https://www.avient.com/sites/default/files/2025-02/Mevopur White Formulation for PCR Well Plates - Case Study_0.pdf
LABORATORY EQUIPMENT
MANUFACTURER
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/sites/default/files/2020-08/willowwood-prosthetics-case-study.pdf
After extensive testing, including mechanical testing to
ISO 10328 standards and a six-month participant clinical
trial, WillowWood introduced DuraWalk™, their most
advanced low-activity foot.
https://www.avient.com/sites/default/files/2022-12/Cesa Fiber Additives Antimicrobials Product Bulletin.pdf
PRODUCT BULLETIN
KEY BENEFITS
Avient’s antimicrobial concentrates for fiber
applications provide the following benefits:
• High active-ingredient loading which translates
to excellent efficacy at low let-down ratios
• Easily withstand 50 washings in ISO 20743
standard tests
• Also applicable for bi-component technology
• Low levels of abrasiveness means higher
process performance—reducing cost in the
spinning phase
• Can be combined with colors and with other
additives (e.g., flame retardants) into a single
combination concentrate for convenience
• Product guidance and technical assistance from
our experts
Copyright © 2022, Avient Corporation.
https://www.avient.com/sites/default/files/2023-12/Cesa Light Additives for Injection Molding Product Bulletin.pdf
The white ABS
plastic samples, produced with and without Cesa
Light Additives, were exposed to simulated sunlight
conditions using the weathering test ISO 4892-
2:2013.
https://www.avient.com/sites/default/files/2025-01/NEUSoft Product Selection Guide.pdf
Whether your application demands can be supported
by the NEUSoft Express color palette or require
customization, all our NEUSoft TPUs are designed with
patient safety and regulatory specifications in mind,
complying with ISO 10993 and USP Class VI standards.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified
manufacturing sites, providing global
consistency and increased security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Non-phthalate and formulated without
animal-derived substances
• Available as concentrates or ready-to-use
formulations in a wide range of polymers
• Functionality and color can be combined in
one product for convenience
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
• Documentation support for approval or
transition to comply with (new) regulations
such as IVDR
APPLICATION BULLETIN
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2025-02/31307-Certificate-17JUL2024.pdf
Certificate Avient Corporation
S
E
s
Certificate Of Conformance
This is to certify that the Quality Management System of:
Avient Corporation
33587 Walker Road, Building 428
Avon Lake OH
44012
United States
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:
Manufacture of plastic compounds, color and performance additives, engineered
thermoplastics, vinyl resins, custom mixed plastic materials, custom and commodity colorants
for plastics, polyurethane systems, and plasticizers with design and sampling support at
Suwanee, GA, and purchasing, customer service, logistics, quality, design and sampling
support at PolyOne Corporate Headquarters at Avon Lake, OH, and distribution of resins
Certificate No: 31307
Certification Date: 12 OCT 1995
Effective Date: 11 JUL 2024
Expiration Date 07 OCT 2025
Revision Date: 17 JUL 2024
Dominic Townsend, President
Page 1 of 4
S
E
s
ISO 9001:2015
Certificate Of Conformance
ANNEX
Certificate No.: 31307
Avient Corporation
At the below facilities
The Manufacture of Pultruded and Filament wound components Pultrusion and CRTM 3943, Valley East Industrial
Drive, Buildings 1,2,3,4
Birmingham - AL 35217 United
The Manufacture of Pultruded and Filament wound components Pultrusion and Filament Wound
Tubing
3968, Valley East Industrial
Drive, Building 5 Birmingham -
AL 35217 United States
The Manufacture of Pultruded and Filament wound components Pultrusion 3950, Valley East Industrial
Drive, Building 6 Birmingham -
AL 3517 United States
Corporation
Management of QMS.
https://www.avient.com/sites/default/files/2022-08/ISO9001-2015 EN -EM.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
Certificate No:
2997-2006-AQ-RGC-RvA
Initial certification date:
08 June, 2006
Valid:
11 April, 2022 – 11 April, 2025
This is to certify that the management system of
Polyone - Suzhou, China
EM Sector, 77 Shenggang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China,
215024
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 Plastic Compounding Material
Certificate No: 2997-2006-AQ-RGC-RvA
Place and date: Shanghai, 27 April, 2022
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
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.
https://www.avient.com/sites/default/files/2024-12/ISO9001_English_Suzhou ColorMatrix.pdf
Ltd
Business Registration Number: 91320505799067336K
Registered I Operation Address: 13 Plant, No.855, Zhujiang Road, Suzhou New District, Jiangsu Province, China
by reason of its
Quality Management System
has been awarded this certificate for compliance with the standard
ISO 9001:2015
The Quality Management System Applies in the following area:
Production Activities of Plastic Colorant & Additive (UV Blockers, Anti-Oxidation, Anti-Aging)
Certified since: January 8, 2009 Valid from: January 16, 2024 Valid until: January 4, 2027
the expiry date of last certification cycle: January 4, 2024 the date of recertification audit: December 21, 2023 to December 22, 2023
After a surveillance cycle, the certificate is valid only when used together with an Acceptance Notice of Surveillance Audit issued by CQC.