https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured under ISO 13485 procedures
• Documented change control beyond
CAS number, reducing risk of change
• Can be used on common injection molding
and extrusion machines—set-up support by
a technical assistance team
• Available for use in polyolefins, styrenics
and copolymers
• Can be combined with colorants
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP and (incl. class VI)
- European Pharmacopeia, monograph 3.1.3/
3.1.5 (polyolefin packaging materials)
- USP (polyethylene)
- Elemental impurities as per ICH Q3D
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact according to USA FDA and
EU norms
APPLICATION BULLETIN
Sustainability Spotlight
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-10/ISO13485 -2016 - 2021.2.20~2024.2.19 -EN.pdf
China
has been assessed and certified as meeting the requirements of
麟 ISO 13485:2016
EN ISO 13485:2016
’骥鑫馨瓤) For the foiowing actratEes
Design and manufacture of medical grade thermoplastic elastomers
for non-active medical devices and active medical devices
遴;舞蒸;撇蒸 (non-implantable)
:护、::于 b入沙黔娜;舞睡莎:器器舞蟒檬非拟拐称群亘爸竺舀‘。
https://www.avient.com/sites/default/files/2021-12/PREPERM _ Edgetek Low-loss Dielectric Thermoplastics Technical Bulletin.pdf
KEY PROPERTIES AND PERFORMANCE
FR GRADES H GRADES PEEK GRADES LCP GRADES FLEX GRADES
PROPERTIES CONDITION ISO UNIT PPE400FR PPE700FR PPE950FR PPE1200FR H1500HF H2300HF PEEK700 PEEK900 PEEK1000 PEEK1200 LCP650 LCP800 LCP950 FLX400 FLX700 FLX1100
Dielectric Constant (Dk) 2.4 GHz 4.0 7.0 9.5 12.0 15.0 23.0 7.0 9.0 10.0 12.0 6.5 8.0 9.5 4.0 7.0 11.0
Loss Tangent (Df) 2.4 GHz 0.0030 0.0039 0.0042 0.0045 0.0010 0.0037 0.0024 0.0025 0.0024 0.0027 0.0043 0.0045 0.0047 0.0010 0.0009 0.0012
Density 1183 g/cm3 1.44 1.97 2.20 2.50 2.60 3.40 1.94 2.20 2.30 2.40 2.00 2.15 2.30 1.52 1.93 2.50
Melt Flow Index (MFI)
5 kg, 300 °C
(unless noted)
1113 g/10 min 17 12 13 5 5 8 15 @ 380 °C 13 @ 380 °C 10 @ 380 °C 6 - - - 11 @ 230 °C 2 @ 230 °C 0.3 @ 230 °C
Tensile Strength at Break 23 °C/73 °F 527 MPa 47 52 44 45 23 40 64 62 65 67 75 80 75 11 17 25
Flexural Modulus 23 °C/73 °F 178 MPa 3100 4500 - 9300 2100 5000 6200 7600 9200 11000 8000 8500 8500 1400 1600 2900
Unnotched Izod 23 °C/73 °F 180 kJ/m2 NB 42 20 9 17 10 28 25 18 15 31 20 12 NB NB NB
-20 °C/-4 °F 180 kJ/m2 - - - - 17 10 - - - - - - - - -
Notched Izod 23 °C/73 °F 180 kJ/m2 14 6 4 3 5 4 6 4 4 4 10 6 4 59 23 13
-20 °C/-4 °F 180 kJ/m2 - - - - 5 4 - - - - - - - - - -
STANDARD GRADES RADOME GRADES
PROPERTIES CONDITION ISO UNIT PPE260 PPE300 PPE320 PPE350 PPE400 PPE440 PPE500 PPE650 PPE800 PPE950 PPE1200 RS260 RB260 RS265FR
Dielectric Constant (Dk) 2.4 GHz 2.6 3.0 3.2 3.5 4.0 4.4 5.0 6.5 8.0 9.5 12.0 2.6 2.6 2.7
Loss Tangent (Df) 2.4 GHz 0.0009 0.0009 0.0010 0.0009 0.0009 0.0009 0.0009 0.0009 0.0009 0.0009 0.0010 0.0009 0.0012 0.0032
Density 1183 g/cm3 1.07 1.18 1.21 1.27 1.43 1.50 1.62 1.86 2.10 2.20 2.40 1.06 1.08 1.09
Melt Flow Index (MFI) 5 kg, 300 °C 1113 g/10 min 15 15 16 14 14 14 15 11 10 4 2 21 16 25
Tensile Strength at Break 23 °C/73 °F 527 MPa 40 45 47 50 50 48 45 43 37 37 36 50 42 52
Flexural Modulus 23 °C/73 °F 178 MPa 2700 2400 2000 2600 2800 2700 2600 2600 2300 2600 2600 2200 2200 2600
Unnotched Izod 23 °C/73 °F 180 kJ/m2 NB NB NB NB NB NB NB NB 50 28 24 NB NB NB
-20 °C/-4 °F 180 kJ/m2 NB NB NB NB NB NB NB 50 47 27 25 NB NB NB
Notched Izod 23 °C/73 °F 180 kJ/m2 8 55 69 35 22 20 15 9 8 5 4 19 14 11
-20 °C/-4 °F 180 kJ/m2 8 15 20 14 12 10 9 8 8 5 4 10 12 10
PREPERM™ SERIES
PROPERTIES CONDITION ISO UNIT 8027 8025 8037 8019 8028 8026 8044 8029 8041 8045 8048 8036 8056 8031
Dielectric Constant (Dk) 1 GHz, 23 °C 3.0 3.1 3.4 3.6 3.8 4.4 4.8 5.3 5.4 5.9 6.0 7.0 7.3 9.0
Loss Tangent (Df) 1 GHz, 23 °C 0.0012 0.0012 0.0008 0.0010 0.0010 0.0010 0.0004 0.0008 0.0006 0.0002 0.0006 0.0007 0.0002 0.0007
Density 1183 g/cm3 1.25 1.26 1.35 1.39 1.45 1.59 1.72 1.75 1.79 1.89 1.88 2.06 2.086 2.25
Melt Flow Index (MFI) 5 kg, 300 °C 1113 g/10 min 16 19 10 11 15 13 10 10 15 15 19 10 18 4.7
Tensile Strength at Break 23 °C/73 °F 527 MPa 59 54 54 62 59 54 52 58 52 45 49 45 37 38
Flexural Modulus 23 °C/73 °F 178 MPa 2780 2560 2850 3060 3350 3700 3157 4300 4320 3137 4150 3370 2560 4200
Notched Izod 23 °C/73 °F 180 kJ/m2 15.3 14 14.8 14 12.6 10.4 9.9 8.6 7.4 7.9 6.6 7.1 6.2 6.8
EDGETEK™ 7600 SERIES
Copyright © 2021, Avient Corporation.
https://www.avient.com/sites/default/files/2020-10/auto-injector-application-study.pdf
Pigments and eye-catching special
effects
• Prompt, precise and custom color
matching
• Biocompatible functional additives
• FDA CFR 21, USP VI, ISO 10993-X,
and/or USP 661-X
• ISO 13485 facilities
Avient Corporation 5
4.
Requirements:
Skin contact colorant certified
for ISO 10993 biocompatibility
Solution:
OnColor™ HC Plus, MEVOPUR®
5.
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
应用:
VERSAFLEX™ CL与DYNAFLEX™
热塑性弹性体
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
USP VI级,ISO 10993,
食品接触
USP VI级,ISO 10993,
US食品接触
USP VI级,ISO 10993,
食品接触
USP VI级,ISO 10993
USP VI级,ISO 10993,
食品接触
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、
辐射灭菌
高压灭菌、环氧乙烷、
辐射灭菌
应用:
VERSALLOY™ HC与VERSAFLEX™ HC
热塑性弹性体
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
辐射灭菌
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
应用:
VERSAFLEX™ CL与DYNAFLEX™
热塑性弹性体
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/2020-07/tpes-for-healthcare-industry-bulletin.pdf
Versaflex™ & Versalloy™ Specialty Engineered Materials
Thermoplastic Elastomers for Healthcare Applications
Delivering specialized thermoplastic elastomer (TPE) solutions for demanding healthcare applications,
Avient has performance-grade materials that are approved for USP VI, ISO 10993-4 and 10993-5.
VERSAFLEX™
HC MEDICAL
TUBING SERIES
• Improve extrusion
rates, achieve high
service temperature
performance or
increase clarity
in medical tubing
• Meet
biopharmaceutical
needs for weldability
and minimize
extractables during
processing
VERSALLOY™
HC SERIES
• Obtain better flow in
long, thin paths and
lower shrink rates
versus typical TPVs
with our alloys, made
with Santoprene™
TPV
• Color easily and
obtain a smooth
tactile feel
VERSAFLEX™
HC GASKETS &
STOPPERS SERIES
• Achieve no coring,
good puncture and
resealability in static
stoppers
• Meet low COF
and low stiction
requirements in
dynamic seals
VERSAFLEX™
CL E SERIES
• Increase clarity and
flexibility in bags,
bottles and films
• Mitigate risk with
plasticizer-free
formulations for
film extrusion
• Deliver excellent
odor & O
2
barrier
performance for
film extrusion
INDUSTRY BULLETIN
TPE HEALTHCARE PRODUCT SELECTOR GUIDE
Versaflex™ HC MT Series
Versaflex™ HC MT222 Clear 66A 0.88 14 - 334 2.30 629 4.34 898 6.19 430 220 36 ✔ ✔
High clarity,
without plasticizers
Versaflex™ HC MT224 Clear 75A 0.89 19 - 468 3.23 773 5.33 1360 9.40 530 321 56 ✔ ✔
Versaflex™ HC MT226 Clear 84A 0.88 20 - 606 4.17 885 6.10 1600 11.00 600 433 76 ✔ ✔
Versaflex™ HC MT317 Clear 68A 0.89 17 69 450 3.10 660 4.55 870 6.00 470 221 39 ✔ ✔ Very high service temperature
Versaflex™ HC BT218 Natural 67A 0.89 19 69 381 2.60 683 4.70 1186 8.20 608 - - ✔ ✔ Weldable, kink resistant
Versaflex™ HC Gaskets & Stoppers Series
Versaflex™ HC 2110-35N Natural 34A 0.90 19 47 145 1.00 261 1.80 400 2.76 620 97 17 ✔ ✔ Good resealing
Versaflex™ HC 2110-43N Natural 43A 0.98 12 46 134 0.92 368 2.54 723 4.98 710 - - ✔ ✔ Good compression set
Versaflex™ HC 2110-57B Black 59A 1.01 20 37 369 2.54 558 3.85 537 3.70 350 147 26 ✔ ✔ Low stiction
Versaflex™ CL E Series
Versaflex™ CL E85 Clear 84A 0.90 20 72 752 5.18 1160 8.00 1550 10.70 450 433 76 ✔ ✔
High clarity, without
plasticizers; E95 also offers
excellent odor & O
2
barrier
Versaflex™ CL E90 Clear 90A 0.90 27 73 1000 6.89 1230 8.50 1830 12.60 57 - - ✔ ✔
Versaflex™ CL E95 Clear 95A 0.90 38 71 1680 11.60 1730 11.90 2500 17.20 580 720 126 ✔ ✔
Versaflex™ HC 3810 Series
Versaflex™ HC 3810-20N Natural 20A 0.88 16 54 123 0.80 185 1.30 342 2.40 650 - - ✔ -
Formulated without
animal derivatives,
excellent colorability,
translucent
Versaflex™ HC 3810-30N Natural 30A 0.89 18 58 170 1.20 245 1.70 459 3.20 680 - - ✔ -
Versaflex™ HC 3810-40N Natural 40A 0.88 19 59 191 1.30 275 1.90 506 3.50 670 - - ✔ -
Versaflex™ HC 3810-50N Natural 50A 0.89 21 61 264 1.80 366 2.50 699 4.80 690 - - ✔ -
Versaflex™ HC 3810-60N Natural 60A 0.88 24 65 459 3.20 594 4.10 790 5.40 510 - - ✔ -
Versaflex™ HC 3810-70N Natural 70A 0.88 28 67 535 3.70 684 4.70 1000 6.90 570 - - ✔ -
Versaflex™ HC 3810-80N Natural 80A 0.88 30 67 689 4.80 869 6.00 1390 9.60 620 - - ✔ -
Versaflex™ HC 3810-90N Natural 90A 0.88 27 89 1087 7.50 1350 9.30 1890 13.00 570 - - ✔ -
Versalloy™ HC 9210 Series
Versalloy™ HC 9210-45N Natural 45A 0.89 19 39 160 1.10 320 2.20 484 3.33 480 100 18 - ✔
Smooth surface
aesthetics
Versalloy™ HC 9210-55N Natural 53A 0.89 20 44 208 1.44 335 2.31 580 4.00 610 120 21 - ✔
Versalloy™ HC 9210-70N Natural 70A 0.89 23 53 356 2.45 510 3.52 780 5.38 590 180 32 - ✔
Versalloy™ HC 9220 Series
Versalloy™ HC 9220-70 Natural 70A 0.95 17 51 453 3.12 - - 643 4.43 265 208 36 ✔ ✔
ExtrudableVersalloy™ HC 9220-80 Natural 80A 0.94 18 59 553 3.67 777 5.36 945 6.52 415 208 36 ✔ ✔
Versalloy™ HC 9220-90 Natural 90A 0.94 25 55 1030 8.13 1350 9.33 1945 13.45 620 400 70 ✔ ✔
Standard Healthcare Grades
Versaflex™ G2705N Natural 60A 0.88 - - - - 528 3.64 670 4.62 470 - - ✔ ✔ Natural, high strength
Versaflex™ CL 2242 Clear 43A 0.89 23 - 152 1.05 294 2.02 731 5.00 780 124 22 ✔ ✔
High clarity, boilable
Versaflex™ CL 2250 Clear 50A 0.89 20 - 220 1.52 337 2.32 827 5.70 770 140 25 ✔ ✔
Versaflex™ OM Series
Versaflex™ OM 1040X Natural 42A 0.92 22 - 180 1.24 301 2.08 504 3.47 580 100 18 ✔ ✔ ABS/PC
overmoldVersaflex™ OM 3060 Clear 59A 0.90 33 - 420 2.90 360 2.48 500 3.45 480 180 32 ✔ ✔
Color Hardness Specific Gravity
Compression Set
@ 23°C
Compression Set
@ 100°C
100% Modulus 300% Modulus Tensile Strength Elongation Tear Strength
ISO
10993
USP VI
Special
Characteristics
ASTM Shore A ASTM/ISO ASTM % ASTM % ASTM psi Mpa ASTM psi Mpa ASTM psi ISO Mpa ASTM % ASTM pll ISO kN/m
GENERAL PROPERTIES TENSILE PROPERTIES OTHER
For further information on specific grades, review technical data sheets.
https://www.avient.com/sites/default/files/2024-05/Mevopur-Surgical Gown-Case study snapshot_0520.pdf
Medical textile manufacturer
LEARN MORE
MEDICAL TEXTILE
MANUFACTURER
S U R G I C A L D R A P E S & G O W N S
• Pre-tested for ISO 10993 biocompatibility standard
• Available in standard blue or other customized colors
• Compatible with ETO sterilization
• Suitable for use in non-woven SMS spunbond layer
• Offered standard blue and custom colors
such as green
• Pre-tested raw materials for biocompatibility
ISO10993 standard
• Manufactured under ISO 13485 certified
medical sites with change control in place
MevopurTM Healthcare Colorants and
Formulations
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-07/mevopur-pharma-packaging-1-page-case-study.pdf
PHARMACEUTICAL
PACKAGING OEM
V I A L S , B O T T L E S &
C O N T A I N E R S
• Raw materials pre-tested to USP 661.1 and ICHQ3D
guidelines
• Stabilization during molding and sterilization processes for
both opaque and transparent polymer materials
• Certified formulations available globally
• Offered pre-tested raw materials and
produced in an ISO 13485 certified site,
minimizing risk across the pharmaceutical
value chain
• Delivered specialized formulated solutions
to meet stringent pharmaceutical packaging
requirements
• Provided global formulations transferrable
from our three ISO 13485 certified facilities
Mevopur™ Healthcare Concentrates
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-09/mevopur-colors-and-additives-for-ivd-devices-application-bulletin-cn.pdf
主要特性
在三个通过ISO 13485认证的医疗生产线生
产全球统一的配方,提供全球一致性和供应
链保障
变更控制记录不限于CAS编号级别,降低变
更风险
•
•
不含动物源性物质和邻苯二甲酸盐
可用作各种聚合物的母粒或即用型配方
为方便起见,可在一个产品中实现功能性和颜
色的组合
•
•
•
法规支持
经过预测试的原材料:
- ISO 10993-1
- USP 第、章(VI类)
- USP (指南),6.2.3 可萃取元素;
USP
- ICHQ3D/USP 2 可萃取金属
- 欧洲药典 3.1 聚烯烃(如适用)
FDA发布的注册药品主文件(III类)和/或医疗
器械主文件
为符合(新)法规(如IVDR)的批准或过渡提
供文档支持
•
•
•
适用医疗保健使用限制—见下文。
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途:
(a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或
(b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械;或者
(c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。
https://www.avient.com/sites/default/files/2024-08/Avient-2023-Sustainability-Report_5.pdf
Avient has 102 global manufacturing facilities. 96% of these sites are certified through independent third
parties to management system standards including ISO:14001, ISO:50001, ISO:22000, ISO:45001, ISO:9001, and
Responsible Care®.
This methodology was developed in accordance with ISO 14067:2018 for product carbon
footprint and is aligned with ISO 14040/140440 for life cycle analysis.
Additionally, Avient’s self-assessments, based on ISO 9001/IATF 16949, are requested of suppliers in order to provide insight into the
core components of their Quality Management Systems (QMS) and subsequently used as approval criteria for Avient’s most sensitive end applications.