https://www.avient.com/sites/default/files/2024-01/Global Standard Response_Dec 2023.pdf
We thank you for your understanding, and we look forward to serving your needs.
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Table of contents
A Message from our Global Quality
Manager ...............................................................2
Avient Corporation: Overview ............................4
Avient Policy for Customer Audits ......................5
Management Responsibility ...............................6
Product Liability Insurance .............................6
Ethics - Code of Conduct.................................6
Modern Slavery Statement.............................6
Conflict Mineral Policy....................................6
Technical Data Sheets.....................................6
Safety Data Sheets..........................................6
Regulatory Requests and Certificates
(FDA certificate, Absence declaration,
REACH, SDS) ........................................6
Safety Performance ........................................6
Environmental Performance...........................6
Energy Management ......................................6
Business Continuation Plan.............................6
Preventive - Predictive Maintenance..............6
Financial Report..............................................6
Quality Management..........................................7
3rd Party Certification......................................7
Complaint Handling ........................................7
Continuous Improvement...............................7
Traceability .....................................................7
Record Retention............................................7
IT Security.........................................................8
Firewall .........................................................8
Critical Data ..................................................8
IT Disaster Recovery .....................................8
IT Systems of Use Policy ...............................8
Annex 1 - Special dispositions related to ISO
13485 certification for Mevopur .......................9
Change control .............................................9
Validation .....................................................9
Control of documents and records ...............9
Supplier approval and supplier evaluation ...9
Traceability ...................................................9
Material management ..................................9
Release of finished products.........................9
Control of Non-conforming products,
complaints handling, recall and CAPA..........9
Annex 2 – special dispositions related to ISO
22000 certification............................................10
Change..........................................................10
HACCP ..........................................................10
Control of documents and records ...............10
Material management ..................................10
Supplier approval and supplier evaluation ...10
Traceability ...................................................10
Release of finished products.........................10
Control of Non-conforming products,
complaints handling, recall and CAPA..........10
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Avient Corporation: Overview
The Avient website is your home base for information about the company:
https://www.avient.com/
To find our facility locations:
https://www.avient.com/contact/global-directory-and-contacts
For more information about our management systems certifications, including ISO, go to:
Avient Governance (corporate policies and the Avient Code of Conduct):
https://www.avient.com/investors/governance
Financial reports:
https://www.avient.com/investors
Avient Sustainability Report:
https://www.avient.com/company/sustainability
https://www.avient.com/
https://www.avient.com/contact/global-directory-and-contacts
https://www.avient.com/investors/governance
https://www.avient.com/investors
https://www.avient.com/company/sustainability
5
Avient Policy for Customer Audits
Avient may permit audits of facilities, subject to:
Advanced notice and an audit agenda provided at least thirty (30) days in
advance or as agreed by the Avient location to be audited for a routine audit
Standard handling time frame:
1 Business Day to
confirm receipt and
r .ecord it in our system
15 Business days to
analyze problem,
provide root cause
and action plan.
30 days to close
complaint
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The overall processing times may vary depending on the complexity of the issue and resources needed.
The
record retention period for these records is three
(3) years.
https://www.avient.com/investors/events-presentations?page=5
Avient Q1 2023 Earnings – May 3, 2023
Morgan Conference - 3/1/2022
Avient Q4 2021 Earnings - February 8, 2022
https://www.avient.com/investors/events-presentations?page=0
Avient Q1 2023 Earnings – May 3, 2023
Morgan Conference - 3/1/2022
Avient Q4 2021 Earnings - February 8, 2022
https://www.avient.com/investors/events-presentations?page=1
Avient Q1 2023 Earnings – May 3, 2023
Morgan Conference - 3/1/2022
Avient Q4 2021 Earnings - February 8, 2022
https://www.avient.com/investors/events-presentations?page=11
Avient Q1 2023 Earnings – May 3, 2023
Morgan Conference - 3/1/2022
Avient Q4 2021 Earnings - February 8, 2022
https://www.avient.com/investors/events-presentations?page=10
Avient Q1 2023 Earnings – May 3, 2023
Morgan Conference - 3/1/2022
Avient Q4 2021 Earnings - February 8, 2022
https://www.avient.com/investors/events-presentations?page=8
Avient Q1 2023 Earnings – May 3, 2023
Morgan Conference - 3/1/2022
Avient Q4 2021 Earnings - February 8, 2022
https://www.avient.com/investors/events-presentations?page=3
Avient Q1 2023 Earnings – May 3, 2023
Morgan Conference - 3/1/2022
Avient Q4 2021 Earnings - February 8, 2022
https://www.avient.com/sites/default/files/2022-07/REMAFIN EP White Masterbatches for Pharma Application Bulletin_CN.pdf
主要特性
生产符合高于CAS编号级别的变更控制原则
(与MEVOPUR母粒类似),降低变更风险
不含动物源性物质和邻苯二甲酸盐
适用于吹膜、注塑、吹塑和挤出
注册药品主文件(III型)
食品接触符合FDA/EU*要求
法规支持
原材料根据以下法规测试:
- ISO 10993-1
- USP第、章,包括VI级别,符合眼
科和鼻腔用药物要求
- 欧洲药典3.1.3/3.1.5(聚烯烃)
- 美国药典(聚乙烯)
- ICH Q3D 杂质元素
- USP和USP,透光率
载体材料 耐光性 热稳定性 产品代码颜料含量/类型
HDPE 50% TiO2
8 300°C PH00075525
LLDPE 60% TiO2
8 300°C PL00075542
LLDPE 70% TiO2
8 300°C PL00075545
PP 50% TiO2
8 300°C PP00075717
适用医疗保健使用限制—见下文。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用:
(1) 接触人体组织或体液长达30天或更长时间;
(2)“整形”(整容或重建)手术;
(3) 生殖植入物或任何节育器械;或者
(4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
https://www.avient.com/sites/default/files/2020-12/artisan-thermoplastics-nylon-processing-guide.pdf
Processing Guide 3
Start Up & Shut Down Recommendations
Purge Compound 2–3 melt flow PP or purging compound.
Half-round runners are not recommended
3.
Place vents at each 90° intersection and vent to atmosphere
8.