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/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
Anti-inflammatory,
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/products/polymer-colorants/healthcare-colorants
Based on polysulfone resins and tested to ISO 10993, this line of opaque and transparent colorants is specifically formulated to achieve high heat resistance in healthcare applications.
Formulated with raw materials tested to ISO, USP, EP, and ICH Q3D protocols, the portfolio includes standard color ranges to speed up time to market and custom color solutions tailored to customer requirements.
https://www.avient.com/sites/default/files/2024-08/PCF One-pager.pdf
CERTIFIED FOR ACCURACY AND
RELIABILITY
Our PCF Calculator is
third-party certified
by TÜV Rheinland and
aligns with the ISO
14067:2018 standard for quantifying and reporting
the carbon footprint of a product.
https://www.avient.com/sites/default/files/resources/Lahnstein_ISO50001.pdf
Avient Colorants Germany GmbH
Hohenrhein 1
56112 Lahnstein
Germany
Scope
Production of Color Concentrates and Compounds
Normative base
ISO 50001:2018 Energy Management System
Reg. no. 46089 Validity 17. 12. 2020 – 16. 12. 2023
Issue 12. 04. 2021
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.
https://www.avient.com/sites/default/files/2021-07/eccoh-optical-cable-sheath-case-study-one-pager.pdf
WIRE &CABLE
COMPANY
O P T I C A L C A B L E S H E A T H
• Excellent resistance to fungi and mildew
• Good UV resistance
• Meet flame retardant standard IEC 60332-3C
• Provided an anti-fungi solution with an ISO
846 rating of 0, showing no growth under
microscope
• Formulated solution to meet flammability
performance demands for IEC60332-2 or
GBT 18380.22-2008 compliance
• Complied with Biocidal Product Regulation
(EU) No528/2012 (BPR)
ECCOH™ Thermoplastic Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/versaflex-cpap-tubing-film.pdf
Versaflex - CPAP tubing film
CPAP TUBING
C O R R U G A T E D T U B I N G F I L M
• Replacement for polyolefins
• Good spring-back
• Bondable cuffs
• Clear & clean look
• Minimize humidity and condensation within the tube
• No noticeable odor
• FDA, ISO 10993 & USP VI compatible
• Provided TPE solution to meet market
expectations for improved user comfort &
aesthetics
• Reduced tube noise and improved drape
compliance with new material solution
versus polyolefins
• Offered solution with improved thermal
properties to combat humidity
Versaflex™ CL2250
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-12/Versaflex OM TPEs for Sealing Ring of Blood Lancet.pdf
BLOOD LANCET
MANUFACTURER
S E A L I N G R I N G
• Compliance with strict regulations for medical materials
• Excellent sealing performance
• Good compression set
• Provided a recycled TPE solutions
compared to silicone without increasing
system cost
• Delivered a TPE that complied with ISO
10993-4 & -5 and USP Class VI
• Supported a change to an injection molded
material to ease production and enhance
assembly capabilities
Versaflex™ HC TPEs – OM1040-1 Grade
KEY REQUIREMENTS
WHY AVIENT?