https://www.avient.com/news/avient-feature-specialty-technologies-and-services-healthcare-mdm-west-2023
Manufactured across a global network of ISO 13485 facilities, they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, and ICH Q3D.
Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines.
They are offered in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety.
https://www.avient.com/news/archives?page=51
PolyOne Specialty Coatings and Inks Kennesaw, GA Plant Achieves ISO 9001-2008 Certification
CLEVELAND – PolyOne today announced that its Specialty Coating and Inks plant in Kennesaw, GA recently achieved ISO 9001-2008 certification.
https://www.avient.com/news/archives?page=14
Avient Site in Glendale, Arizona Earns ISO 13485 Certification
The Avient facility in Glendale, AZ recently received ISO 13485 certification demonstrating the company’s commitment to providing healthcare solutio
https://www.avient.com/sites/default/files/resources/PolyOne%2520Standard%2520Quality%2520Response_2016_6_9.pdf
Avon Lake, OH 44012
P: +1 (440) 930-3000
I: +1 (866) 737-2066
F: +1 (440) 930-3064
Dear Valued Customer:
Thank you for your inquiry regarding the quality system at PolyOne.
ISO certificates can be found at
www.polyone.com under Quick Links > ISO
List.
Yes.
5.2 Supplier Management
1.
https://www.avient.com/news/archives?page=27
Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials
Caption: Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei).
https://www.avient.com/news/polyone-expands-lineup-pre-certified-biocompatible-healthcare-colorants-and-additives
These colorants and additives are pre-certified to meet USP Class VI or ISO 10993 biocompatibility testing for global healthcare applications, such as medical devices, pharmaceutical, and health & wellness products.
We can now offer expanded resin families that incorporate biocompatible functional additives, in both masterbatch and compounded forms, that meet or exceed industry standards for USP Class VI or ISO 10993 biocompatibility testing.”
Michelle Maniscalco
Senior Manager, Marketing Communications
PolyOne Corporation
+1 440-930-1988
michelle.maniscalco@avient.com
https://www.avient.com/sites/default/files/2023-09/65799-Certificate-26SEP2023%5B1%5D.pdf
Autopista Medellín KM 2.5 –
Vía Parcelas KM 1, Vereda Sibéria
COTA, Cundinamarca
Colombia
Activity: Manufacture, Laboratory (QC and Colormatching), Sales Activity: Administration, Site management, Manufacture, Laboratory,
Maintenance, Infrastructure, Warehouse and Transport, Sales
Page 4 of 10
ABS Quality Evaluations
Avient Corporation
ISO 9001:2015
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Kalisabi No. 1, Kec.
No: 149/1
Gebze, Kocaeli 41400
Turkey
Facility: Avient Turkey Renklendirici ve Katkı Maddeleri Sanayi ve Ticaret A
5.
https://www.avient.com/news/specialty-polymer-solutions-avient-improved-durability-and-sustainability-healthcare-products-pharmapack-2023
All materials in this range are formulated to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS.
All the materials are manufactured in ISO 13485-2016 certified sites and supported by testing to ISO 10993-1, USP, EP, and ICH Q3D protocols.
Avient is exhibiting at Pharmapack in Hall 7.2, booth D70, at the Paris Expo in Porte de Versailles, France, February 1-2, 2023.
https://www.avient.com/investor-center/news/avient-appoints-ashish-k-khandpur-chief-executive-officer-effective-december-1-2023
December 1, 2023
December 1, 2023
Rose, Vice President, Marketing and Communications, Avient Corporation, +1 440-930-3162, kyle.rose@avient.com
https://www.avient.com/sites/default/files/2020-09/oncolor-hc-product-bulletin-1.pdf
Also available are OnColor HC Plus Colorants,
certified to meet or exceed USP Class VI and ISO
10993 bio-compatibility requirements.
KEY CHARACTERISTICS
• Polymer colorants formulated specifically for
healthcare product applications
• Meets and exceeds various material
performance requirements including
FDA 21 CFR, ISO 10993 and USP Class VI
• HC Plus colorants certified for bio-compatibility
• Available as pre-color, concentrate,
masterbatch or Smartbatch™ combined
colorant/additive solution
• Wide range of colors, striking special effects
and custom color matching
MARKETS AND APPLICATIONS
OnColor™ HC and HC Plus Colorants are an
excellent choice for medical devices and parts,
pharmaceutical or cosmetic packaging, and many
other healthcare related polymer applications.