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/2022-04/Asia SEM Healthcare Product Selection Guide_CN.pdf
Versaflex™ OM3060
PP包覆成型 硬度 法规 灭菌 特性
28A 环氧乙烷 柔软的半透明材料,粘性好
43A 环氧乙烷 高度可着色的解决方案,
粘性好,不易压缩变形
42A/ 50A 环氧乙烷 透明的耐高温级材料;
ABS、PC可粘合
60A 环氧乙烷/蒸汽 弹性高,不易压缩变形
20A-90A 环氧乙烷 用途广泛,无填充
ABS,PC包覆成型 硬度 法规 灭菌 特性
40A USP VI级,ISO 10993 环氧乙烷 半透明
60A USP VI级,ISO 10993 环氧乙烷 透明
VERSAFLEX™ CL与DYNAFLEX™
包覆成型,符合人体
工程学设计
触感柔软,有利于形成良好的表面
有多种颜色效果和纹理可供选择
提高抓握力、缓冲力和舒适度
提高性能表现,如密封性能、减震、隔氧、
耐刮擦和耐磨性能
降低装配成本,加工性能良好
可牢固包覆于各种基材上
血糖仪
医用工具包覆成型
注射笔
分析仪器
Dynaflex™ G2706
Dynaflex™ G2711
Versaflex™
CL2242 & CL2250
Versaflex™ G2705 N
Versaflex™ HC3810
Versaflex™ OM1040
US食品接触
USP VI级,ISO 10993
材料描述 硬度 法规 灭菌 特性
45A USP VI级
55A USP VI级
70A USP VI级
43A 环氧乙烷
34A
USP VI级,
ISO 10993-4/5
FDA,USP VI级,
ISO 10993
57A
挤出级,耐高温
再密封,压缩变形性能提高
摩擦低
Versalloy™ HC 9210-55N
Versalloy™ HC 9210-70N
Versalloy™ HC 9220-43N
Versaflex™ HC 2110-35N
Versaflex™ HC 2110-57B FDA,USP VI级,
ISO 10993
环氧乙烷 加工性能良好,表面光洁、美观
环氧乙烷
环氧乙烷
加工性能良好,表面光洁、美观
加工性能良好,表面光洁、美观
高压灭菌、环氧乙烷、
高压灭菌、环氧乙烷、
VERSALLOY™ HC与VERSAFLEX™ HC
密封和再密封
柔软的橡胶质感
无抽芯,静态推塞被刺穿后再密封性良好
满足动态密封的低摩擦系数要求
可萃取物含量低
适合在聚烯烃上包覆成型
密封和密封隔膜
密封件和卫生垫圈
注射器推塞和塞头
Versalloy™ HC 9210-45N
材料描述 硬度 法规 灭菌 特性
65A/ 75A/ 84A
54A
67A
高压灭菌器
透明度高,不含增塑剂,无油
工作温度高,可高温灭菌
环氧乙烷、辐射灭菌
Versaflex™ HC MT555
Versaflex™ HC BT218
VERSAFLEX™ CL与DYNAFLEX™
高透明度级,不含增塑剂
无色透明级,配方不含邻苯二甲酸酯增塑剂
符合医疗法规USP VI级和ISO 10993-4、5的
要求
食品接触用并符合FDA标准
可高压灭菌和辐射灭菌
可萃取物含量低
透明度高(雾度50 4.1, 100 4.5, 100 4, 70 6, 70
拉伸模量(MPa) 2200 2700 2600 2350 1820 1820
挠曲强度(MPa) 80 90 104 86 68 68
挠曲模量(MPa) 2500 2700 2500 2300 1980 1590
HDT:0.45、1.8(MPa) 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70
UL-94等级,3.0mm 5VA V-0 5VA V-0 HB V-0
UL-94等级,1.5mm V-0 V-0 5VB V-0 HB V-0
UL-94等级,0.75mm V-1 V-2 V-0 无 无 V-2
竞争材料对比
医疗保健特种工程聚合物配方
TRILLIANT™ HC热塑性塑料
Trilliant™ HC高性能热塑性弹性体系列配方是专为应对日趋严苛的医疗器械和设备而开发的。
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/2024-05/ISO14001 Global Cert_Avient_2024.pdf
This is to certify that the Environmental Management System of:
Avient Corporation HQ
33587 Walker Road
The Environmental Management System is applicable to:
Certificate No: 65537
Certification Date: 29 September 2023
Effective Date: 22 March 2024
Expiration Date: 27 September 2026
Revision Date: 22 March 2024 Dominic Townsend, President
CORPORATE SUPPORT ACTIVITIES, DESIGN, MANUFACTURE AND DISTRIBUTION OF COLOUR AND ADDITIVE
CONCENTRATES, THERMOPLASTIC RESINS AND PELLETS, SPECIALTY COMPOUNDS AND COLORANTS.
This certificate may be found on the ABS QE Website (www.abs-qe.com).
For certificates issued in the People's Republic of China information may also be
verified on the CNCA website (www.cnca.gov.cn).
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/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/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/2024-02/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/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.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
• Standard concentrates in a PE carrier and
on request in PP
• Pre-colored formulations can be supplied in
specific resins selected for the application
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)
• Food contact established with FDA/EU*
APPLICATION BULLETIN
DRUG TYPE COLOR
DESCRIPTION
PANTONE
REFERENCE
AVIENT PRODUCT
CODE PE BASED
Adrenergic agonist
combinations Light Green 373 C PE6M176349
Adrenergic agonists Purple 2583 C PE4M176057
Anti-infectives Tan 467 C PE8M176130
Anti-inflammatory,
nonsteroidal Grey Cool Grey 4 C PE7M176184
steroids Pink 197 C PE3M176237
Anti-inflammatory,
immunomodulators Olive Green 5763 C On request
Beta-blockers Yellow Yellow C PE1M176160
Beta-blocker combinations Dark Blue 281 C PE5M176272
Carbonic anhydrase inhibitors Orange 1585 C PE2M176089
Cytotoxic Black 6 C PL9M176008
Miotics Dark Green 348 C PE6M176267
Mydriatics and cycloplegics Red 1797 C PE3M176236
Prostaglandin analogues Turquoise 326 C PE5M176273
Healthcare use limitations apply—see below.