https://www.avient.com/sites/default/files/resources/NOVEL_THERMOPLASTIC_ELASTOMERS_FOR_UNIVERSAL_OVERMOLDING_ON_DISSIMILAR_THERMOPLASTICS.pdf
The barrel temperature of the
injection molding machine was set from 180°C to 220°C (360°F to 430°F) and the injection velocity
from 0.7 inch/sec to 2.0 inch/sec.
https://www.avient.com/products/polymer-additives/fiber-additives/cesa-fiber-additives
Learn how one manufacturer used compliant Cesa™ Fiber Additives in nonwoven medical face masks
Explore the power of polymer solutions for hygiene & medical nonwovens
Discover how Avient's polymer colorants and additives can help increase the performance and appeal of nonwovens used in hygiene and medical applications
https://www.avient.com/sites/default/files/2022-07/Lewiston 308872_en_13485_21%5B43%5D.pdf
Lewiston, ME, 04240
United States of America
Scope
Avient CAI
Design and manufacture of colour and additive
concentrates and specialty compounds for
the Healthcare and Medical device market.
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 45484 Validity 01.03.2022 – 28.02.2025
Issue 01.03.2022
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/2023-10/308659_en_46154.pdf
Ltd.
30, Hsing Pang Road
33068 Taoyuan Taiwan
Scope
Design and manufacture of colour and additive
concentrates and specialty compounds for the
Healthcare and Medical device market.
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 46154 Validity 12.01.2022 – 11.01.2025
Issue 12.01.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
F.
https://www.avient.com/sites/default/files/resources/PolyOne%25202013%2520Annual%2520Report.pdf
Global Corporate Account Director,
Dow Advanced Materials, The Dow Chemical Company (a global provider of chemicals and plastics)
July 2009 to May 2010, Global Strategic Marketing Director, Dow Coating Solutions, The Dow
Chemical Company, March 2008 to July 2009.
Global Business Director, Polypropylene, The Dow
Chemical Company, May 2007 to March 2008.
Global Marketing Executive, UCON™ Fluids and
Lubricants, The Dow Chemical Company, March 2002 to May 2005.
20 POLYONE CORPORATION
PART II
ITEM 5.
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-bt218-biopharmaceutical-tubing-case-study.pdf
MEDICAL TUBING
EXTRUDER
B I O P H A R M A C E U T I C A L
T U B I N G
• Low leachables & extractables
• Great tensile performance and kink resistance
• Good thermal weldability
• Excellent clarity and medical blue tint
• ISO 10993-4 & 5, USP Class VI & Animal Derivative Free
(ADF)
• Supplied drop-in material replacement to
overcome supply constraints of incumbent TPE
• Offered a lower extractable profile than
comparable materials in the market
• Enabled easy material transition without changes
in tooling or thermal welding machine settings
• Formulated solution with proprietary additives to
provide clarity and prevent yellowing after
sterilization
Versaflex™ HC BT218 Thermoplastic
Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2025-01/Stethoscope Dispersions Case Study Snapshot.pdf
MEDICAL DEVICE
MANUFACTURER
S T E T H O S C O P E S
• Provide a silicone paste colorant dispersion for liquid silicone
rubber (LSR) to use in stethoscope ear tips
• Create a custom-colored vinyl plastisol formulation for
stethoscope tubing
• Harmonize color across materials to meet specific process
and performance requirements
• Deliver effective communication and cross-functional
collaboration
• Offered dependable silicone paste colorants
that allowed for comfort and easy sterilization
• Provided a colored vinyl plastisol to reduce
tackiness and support product longevity
• Collaborated internally to align all materials and
provide color consistency across components
• Supported fast color changes and met quality
specifications through constant communication
and technical expertise
Silcopas Silicone Paste Colorants and
CORE Vinyl Plastisols for Healthcare
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/vinyl-formulations/vinyl-plastisols-organosols/core-vinyl-plastisols-healthcare
https://www.avient.com/products/polymer-colorants/colorant-dispersions/colorants-liquid-silicone-rubber
Slide 1: Medical device manufacturer
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/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
Fast, accurate and reliable results
aid medical professionals to understand the
illness and develop the strategy for an effective
treatment.
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/resources/safety-data-sheets?page=4409
MEDICAL ORANGE PE
MEDICAL GREEN PE