https://www.avient.com/industries/healthcare/drug-delivery-systems/auto-injectors-and-drug-delivery-pens
ISO 13485 certified manufacturing sites
ISO 10993 and USP Class VI compliant solutions
https://www.avient.com/news/avient-showcase-newest-additions-its-healthcare-portfolio-mdm-west-2025
Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.
https://www.avient.com/sites/default/files/2023-02/PH - 15701960 AVIENT ASSESSE ISO 14001.pdf
Certificate of Approval
Certificate n°: FR079697-1
Contract n°: 15701960 Revision date: 22 February
2023
Laurent CROGUENNEC - President
Local office: Bureau Veritas Certification France
Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense
Further clarifications regarding the scope of this certificate the applicability of the
management system requirements may be obtained by consulting the organization.
To check this certificate validity, please call + 33(0) 1 41 97 00 60.
AVIENT BELGIUM
2, RUE MELVILLE WILSON
5330 ASSESSE- BELGIUM
Bureau Veritas Certification France certify that the Management System of the above
organization has been audited and found to be in accordance with the requirements of the
management system standard detailed below:
Standard
ISO 14001 : 2015
Scope of certification
DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE
CONCENTRATES, THERMOPLASTIC RESINS AND
SPECIALITY COMPOUNDS.
https://www.avient.com/sites/default/files/2025-01/ISO 13485 Shanghai %28ZhangJiang%29%2C China.pdf
MSC Certificate
Place and date: For the issuing office:
Høvik, 23 January 2025 DNV Product Assurance AS
Veritasveien 1, 1363 Høvik, Norway
Cecilie Gudesen Torp
Management Representative
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ICP-4-5-i5-ISO13485-f1 rev2
ACCREDITED UNIT: DNV Product Assurance AS, Veritasveien 1, 1363 Høvik, Norway - TEL: +47 67 57 99 00. www.dnv.com
MANAGEMENT SYSTEM
CERTIFICATE
Certificate no.:
240625-2017-AQ-RGC-NA-PS
Initial certification date:
14 September 2017
Valid:
08 February 2025 – 07 February 2028
This is to certify that the management system of
PolyOne-Shanghai, China
88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode:
91310000607342402D)
has been found to conform to the Quality Management System standard:
ISO 13485:2016
This certificate is valid for the following scope:
Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates
Used for the Plastic Parts of Medical Devices
http://www.dnv.com
https://www.avient.com/sites/default/files/2020-11/syncure-xlpe-processing-guide-spanish.pdf
Precauciones: el extrusor no debe dejarse en reposo con el material
en el barril.
Purgar constantemente en la medida de lo posible.
EXTRUSOR
Tornillo 1½" to 6" para polietileno—Maddock; relación de compresión 3:1
Cabezal De presión
Dado Del tamaño adecuado para una hilera de 1/8" o menos
L/D 24:1 o superior
Paquete de mallas Malla de 20/60/60/20
Canal de enfriamiento 50–65°C
Alimentador Gravimétrico—3 compartimentos (para el color)
Condiciones de secado, solo para
catalizador
Desecante, 4 horas a 60°C
PROCESAMIENTO
Temperatura
Precalentamiento del alambre 110–120°C
Zonas de alimentación 165°C
Transición 170°C
Dosificación 177°C
Cabezal/dado 182°C
Material fundido 177–190°C
Llama a la punta del salida del dado Sí
Velocidad de la línea
La velocidad superior de la línea mejora mezclado de los dos
compuestos y apariencia superficial del dislamiento de la superficie
Compuesto de purga HDPE
www.avient.com
Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2024-12/ISO-9001_English_Shanghai Zhangjiang.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
MANAGEMENT SYSTEM
CERTIFICATE
Certificate no.:
7071-1998-AQ-RGC-RvA
Initial certification date:
28 April 1998
Valid:
30 March 2024 – 29 March 2027
This is to certify that the management system of
PolyOne-Shanghai, China
No. 88, Guo Shou Jing Road, Z.
Park, China (Shanghai) Pilot Free Trade Zone,
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 Colour and Additive Concentrates
http://www.dnv.com/assurance
Certificate no.: 7071-1998-AQ-RGC-RvA
Place and date: Shanghai, 20 March 2024
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ACCREDITED UNIT: DNV Business Assurance B.V., Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
Page 2 of 2
Appendix to Certificate
PolyOne-Shanghai, China
Locations included in the certification are as follows:
Site Name Site Address Site Scope
PolyOne Polymer (Tianjin) Company
Limited
No. 28#C, Jin Bin Hi-Tech Industrial Park,
No. 156, Nan Hai Road, Tianjin Economic-
Technological Development Area, Tianjin,
China 300457
Manufacture of Colour and Additive
Concentrates
PolyOne-Shanghai, China No. 88, Guo Shou Jing Road, Z.
https://www.avient.com/sites/default/files/2023-03/Onflex-Cell Pack Cooling Tube-Application Snapshot.pdf
AVIENT SOLUTION
V E H I C L E B AT T E RY
M A N U FA C T U R E R
C E L L P A C K C O O L I N G T U B E
• Comply with ISO 3384-1:2011 for TPE compression set
• Comply with ISO 11359-2:1999 standard for linear thermal
expansion
• Good ethanediol resistance
• Good sealing performance
• Customized a Shore 60A hardness TPE
formulation with good physical property
retention
• Achieved good compression set and bonding
performance with PA12
• Qualified thermal expansion by customer
• Provided excellent ethanediol resistance under
both low and high temperature conditions
KEY REQUIREMENTS
CHEMICAL RESISTANCE + SEALING
LEARN MORE
OnFlex™ TPE Custom Formulation
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2021-01/avient-colorants-belgium-registered-publication.pdf
L'assemblée décide de modifier l'article 1 des statuts et de le remplacer, tel que repris ci-dessous
dans le nouveau texte des statuts adopté par la présente assemblée.
Article 1.
Cet extrait est délivré avant enregistrement conformément à l'article 173, 1° bis du Code des Droits
d'Enregistrement.
https://www.avient.com/sites/default/files/2024-12/Avient Norwalk A2LA ISO17025-17.pdf
No. 0962.01) 09/05/2023 Page 1 of 1
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
AVIENT CORPORATION
80 North West Street
Norwalk, OH 44857
Craig Polta Phone: 419 660 4278
MECHANICAL
Valid To: September 30, 2025 Certificate Number: 0962.01
In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this
laboratory to perform the following tests on plastics:
Test Method(s)
Test Name
ASTM D256; ISO 180 Notched Izod
ISO 179 (1eA) Determination of Charpy Impact
ASTM D523 Gloss
ASTM D618 (Method A) Conditioning of Test Specimens
ASTM D792 (Method A) Specific Gravity
ASTM D1238 (Method B) Melt Flow Rate
ASTM D3012 Thermal Oxidative Stability
ASTM D3641 Injection Molding Test Specimens
FMVSS 302 Flammability
ASTM E1331; SAE J1545 Spectrophotometric Color Difference
SAE J1885 (Rev.
MAR2005)1, J2412, J2527;
BO 116-01
Xenon Arc Weathering (Exposure Testing)
SAE J361 Visual Inspection of Automotive Trim
GM9302P, GMW17141 Stress Mark Susceptibility
GMW14688 Scratch and Mar Resistance (Erichsen)
BN108-13, BO162-01 Resistance to Scratching
GMW3205 Resistance to Odor Propagation of Interior Materials
1 This laboratory’s scope contains a superseded method.
This accreditation demonstrates
technical competence for a defined scope and the operation of a laboratory quality management system
(refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
https://www.avient.com/sites/default/files/2024-12/ISO9001 2015 Certificate for Shenzhen Plant%282024-2027%29.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
MANAGEMENT SYSTEM
CERTIFICATE
Certificate no.:
3033-2006-AQ-RGC-RvA
Initial certification date:
07 November 2018
Valid:
08 November 2024 – 07 November 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
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:
Development and Manufacture of Masterbatch, Pigment Concentration, Plastisol;
Manufacture of Plastic Compounding Material
http://www.dnv.com/assurance
证书制作地点及日期:
证书认可签发机构:
上海, 2024年10月 10日 DNV - Business Assurance
中国上海市长宁区虹桥路1591号9号楼A座 邮编:
200336 电话: +86 21 32799000
朱海明
管理代表
未履行认证协议中规定条款会导致此证书失效,获证组织必须定期接受监督审核并经审核合格此证书方继续有效。
获得认可的单位: DNV Business Assurance B.V., Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
本证书信息可在国家认证认可监督管理委员会官方网站(WWW.CNCA.GOV.CN) 上查询
管理体系认证证书
证书号码:
3033-2006-AQ-RGC-RvA
首次签发日期:
2018年11月 07日
有效期限:
2024年11月 08日 – 2027年11月 07日
兹证明
普立万聚合体(深圳)有限公司
中国广东省深圳市宝安区沙井镇蚝乡路启航工业园1号 518104
统一社会信用代码:9144030076498189X0
质量管理体系符合 :
GB/T 19001-2016 / ISO 9001:2015标准
此证书对下列范围有效:
色母粒,色浆,增塑溶胶的开发和制造;塑料改性材料的制造
http://www.dnv.com/assurance
WWW.CNCA.GOV.CN)上查询