https://www.avient.com/sites/default/files/2024-02/Santa Clara_ISO22000.pdf
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/sites/default/files/2024-07/Versaflex TPE for Orthopedic Sole Insert - Application Snapshot.pdf
O RT H O P E D I C PA RT S
M A N U FAC T U R E R
O R T H O P E D I C S O L E I N S E R T
• A super soft TPE (
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/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/2022-12/15719637-22-AVIENT ESPAÑA SL-INGLES.pdf
Certificate Number:Certificate Number:
Certificate expiration date:Certificate expiration date:
Effective date:Effective date: 31-10-202231-10-2022
30-10-202530-10-2025
Expiry date of previous cycle:Expiry date of previous cycle: 30-10-202230-10-2022
31-10-201631-10-2016
ES133794ES133794
Scope of certification:Scope of certification:
MANUFACTURING OF MASTERBATCHES, ADDITIVESMANUFACTURING OF MASTERBATCHES, ADDITIVES
AND COMPOUNDS FOR PIGMENTING THERMOPLASTICAND COMPOUNDS FOR PIGMENTING THERMOPLASTIC
MATERIALS USED IN FOOD INDUSTRYMATERIALS USED IN FOOD INDUSTRY
ISO 22000:2018ISO 22000:2018
POLIGONO INDUSTRIAL EZCABARTE, C/H, Nº3 - 31194 - ORICAIN -
NAVARRA - ESPAÑA
AVIENT ESPAÑA, S.L.AVIENT ESPAÑA, S.L.
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.
https://www.avient.com/sites/default/files/2024-12/ISO14001_English_Suzhou ColorMatrix.pdf
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.
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/sites/default/files/2025-05/QMS10207-Certificate-02MAY2025%5B60%5D.pdf
Certificate Magna Colours Limited
Certificate Of ConformanceCertificate Of Conformance
This is to certify that the Quality Management System of:
Magna Colours LimitedMagna Colours Limited
Unit 3 Dodworth Business Park, Dodworth
Barnsley South Yorkshire
S75 3SP
United Kingdom
has been assessed by ABS Quality Evaluations, Inc. and found to be in
conformance with the requirements set forth by:
ISO 9001:2015ISO 9001:2015
The Quality Management System is applicable to:
The Provision of a Service Of Sourcing, Procuring, Design, Manufacturing and Distribution of
Specialty Colouration Products and Chemical Auxiliaries for use the Textile, Dying, Printing
and Finishing Industries.