https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
The nucleating agents also foster constant process
settings throughout part manufacturing with a
higher crystallization temperature for improved
crystallization speed.
REGULATORY SUPPORT
• Drug delivery devices
• Pharmaceutical packaging
• Medical equipment
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 the risk of change
• Allows crystallization in semi-crystalline
polymers to begin faster and complete earlier
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*
APPLICATION BULLETIN
* FDA/EU compliance information available upon request
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/resources/Polyone%2520AR.pdf
Consequently, you should
not consider any such list to be a complete set of all potential risks or uncertainties.
Name Age Position
Robert M.
The GeonTM brand name carries strong recognition globally.
https://www.avient.com/sites/default/files/2024-08/Avient 2023 Sustainability Report_6.pdf
We set an interim 2030 goal to attain 60% of
our electricity from renewable sources.
State of Ohio filings and contributions are publicly available at www.ohiosos.gov
Those who file reports can remain anonymous.
https://www.avient.com/knowledge-base/article/quality-design
Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF).
Disclosure of ingredients for purpose of regulatory filings (under specific confidentiality agreements).
https://www.avient.com/knowledge-base/article/quality-design?ind[]=6598
Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF).
Disclosure of ingredients for purpose of regulatory filings (under specific confidentiality agreements).
https://www.avient.com/knowledge-base/article/quality-design?rtype[]=1164
Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF).
Disclosure of ingredients for purpose of regulatory filings (under specific confidentiality agreements).
https://www.avient.com/sites/default/files/2022-08/ISO9001-2015 EN -EM.pdf
China
TEL: +86 21 32799000
Zhu Hai Ming
Management Representative
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
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.
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 - Suzhou, China
Locations included in the certification are as follows:
Site Name Site Address Site Scope
PolyOne Management
(Shanghai) Co., Ltd.
https://www.avient.com/sites/default/files/2021-04/shanghai-9001.pdf
China
TEL: +86 21 32799000
Zhu Hai Ming
Management Representative
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
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.
TEL:+31(0)102922689. www.dnvgl.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, 156 Nan Hai Road,
Tianjin Economic-Technological,
Tianjin, China, 300457
Manufacture of Masterbatch
PolyOne-Shanghai, China No. 88, Guo Shou Jing Road, Z.
https://www.avient.com/sites/default/files/2024-12/ISO-9001_English_Shanghai Zhangjiang.pdf
MSC Certificate
Place and date: For the issuing office:
Shanghai, 20 March 2024 DNV - Business Assurance
Building 9, No. 1591 Hongqiao Road,
Changning DistrictShanghai China 200336
Zhu Hai Ming
Management Representative
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
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/knowledge-base/article/regulatory-issues?ind[]=6598
We support your Device Master File submission for healthcare materials by developing and maintaining U.S.
FDA Drug Master Files and Medical Application Files.