https://www.avient.com/resources/safety-data-sheets?page=348
49187GNS BETA RED 2
49200GNS BETA RED 10
https://www.avient.com/knowledge-base/case-study/new-approach-restores-efficiency-pulmonary-device-manufacturing
It also could be sterilized by ethylene oxide and gamma radiation, and it offered USP Class VI and RoHS compliance to accelerate approvals and time to market.
https://www.avient.com/news/polyone-hires-john-midea-senior-vice-president-global-operations-and-process-improvement
Midea will lead PolyOne’s award-winning global operational excellence initiatives, including manufacturing process improvement, environmental health and safety, global sourcing and logistics, Lean Six Sigma training and deployment, and integration of acquisitions.
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/2020-07/versaflex-hc-syringe-plunger-english.pdf
Versaflex HC - Syringe Plunger - English
SYRINGE
MANUFACTURER
D I S P O S A B L E S Y R I N G E
P L U N G E R
• USP VI and ISO 10993-4,5 compliant
• Sterilize by gamma & EtO
• Long-term sealing performance
• Low coefficient of friction (COF)
• Consistent performance across barrel sizes
• Provided a formulated solution that met
rigorous medical application requirements
• Improved global supply continuity
• Increased process efficiency by replacing
previous thermoset material with TPE
Versaflex™ HC 2110-57B
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/versaflex-bvm-resuscitator-bag.pdf
Versaflex - BVM Resuscitator Bag
BAG-VALVE-MASK (BVM)
MANUFACTURER
R E S U S C I T A T O R B A G
• Compatible gamma sterilization process
• Achieve desired elastomeric properties
• PVC-free formulation
• FDA, ISO 10993, USP VI compliant
• Repeatable injection molding process
• Complemented customer expertise with
technical support in material selection, part &
tool design, and process development
• Customized TPE offered customer an
alternative to vinyl without sacrificing
performance
• Improved process efficiency and overall
system costs through injection molding method
Customized Versaflex™ TPE
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/versaflex-hc-syringe-plunger-spanish.pdf
Versaflex HC - Syringe Plunger - Spanish
FABRICANTE DE
JERINGAS
É M B O L O D E J E R I N G A
D E S E C H A B L E
• Cumplir con las normas USP VI e ISO 10993-4,5
• Esterilización con gamma y EtO
• Rendimiento de sellado a largo plazo
• Bajo coeficiente de fricción (COF)
• Rendimiento uniforme en jeringas de diferentes diámetros
• Ofreció una solución formulada que cumple
con los requerimientos rigurosos de una
aplicación médica
• Mejoró la continuidad del suministro global
• Aumentó la eficiencia del proceso al
sustituir el material termoestable anterior
con un TPE
Versaflex™ HC 2110-57B
REQUERIMIENTOS CLAVE
¿POR QUÉ AVIENT?
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Medical Devices Application Bulletin.pdf
The portfolio includes formulations
for UV protection, friction reduction, protection
against oxidation, improved clarity, gamma/e-beam
sterilization protection, reduction of static electricity
buildup, laser marking/welding, and more.
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.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Pharma Pkg Application Bulletin.pdf
The portfolio includes
formulations for UV protection, slip/torque
reduction, protection against oxidation,
improved clarity, gamma/e-beam sterilization
protection, and more.
for API handling
Permanent/non-migrating;
fast decay time independent
of % relative humidity
Antistatic masterbatch
for PE films
Cost effective, long-lasting, migrating
type but with biological evaluation
Gamma/e-beam
sterilization protection
of the polymer
Preserving the properties of PP and
COC/COP.