https://www.avient.com/sites/default/files/2023-01/Mevopur Colorants _ Additives Brochure.pdf
GLOBAL ISO 13485 MANUFACTURING
FOOTPRINT
Avient’s certified sites are located on three
continents and offer manufacturing support, project
transfer and back-up supply to reduce supply
chain risk.
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.
They are
manufactured at ISO 13485 certified sites with
bio-compatible raw materials and documented
change control.
https://www.avient.com/sites/default/files/2020-08/2020-composite-springs-product-selection-install-guide.pdf
TEMPERATURE, MPa
Temperature (C)
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M
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us
(G
FLEXURAL MODULUS VS.
TEMPERATURE, GPa
Temperature (C)
FLEXURAL FATIGUE STRENGTH, MPa
Cycles to Failure (in thousands)
F
at
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ue
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INSTALLATION INSTRUCTIONS
Proper installation of composite springs from Avient is
essential to achieve optimal performance and maximum
service life.
Hole diameters should be 1/32" (.8mm) larger in diameter
than the diameter of mounting bolts.
https://www.avient.com/sites/default/files/resources/Lahnstein_ISO50001.pdf
Avient Colorants Germany GmbH
Hohenrhein 1
56112 Lahnstein
Germany
Scope
Production of Color Concentrates and Compounds
Normative base
ISO 50001:2018 Energy Management System
Reg. no. 46089 Validity 17. 12. 2020 – 16. 12. 2023
Issue 12. 04. 2021
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.
https://www.avient.com/sites/default/files/2023-12/Versaflex OM TPEs for Sealing Ring of Blood Lancet.pdf
BLOOD LANCET
MANUFACTURER
S E A L I N G R I N G
• Compliance with strict regulations for medical materials
• Excellent sealing performance
• Good compression set
• Provided a recycled TPE solutions
compared to silicone without increasing
system cost
• Delivered a TPE that complied with ISO
10993-4 & -5 and USP Class VI
• Supported a change to an injection molded
material to ease production and enhance
assembly capabilities
Versaflex™ HC TPEs – OM1040-1 Grade
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-08/trilliant-case-study-1.pdf
https://www.avient.com/sites/default/files/2021-05/dock-shelter-1-page.pdf
https://www.avient.com/sites/default/files/2020-10/wire-cable-1-pager.pdf
https://www.avient.com/sites/default/files/2021-04/shanghai-9001.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands.
Park, Pudong, Shanghai China, 201203
and the sites as mentioned in the appendix accompanying this certificate
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 Masterbatch
Certificate No: 7071-1998-AQ-RGC-RvA
Place and date: Shanghai, 19 March, 2021
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ACCREDITED UNIT: DNV GL Business Assurance B.V., Zwolseweg 1, 2994 LB, Barendrecht, Netherlands.
https://www.avient.com/sites/default/files/2025-05/QMS10207-Certificate-02MAY2025%5B60%5D.pdf
Certificate Magna Colours Limited
Certificate Of Conformance
This is to certify that the Quality Management System of:
Magna Colours Limited
Unit 3 Dodworth Business Park, Dodworth
Barnsley South Yorkshire
S75 3SP
United Kingdom
has been assessed by ABS Quality Evaluations, Inc. and found to be in
conformance with the requirements set forth by:
ISO 9001:2015
The Quality Management System is applicable to:
The Provision of a Service Of Sourcing, Procuring, Design, Manufacturing and Distribution of
Specialty Colouration Products and Chemical Auxiliaries for use the Textile, Dying, Printing
and Finishing Industries.
Page 1 of 1
https://abs.zertic.com
https://abs.zertic.com
https://www.avient.com/sites/default/files/2024-07/TPE Whitepaper_0.pdf
Specifically, here are five ways TPEs can help the
healthcare industry meet an anticipated capacity
crunch:
1.
In addition, the formulation
meets ISO 15759 requirements for medical infusion equipment and is
manufactured in an ISO 13485 facility.