https://www.avient.com/sites/default/files/2021-10/dynaflex-knee-brace-case-study-one-pager.pdf
HEALTHCARE DEVICE
MANUFACTURER
W E B K N E E B R A C E
• Good bonding to polypropylene (PP)
• Flexible and soft-touch feel
• Skin contact, general FDA compliance
• Good tensile strength and resilience
• Excellent colorability
• Offered material that passed the required
FDA regulations
• Provided high elasticity memory and ultra
soft tactile finish to meet the comfort and
pleasant surface feeling requirements
• Delivered TPE with easy and stable
processing and colorability
DynaflexTM Thermoplastics Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/dynaflex-g-cooler-feet-wagon-wheel-tread.pdf
Dynaflex G - Cooler Feet & Wagon Wheel Tread
COOLER
MANUFACTURER
C O O L E R F E E T & W A G O N
W H E E L T R E A D
• Abrasion resistance and excellent tear strength
• UV and heat stability
• Overmoldable to PP or PC
• Provided durable TPE materials at target
durometers to achieve component-specific
performance requirements
• Offered rapid response technical support
for mold trials and guidance on processing
best practices
• Delivered consistent material quality
globally and with short lead times
Dynaflex™ G
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2022-07/Mevopur Standard Colors Product Bulletin-CN.pdf
母粒和预着色料可用于多种聚合物,包括PE,
PP,PEBA,PC,ABS等。
™
在三个通过ISO 13485认证的医疗产线生产
全球统一的配方,提供全球一致性和供应链
保障
提供文件化的变更控制
原料指纹图谱和常规批次测试
多种标准颜色缩短产品开发时间
产品组合里符合标准的颜色用于:
- 注射针头ISO 6009
- 眼科容器盖(美国眼科学院 / AAO -
American Academy of Ophthalmology)
颜色 潘通色
参照 PE 基料 PP 基料 透明PP 基料 PEBA 基料 PC 基料 ABS 基料*
— PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206
102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958
158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939
199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037
196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039
2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978
292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402
285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404
288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406
346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070
3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068
348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072
425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297
Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295
7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871
463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869
Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896
颜色可能与显示的实际颜色有所不同。
透明PP 基料*
白色
黄色
橙色
红色
粉色
紫色
浅蓝色
正蓝色
深蓝色
浅绿色
蓝绿色
正绿色
深灰色
正灰色
米色
棕色
黑色
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。
TRILLIANT™
HC8920
TRILLIANT™
HC2020
Trilliant™ HC2020
材料描述 基料
共聚酯
Trilliant™ HC8910/8920 聚酮/ABS共混物
Trilliant™ HC2120 Tritan
Trilliant™ HC3120 PC
Trilliant™ HC5210 PP
Trilliant™ HC6010 PA6
Trilliant™ HC6610 PA66
Trilliant™ GRV-NP-110-W PA12
TRILLIANT™ HC热塑性塑料
作为FR PC/ABS、FR PC/PET和FR COPE的
耐化学性替代品,在各种颜色的应用中,其
阻燃等级在1.5mm和0.75mm厚度下分别可
达到UL 94黄卡V-0级和V-1级。
在对普通消毒剂的耐受性方面优于PC/ABS、
PC/PET和COPE
暴露在普通医院消毒剂下72小时后仍能保持
抗拉强度,相较于PC混合物和COPE,具有
更出色的长期耐化学性
具有良好的抗冲击性和耐热性
有自然色等级、标准医用颜色或定制预着色
产品可供选择
医疗设备外壳
核磁共振成像、X射线、CT扫描仪部件
手术器械,如吻合器、解剖器、剪刀等
自动注射笔
测试项 比重
熔体流动指数
(230OC,
2.16KG)
抗拉强度 挠曲强度 挠曲模量 冲击强度
缺口,IZOD 测试项
方法 ASTM D-792 ASTM D-1238 ASTM D-638 ASTM D-790 ASTM D-790 ASTM D-256 ASTM D-257
单位 -- g/10min MPa MPa MPa J/m Ohms/sq.
https://www.avient.com/sites/default/files/2023-01/Mevopur Standard Colors Product Bulletin _ Color Card.pdf
Concentrates and pre-colored formulations are
available for a wide range of polymers, including
PE, PP, PEBA, PC, ABS, and others.
KEY CHARACTERISTICS
• Globally harmonized formulations are
manufactured at four ISO 13485 certified
medical sites, providing global consistency
and increased security of supply
• Documented change control available
• A range of standard colors eliminates color
matching to expedite development time
• The portfolio includes compliant colors for
use in:
- Needle hub applications: ISO 6009
- Ophthalmic container closures
(American Academy of Ophthalmology)
REGULATORY SUPPORT
• A library of pre-tested raw materials including:
- 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*
HEALTHCARE APPLICATIONS
• Medical devices such as catheters, surgical and
dental instruments, and drug delivery devices
• Pharmaceutical packaging including vials
and bottles
• Diagnostics for blood analysis or In Vitro
Diagnostics (IVD)
PRODUCT BULLETIN & COLOR CARD
* FDA/EU compliance information available upon request; exceptions may occur
Color Pantone
Reference PE Base PP Base Transparent
PP Base PEBA Base PC Base Transparent
PC Base* ABS Base*
White — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206
Yellow 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958
Orange 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939
Red 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037
Pink 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039
Violet 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978
Light Blue 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402
Mid Blue 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404
Dark Blue 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406
Light Green 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070
Bluish Green 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068
Medium Green 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072
Dark Gray 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297
Mid Gray Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295
Beige 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871
Brown 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869
Black Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896
Colors may vary from actual color shown.
https://www.avient.com/sites/default/files/2023-10/Cesa Unify A4R Product Bulletin.pdf
For this reason packaging
often contains layers of both PP and PE based on
its functionality.
It works by bringing
incompatible polymers – such as PP and PE –
together by forming them into a homogenous
polymer mixture that increases mechanical
properties based on polymer modification.
This
literature shall NOT operate as permission, recommendation, or inducement to practice any patented invention without permission of the patent owner.
1.844.4AVIENT
www.avient.com
KEY CHARACTERISTICS
• Designed for polyolefin recycling and to
enhance circularity
• Helps bring incompatible polymers together
by forming them into a homogenous polymer
mixture
• Improves the mechanical performance of mixed
PP/PE streams
• Increases impact strength by up to 50%
• Increases ductility by up to 100% for improved
performance
• Maintains mechanical strength properties close
to polymer starting point
• The end result is that the characteristics of rPP
remain with higher impact properties
• Good cost-performance ratio
• Can be combined with color into a single
masterbatch product for convenience
• Product guidance and technical assistance
is available from our experts
MARKETS & APPLICATIONS
• Recycled polyolefins
• Packaging, consumer & others
• High-value polyolefin applications with recycled
material content
• Virgin polymers which will be recycled after the
use phase
Currently unavailable in North America—please contact your
Avient representative for further information.
https://www.avient.com/sites/default/files/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.pdf
This portfolio is based on a PE carrier, but can be
provided in a PP carrier on request.
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.
For containers/bottles, Avient also offers Remafin™ EP White Colorants,
available in low density and high density PE and PP resins.
https://www.avient.com/investor-center/news/polyone-appoints-mark-crist-president-color-additives-inks-scott-horn-president-distribution
Robert M.
https://www.avient.com/investor-center/news/polyone-expands-specialty-color-and-additives-expertise-acquisition-iqap-masterbatch
Robert M.
https://www.avient.com/products/advanced-composites/composite-ballistic-protection/thermoballistic-thermoplastic-panels
1350 ft/sec
411 m/sec