https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
APPLICATIONS
• Medical devices
• Drug delivery devices
• Labware
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number level, reducing risk of change
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
• Food contact established with FDA/EU*
* FDA/EU compliance information available upon request
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2021-04/colormatrix-optica-specialty-toners-for-pc-product-bulletin.pdf
MARKETS AND APPLICATIONS
ColorMatrix Optica is formulated for
PC resins used in the production of:
• Automotive interiors
• Appliance housings
• Consumer goods
• Food packaging
• Finished materials such as
PC sheet
• Electrical & Electronics
REGULATORY
• No heavy metals or restricted
ingredients
• In-house chemical testing and
verification system compliant with
ISO ISO/IEC 17025:2005
• Dedicated product stewardship
team globally and locally
https://www.avient.com/sites/default/files/2023-10/ISO13485 -2016 - 2021.2.20~2024.2.19 -EN.pdf
China
has been assessed and certified as meeting the requirements of
麟 ISO 13485:2016
EN ISO 13485:2016
’骥鑫馨瓤) For the foiowing actratEes
Design and manufacture of medical grade thermoplastic elastomers
for non-active medical devices and active medical devices
遴;舞蒸;撇蒸 (non-implantable)
:护、::于b入沙黔娜;舞睡莎:器器舞蟒檬非拟拐称群亘爸竺舀‘。
https://www.avient.com/sites/default/files/2024-12/ISO9001 2015 Certificate for Shenzhen Plant%282024-2027%29.pdf
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
https://www.avient.com/sites/default/files/2024-09/24 EN 47.pdf
CERTIFICATE
Signed for the certification body:
Eric Louys
Chairman Certification Committee
CERTIFICATE
EN ISO 50001 : 2018
Energy Management System
VINÇOTTE nv
Jan Olieslagerslaan 35, 1800 Vilvoorde, Belgium
This is to certify that Avient
Located at Rue Melville Wilson 2
5330 Assesse
Belgium
has established and maintains an energy management system according the requirements of
EN ISO 50001 : 2018 “Energy Management System” for:
Design and manufacture of colour and additive concentrates, thermoplastic resins and
speciality compounds
This certificate is based on the result of an energy audit documented in the audit report 61231731.
Certificate number: 24 EN 47
Valid from 1 February 2024 to 31 January 2027
Further clarifications regarding the scope of this certificate and the applicability of EN ISO 50001 : 2018
requirements may be obtained by consulting the organization.
https://www.avient.com/sites/default/files/2023-02/PH - 15701960 AVIENT ASSESSE ISO 14001.pdf
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/2020-07/ISO 45001 14 March 2026.pdf
F-27, MIDC,
Ranjangaon, Shirur,
Pune, Maharashtra 412 220
India
ISO 45001:2018
The Occupational Health and Safety Management is applicable to:
Certificate No: 55689
Certification Date: 15 March 2017
Effective Date: 09 March 2023
Expiration Date: 14 March 2026
Revision Date: 15 March 2023 Dominic Townsend, President
DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY
COMPOUNDS.
https://www.avient.com/sites/default/files/2020-07/PH -AVIENT LUXEMBOURG - 15608678 - ISO 14001.pdf
POLYONE FRANCE TOSSIAT
43, PLACE DE LA GARE
01250 TOSSIAT
FRANCE
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
THE DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE CONCENTRATES FOR
THERMOPLASTICS
Certification/Recertification Cycle Start Date: 03 May 2023
Subject to the continued satisfactory operation of the organization’s Management System,
this certificate expires on: 02 May 2026
Expiry date of previous cycle: NA
Certification/Recertification Audit date: 08 March 2023
Original Cycle Start Date: 15 July 2011
Certificate n°: FR081968-1
File n°:15608678 Revision date:24 April 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.
https://www.avient.com/sites/default/files/2020-07/ISO 14001 - 14 March 2026.pdf
F-27, MIDC,
Ranjangaon, Shirur,
Pune, Maharashtra 412 220
India
ISO 14001:2015
The Environmental Management System is applicable to:
Certificate No: 55688
Certification Date: 15 March 2017
Effective Date: 09 March 2023
Expiration Date: 14 March 2026
Revision Date: 21 March 2023 Dominic Townsend, President
DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY
COMPOUNDS
This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/sites/default/files/2024-12/ISO-14001_English_Shanghai Zhangjiang.pdf
Park, China (Shanghai) Pilot Free Trade Zone,
Shanghai, China 201203
has been found to conform to the Environmental Management System standard:
ISO 14001:2015
This certificate is valid for the following scope:
Design and Manufacture of Colour and Additive Concentrates
http://www.dnv.com/assurance