https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-dynaflex-medical-face-mask.pdf
E U R O P E A N M E D I C A L
D E V I C E M A N U FA C T U R E R
F A C E M A S K V E N T I L A T I O N
V A L V E
• ISO 9001 and USP VI compliant
• Compatible with overmolding onto PP
• Translucent and highly colorable
• Soft touch
• Provided valuable regulatory support and
documentation, enabling faster internal trials and
material qualification for this customer
• Worked together with customer to select the best
material from a broad portfolio of medical TPE
grades
• Trusted as a polymer supplier for multiple
healthcare applications
Dynaflex™ G2711 Thermoplastic Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-08/versaflex-machine-cover-case-study-one-pager.pdf
RE S P IRATORY
DE VICE
MANUFACT URE R
C P A P M A C H I N E C O V E R
• Good aesthetics with high COF for grip functionality
• Chemically bondable to FR PC/ABS down to 1mm
• NCS S 9000-N color suitable for UV laser marking to white
• Good scratch and mar resistance
• Good chemical resistance to detergents, alcohols and bleach
• Pass VOCs & out-gassing in accordance to ISO 18562-3/2:2017
• Customized formulation to balance mar
resistance, flow, and laser marking
whiteness and clarity
• Collaborated on tooling improvements to
widen processing window and increase
yield rate
• Provided application development and on-
site technical support to manage short
shot, sink marks, burn marks and air trap
Customized VersaflexTM TPEs
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-11/ISO14001.2015.pdf
Page 1 / 1
has been assessed and certified as meeting the requirements of
ISO 14001:2015
For the following activities
The Design and Manufacturing of Plastic Color Concentrated, Plastic Additive Concentrated and Pigment Powder for Thermoplastic &
Rubber Industries.
https://www.avient.com/sites/default/files/2021-04/shanghai-14001.pdf
Park, Pudong, Shanghai, China, 201203
has been found to conform to the Environmental Management System standard:
ISO 14001:2015
This certificate is valid for the following scope:
Design and Manufacture of Masterbatch
https://www.avient.com/sites/default/files/resources/Tangerang_ISO22000.pdf
Cibodas
Kecamatan Cibodas, Tangerang 15138
Indonesia
Scope
Category I
Production of customer specific Masterbatches
for Food packaging materials on the dedicated
extrusion lines
Normative base
ISO 22000:2018 Food Safety Management Systems
Requirements for any organization in the food chain
Reg. no. 46391 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Made
sqs.ch
F.
https://www.avient.com/sites/default/files/resources/Jurong_ISO22000.pdf
Avient Colorants Singapore Pte Ltd
8 Third Chin Bee Road
Jurong Industrial Estate
Singapore 618684
Singapore
Scope
Category I
Production of customer specific Masterbatches
for Food packaging materials on the dedicated
extrusion lines
Normative base
ISO 22000:2018 Food Safety Management Systems
Requirements for any organization in the food chain
Reg. no. 46390 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Made
sqs.ch
F.
https://www.avient.com/sites/default/files/2024-10/ISO9001证书 %28英文版%29 -2024.pdf
462307-2021-AQ-RGC-RvA
Initial certification date:
23 June 2021
Valid:
24 June 2024 – 23 June 2027
This is to certify that the management system of
Avient China Company Limited
No. 188, Quanzhou Road, Zhongxin Suchu High-Tech Industrial Development Park, Chuzhou,
Anhui, China
has been found to conform to the Quality Management System standard:
GB/T 19001-2016 / ISO 9001:2015
This certificate is valid for the following scope:
Design and Manufacture of Color Concentrates, Filling Concentrates and Additive
Concentrates
http://www.dnv.com/assurance
https://www.avient.com/sites/default/files/2025-02/case study snapshot-Ostomy bag-G2705.pdf
PowerPoint Presentation
M E D I C A L D E V I C E
M A N U FA C T U R E R
O S T O M Y B A G S E A L S
• Comply with ISO 10993 and FDA Class II medical device
regulations
• Offer Good sealing performance
• Provide technical supports for processing
recommendations
• Deliver a high compression set materials to improve
comfort
• Provided a medical-grade TPE to help the
customer meet necessary regulatory
specifications and gain market share
• Provided technical support during design
and the manufacturing process for EVA
bonding
• Delivered soft-touch feel and excellent
sealing performance
Versaflex HC Thermoplastic Elastomers -
G2705 Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-11/polyone-cr-sro-notarial-deed-name-change-to-avient-material-solutions-cr-sro-oct-27-2021.pdf
se sídlem 9638 Pommerloch, route de Bastogne 19,
Lucemburské velkovévodství, registrační číslo B145542, zastoupený zmocněncem Mgr.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Bio-based Polymer Solutions Application Bulletin.pdf
KEY CHARACTERISTICS
• Available for polyethylene, polypropylene, ABS,
polycarbonate and styrenics
• Bio-content of resin carrier varies from 70% to
100% depending on polymer—calculated to
ASTM D6866 standard
• Manufactured at four ISO 13485 certified sites,
providing global consistency and security of
supply
• Documented change control beyond CAS
number, reducing risk of change
• Drop-in solutions that can be processed like
fossil-based grades on common injection
molding and extrusion machines
• Can be provided as ready-to-use pre-colored
or additive formulation
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP and (incl. class VI)
- European Pharmacopeia, monograph 3.1.3/
3.1.5 (polyolefin packaging materials)
- USP (polyethylene)
- Elemental impurities as per ICH Q3D
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact according to US FDA and
APPLICATION BULLETIN
Sustainability Spotlight
Bio-polymers
Healthcare use limitations apply—see below.