https://www.avient.com/sites/default/files/2024-02/Santa Clara_ISO22000.pdf
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Certificate
The SQS herewith attests that the organisation named below has a management system that meets
the requirements of the normative base mentioned.
Plasticos 28
Santa Clara Coatitla
55540 Ecatepec de Morelos, Estado de México
Mexico
Scope
Category I
Production of customer specific Masterbatches
for Food packaging materials on the dedicated
extrusion lines
Normative base
ISO 22000:2018 Food Safety Management Systems
Requirements for any organization in the food chain
Reg. no. 46389 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Made
sqs.ch
F.
https://www.avient.com/industries/healthcare/drug-delivery-systems
Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards.
Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards.
https://www.avient.com/news/‘future-proof’-pharma-packaging-avient-launches-new-regulatory-compliant-mevopur-amber-masterbatches
Produced under rigorous cGMP and medical manufacturing protocols, the new amber color concentrates are made in three dedicated EN ISO 13485-2016 registered facilities using only medical-grade ingredients.
They are formulated without animal-derived substances and phthalates, and have been pre-tested for compliance with:
• ISO 10993-1 and USP parts , (including class VI)
• European Pharmacopoeia, monograph 3.1.15
• USP and
• elemental analysis, as per ICH Q3D
https://www.avient.com/content/sds-iso-reach-rohs-ul
https://www.avient.com/news/specialty-healthcare-polymer-solutions-be-showcased-avient-mdm-west-2024
All Mevopur formulations are manufactured across a global network of ISO 13485 facilities, and they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, European Pharmacopeia, and ICH Q3D.
They are available in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards.
https://www.avient.com/company/policies-and-governance/email-fraud-information
Global ISO Certificate Library
https://www.avient.com/sites/default/files/2025-03/65536-Certificate-05MAR2024.pdf
Certificate No: 65536
Certification structure: MULTI-SITEMULTI-SITE
Certification Date: 29 SEP 2023
Effective Date: 27 FEB 2025
Expiration Date: 27 SEP 2026
Revision Date: 05 MAR 2025
Dominic Townsend, PresidentDominic Townsend, President
Copyright as of the Effective Date, ABS Quality Evaluations, Inc.
For certificates issued in the People’s Republic of China information may also be verified on the Certification and Accreditation
Administration of the People’s Republic of China’s website (www.cnca.gov.cn).
For certificates issued in the People’s Republic of China information may also be verified on the Certification and Accreditation
Administration of the People’s Republic of China’s website (www.cnca.gov.cn).
https://www.avient.com/news/avient-shares-customer-success-healthcare-high-temperature-pre-colored-solutions-k-2022
Because Transcend is fully bio-compatible per ISO 10993 standards, we’re helping customers speed up development and market introduction.
They are tested to ISO 10993 standards and can be customized with the addition of functional additives to enhance product performance.
https://www.avient.com/sites/default/files/2024-12/IATF16949 2016 Certificate for PolyOne shenzhen-EN2024.pdf
IATF Certificate
Place and date: For the issuing office:
Katy, TX, 10 December 2024
Revision 2
DNV - Business Assurance
1400 Ravello Drive, Katy, TX, 77449-
5164, USA
Sherif Mekkawy
Management Representative
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ACCREDITED UNIT: DNV Business Assurance USA Inc., 1400 Ravello Drive, Katy, TX, 77449-5164, USA - TEL: +1 281-396-1000. www.dnv.com
Page 1 of 2
MANAGEMENT SYSTEM
CERTIFICATE
Certificate no.:
273138-2018-AQ-RGC-IATF
IATF Certificate No:
0558323
Valid:
10 December 2024 – 09 December 2027
This is to certify that the management system of
Polyone - Shenzhen Co., Ltd.
No. 1, Qihang Industry Park, Haoxiang Road, Shajing Town, Baoan, Shenzhen, Guangdong,
China 518104 (USI: C5M65R)
and, if applicable, the remote supporting locations as mentioned in the Appendix accompanying
this Certificate
has been found to conform to the Quality Management System standard:
IATF 16949:2016
This certificate is valid for the following scope:
DESIGN AND MANUFACTURE OF PLASTIC COMPOUNDING MATERIAL
EXCLUSION: NONE
http://www.dnv.com
Certificate no.: 273138-2018-AQ-RGC-IATF
IATF Certificate No: 0558323
Place and date: Katy, TX, 10 December 2024
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/sites/default/files/2023-07/Versaflex HC _ Versaflex HC BIO - BT Series Product Overview.pdf
KEY CHARACTERISTICS
• Meets critical need for thermal weldability
and kink resistance
• Minimizes extractables during processing
• Provides excellent tensile strength
• Complies with USP VI and ISO 10993-4, -5, -11
certifications
• Suitable for gamma and autoclave
sterilization methods
• Bio-based grade option formulated with nearly
40% Gen 1 biomass content
PRODUCT OVERVIEW
1.844.4AVIENT
www.avient.com
Copyright © 2023, Avient Corporation.