
non-yellowing; proven safety record in wire and cable applications;
high temperature grades available
TPE, TPC-ET, TPU & POE
Thermoplastic
Polyester
Arkema Pebax®
Flexibility; chemical resistance; easy processing; abrasion resistance;
low coefficient of friction
Thermoplastic
Polyester
Elastomers
(TPC-ET)
DuPont™ Hytrel®
REACH, RoHS and WEEE compliant; wide range of flexibility, stiffness,
and processing options; 30D-82D; BPA-free; excellent flex fatigue and toughness;
low temperature flexibility; good chemical resistance
Thermoplastic
Polyurethane
Covestro Texin®
RoHs, WEEE, and REACH compliant; excellent memory and recoil; abrasion resistance;
Texin® Rx Series - medical grade Polyether TPU – 70A to 80D
Polyolefin
Elastomer
(POE)
Avient ECCOH™ Non-halogenated flame retardant; high flexibility;
environmental stress cracking resistance (ESCR); good electrical properties
PA
Polyamide
(Nylon, PA)
Arkema Rilsan®
(PA)
Chemical resistance; easy processing; abrasion resistance;
low coefficient of friction; dimensional stability
WIRE & CABLE: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY,
Applications include:
• Plug molding
• Flexible jacket
• Heater cable
insulation
• Flexible cords
• Coil cords & cable
Wire & Cable Component Solution Needs:
• Materials compliant with UL, RoHS, REACH & WEEE, if needed
• Materials with good chemical, moisture & abrasion resistance
• Low smoke & non-halogen materials
CUSTOM AVIENT SOLUTIONS FOR MEDICAL EQUIPMENT
Custom Solution Needs Avient™ Custom Solutions
Specialized materials to meet unique
application requirements
Avient Trilliant™ Healthcare products are a line
of customized solutions specific for regulated
medical devices; color branding expertise
FDA-registered pre-colored resins
and masterbatch options; color coding
for safety and brand recognition
Avient collaborates with key material suppliers
to provide FDA-approved pre-colored resins
Avient OnColor™ HC Plus offers customizable color
masterbatch solutions pre-certified for biocompatibility
using ISO 10993 and USP Class VI test protocol
Reduced growth of microbes
Avient WithStand™ additive technologies inhibit
growth of microbes that often cause odor,
staining and loss of mechanical properties
AVIENT DISTRIBUTION
Healthcare Supplier Line Card
You face a unique set of challenges when designing parts for the healthcare industry.
https://www.avient.com/sites/default/files/2021-02/2021-medical-devices-selection-guide.pdf
RIGID COMPONENTS: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY,
& MONITORING EQUIPMENT
(housings & covers, monitor bezels, body panels, handles, battery enclosures, access panels, wands, coils)
Rigid
Component
Materials compliant
with ISO 10993
& USP Class VI,
if required
UL approved
resins to meet
flammability
requirements
Housings with
toughness & good
impact resistance
Enclosures &
components that
withstand repeated
cleanings
High-flow materials
for components
with complex
designs
Copolyester, Polyester & PC/Polyester Blends
Copolyester Eastman Tritan™
(Copolyester)
High chemical resistance to a wide variety of hospital
disinfectants; excellent toughness and impact resistance after
disinfection; retains color and gloss after sterilization and
disinfection; does not contain BPA, BPS or halogens
Polybutylene
Terephthalate
(PBT)
DuPont™ Crastin® & Rynite® (FR-
PBT)
30% glass reinforced; flame retardant; good mold flow
and electrical properties; high strength, stiffness,
dimensional stability and heat resistance
Polyester
(PC/PET) &
Polybutylene
Terephthalate
(PC/PBT)
Covestro Makroblend®
(FR-PC/PET) & (FR-PC/PBT) Strength; toughness; chemical resistance; flame retardant
Covestro Makroblend®
(Non-FR PC/PBT)
Strength; toughness; chemical resistance;
limited biocompatibility
Trinseo EMERGE™
(FR-PC/PET)
Chemical resistance; ignition resistance;
limited biocompatibility
PA, PVC, PC & PMMA
Polyamide
(Nylon, PA)
Avient Trilliant™ XR
Radiation Shielding
(PA)
Radiation shielding; green alternative for lead
replacement; enhanced design freedom vs. lead;
available in hard and soft durometers
Arkema Rilsan® MED (PA11) &
Rilsamid® MED (PA12)
Chemical resistance; transparent and opaque;
easy processing; creep resistance; temperature resistance;
BPA-free; sterilizable by gamma, EtO and steam
Polyvinyl
Chloride
GEON Performance Solutions
Resilience™ HC (PVC)
Excellent chemical resistance; good strength and stiffness;
very good surface quality; inherently flame resistant;
available in all medical colors; excellent
solvent bonding to PVC
Polycarbonate
(PC) Trinseo EMERGE™ (PC) Ignition resistant; transparent and opaque;
glass-filled also available
PolyMethyl
Methacrylate
(PMMA)
Altuglas Plexiglas® Acrylics
(PMMA)
Clarity; easy processing; chemical resistance;
BPA free; ideal for light piping and lenses
Styrenics & FR-PC/ABS Blends
Styrenics
Trinseo MAGNUM™
(ABS)
Opaque; custom colors; excellent impact and flow;
low residuals; full biocompatibility
INEOS Styrolution
Terlux® HD
(MABS)
Good clarity; good heat and overall chemical resistance;
good impact strength; good solvent bonding to PVC;
outstanding surface quality
INEOS Styrolution
Lustran® & Novodur® HD (ABS)
Opaque appearance; outstanding chemical resistance;
high impact strength; excellent balance of properties;
ease of processability; bondable
FR-
Polycarbonate/
ABS
Covestro Bayblend®
Flame retardant; good impact resistance;
dimensional stability; toughness
Trinseo EMERGE™
Ignition resistant; limited biocompatibility; high flow;
easy processing; glass-filled also available
Flexible
Component
Solution Needs:
Comfortable
handles
& grips
Water-tight seals
Durable feet
or casters
Durable
keypads
Flow
control
TPE, TPC-ET, TPU, TPV & Flexible PVC
Thermoplastic
Avient Versaflex™ HC
Overmolding Series
Proven healthcare solutions with hardness ranges 42–65
Shore A; autoclave, radiation and EtO sterilizable;
bondable to many substrates; customizable haptics
Arkema Pebax® MED
Sterilizable by gamma and EtO; low energy return;
soft touch; chemical resistance; overmolding material
Thermoplastic
Polyester
DuPont™ Hytrel®
Wide range of flexibility, stiffness, and processing
options; Shore D between 30-82; BPA-free; excellent
flex fatigue and toughness; low temperature flexibility;
good chemical resistance
Thermoplastic
Polyurethane
Covestro Texin®
Biocompatible; soft touch; sterilizable; good chemical
resistance; overmold for grips and handles; excellent
bonding to polar substrates like PC; 70A to 95A
Thermoplastic
Vulcanizate
(TPV)
Avient Versalloy™
(TPV)
Proven healthcare solutions with hardness ranges 45–90
Shore A; autoclave, radiation and EtO sterilizable;
natural and colorable; smooth texture; bonds to PP
Exxon Mobil Santoprene™ (TPV) Durable sealing performance; elastic recovery; excellent
chemical resistance; compliance with medical standards
Flexible
Polyvinyl
Chloride
GEON Performance Solutions
Geon™ Flexible PVC
Engineered exclusively for the healthcare market; transparent
and opaque colors; radiopaque grades available; durometer
ranges from 55A to 40D; gamma and EtO sterilizable
Thermoset Silicone Elastomers
Thermoset
Silicone
Elastomers/
Liquid Silicone
Rubber
DuPont™ Liveo™
Silicone Elastomers (LSR)
Biocompatible; non-irritating and non-sensitization;
sterilizable; made without plasticizers, phthalates or latex
FLEXIBLE COMPONENTS: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY,
MONITORING EQUIPMENT
(o-rings, gaskets, wheels, soft touch grips/handles, keypads/displays, diaphragms, seals)
WIRE & CABLE: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY,
& MONITORING EQUIPMENT
(plug molding, heater cable insulation, flexible jacket, flexible cords, coil cords & cable)
Wire and Cable
Component
Solution Needs:
Materials compliant
with UL, RoHS,
REACH & WEEE, if
needed
Materials with
good chemical,
moisture & abrasion
resistance
Low smoke & non-
halogen materials
PVC
Polyvinyl
Chloride
GEON Performance Solutions
Geon™ Flexible PVC
Inherent flame resistance; halogen-free; excellent
chemical resistance; non-yellowing; proven safety record
in wire and cable applications; high temperature
grades available
TPE, TPC-ET, TPU & POE
Thermoplastic
Polyester
Arkema Pebax®
Flexibility; chemical resistance; easy processing;
abrasion resistance; low coefficient of friction
Thermoplastic
Polyester
Elastomers
(TPC-ET)
DuPont™ Hytrel®
REACH, RoHS and WEEE compliant; wide range of flexibility,
stiffness, and processing options; 30D-82D; BPA-free;
excellent flex fatigue and toughness; low temperature
flexibility; good chemical resistance
Thermoplastic
Polyurethane
Covestro Texin®
RoHs, WEEE, and REACH compliant; excellent memory
and recoil; abrasion resistance; Texin® Rx Series -
medical grade Polyether TPU – 70A to 80D
Polyolefin
Elastomer
(POE)
Avient ECCOH™
Non-halogenated flame retardant; high flexibility;
environmental stress cracking resistance (ESCR);
good electrical properties
PA
Polyamide
(Nylon, PA)
Arkema Rilsan®
(PA)
Chemical resistance; easy processing; abrasion resistance;
low coefficient of friction; dimensional stability
CUSTOM AVIENT SOLUTIONS FOR MEDICAL EQUIPMENT
Custom Solution Needs Avient™ Custom Solutions
Specialized materials to meet unique
application requirements
Avient Trilliant™ Healthcare products are a line
of customized solutions specific for regulated
medical devices; color branding expertise
FDA-registered pre-colored resins
and masterbatch options; color coding
for safety and brand recognition
Avient collaborates with key material suppliers
to provide FDA-approved pre-colored resins
Avient OnColor™ HC Plus offers customizable color
masterbatch solutions pre-certified for biocompatibility
using ISO 10993 and USP Class VI test protocol
Reduced growth of microbes
Avient WithStand™ additive technologies inhibit
growth of microbes that often cause odor,
staining and loss of mechanical properties
AVIENT DISTRIBUTION
Healthcare Supplier Line Card
You face a unique set of challenges when designing parts for the healthcare industry.
https://www.avient.com/sites/default/files/2020-12/sem-tri-fold-selection-guide.pdf
a wholly-owned subsidiary of Avient Corporation
NAME BASE RESIN(S) AVAILABLE FEATURES1
Trilliant™
ABS, LCP, PA, PC,
ABS, PA 6, PA 66,
PC/ABS, PC/PSU,
PEBA, PEEK, PES,
POM, PPA, PSU
Certified to USP Class VI
Formulations locked down
Drug master file submissions by product stewardship
Pre-colored, small lot production down to 50 lb–250 lb
Sterilization, chemical resistance, and secondary process guidance
Adherence to FDM-GMP manufacturing standards
Antimicrobial technologies
Materials for radiation shielding protection
NEU™
Specialty
Materials2
PEBA, TPU, PA 11, PA 12,
PP, PE, TPE
Radiopacifiers, stabilizers, and surface modifiers
Antimicrobial technologies
Pre-colored formulations
Small lot capabilities
Short lead times
Versaflex™ HC TPE
Overmolding
Clear and heat resistant
Ultra clear grades
Ultra soft TPE gels, 30 shore OO
FDA, USP Class VI, ISO 10993 approved grades
Sterilizable under autoclave, radiation, and EtO gas
HEALTHCARE SPECIALTY THERMOPLASTICS
reSound™ R
Recycled
Formulations
PA6, PA66, PC
Transportation, Consumer,
Household Appliance,
Electrical & Electronics,
PA grades: Up to 100% recycled content
PC grades: Up to 70% recycled content
PIR and PCR grades available
Support the circular economy
Comparable performance to prime grades
Customizable solution
Surround™ ABS, PP, PBT, PC, PA 66 Transportation, Electrical
Integrated EMI/RFI shielding
Long fiber technology
Conductive properties
Galvanic corrosion protection
Lightweighting and ease of processing
Stat-Tech™
ABS, PA, PC, PC/ABS,
PC/PSU, PEEK, PEI,
PES, PP, PPA
Transportation, Electrical
Integrated EMI/RFI shielding
Conductive properties
Anti-static/dissipative properties
Corrosion resistance
Lightweighting and ease of processing
Clean room materials for semiconductors available
Therma-Tech™ LCP, PA, PEEK, PP,
PPA, PPS Consumer, Transportation
Thermally conductive
Low coefficient of thermal expansion
SPECIALTY ENGINEERED THERMOPLASTICS
Barricade™
Elastomers
with Fortrex™
Technology
Barricade™ high-performance
elastomers bring next genera-
tion technology to market to
bridge the gap between tradi-
tional TPEs and silicone
Healthcare, Industrial
Aerospace, Appliances,
Electronics
High temperature compression set
Processes on thermoplastic injection molding
and extrusion equipment
Customizable and colorable
Process simplicity
CROSSLINKABLE ELASTOMERS
Barricade formulations leverage licensed Fortrex™ technology.
Consumer, Packaging,
Healthcare, Electrical &
Electronics, Appliance
Clear and heat resistant TPEs
Ultra clear grades
Ultra soft TPE gels, 30 shore OO
FDA, USP Class VI, ISO 10993 approved grades
NSF and UL listings
Sterilizable under autoclave, radiation, and EtO gas
GLS™ THERMOPLASTIC ELASTOMERS
* Commercially available in North America only
NAME BASE RESIN(S) AVAILABLE FEATURES1
ECCOH™ Polyolefin
Flame retardant, low smoke and fume, zero halogen (LSFOH)
Cross-linkable grades
Chemical, oil, and gel resistant
Flexible, low friction, easy-peel, and high speed processing
Compatible with Avient additives and color masterbatches
FireCon™ CPE, CPE Alloy
Low and medium voltage cable jacketing
Flame retardant and 90°C deformation resistance
Oil resistance
RoHS grades available
Maxxam™ FR PE, PP UL Yellow Card for plenum applications
Halogen-free flame retardant grades available
Maxxam™ SY Foamable PP co-polymer
Easy processing
Variety of final densities available
Syncure™ XLPE
High performance moisture cure technology
UL bulletinized XHHW2 and VW1
Temperature, abrasion, and oil resistant
WIRE AND CABLE SPECIALTY THERMOPLASTICS
To learn more, please visit avient.com
or call +1.844.4AVIENT (+1.844.428.4368).
https://www.avient.com/company/sustainability/sustainability-report/products/product-stewardship-global-chemical-management-product-excellence
Avient has 102 global manufacturing facilities. 96% of these sites are certified through independent third parties to management system standards including ISO:14001, ISO:50001, ISO:22000, ISO:45001, ISO:9001, and Responsible Care®.
This methodology was developed in accordance with ISO 14067:2018 for product carbon footprint and is aligned with ISO 14040/140440 for life cycle analysis.
Major Non-Conformances at ISO Sites
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-bt218-biopharmaceutical-tubing-case-study.pdf
MEDICAL TUBING
EXTRUDER
B I O P H A R M A C E U T I C A L
T U B I N G
• Low leachables & extractables
• Great tensile performance and kink resistance
• Good thermal weldability
• Excellent clarity and medical blue tint
• ISO 10993-4 & 5, USP Class VI & Animal Derivative Free
(ADF)
• Supplied drop-in material replacement to
overcome supply constraints of incumbent TPE
• Offered a lower extractable profile than
comparable materials in the market
• Enabled easy material transition without changes
in tooling or thermal welding machine settings
• Formulated solution with proprietary additives to
provide clarity and prevent yellowing after
sterilization
Versaflex™ HC BT218 Thermoplastic
Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2025-01/NEUSoft Product Selection Guide.pdf
Whether your application demands can be supported
by the NEUSoft Express color palette or require
customization, all our NEUSoft TPUs are designed with
patient safety and regulatory specifications in mind,
complying with ISO 10993 and USP Class VI standards.
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.
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.
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.