https://www.avient.com/sites/default/files/2020-09/oncolor-hc-product-bulletin-1.pdf
Also available are OnColor HC Plus Colorants,
certified to meet or exceed USP Class VI and ISO
10993 bio-compatibility requirements.
KEY CHARACTERISTICS
• Polymer colorants formulated specifically for
healthcare product applications
• Meets and exceeds various material
performance requirements including
FDA 21 CFR, ISO 10993 and USP Class VI
• HC Plus colorants certified for bio-compatibility
• Available as pre-color, concentrate,
masterbatch or Smartbatch™ combined
colorant/additive solution
• Wide range of colors, striking special effects
and custom color matching
MARKETS AND APPLICATIONS
OnColor™ HC and HC Plus Colorants are an
excellent choice for medical devices and parts,
pharmaceutical or cosmetic packaging, and many
other healthcare related polymer applications.
https://www.avient.com/sites/default/files/2021-09/avient-hong-kong-holding-certificate-of-change-of-name-aug-2-2021.pdf
公公公公 司司司司 更更更更 改改改改 名名名名 稱稱稱稱 證證證證 明明明明 書書書書
CERTIFICATE OF CHANGE OF NAME
本 人 謹 此 證 明
I hereby certify that
POLYONE HONG KONG HOLDING LIMITED
已 藉 特 別 決 議 更 改 其 名 稱 , 該 公 司 根 據
having by special resolution changed its name, is n ow incorporated under the
香 港 法 例 第 622 章 《 公 司 條 例 》 註 冊 的 名 稱 現 為
Companies Ordinance (Chapter 622 of the Laws of Hon g Kong) in the name of
Avient Hong Kong Holding Limited
本 證 明 書 於 二二二二 OOOO 二二二二 一一一一 年 八八八八 月 二二二二 日 發 出 。
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/2021-09/cai-biopolymers-brochure-2021.pdf
Use of Biopolymers in Packaging Types
Introduction to Biopolymers
Less
Frequently
Used
More
Frequently
Used
Single Use Bottles
Single Use Cups, Tubs & Trays
Clothing Packaging Bags
Pre-packed Fruit Bags
Vegetable Bags
Coffee Capsules
Carrier Bags
Fruit Labels
Fast Food Trays (closed system
)
Teabags
Biowaste Bags
To ensure compliance with requirements and
regulations, suitable certification is of crucial
importance.
Avient is a TÜV Austria certified masterbatch
supplier and can help support and secure the
full certification process of a final part.
In compliance with certification requirements,
Avient biocolorants can offer a large spectrum
of color possibilities supporting differentiation
and appeal at consumer level.
https://www.avient.com/sites/default/files/2021-12/Chemically Resistant Materials Whitepaper.pdf
MATERIAL BRIEF DESCRIPTION
FR PC/ABS Flame retardant, chemical resistance, high ESCR
FR PC/PET Flame retardant, impact modified, chemical resistant
FR PC/PBT Skin-contact biocompatible, flame retardant, high chemical resistance
FR Copolyester
Flame retardant, chemical resistant, may incorporate agency-rated materials
to meet USP Class VI or ISO 10993 requirements
Trilliant™ HC8910 Unfilled PK blend, BPA-free, high chemical resistance, may incorporate
agency-rated materials to meet USP Class VI or ISO 10993 requirements
Trilliant™ HC8920 FR
Non-halogenated flame retardant PK blend, BPA-free, high chemical resistance, may
incorporate agency rated materials to meet USP Class VI or ISO 10993 requirements
Edgetek™ ET8900 CR Unfilled PK blend, high chemical resistance
Edgetek™ ET8900 HI CR High impact PK blend, high chemical resistance
Edgetek™ ET8920 FR CR Non-halogenated flame retardant PK blend, high chemical resistance
Table 2.
https://www.avient.com/sites/default/files/2022-02/MEVOPUR Bio-based Solutions Application Bulletin_JP.pdf
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)
- 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
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/2022-09/FR Healthy Bldg Codes Application Snapshot.pdf
P R O F I L E / S H E E T E X T R U D E R
R A I L S A N D K I C K P L A T E S
• Convert existing PVC profile and sheet rails and kick plates to
polyolefin resin to meet Class A fire safety (ASTM E84)
• Provide a system that meets healthy building certifications
and approvals
• Utilize a more sustainable flame retardant technology,
removing brominated or halogenated flame retardants from
the environment
• Achieve non-compromising performance in aesthetics,
impact, dimensional stability, CLTE, and E84 testing
• Provided broad flame retardant platform, backed by
extensive application and industry expertise, to meet
global flammability standards
• Has largest UL94 recognized Prospector membership
with HB, V-0, V-1, V-2 and 5VA/5VB ratings, and broad
glow wire performance products
• Included in-house UL certified labs and manufacturing
locations to perform UL94 material sampling and testing
• Supported application development to meet fire safety
standards, address current or emerging healthy building
codes, smart home requirements, and LEED credits
• Offered custom formulations in small lot quantities
Cesa™ Flam Non-Halogen Flame Retardants
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
CERTIFICATIONS + QUALITY
LEARN MORECopyright © 2022, Avient Corporation.
https://www.avient.com/sites/default/files/2023-03/Cergy-AVIENT LUXEMBOURG-2022-Décret 2021-461 Certfificate.pdf
MAIA+
N° rapport :223-2023-000066-FR 10898066 0.5
jour
Date Début / Fin :04/11/2022 /04/11/2022 PolyOne France - site de Saint Ouen l'Aumône 1 /11
ATTESTATION DE RECONNAISSANCE
Attribué à
PolyOne France - site de Saint Ouen l'Aumône
14 avenue de l'Eguillette / ZA du Vert Galant
95310 - SAINT OUEN L'AUMONE - FRANCE
Bureau Veritas Certification certifie que les prestations de l’entreprise susmentionnée
ont été évaluées et jugées conformes aux caractéristiques énoncées dans le décret
en vigueur à la date d’édition du présent certificat :
Décret n°2021-461 du 16 avril 2021 relatif à la
prévention des pertes de granulés de plastiques
industriels dans l’environnement
Sous réserve du respect des caractéristiques vérifiées, cette attestation est
valable jusqu’au : 16/02/2026
Date originale : 17/02/2023
Attestation n°: 223-2023-000066-FR Date : 17/02/2023
Affaire n°: 10898066
Laurent CROGUENNEC - Président
Adresse de l’organisme certificateur : Bureau Veritas Certification France
Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense
Des informations supplémentaires concernant le périmètre de cette attestation ainsi que
l'applicabilité des exigences du décret peuvent être obtenues en consultant l'organisme.
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
Black
Gravi-Tech REC
GT5200-5079
Black
Gravi-Tech REC
GT5200-5060
Black
Gravi-Tech REC
GT5200-5057
Black
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
Black
Gravi-Tech REC
GT7300-5025
Black
Gravi-Tech REC
GT6000-5032
Black
Gravi-Tech REC
GT6000-5031
Black
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.