https://www.avient.com/sites/default/files/2020-07/versaflex-bvm-resuscitator-bag.pdf
Versaflex - BVM Resuscitator Bag
B A G - VA LV E - M A S K ( B V M )
M A N U FA C T U R E R
R E S U S C I T A T O R B A G
• Compatible gamma sterilization process
• Achieve desired elastomeric properties
• PVC-free formulation
• FDA, ISO 10993, USP VI compliant
• Repeatable injection molding process
• Complemented customer expertise with
technical support in material selection, part &
tool design, and process development
• Customized TPE offered customer an
alternative to vinyl without sacrificing
performance
• Improved process efficiency and overall
system costs through injection molding method
Customized Versaflex™ TPE
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-02/custom-gls-tpe-touriquet-band-case-study-one-pager.pdf
G L O B A L E L A S T I C &
R U B B E R P R O D U C T
M A N U FA C T U R E R
T O U R N I Q U E T B A N D
• Hardness 45, shore A
• Thickness 0.5mm and Tensile set
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/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/2021-09/avient2020sustainabilityreport-9-2-21.pdf
Combined,
these facilities have a total of 205 certifications to an ISO or Management System and
standards.
For our sensitive applications, in
addition to ISO9001, we have implemented ISO 13485 and Good Manufacturing
Processes (GMP). 100% of our facilities producing those sensitive applications and
warehouses are GMP audited within a 3–year period.
Our goal in 2021 is to develop processes
and procedures and a position statement on critical customer information, and fully
prioritize the product portfolio in all critical markets/materials.
75
ISO Certified
Facilities
ZERO
Product
Recalls
Major Non-Conformances
at ISO Sites
0
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Sustainability Report | 2020 59Sustainability Report | 2020 59
Management Approach:
Supplier Collaboration
Avient’s value extends not only to consumers through specialty products,
but beyond the boundaries of our own processes and operations.
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.