https://www.avient.com/sites/default/files/2024-12/ISO 14001_English_Changzhou.pdf
Unified social credit code: 91320412MA1NMF5W4P
is in conformity with Environmental Management System Standard:
GB/T 24001-2016 / ISO 14001:2015
The certificate is valid to the following product(s)/service:
Coating Processing of Textile (Yarn) and Glass
Products (Yarn) and Related Management Activities
Registration Address/ Physical Address: R&D Workshop 5, No. 8, Lanxiang Road,
West Taihu Science and Technology Industrial Park, Changzhou City, Jiangsu
Province, P.
https://www.avient.com/sites/default/files/resources/0514_02%2520PDI%2520ISO17025%2520Chemical_Extension%2520Cert2019.pdf
Avon Lake, OH
for technical competence in the field of
Chemical Testing
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005
General requirements for the competence of testing and calibration laboratories.
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).
Presented this 30th day of March 2018.
_______________________
Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 0514.02
Valid to December 31, 2019
Revised October 08, 2019
0514-02.pdf
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005
Test Method or Standard:
Test Description:
0514-02c.pdf
https://www.avient.com/sites/default/files/2024-12/GMP_Pune_Polyone Polymers -798019.pdf
LoC No: 798019/2023 Page 1 of 1
Letter of Conformity
Good Manufacturing Practices — Guidelines
The Letter of Conformity is granted to
Polyone Polymers India Private Limited
Plot No.
F -27, MIDC, Ranjangaon,
Taluka – Shirur, Pune
Maharashtra
412220
India
Hold this Opinion Statement No. 798019/2023
The Organization has demonstrated that they have followed the guidelines provided for Good Manufacturing
Practices as per the ICHQ7 guidelines in their organization for the following Business activity:
Research and Development, Manufacture of Color additives, Concentrates and Specialty Formulations
for intended use in pharma and other industries
Theuns Kotze, Managing Director – IMETA Assurance
Last Audit Date: 31.10.2023
BSI Group India Private Limited T: +91-4762-9000
(CIN U74899DL1999PTC101381 info.in@bsigroup.com
The Mira Corporate Suites bsigroup.com/en-IN
Plot 1&2, Ishwar Nagar,
Mathura Road New Delhi-110065, India
https://www.avient.com/sites/default/files/2024-12/ISO 14001_Chinese_Changzhou.pdf
环境管理体系认证
证书编号:04624E12884R1S
兹证明:
法博莱恩纱线(常州)有限公司
统一社会信用代码:91320412MA1NMF5W4P
环境管理体系符合:
GB/T 24001-2016 / ISO 14001:2015 标准
证书覆盖范围:
纺织品(纱线)、玻璃制品(纱线)的包覆加工及相关管
理活动
注册地址/实际地理地址:江苏省常州西太湖科技产业园兰香路 8 号研发车间
5 厂房
颁证日期:2024-10-26
有效期至:2027-10-25
初次颁证日期:2021-10-28
证书编号
受审核方
组织机构代码
认证范围
注册地址
生产办公地址
注册日期
有效期至
初次颁证日期
二维码
https://www.avient.com/sites/default/files/2024-09/Terms and Conditions of Sale for Denmark.pdf
These Terms and Conditions govern the sale of Products to another (“Buyer”) by Avient Cor-
poration and its affiliates (“Seller”).
1.
Udlevering af en prøve eller
udviklingsmateriale udgør ikke en tilladelse, anbefaling
eller tilskyndelse til at udøve en patenteret opfindelse
uden tilladelse fra patentindehaveren.
Køber må
ikke beholde en kopi heraf.
https://www.avient.com/sites/default/files/2022-04/MEVOPUR LQ for Silicone Elastomers.pdf
Customized color solutions are
available on request
• Production under ISO 13485 / GMP quality
system with change control management
• Fingerprinting of raw materials and routine
batch testing
• Extractability evaluated in hexane, isopropanol,
and water according
to ISO 10993 part 18
REGULATORY SUPPORT
• Raw materials are pre-tested to biologically-
evaluated raw materials using ISO 10993-1 and
USP chapters , Class VI
• DMF/MAF documentation filed with the FDA
for all standard colors
APPLICATIONS
MEVOPUR LQ formulations can be applied
in demanding applications including:
• Medical devices such as catheter tubing
& connectors, syringe tips, and needleless
connectors
• Skin contact devices such as wearables
or soft-touch surfaces of medical devices
PRODUCT BULLETIN
MEVOPUR™-LQ YELLOW (PMS1205C)
Product Code FZ1M415005
MEVOPUR™-LQ TRANS YELLOW
Product Code FZ1M415006
MEVOPUR™-LQ BLUE (PMS292C)
Product Code FZ5M415008
MEVOPUR™-LQ TRANS BLUE
Product Code FZ5M415009
MEVOPUR™-LQ RED (PMS198C)
Product Code FZ3M415008
MEVOPUR™-LQ TRANS RED
Product Code FZ3M415009
MEVOPUR™-LQ GREEN (PMS346C)
Product Code FZ6M415008
MEVOPUR™-LQ TRANS GREEN
Product Code FZ6M415009
MEVOPUR™-LQ VIOLET (PMS2655C)
Product Code FZ4M415003
MEVOPUR™-LQ TRANS VIOLET
Product Code FZ4M415004
CUSTOM-MADE Individual options
Customized colors
are also available to
meet your needs,
please contact us.
Avient products have not been designed for nor are they promoted or intended for use in:
(a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under
US Pharmacopoeia (USP) or ISO standards; or
(b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or
(c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.
Without limiting the generality of this statement, Avient products shall not be used in any medical device application intended for:
(1) exposure to human tissue or body fluids for 30 days or greater;
(2) “plastic” (cosmetic or reconstructive) surgery use;
(3) reproductive implants or any birth control device; or
(4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life.
https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-premier-healthcare-colorants
Get Help Now
+1-866-737-2066
Tested to ISO 10993
https://www.avient.com/news/avient-unveils-high-temperature-vibrant-colorants-healthcare-mdm-west-2022
They are tested to ISO 10993 standards, and can be customized with the addition of functional additives to enhance product performance.
Media contact
Scott Collins
scollins@collins-marcom.com
+1 216.382.8840
https://www.avient.com/news/avient-launches-two-new-sustainable-polymer-solutions-medical-and-pharmaceutical-applications-during-pharmapack-europe-2021
MEVOPUR medical-grade materials are produced according to ISO13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.
https://www.avient.com/idea/reduce-carbon-footprint-medical-plastics
Like all Mevopur products, Mevopur Healthcare Bio-based Polymer Solutions use raw materials pre-tested to ISO 10993-1, USP and , EP 3.1.3 / 3.1.5 (polyolefin packaging materials), USP (polyethylene) and ICH Q3D (elemental impurities).