https://www.avient.com/sites/default/files/2021-08/versaflex-machine-cover-case-study-one-pager.pdf
RESPIRATORY
DEVICE
MANUFACTURER
C P A P M A C H I N E C O V E R
• Good aesthetics with high COF for grip functionality
• Chemically bondable to FR PC/ABS down to 1mm
• NCS S 9000-N color suitable for UV laser marking to white
• Good scratch and mar resistance
• Good chemical resistance to detergents, alcohols and bleach
• Pass VOCs & out-gassing in accordance to ISO 18562-3/2:2017
• Customized formulation to balance mar
resistance, flow, and laser marking
whiteness and clarity
• Collaborated on tooling improvements to
widen processing window and increase
yield rate
• Provided application development and on-
site technical support to manage short
shot, sink marks, burn marks and air trap
Customized VersaflexTM TPEs
WHY AVIENT?
https://www.avient.com/sites/default/files/2022-07/Avient 2021 Sustainability Report 7-26-22.pdf
Sustainability Report | 2021 58
Product Excellence
Avient subscribes to several ISO Management Systems to ensure continual improvement.
Combined, Avient facilities have a
total of 286 management system certifications.
In 2021, we partnered with Carbon Minds to standardize our approach to PCF, which is
certified for ISO 14040/140440 compliance by TÜV Rheinland*.
https://www.avient.com/sites/default/files/2021-09/avient2020sustainabilityreport-9-2-21.pdf
Where it makes sense, we have gone beyond
basic legal requirements, such as Responsible Care certification and implementation of the Product Safety Code.
Through this data, we create safety data sheets,
customer certification statements for appropriate use and product safety improvements.
Combined,
these facilities have a total of 205 certifications to an ISO or Management System and
standards.
https://www.avient.com/sites/default/files/2021-01/amendment-to-articles-commercial-registration-avient-corporation.pdf
Brown:
Please be advised that the office of the Secretary of State has reviewed your pre-
clearance request for the Certificate of Amendment for PolyOne Corporation.
If you wish to expedite the amendment certificate
the fees are listed.
NOW, THEREFORE, BE IT RESOLVED, that, effective as of the time and date that
the applicable certificate is accepted for filing by the Ohio Secretary of State (the
“Effective Time”), the name of the Company shall be changed from “PolyOne
Corporation” to “Avient Corporation.”
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Bio-based Polymer Solutions Application Bulletin.pdf
KEY CHARACTERISTICS
• Available for polyethylene, polypropylene, ABS,
polycarbonate and styrenics
• Bio-content of resin carrier varies from 70% to
100% depending on polymer—calculated to
ASTM D6866 standard
• Manufactured at four ISO 13485 certified sites,
providing global consistency and security of
supply
• Documented change control beyond CAS
number, reducing risk of change
• Drop-in solutions that can be processed like
fossil-based grades on common injection
molding and extrusion machines
• Can be provided as ready-to-use pre-colored
or additive formulation
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 US FDA and
APPLICATION BULLETIN
Sustainability Spotlight
Bio-polymers
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
REGULATORY SUPPORT
• Drug delivery devices
• Pharmaceutical packaging
• Medical equipment
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number level, reducing the risk of change
• Allows crystallization in semi-crystalline
polymers to begin faster and complete earlier
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
* FDA/EU compliance information available upon request
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-05/Mevopur Healthcare Colorants and Formulations Amber for Pharma Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number level, reducing risk of change
• Non-phthalate and formulated without
animal-derived substances
• Different tones of amber available on request
—more or less red or yellow and/or lighter
or darker
• Also available in liquid form
REGULATORY SUPPORT
• Pre-tested raw materials:
- ISO 10993-1 and USP parts
(Class VI)
- European Pharmacopeia, monograph
3.1.15, USP and elemental analysis
as per ICH Q3D
- USP criteria appearance of solution,
color
• Registered Drug Master File (Type III) by
the FDA
• Food contact compliance established with
FDA/EU*
• YBB00102002-2015 (oral liquid pharmaceutical
PET bottles) compliance support
APPLICATION BULLETIN
* FDA/EU compliance
information available
upon request
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2022-12/reSound Ultra Low Carbon Footprint TPE Product Bulletin_0.pdf
Calculated using the ISO 14067:2018 standard,
the greenhouse gas (GHG) emissions are lowered
by carbon sequestration and Avient’s green
manufacturing practices.
Calculated according to ISO 14067:2018
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/2022-07/Mevopur Standard Colors Product Bulletin-CN.pdf
Mevopur Standard Colors Product Bulletin-CN3.26-1
MEVOPUR™ 着色剂
医疗应用的标准颜色
关键特性
监管支持
预先测试的原材料库,包括:
- ISO 10993
- USP , (class VI)
- USP
- ICHQ3D 可提取金属
- EuPh
向FDA提交的DMF / MAF文档适用于所有标
准颜色
医疗应用
医疗设备,例如导管,手术和牙科器械或药
物输送设备
药物包装,包括药瓶或瓶子
血液分析诊断或体外诊断(IVD)
产品公告 & 色卡
MEVOPUR 着色剂解决方案组合专为当今日益复
杂的医疗保健应用而设计。
™
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。