https://www.avient.com/news/plastics-and-rubber-thailand-2024-include-avients-showcase-specialty-and-sustainable-materials
Avient’s Product Carbon Footprint (PCF) Calculator: a tool that is third-party-certified by TÜV Rheinland, developed to evaluate the carbon footprint of Avient’s specialized and sustainable material solutions to help companies address the growing demand to create and meet sustainability commitments, understand the environmental impact of products, and navigate the complex landscape of reducing carbon emissions, particularly for upstream materials, and aligns with the ISO 14067:2018 standard for quantifying and reporting the carbon footprint of a product
https://www.avient.com/news/avient-present-broad-array-innovative-and-sustainable-materials-solutions-chinaplas-2025
Colorant Chromatics™ Transcend™ Premier Healthcare Colorants: based on polysulfone and PEEK resins with the capability of withstanding up to 1,000 autoclave cycles and high-heat sterilization at 150°C, these colorants are formulated with ingredient materials that have been successfully tested for ISO 10993 biocompatibility and are available in a line of bright and vivid transparent or opaque shades
https://www.avient.com/resources/safety-data-sheets?page=4561
Geon(TM) DB5261 Neutral TT Iso Stable
https://www.avient.com/sites/default/files/2022-03/MEVOPUR Chemical Foaming Agents Application Bulletin_JP.pdf
主な特徴
ISO 13485の管理基準化で製造。
規制対応
評価試験*:
- ISO 10993-1
- USP および (Class VI)
- 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ
レフィン系包装材料)
- USP (ポリエチレン)
- ICH Q3Dに準拠した元素不純物分析
DMF(Type III)および Device Master File 登
録済み
米国FDAおよびEUの食品接触規格
軽量化
ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。
a) 米国食品医薬品局(FDA)または国際標準化機構(ISO)により「インプラント」機器として分類される医療機器、または米国薬局方(USP)または ISO 規格で定義される「パーマネント」
機器、または
(b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または
(c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。
https://www.avient.com/sites/default/files/2024-07/TPE Whitepaper_0.pdf
In addition, the formulation
meets ISO 15759 requirements for medical infusion equipment and is
manufactured in an ISO 13485 facility.
https://www.avient.com/sites/default/files/2024-12/67599-Certificate-06DEC2024.pdf
Certificate Avient Corporation
Certificate Of Conformance
This is to certify that the Quality Management System of:
Avient Corporation
33587 Walker Road
Avon Lake OH
44012
has been assessed by ABS Quality Evaluations, Inc. and found to be in
conformance with the requirements set forth by:
ISO 9001:2015
The Quality Management System is applicable to:
Design and manufacture of colour and additive concentrates, thermoplastic resins and
specialty compounds
Certificate No: 65799
Certification Date: 01 OCT 2020
Effective Date: 25 SEP 2023
Expiration Date 30 SEP 2026
Revision Date: 06 DEC 2024
Dominic Townsend, President
Page 1 of 4
ISO 9001:2015
Certificate Of Conformance
ANNEX
Certificate No.: 65799
Avient Corporation
At the below facilities
Avient Corporation -
Avon Lake, OH
Management of QMS, Design and manufacture of colour and additive concentrates,
thermoplastic resins and specialty compounds
33587 Walker Road Avon Lake OH
44012 United States
Avient (Argentina) SA Administration, Site management, Manufacture, Laboratory (QC and Colormatching),
Procurement, Maintenance, Infrastructure, Warehouse and Transport, Sales
Av.
https://www.avient.com/sites/default/files/resources/ISO9001.2015PolyOneShanghai%25282018-2021%2529.pdf
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:
ISO 9001:2015/GB/T 19001-2016
This certificate is valid for the following scope:
Design and Manufacture of Masterbatch
C ertificate No: 7071-1998-AQ-RGC-RvA
P lace and date: Shanghai, 30 March, 2018
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/sites/default/files/resources/19.2540_C%2520Colorant%2520Chromatics%25209001-2015%2520Certificate%2520EXP%25202021%25209-24-2018.pdf
Certificate of Registration 9001:2015 MSP
9001:2015–MSP-ANAB-US (2.0)
Page 1 of 2
Certificate of Registration
of Quality Management System
to ISO 9001:2015
The National Standards Authority of Ireland certifies that:
Colorant Chromatics Ab
Kroklundsvagen 346
AX-22 320 Odkarby
Aland
Finland
has been assessed and deemed to comply with the
requirements of the above standard in respect of the scope of
operations given below:
The Design, Manufacture and Sales of
Fluoropolymer Color Concentrates and
Compounds
Additional sites covered under this multi-site certification are listed on the
Annex (File No. 19.2540/C)
Approved by:
Geraldine LarkinChief
Executive Officer
Approved by:
Lisa Greenleaf
Operations Manager
Registration Number: 19.2540/C
Certification Granted: May 15, 1997
Effective Date: Oct 20, 2018
Expiry Date: Oct 19, 2021
National Standards Authority of Ireland, 20 Trafalgar Square, Nashua, New Hampshire, NH 03063, USA T +1 603 882 4412
9001:2015–MSP-ANAB-US (2.0)
Page 2 of 2
Annex to Certificate Number: 19.2540/C
Scope of Registration:
The Design, Manufacture and Sales of Fluoropolymer Color
Concentrates and Compounds
Activity Location
Central Management Group,
Design, Manufacture
Colorant Chromatics
Kroklundsvagen 346
AX-22 320 Odkarby
Aland
Finland
File No.: 19.2540/C
Headquarters, Sales, Distribution Colorant Chromatics Europe B.V.
https://www.avient.com/sites/default/files/2024-02/Gravi-Tech REC Recycled Formulations Product Bulletin.pdf
KEY CHARACTERISTICS
• Customized density offering a wide range of
specific gravities (1.2–11 gm/cm3)
• Based on recycled resin from PIR and PCR
sources
• Broad modulus range, from very flexible to very
rigid grades
• Corrosion resistance that withstands oxidization
for long-term use and benefit
• Chemical resistance can be adapted depending
on base resin as required
• Provides visual surface effects, aesthetics, and
cool touch
• Design flexibility and processing ease
MARKETS AND APPLICATIONS
Applications in packaging and consumer goods in
which a more sustainable solution is preferred:
• Cosmetic caps and closures
• Perfume caps
• Spirit bottle caps
• Luxury boxes
• Handles and knobs
SUSTAINABILITY BENEFITS
• Formulated with recycled resin from
post-industrial recycled (PIR) and/or
post-consumer recycled (PCR) sources including
ocean bound plastic waste
• Reduces waste and supports the circular
economy
• Reduces carbon footprint compared to fossil
feedstock alternatives
• Simplifies manufacturing and lowers costs
versus metal
PRODUCT BULLETIN
CHARACTERISTICS UNITS
Gravi-Tech REC-CI
GT5200-5089 PT
Natural
Gravi-Tech REC
GT5200-5075
Black X2
Gravi-Tech REC
GT5200-5078
Gravi-Tech REC
GT5200-5079
Gravi-Tech REC
GT5200-5060
Gravi-Tech REC
GT5200-5057
Base Resin Ocean Bound
rPP rPP rPP rPP rPP rPP
Recycled Content/Filler g/cm >98% PIR+PCR 60% PIR/Mineral >95%
PIR/Mineral
>95%
PIR+PCR/Mineral 30% PIR/Mineral 30% PIR/Mineral
Density (ISO 1183) g/ccm 1.2 1.2 1.2 1.2 1.9 2.0
CHARACTERISTICS UNITS
Gravi-Tech REC
GT7300-5034 X2 FD
Natural
Gravi-Tech REC
GT7300-5036
Gravi-Tech REC
GT7300-5025
Gravi-Tech REC
GT6000-5032
GT6000-5031
Base Resin ABS rABS/ABS rABS rPA6 rPA6
Recycled Content/Filler g/cm 50% PIR/Mineral 65% PIR/Mineral 10% PIR/Mineral 20% PIR/Mineral 20% PIR/Mineral
Density (ISO 1183) g/ccm 1.5 1.5 2.2 2.7 2.8
AVAILABLE GRADES
Copyright © 2024, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Colorants and Formulations Special Effects Application Bulletin_0.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified
manufacturing sites, providing global
consistency and increased security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Non-phthalate and formulated without
animal-derived substances
• Available as pre-colored formulation or
concentrate and for use in different polymers
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
* Design note: Effect colors require careful consideration of part design and
polymer flow paths to minimize visible flow lines.