https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
Avient products have not been designed for nor are they promoted or intended for use in:
(a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under
US Pharmacopoeia (USP) or ISO standards; or
(b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or
(c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.
Without limiting the generality of this statement, Avient products shall not be used in any medical device application intended for:
(1) exposure to human tissue or body fluids for 30 days or greater;
(2) “plastic” (cosmetic or reconstructive) surgery use;
(3) reproductive implants or any birth control device; or
(4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device, including the suitability of all raw materials and
components used for its manufacture, and with all applicable laws and regulations.
1.844.4AVIENT
www.avient.com
https://www.avient.com/knowledge-base/article/apparent-hardness-vs-thickness-overmold-applications
Many rubbers, soft plastics, urethanes and TPE’s are rated on the “Shore A” scale.
https://www.avient.com/knowledge-base/article/apparent-hardness-vs-thickness-overmold-applications?rtype[]=1164
Many rubbers, soft plastics, urethanes and TPE’s are rated on the “Shore A” scale.
https://www.avient.com/news/avient-launches-non-pfas-process-aid-extrusion-applications-npe-2024
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Avient Launches Non-PFAS Process Aid for Extrusion Applications at NPE 2024
Avient launches new Cesa™ Non-PFAS Process Aid for PE and PP extrusion applications at NPE 2024, enabling processing performance, productivity, and stability comparable to traditional fluoropolymer-based solutions.
Our new Cesa processing aid helps to improve productivity and process stability for film or sheet extrusion, pipe extrusion, or extrusion blow molding,” said Mayendran Pillay, Marketing Director, Color & Additives North America at Avient.
https://www.avient.com/news/archives?page=15
Avient Launches New Stat-Tech™ TPEs & PTFE-Free LubriOne™ Internally Lubricated Formulations at Fakuma 2023
Avient Unveils PTFE-Free and Non-Halogen Flame Retardants for Polycarbonate at Fakuma 2023
New PTFE-free and non-halogen Cesa™ Flame Retardant Additives can help producers of polycarbonate E&E applications prepare for possible future P
https://www.avient.com/sites/default/files/2021-07/lubrione-for-conveyor-belt-gears-application-bulletin.pdf
KEY CHARACTERISTICS
• Excellent wear resistance
• Reduced friction, heat build-up, noise
and vibration
• Improved processability and surface finish
on parts
• Lower power requirements and
low maintenance
• Design flexibility
• Reduced weight
APPLICATION BULLETIN
SOLUTIONS AVAILABLE
LubriOne™ Portfolio
PA66, PA6 and Polyketone
formulations with
10%–30% glass fiber
reinforcement available
Lubricants & Performance
Lubricant Color Performance
LubriOne NN PTFE Natural Shears and creates a PTFE film transferred
to the matting surface.
In combination with PTFE
provides immediate lubrication.
LubriOne LB8900
(PTFE grades only)
Molybdenum
Disulfide Grey Reduces “slip stick” and acts as
nucleating agent.
https://www.avient.com/sites/default/files/2024-07/CCG Application Snapshot Evoluscend Mold Release_Final.pdf
PowerPoint Presentation
M E D I C A L C O N N E C T O R S
• Ongoing production with no change to regular set up
• Excellent processing and demolding performance
• Color stability during processing
• Excellent chemical and impact resistance
• Enabled efficient ongoing production rates without
changing any processing parameters
• Safeguarded color stability and transparency
during processing for optimal aesthetics
• Ensured regulatory requirements for
biocompatible ISO109931 and FDA were met
• Provided a solution effective across a range of
high-temperature polymers, including PEEK,
PPSU, PES, PSU, PEI, LCP, and PPS
Colorant Chromatics Evoluscend non-
PFAS* high-temperature polymer mold release
additive
KEY REQUIREMENTS WHY AVIENT
AVIENT SOLUTION
PRODUCTIVITY + REGULATORY
LEARN MORE
ELECTRICAL
COMPONENT OEM
(*) A non-PFAS additive manufactured without non-intentionally added (NIA) PFAS or PTFE.
(*) manufactured without intentionally added PFAS and without PTFE
(1) refers to sulfone products only
https://www.avient.com/products/polymer-additives/processing-enhancement-additives/colorant-chromatics-evoluscend-non-pfas-high-temperature-mold-release-additive
Slide Number 1
https://www.avient.com/sites/default/files/2022-03/Asia SEM Healthcare Product Selection Guide %281%29.pdf
SPECIALTY
ENGINEERED
MATERIALS FOR
HEALTHCARE
PRODUCT SELECTION GUIDE
Careful consideration must be given to materials used for medical
devices and their impact on patient safety.
Common applications include medical device overmolds, medical and biopharma tubing,
and gaskets and stoppers.
PP OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Dynaflex™ G2706 28A USP Class VI, ISO 10993,
Food contact EtO Soft translucent grade,
grippy feel
Dynaflex™ G2711 43A USP Class VI, ISO 10993,
Food contact EtO Highly colorable solution,
grippy feel, low compression set
Versaflex™
CL2242 & CL2250 42A/ 50A USP Class VI, ISO 10993,
US Food contact EtO Clear boilable grades;
ABS, PC bondable
Versaflex™ G2705 N 60A USP Class VI, ISO 10993,
Food contact EtO/Steam High resilience,
low compression set
Versaflex™ HC3810 20A-90A USP Class VI, ISO 10993 EtO General purpose, unfilled
ABS, PC OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Versaflex™ OM1040 40A USP Class VI, ISO 10993 EtO Translucent
Versaflex™ OM3060 60A USP Class VI, ISO 10993 EtO Clear
VERSAFLEX™ CL AND DYNAFLEX™ TPEs
OVERMOLDING FOR
ERGONOMICS
• Adds good tactile surface with soft-touch feel
• Available in a variety of color effects and
textures
• Improves grip, cushion, and comfort
• Enhances functional performance like sealing
properties, vibration damping, oxygen
barrier, and scratch and abrasion resistance
• Reduces assembly costs, good processability
• Offers excellent adhesion to a wide range of
substrates
• Glucometers
• Medical tools overmolds
• Injector pens
• Analysis devices
VERSALLOY™ HC & VERSAFLEX™ HC TPEs
SEALING & RESEALING
• Rubbery feel and soft touch
• No coring, good puncture, and
resealability in static stoppers
• Meets low coefficient of friction
requirements in dynamic seals
• Low extractables
• Suitable to overmold onto polyolefins
• Sealing and resealing septum
• Seals and sanitary gaskets
• Syringe plungers and tips
MATERIAL DESCRIPTION HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Versalloy™
HC 9210-45N 45A USP Class VI EtO Good processability,
HC 9210-55N 55A USP Class VI EtO Good processability,
HC 9210-70N 70A USP Class VI EtO Good processability,
HC 9220-43N 43A USP Class VI,
ISO 10993-4/5 EtO Extrusion grade,
high temperature resistance
Versaflex™
HC 2110-35N 34A FDA, USP Class VI,
ISO 10993
Autoclave EtO
radiation Resealing, elevated comp set
Versaflex™
HC 2110-57B 57A FDA, USP Class VI,
ISO 10993
Autoclave EtO
radiation Low stiction
VERSAFLEX™ CL AND DYNAFLEX™ TPEs
HIGH CLARITY
GRADES WITHOUT
PLASTICIZERS
• Water clear grades formulated without
phthalate plasticizers
• Meets medical regulatory USP Class VI and
ISO 10993-4,5
• Food contact and FDA compliant
• Autoclave and radiation stable
• Low extractable
• High clarity (Haze 50 4.1, 100 4.5, 100 4, 70 6, 70
Tensile Modulus (MPa) 2200 2700 2600 2350 1820 1820
Flexural Strength (MPa) 80 90 104 86 68 68
Flexural Modulus (MPa) 2500 2700 2500 2300 1980 1590
HDT: 0.45, 1.8 (MPa) 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70
UL-94 Rating @ 3.0 mm 5VA V-0 5VA V-0 HB V-0
UL-94 Rating @ 1.5 mm V-0 V-0 5VB V-0 HB V-0
UL-94 Rating @ 0.75 mm V-1 V-2 V-0 None None V-2
COMPETITIVE MATERIAL COMPARISON
ENGINEERED POLYMER FORMULATIONS
FOR HEALTHCARE
TRILLIANT™ HC THERMOPLASTICS
The family of Trilliant™ HC high-performance thermoplastics is formulated to meet the growing challenges
of medical devices and equipment.
https://www.avient.com/news/pvdf-processing-aids-enhancing-extrusion-efficiency-now-available-avient
Avient’s new Colorant Chromatics™ PVDF Processing Aids are an excellent choice for wire & cable extrusion
These high-performance processing aids can enhance production efficiencies during PVDF extrusion.
They can reduce or eliminate die build-up for cleaner, more consistent extrusion.
https://www.avient.com/knowledge-base/article/polymer-services-frequency-asked-questions
Common examples are epoxy, silicone, and polyurethane (PU).
Profile extrusion
Co-extrusion film and wire & cable