https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
KEY CHARACTERISTICS
• Manufactured under change control principles
beyond CAS number (similar level as MEVOPUR
concentrates), reducing risk of change
• Free from animal-derived substances and
phthalates
• Suitable for blown film, injection molding,
blow molding and extrusion
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP chapters , including Class VI,
a requirement for ophthalmic and nasal drugs
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
- USP and USP light transmission
• Registered Drug Master File (Type III)
• Food contact compliance established with
FDA/EU*
APPLICATION BULLETIN
CARRIER
MATERIAL
PIGMENT
CONTENT/TYPE
LIGHT
FASTNESS
THERMAL
STABILITY
PRODUCT
CODE
HDPE 50% TiO2
8 300°C PH00075525
LLDPE 60% TiO2
8 300°C PL00075542
LLDPE 70% TiO2
8 300°C PL00075545
PP 50% TiO2
8 300°C PP00075717
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations for Needle Hubs 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
• Color can be combined with additives to
enhance performance and protection
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 Device Master File
• Food contact established with FDA/EU*
NOMINAL
OUTSIDE
DIAMETER OF
NEEDLE (MM)
COLOR
DESCRIPTION RAL PANTONE TRANSPARENT
PRODUCT CODE
OPAQUE
PRODUCT
CODE
0.4 Medium Grey 7035 423 C PP7M665125 PP7M665127
0.45 Brown 8017 7588 C PP8M665294 PP8M665296
0.5 Orange 2003 173 C PP2M665298 PP2M665300
0.55 Medium Purple 4005 7676 C PP4M665290 PP4M665292
0.6 Deep Blue 5010 288 C PP5M665894 PP5M665896
0.7 Black 9005 Black C PP9M664950 PP9M664952
0.8 Deep Green 6001 7483 C PP6M665687 PP6M665689
0.9 Yellow 1021 115 C PP1M665211 PP1M665213
1.1 Cream 1015 7401 C PP0M665290 PP0M665292
1.2 Pink 3015 502 C PE3M665725 PP3M665727
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
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/sites/default/files/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.pdf
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
• Standard concentrates in a PE carrier and
on request in PP
• Pre-colored formulations can be supplied in
specific resins selected for the application
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)
• Food contact established with FDA/EU*
APPLICATION BULLETIN
DRUG TYPE COLOR
DESCRIPTION
PANTONE
REFERENCE
AVIENT PRODUCT
CODE PE BASED
Adrenergic agonist
combinations Light Green 373 C PE6M176349
Adrenergic agonists Purple 2583 C PE4M176057
Anti-infectives Tan 467 C PE8M176130
Anti-inflammatory,
nonsteroidal Grey Cool Grey 4 C PE7M176184
steroids Pink 197 C PE3M176237
Anti-inflammatory,
immunomodulators Olive Green 5763 C On request
Beta-blockers Yellow Yellow C PE1M176160
Beta-blocker combinations Dark Blue 281 C PE5M176272
Carbonic anhydrase inhibitors Orange 1585 C PE2M176089
Cytotoxic Black 6 C PL9M176008
Miotics Dark Green 348 C PE6M176267
Mydriatics and cycloplegics Red 1797 C PE3M176236
Prostaglandin analogues Turquoise 326 C PE5M176273
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2020-11/gls-tpes-soft-touch-selection-guide.pdf
GENERAL PURPOSE GLS TPES FOR PACKAGING
SOFT TOUCH GRIPS BONDING TO POLAR SUBSTRATES
GENERAL PURPOSE GLS TPES FOR PACKAGING
SOFT TOUCH GRIPS BONDING TO NON POLAR SUBSTRATES
Dynaflex™
G2711
Dynaflex™
G2780
Dynaflex™
G6713
Dynaflex™
G7960
Versalloy™
XL9045
Versaflex™
CL40
Aesthetics Grippy, 43A
Low tack, 84A
Extra soft, 13A
Rubbery, 60A
& opaque
Matte, 45A
& natural
Grippy, 40A
& water clear
Special
Characteristics
Grippy medical
grade PP & PE OM Extra soft General
purpose
High flow &
fast setup Water clear
Regulatory FDA, EU &
USP VI FDA FDA & EU FDA FDA FDA & EU
Overmolding Polypropylene Polypropylene &
Polyethylene Polypropylene Polypropylene Polypropylene Polypropylene
Versaflex™
CL 2250
Versaflex™
OM 3060
Versaflex™
CE 3120-65
Versaflex™
CE 3620
Versollan™
RU 2205
Aesthetics Grippy, 50A
& clear
Grippy, 59A
& clear
Silky feel, 65A
Silky feel, 65A
Grippy, 65A
Special
Characteristics Clear overmold Clear overmold Abrasion resistance
& high strength
Low compression set
& high flow
Abrasion resistance
& high strength
Regulatory FDA & USP VI FDA & USP VI UL 94 FDA &
ISO 10993-10 —
Overmolding Polycarbonate Polycarbonate
& ABS
Polycarbonate,
ABS, Copolyester
& Nylon 12
Polycarbonate,
ABS, Copolyester
& Nylon 12
1.844.4AVIENT
www.avient.com
Copyright © 2020, Avient Corporation.
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.
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.
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.
https://www.avient.com/sites/default/files/2024-11/Stan-Tone HC Plus Product Bulletin_0.pdf
KEY CHARACTERISTICS
• Meets USP Class VI standards
• Biocompatible
• Provides lightfastness, chemical resistance,
and heat stability
• Available in standard single pigment or custom
multi-pigment colors
• LSR and HCR options available
TARGET APPLICATIONS
Stan-Tone HC Plus silicone dispersions are suitable
for a variety of healthcare applications including:
• Catheters and medical tubing
• Medical and surgical equipment
• Labware and diagnostic devices
• Specialty medical devices and wearables
Product
Code Pigment Type % Pigment
(approx.)
https://www.avient.com/sites/default/files/2025-02/31307-Certificate-17JUL2024.pdf
31307
Avient Corporation
At the below facilities
The Manufacture of Pultruded and Filament wound components Pultrusion and CRTM 3943, Valley East Industrial
Drive, Buildings 1,2,3,4
Birmingham - AL 35217 United
The Manufacture of Pultruded and Filament wound components Pultrusion and Filament Wound
Tubing
3968, Valley East Industrial
Drive, Building 5 Birmingham -
AL 35217 United States
The Manufacture of Pultruded and Filament wound components Pultrusion 3950, Valley East Industrial
Drive, Building 6 Birmingham -
AL 3517 United States
Corporation
Management of QMS.