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/2024-08/LATAM CAI Certifications Bulletin _Portuguese_.pdf
Na América Latina,
nossas unidades de produção de cores e aditivos orgulhosamente
conquistaram as certificações ISO 9001:2015, ISO 22000:2018,
ISO 14001:2015, RC 14001®:2023 e IATF 16949:2016.
No. 49862
ISO 14001:2015
Cert.
No. 65536
ISO 22000:2018
Reg.
https://www.avient.com/sites/default/files/2023-06/Cesa_ Stat Antistatic Additives for Automotive - Application Bulletin.pdf
Cesa Stat Antistatic Additives for automotive can
support customers with electrostatic decay time
testing according to Standard DIN EN 61340-2-1
to speed up the development.
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-3810-covid-19-containment-tube-screw-caps-case-study.pdf
DIAGNOSTICS
MANUFACTURER
C O V I D - 1 9 C O N T A I N M E N T
T U B E S C R E W C A P S
• Wide range of durometers with consistent raw materials
• Processing consistencies across the durometer ranges for
an easy transition between materials
• Materials formulated without animal derivatives at a
competitive cost
• Offered a comprehensive range of solutions
to accommodate specific application
demands such as barrier, flexibility, and
sealing performance
• Provided materials manufactured in an ISO
13485 certified facility
• Delivered a series of medical-grade TPEs
that could be extruded and injection molded
Versaflex™ HC 3810 Thermoplastic
Elastomers
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2025-02/Mevopur White Formulation for PCR Well Plates - Case Study_0.pdf
LABORATORY EQUIPMENT
MANUFACTURER
P C R W E L L P L A T E S
• Very high level of TiO2 to prevent “cross-talk” between the wells
during the qPCR fluorescence testing procedure
• Minimized background phosphorescence caused by
agglomeration of TiO2 and/or oxidized (stressed) polystyrene
• Preservation of polystyrene grade properties
• Change control of formulation and manufacturing process
• Robust product quality from batch to batch
• Developed optimally dispersed, ready-to-use
white formulation that maintains adequate signal
transmission, as well as minimizing “cross-talk”
and background phosphorescence
• Optimized the use of general purpose polystyrene
(GPPS) for a good balance between melt flow
and other physical properties, such as stiffness
• Provided comprehensive change control of raw
materials and formulation, with a robust
manufacturing process and quality control under
a third party ISO 13485:2016 certified QMS
Mevopur Healthcare Colorants and Formulations
– pre-colored solution
WHY AVIENT?
https://www.avient.com/products/polymer-colorants/healthcare-colorants/mevopur-healthcare-colorants-and-formulations
Slide 1: laboratory equipment manufacturer
https://www.avient.com/sites/default/files/2020-07/versaflex-mam-cup-spanish.pdf
Versaflex - MAM Cup - Spanish
MAM
T A Z A E N T R E N A D O R A - L E A R N
T O D R I N K ™
• En cumplimiento de las normas de contacto con
alimentos grasos de la Unión Europea*
• Sensación de suavidad y tersura al tacto
• Sin BPA, sin ftalatos
• Gran facilidad de coloración
• Ofreció una solución personalizada para
cumplir con los Requerimientos de contacto
con alimentos grasos y las necesidades de
aplicación en Europa
• Mejoró el atractivo para el cliente con un
material suave, duradero y con color
personalizado
Versaflex™ FFC
KEY REQUIREMENTS
SOLUCIÓN AVIENT
CUMPLE CON LA NORMATIVIDAD DE
ALIMENTOS GRASOS
MÁS INFORMACIÓN* Puede haber limitaciones: Consulte a Avient para obtener más información
Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2020-07/versaflex-philips-avent-bottle-spanish.pdf
Versaflex - Philips Avent Bottle - Spanish
PHILIPS AVENT
S E L L O P A R A B I B E R O N E S
• Normatividad de contacto con alimentos grasos de la
FDA, la Unión Europea y China
• Sellado hermético a temperaturas elevadas para
esterilización
• Satisfacer la necesidad de refrigeración repetida
• Uso de la experiencia en materiales para el
desarrollo de un producto que cumple con
las normas de contacto con alimentos
grasos y ofrece rendimiento de sellado
seguro
• Permitió a las madres convertir sus
biberones Philips AVENT en envases de
almacenamiento de leche materna
Versaflex™ FFC2882-87
REQUERIMIENTOS CLAVE
SOLUCIÓN AVIENT
CUMPLIMIENTO NORMATIVO
MÁS INFORMACIÓN
Copyright © 2020, Avient Corporation.
https://www.avient.com/resource-center?document_type=221&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.