https://www.avient.com/sites/default/files/resources/Polyone%2520Barbastro_ISO%252014001_2015_EXP%25202021_0.pdf
Industrial Valle del Cinca
s/n Apartado 18
22300 Barbastro, Huesca
Spain
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
ISO 14001:2015
The Environment Management System is applicable to:
DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS.
This certificate may be found on the ABS QE Website (www.abs-qe.com).
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2024-03/Global Supplier Quality Manual_2024.pdf
Minimum requirements are adopted from the ISO 9001
standard.
Avient requires a Certification of Analysis (COA) and supplier specification documents for every
shipment of raw material.
This document is property of Avient
6.0 References
Document Title Description
IATF 16949 Automotive Quality Standard
ISO 9001 International Quality Standard
ISO 13485 Healthcare Quality Standard
QF-05 Supplier Self-Assessment Audit Form
QS-05 Control of External Providers Procedure
7.0 Definitions and Acronyms
Term Definition
Audit Examination and evaluation of an organization’s
products and processes
CAPA Corrective Action Preventive Action: Evaluation
process used to eliminate the cause of a non-
conformance or issue
COA Certificate of Analysis
Containment Isolation of nonconforming material to prevent the
shipment of product, and measures taken to prevent
the manufacture of additional product containing the
non-conformance
Corrective Action Actions taken to eliminate the causes of a
nonconformance to prevent recurrence
External Provider Term referenced in ISO 9001.
https://www.avient.com/sites/default/files/2021-04/shanghai-9001.pdf
China
TEL: +86 21 32799000
Zhu Hai Ming
Management Representative
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
Certificate No:
7071-1998-AQ-RGC-RvA
Initial certification date:
28 April, 1998
Valid:
29 March, 2021 – 29 March, 2024
This is to certify that the management system of
PolyOne-Shanghai, China
No. 88, Guo Shou Jing Road, Z.
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
CNSUZ3-SUH9-20240123104552
QUALITY MANAGEMENT SYSTEM\,,
CERTIFICATE
Certificate No. 00124Q30506R5S/3200
We hereby certify that
Color Matrix Plastic Colorants (Suzhou) Co., 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.
Please access www.cqc.com.cn for checking validity of the certificate.
This certificate and its relevant information can query in the website of Certification and Accreditation Administration of
the People's Republic of China ( www.cnca.gov.cn)
https://www.avient.com/sites/default/files/2024-12/ISO14001_English_Suzhou ColorMatrix.pdf
�
ENVIRONMENTAL MANAGEMENT,_,
' J� -
�
Certificate No. 00124E30295R4S/3200
We hereby certify that
Color Matrix Plastic Colorants (Suzhou) Co., Ltd
Business Registration Number: 91320505799067336K
Registered/ Operation Address: 13 Plant, No.855, Zhujiang Road, Suzhou New District, Jiangsu Province, China
by reason of its
Environmental Management System
has been awarded this certificate for compliance with the standard
ISO 14001:2015
The Environmental Management System Applies in the following area:
Production and Related Management Activities of Plastic Colorant & Additive (UV Blockers, Anti-Aging,Anti-Oxidation)
Certified since: June 6, 2012 Valid from: January 17, 2024 Valid until: January 7, 2027
the expiry date of last certification cycle: January 7, 2024 the date ofrecertification 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.
Please access www.cqc.com.cn for checking validity of the certificate.
This certificate and its relevant information can query in the website of Certification and Accreditation Administration of
the People's Republic of China ( www.cnca.gov.cn)
https://www.avient.com/knowledge-base/article/securing-supplies-medical-plastic-solutions?ind[]=6598
For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines.
All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations.
The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.
https://www.avient.com/knowledge-base/article/securing-supplies-medical-plastic-solutions?pname[]=17815
For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines.
All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations.
The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.
https://www.avient.com/company/policies-and-governance/supplier-code-conduct
Global ISO Certificate Library
https://www.avient.com/sites/default/files/2021-07/mevopur-pharma-packaging-1-page-case-study.pdf
PHARMACEUTICAL
PACKAGING OEM
V I A L S , B O T T L E S &
C O N T A I N E R S
• Raw materials pre-tested to USP 661.1 and ICHQ3D
guidelines
• Stabilization during molding and sterilization processes for
both opaque and transparent polymer materials
• Certified formulations available globally
• Offered pre-tested raw materials and
produced in an ISO 13485 certified site,
minimizing risk across the pharmaceutical
value chain
• Delivered specialized formulated solutions
to meet stringent pharmaceutical packaging
requirements
• Provided global formulations transferrable
from our three ISO 13485 certified facilities
Mevopur™ Healthcare Concentrates
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
CERTIFICATION + AVAILABILITY
LEARN MORE
© 2021, Avient Corporation, All Rights Reserved
https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/mevopur-custom-colors-and-formulations
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.