https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Bio-based Polymer Solutions Application Bulletin.pdf
Mevopur™ Healthcare Bio-based Polymer Solutions
for Medical Devices and Pharmaceutical Packaging
Manufacturers of medical devices and
pharmaceutical packaging are increasingly faced
with the challenge of integrating sustainability into
the design of their products.
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.
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/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
The nucleating agents also foster constant process
settings throughout part manufacturing with a
higher crystallization temperature for improved
crystallization speed.
REGULATORY SUPPORT
• Drug delivery devices
• Pharmaceutical packaging
• Medical equipment
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number level, reducing the risk of change
• Allows crystallization in semi-crystalline
polymers to begin faster and complete earlier
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP biological
evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact established with FDA/EU*
APPLICATION BULLETIN
* FDA/EU compliance information available upon request
Healthcare use limitations apply—see below.
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/sites/default/files/2023-05/Cesa Light Diffusion Additives for Automotive - Product Overview.pdf
Cesa™
Light Diffusion Additives enable manufacturers to
develop consumer-pleasing automotive lighting
systems that also meet OEM’s demands for
manufacturability and cost management.
Our expertise is in
understanding a designer’s idea and developing
the appropriate formulation to turn it into a
manufacturing reality.
Information we may require includes:
• Which material will be used to manufacture the lens?
https://www.avient.com/sites/default/files/2021-01/eccoh-cpr-product-bulletin.pdf
ECCOH™ Specialty Solutions
Helping Cable Manufacturers Meet CPR Standards
PRODUCT BULLETIN
ECCOH™ Low Smoke and Fume Non-Halogen
(LSFOH) formulations offer a range of non-
halogen, flame retardant solutions that enable
manufacturers to meet the Construction Products
Regulation (CPR) standards set out by the
harmonized European Standard, EN13501.
SELECTING THE RIGHT
ECCOH SOLUTION
Avient provides additional technical services
to help cable manufacturers find the right CPR
compliant cable solutions.
The cable design, other
materials used in the cable, and the cable manufacturing process can all influence CPR test results.
https://www.avient.com/sites/default/files/2020-08/eccoh-cpr-product-bulletin.pdf
ECCOH™ Specialty Solutions
Helping Cable Manufacturers Meet CPR Standards
PRODUCT BULLETIN
ECCOH™ Low Smoke and Fume Non-Halogen
(LSFOH) formulations offer a range of non-
halogen, flame retardant solutions that enable
manufacturers to meet the Construction Products
Regulation (CPR) standards set out by the
harmonized European Standard, EN13501.
SELECTING THE RIGHT
ECCOH SOLUTION
Avient provides additional technical services
to help cable manufacturers find the right CPR
compliant cable solutions.
The cable design, other
materials used in the cable, and the cable manufacturing process can all influence CPR test results.
https://www.avient.com/sites/default/files/2025-03/ISO 13485 2025.pdf
Validity
Avient Switzerland GmbH
Hauptstrasse 30
4127 Birsfelden
Switzerland
Design and manufacture of colour and additive
concentrates and specialty compounds for the Healthcare
and Medical device market.
Ltd.
30, Hsing Pang Road
33068 Taoyuan Taiwan
Design and manufacture of colour and additive
concentrates and specialty compounds for the Healthcare
and Medical device market.
Lewiston, ME, 04240
United States of America
Design and manufacture of colour and additive
concentrates and specialty compounds for the Healthcare
and Medical device market.
https://www.avient.com/sites/default/files/2024-07/TPE Whitepaper_0.pdf
These sweeping trends have applied intense
pressure on manufacturers to produce greater
quantities of products in shorter periods of time.
Manufacturing steps for vulcanized rubber—
pre-mixing the formulation, subsequent mixing
on a two-roll mill, parts molding and secondary
operations, including washing off unreacted surplus
materials—present manufacturers with a costly,
protracted and outdated process.
Notable advantages
include streamlined manufacturing, resealing performance and coring
resistance.
https://www.avient.com/sites/default/files/2021-04/shanghai-9001.pdf
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.
TEL:+31(0)102922689. www.dnvgl.com/assurance
Page 2 of 2
Appendix to Certificate
PolyOne-Shanghai, China
Locations included in the certification are as follows:
Site Name Site Address Site Scope
PolyOne Polymer (Tianjin)
Company Limited
No.28#C, Jin Bin Hi-Tech
Industrial Park, 156 Nan Hai Road,
Tianjin Economic-Technological,
Tianjin, China, 300457
Manufacture of Masterbatch
PolyOne-Shanghai, China No. 88, Guo Shou Jing Road, Z.
Park, Pudong,
Shanghai, China, 201203
Design and Manufacture of Masterbatch
https://www.avient.com/sites/default/files/2024-12/ISO-9001_English_Shanghai Zhangjiang.pdf
Park, China (Shanghai) Pilot Free Trade Zone,
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 Colour and Additive Concentrates
http://www.dnv.com/assurance
Certificate no.: 7071-1998-AQ-RGC-RvA
Place and date: Shanghai, 20 March 2024
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ACCREDITED UNIT: DNV Business Assurance B.V., Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
Page 2 of 2
Appendix to Certificate
PolyOne-Shanghai, China
Locations included in the certification are as follows:
Site Name Site Address Site Scope
PolyOne Polymer (Tianjin) Company
Limited
No. 28#C, Jin Bin Hi-Tech Industrial Park,
No. 156, Nan Hai Road, Tianjin Economic-
Technological Development Area, Tianjin,
China 300457
Manufacture of Colour and Additive
Concentrates
PolyOne-Shanghai, China No. 88, Guo Shou Jing Road, Z.
Park, China (Shanghai) Pilot Free
Trade Zone, Shanghai, China 201203
Design and Manufacture of Colour and
Additive Concentrates
http://www.dnv.com/assurance
https://www.avient.com/sites/default/files/2025-02/Mevopur White Formulation for PCR Well Plates - Case Study_0.pdf
L A B O R ATO RY E Q U I P M E N T
M A N U FA C T U R E R
P C R W E L L P L A T E S
• Very high level of TiO2 to prevent “cross-talk” between the wells
during the qPCR fluorescence testing procedure
• Minimized background phosphorescence caused by
agglomeration of TiO2 and/or oxidized (stressed) polystyrene
• Preservation of polystyrene grade properties
• Change control of formulation and manufacturing process
• Robust product quality from batch to batch
• Developed optimally dispersed, ready-to-use
white formulation that maintains adequate signal
transmission, as well as minimizing “cross-talk”
and background phosphorescence
• Optimized the use of general purpose polystyrene
(GPPS) for a good balance between melt flow
and other physical properties, such as stiffness
• Provided comprehensive change control of raw
materials and formulation, with a robust
manufacturing process and quality control under
a third party ISO 13485:2016 certified QMS
Mevopur Healthcare Colorants and Formulations
– pre-colored solution
WHY AVIENT?
https://www.avient.com/products/polymer-colorants/healthcare-colorants/mevopur-healthcare-colorants-and-formulations
Slide 1: laboratory equipment manufacturer