https://www.avient.com/products/thermoplastic-elastomers/onflex-thermoplastic-elastomers
Halogen free, flame retardant TPEs formulated to provide good flexibility, lower moisture absorption, good insulation, and RoHS compliance.
OnFlex™ Thermoplastic Elastomers met soft-touch design requirements and met FDA compliance
https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/remafin-ep-white-colorants
Meets Pharma Packaging Compliance
High loading and optimized dispersion of pigments provide a cost-effective way to meet light transmission requirements while fully supporting regulatory compliance for packaging materials.
Supports regulatory compliance for pharmaceutical packaging materials
https://www.avient.com/sites/default/files/2023-10/Stat-Tech TPE Static Dissipative _ Electrically Conductive Thermoplastic Elastomers Product Overview_A4.pdf
KEY CHARACTERISTICS
• Electrical resistivity range from 10–1010 Ω
• Hardness range from 40–85 Shore A
• Protects critical electrical components from
EMI/RFI
• Reduces static build-up
• Simplifies manufacturing
• Overmolds directly onto polymer substrates
• Meets regulatory compliance requirements of
ATEX and ESD
• Food contact compliance grades are available
MARKETS & APPLICATIONS
Electrical applications that require a flexible
material, and protection from EMI/RFI and static
build-up.
These include:
• Industrial – Conveyor belts (food production
and pharmaceutical industries) and controls
(joy sticks, machinery handles and knobs,
corrugated bellows, tool grips)
• Electrical and electronic devices – Seals and
gaskets, radars and sensors
• ADAS components – Camera systems,
navigation systems, vehicle control systems,
infotainment systems
PRODUCT OVERVIEW
STAT-TECH SOLUTIONS
KEY TECHNICAL PROPERTIES
Material
Description
Base
Resin Color Hardness
Range
Surface
Resistivity (Ω)
Key
Characteristics
ST0100-5003 ESD FD White
VN8904 GP0F025721 TPU White 85 ShA 108 to 109 High elongation, static conductive,
FDA compliance
ST0100-5006 ESD X2 Natural TPU Natural 85 ShA 107 to 109 High elongation, static conductive
ST0200-5001 ESD Natural X1 TPE Natural 40 ShD 107 to 109 High elongation, permanent anti-static,
static conductive
SST0200-5004 ESD Black TPE Black 40 ShA 103 to 105 Electrically conductive,
static dissipative, lower hardness
ST0200-5002 EC ES Black TPE Black 60 ShA 100 to 102 Electrically conductive, high elongation
ST0200-5009 EC Black TPE Black 60 ShA 100 to 102 Electrically conductive, high elongation
Property Unit
Standard
Test
Methods
ST0100-5003
ESD FD White
VN8904
GP0F02571
ST0100-
5006
ESD X2
Natural
5001 ESD
Natural X1
5004 ESD
Black
5002 EC
ES Black
5009 EC
Black
Base Resin TPU TPU TPE TPE TPE TPE
Physical Properties
Hardness Shore ISO 48-4 85A 85A 50D 40A 60 A 60A
Density ISO 1183 1.19 1.15 1 1.01 0.965 1.21
Mechanical Properties
Tensile Strength (Break) Mpa DIN 53404 10 15 15 4 5.7 2.5
Elongation, Break % DIN 53504 600 650 500 300 400 250
Electrical Properties
Surface Resistivity Ω IEC 60093 108 to 109 107 to 109 107 to 109 103 to 105 100 to 102 100 to 102
Volume Resistivity Ω.cm IEC 60093 108 to 109 107 to 109 107 to 109 103 to 105 100 to 102 100 to 102
Color White Natural Natural Black Black Black
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Colorants _ Additives Brochure.pdf
COMPREHENSIVE REGULATORY TESTING
AND DOCUMENTATION
Raw materials tested to:
• ISO 10993-1 and USP , (biological
evaluation)
• European Pharmacopeia 3.1.3/3.1.5 (polyolefin
—materials used for the manufacture of
containers)
• USP (polyethylene—plastic materials of
construction)
• ICH Q3D (elemental impurities)
We provide Drug Master File (Type III) documentation
and other supporting regulatory declarations that
are relevant for the application.
Avient provides color
and functional additive concentrates based on
bio-polymers that follow the concept of consistency
and compliance of our Mevopur portfolio.
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 with all applicable laws and regulations, including
the suitability of all raw materials and components used for its manufacture.
https://www.avient.com/sites/default/files/2022-04/MEVOPUR LQ for Silicone Elastomers.pdf
Customized color solutions are
available on request
• Production under ISO 13485 / GMP quality
system with change control management
• Fingerprinting of raw materials and routine
batch testing
• Extractability evaluated in hexane, isopropanol,
and water according
to ISO 10993 part 18
REGULATORY SUPPORT
• Raw materials are pre-tested to biologically-
evaluated raw materials using ISO 10993-1 and
USP chapters , Class VI
• DMF/MAF documentation filed with the FDA
for all standard colors
APPLICATIONS
MEVOPUR LQ formulations can be applied
in demanding applications including:
• Medical devices such as catheter tubing
& connectors, syringe tips, and needleless
connectors
• Skin contact devices such as wearables
or soft-touch surfaces of medical devices
PRODUCT BULLETIN
MEVOPUR™-LQ YELLOW (PMS1205C)
Product Code FZ1M415005
MEVOPUR™-LQ TRANS YELLOW
Product Code FZ1M415006
MEVOPUR™-LQ BLUE (PMS292C)
Product Code FZ5M415008
MEVOPUR™-LQ TRANS BLUE
Product Code FZ5M415009
MEVOPUR™-LQ RED (PMS198C)
Product Code FZ3M415008
MEVOPUR™-LQ TRANS RED
Product Code FZ3M415009
MEVOPUR™-LQ GREEN (PMS346C)
Product Code FZ6M415008
MEVOPUR™-LQ TRANS GREEN
Product Code FZ6M415009
MEVOPUR™-LQ VIOLET (PMS2655C)
Product Code FZ4M415003
MEVOPUR™-LQ TRANS VIOLET
Product Code FZ4M415004
CUSTOM-MADE Individual options
Customized colors
are also available to
meet your needs,
please contact us.
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.
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/resource-center?document_subtype=0&document_type=59&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=8
Stat-Tech™ TPE meets ATEX standard and FDA food contact compliance in food processing conveyor belt
https://www.avient.com/resource-center?document_type=59&page=8
Stat-Tech™ TPE meets ATEX standard and FDA food contact compliance in food processing conveyor belt
https://www.avient.com/sites/default/files/resources/PolyOne%2520India%2520Terms%2520and%2520Conditions%2520of%2520Sale%2520of%2520Products.May%25202016.pdf
Buyer assumes all risk of patent infringement by
reason of any use Buyer makes of the Product in combination with other
substances or in the operation of any process, and all infringement arising out
of Seller’s compliance with Buyer’s designs, specifications or instructions,
and Buyer shall defend, indemnify and hold Seller harmless from and against
the same.
Buyer assumes all risks and liabilities arising
out of unloading, discharge, storage, handling and use of the Product, or
arising out of compliance or non-compliance with federal, state, municipal or
local laws and regulations governing or controlling such activity, except to
the extent, if any, attributable to Seller’s gross negligence or willful
misconduct.
Either party may suspend performance hereunder (except to
pay for Product already received) in the event of: (1) acts of God, fire,
explosion, flood, hurricanes; (2) strikes, lockouts or other industrial
disturbances or riots; (3) war, declared or undeclared, or acts of terrorism; (4)
compliance with any Federal, state, provincial, municipal or military law,
regulation, order, or rule, foreign or domestic, including priority, rationing,
allocation or preemption orders or regulations, or cancellation of Seller’s or
Buyer’s license to operate its plant; (5) catastrophic failure of facilities used
to manufacture Product, interruption or shortage of transportation, labor,
power, fuel or raw materials; (6) total or partial shutdown due to Seller’s
normal plant turnaround; or (7) any other cause or causes of any kind or
character reasonably outside the control of the party failing to perform,
whether similar or dissimilar from the enumerated causes (a “force
majeure”).
https://www.avient.com/sites/default/files/2022-12/Cesa Fiber Additives Soft Touch Effect Product Bulletin.pdf
KEY BENEFITS
• Highly dispersed additives with high efficacy
at low to moderate dosages
• Excellent compatibility with the application
resin
• Non-phenolic and non-phthalate additives
• Formulated without animal-derived substances
• Food contact compliance according to US FDA
and EU norms
• OEM approvals for hygiene products
• Can be combined with colors into a single
combination concentrate for convenience
• Product guidance and technical assistance
from our experts
https://www.avient.com/sites/default/files/resources/Terms_and_Conditions_of_Sale_for_Finland_%2528English_Language_Version%2529.pdf
Buyer
assumes all risks and liabilities arising out of unloading, discharge, storage,
handling and use of the Product, or arising out of compliance or non-compliance
with applicable laws and regulations governing or controlling such activity.
Subject
to compliance with the above mentioned quantity tolerance thresholds, the
quantity delivered by Seller shall be deemed to be the quantity effectively
ordered by Buyer.
13.
DATA PROTECTION
Buyer hereby agrees that any data in relation with the business relationship
between Buyer and Seller may be processed by Seller, in compliance with
applicable laws and regulations.
15.