https://www.avient.com/sites/default/files/2024-12/IATF16949 2016 Certificate for PolyOne shenzhen-EN2024.pdf
No. 1, Qihang Industry Park, Haoxiang Road, Shajing Town, Baoan, Shenzhen, Guangdong,
China 518104 (USI: C5M65R)
and, if applicable, the remote supporting locations as mentioned in the Appendix accompanying
this Certificate
has been found to conform to the Quality Management System standard:
IATF 16949:2016
This certificate is valid for the following scope:
DESIGN AND MANUFACTURE OF PLASTIC COMPOUNDING MATERIAL
EXCLUSION: NONE
http://www.dnv.com
Certificate no.: 273138-2018-AQ-RGC-IATF
IATF Certificate No: 0558323
Place and date: Katy, TX, 10 December 2024
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/sites/default/files/2022-03/Asia SEM Healthcare Product Selection Guide %281%29.pdf
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
Applications:
• 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
Applications:
• 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,
smooth surface aesthetics
Versalloy™
HC 9210-55N
55A USP Class VI EtO
Good processability,
smooth surface aesthetics
Versalloy™
HC 9210-70N
70A USP Class VI EtO
Good processability,
smooth surface aesthetics
Versalloy™
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/sites/default/files/2022-10/Wall Partitions Mini Case Study.pdf
W A L L PA RT I T I O N
M A N U FAC T U R E R
F O O D P R O C E S S I N G
E N V I R O N M E N T S
• Decrease growth of microbes on plastic surfaces that
come in contact with food products
• Compatibility with sheet extrusion processing
• Maintain all other functional attributes inherent to product,
such as ROHS, flame retardant standards, and specific
brand color
• Seamlessly incorporated multifunctional additives
for optimal performance in reducing microbe
growth
• Developed custom formulation for complex
processing configurations in sheet extrusion
technology
• Provided expertise in antimicrobial performance,
chemical resistance, flame retardance, and
regulatory product stewardship
Cesa™ WithStand™ Antimicrobial Additives and
Smartbatch™ Combination Colorants and Additives
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2022-04/Gas Pipe Mfgr Application Snapshot.pdf
Gas Pipe Mfgr Application Snapshot
G A S D I S T R I BU T I O N
P I P E M A N U FAC T U R E R
P R O F I L E E X T R U S I O N
• Meet Plastic Pipe Institute (PPI) gas distribution pipe
approval requirements for ASTM D2513 and PE2708
MDPE
• Reduce the number of quality complaints through
enhanced color distribution and consistency
• Eliminate late notifications and poor communications with
a higher level of customer service from their supplier
• Provided a PPI-approved colorant as
required with the added benefit of additional
UL and NSF approvals
• Supplied improved solid colorant formulation
resulting in fewer customer complaints
• Offered a premier problem solving approach
with enhanced communications and
increased sense of urgency
OnColor™ Yellow Solid Colorant
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2025-01/ISO 13485 Shanghai %28ZhangJiang%29%2C China.pdf
240625-2017-AQ-RGC-NA-PS
Initial certification date:
14 September 2017
Valid:
08 February 2025 – 07 February 2028
This is to certify that the management system of
PolyOne-Shanghai, China
88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode:
91310000607342402D)
has been found to conform to the Quality Management System standard:
ISO 13485:2016
This certificate is valid for the following scope:
Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates
Used for the Plastic Parts of Medical Devices
http://www.dnv.com
https://www.avient.com/sites/default/files/2025-02/PET Recycling Eco-System Infographic.pdf
© 2024 Avient, All Rights Reserved
RESIN (RPET/PET) PRODUCTION
Create Value
• Increase yield
• Expand applications
• Improve aesthetics
• Reduce energy
ColorMatrix™ Solutions
• rePrize™ IV Builder
• Ionix™ Flake Treatment
• SmartHeat™ RHC Process Aid
• Optica™ Toners & Colors for
Enhanced Recyclability
• Joule™ Reheat Additive
DISTRIBUTION, RETAIL SALES,
CONSUMPTION
Enhance Consumer Experience
• Improve aesthetics and visual
appeal
• Extend shelf life
• Bolster consumer safety
• Improve organoleptics
ColorMatrix™ Solutions
• Ultimate™ UV390 Light Barrier
• Lactra™ Light Blocking Additive
• Triple A™ Acetaldehyde
Scavenger
• Amosorb™ Oxygen Scavenger
• Optica™ Toners
COLLECTION, SORTING,
RECYCLING
Supply Quality Feedstock with
APR* Recognized Solutions
• Expand end-use applications
• Reduce downcycling
• Improve color stability
ColorMatrix™ Solutions
• Ultimate™ UV390 Light Barrier
• Capture™ Oxygen Scavenger
• SmartHeat™ RHC Process Aid
PREFORM MOLDING &
BOTTLE BLOWING
Promote Process Optimization
• Reduce energy
• Reduce bottle blow-outs
• Mitigate stress cracking
• Improve mechanical and
dimensional stability
• Increase throughput
ColorMatrix™ Solutions
• SmartHeat™ RHC Process Aid
• Eze™ Slip AgentPET
RECYCLING
ECO-SYSTEM
PREFORM
MOLDING
& BOTTLE
BLOWING
COLLECTION,
SORTING,
RECYCLING
DISTRIBUTION,
RETAIL SALES,
CONSUMPTION
RESIN
(RPET/PET)
PRODUCTION
* APR - Association of Plastics Recyclers
https://www.avient.com/sites/default/files/2024-03/Luxury Closures Application Bulletin_Online.pdf
Please contact Avient for additional information
HOW GRAVI-TECH MAKES THE DIFFERENCE FOR PACKAGING CLOSURES
IN THE LUXURY COSMETICS AND SPIRITS MARKETS
FOR BRAND OWNERS
Create a weighted closure for a luxury brand
product – Gravi-Tech is a high density, injection
moldable material which can be as lightweight as
plastic or up to four times as heavy as aluminum.
Get the look and touch of metal – With grades
suitable for metalization and electroplating you can
achieve the look and feel of metal
FOR CONVERTERS
Compete in premium markets – Gravi-Tech
material’s luxury aesthetics allow plastics converters
to reach new markets by competing against
aluminum, zinc, iron, or steel and other alloys.
https://www.avient.com/sites/default/files/2020-09/versaflex-pf-technical-bulletin-sept-2020.pdf
TECHNICAL BULLETIN
VERSAFLEX™ PF
Tack Layer for
Surface Protective Films
Properties Versaflex PF MD6727
Versaflex PF
MD6741
Versaflex PF
MD6649
Versaflex PF
9512
Versaflex PF
MD6666
Versaflex PF
MD6748
Versaflex PF
MD6700
Features Low Tack Low Tack; Used for tailoring tack with MD6700 Low-Medium Tack Value Offering
Medium Tack
Low Gel/Residuals Low Tack Build High Tack
Peel Strength Low Low-Medium Medium Medium-High Medium-High High High
Applications Optical Films Home Appliances Plastics Construction/Bare Metals Finished Metals Steel/Painted Metals Bare Metals
MFR @ 190°C/2.16 kg -- 4.5 17 5.4 21 4.8 6.5
MFR @ 230°C/2.16 kg 10 20 -- -- -- -- --
Specific Gravity, g/cc 0.92 0.91 0.92 0.92 0.94 0.94 0.94
Hardness, Shore A 50 49 37 38 37 31 30
G' @ 23°C, Pa 28.0 x 105 10.4 x 106 8.3 x 105 -- 9.9 x 105 11.8 x 105 10.0 x 105
DMA Tg, °C -29 -30 -9 10 11 15 21
LDPE/Versaflex PF Film1 180° Peel, N/25mm
Stainless Steel
after 20 min @ 25°C 0.5 2.2 3.2 6.1 6.7 8.5 8.6
after 7 days @ 25°C 0.6 2.7 4.3 5.5 8.2 8.3 10.3
PMMA2
after 20 min @ 25°C 1.1 1.7 3.8 4.9 6.9 8.3 8.8
after 20 min @ 75°C 2.8 4.1 5.1 6.9 9.0 10.7 11.8
after 7 days @ 75°C 4.0 4.4 5.9 9.8 8.4 9.8 10.3
Polycarbonate3
after 20 min @ 25°C 1.4 2.2 3.8 6.8 6.3 8.4 7.0
after 20 min @ 75°C 3.4 4.8 6.7 8.8 8.8 10.0 11.8
after 7 days @ 75°C 4.6 6.5 7.5 10.6 11.6 10.6 13.8
1 Film thickness: 51 micron LDPE/25 micron Versaflex PF
2 Arkema Plexiglas™ V052-100 (Plexiglas is a trademark of Arkema France Corp.)
3 Sabic Lexan™ L52-111 (Lexan is a trademark of Sabic Innovative Plastics)
PHYSICAL PROPERTIES OF SELECTED VERSAFLEX PF TACK LAYER FORMULATIONS
PRODUCT DESCRIPTION
Versaflex™ PF formulations are specially
developed for the manufacture of co-extruded
surface protective films that apply easily, maintain
tack with minimal build, peel smoothly and
remove completely with little-to-no residue or
ghosting.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
Plastic materials offer opportunities and play an
increasingly vital role: colors aid identification and
automated laboratory processes while functional
additives expand the usable property window of
the polymer in areas such as surface chemistry
or oxygen protection.
Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent
implants, birth control devices, or plastic surgery.
https://www.avient.com/sites/default/files/2021-07/lactra-low-tio2-product-bulletin_0.pdf
DAIRY PACKAGING OPTIONS
Dairy brands have employed various packaging
materials and formats to protect dairy products
from visible light including colored glass, laminated
paperboard cartons, and multilayer plastics.
PRODUCT BULLETIN
LEGISLATION & TARIFFS
As the packaging industry seeks to align with global
sustainability trends, many new legislative changes
surrounding single use plastic packaging can be
observed.