https://www.avient.com/sites/default/files/2020-07/versaflex-bvm-resuscitator-bag.pdf
Versaflex - BVM Resuscitator Bag
B A G - VA LV E - M A S K ( B V M )
M A N U FA C T U R E R
R E S U S C I T A T O R B A G
• Compatible gamma sterilization process
• Achieve desired elastomeric properties
• PVC-free formulation
• FDA, ISO 10993, USP VI compliant
• Repeatable injection molding process
• Complemented customer expertise with
technical support in material selection, part &
tool design, and process development
• Customized TPE offered customer an
alternative to vinyl without sacrificing
performance
• Improved process efficiency and overall
system costs through injection molding method
Customized Versaflex™ TPE
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-02/custom-gls-tpe-touriquet-band-case-study-one-pager.pdf
G L O B A L E L A S T I C &
R U B B E R P R O D U C T
M A N U FA C T U R E R
T O U R N I Q U E T B A N D
• Hardness 45, shore A
• Thickness 0.5mm and Tensile set
https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-dynaflex-medical-face-mask.pdf
E U R O P E A N M E D I C A L
D E V I C E M A N U FA C T U R E R
F A C E M A S K V E N T I L A T I O N
V A L V E
• ISO 9001 and USP VI compliant
• Compatible with overmolding onto PP
• Translucent and highly colorable
• Soft touch
• Provided valuable regulatory support and
documentation, enabling faster internal trials and
material qualification for this customer
• Worked together with customer to select the best
material from a broad portfolio of medical TPE
grades
• Trusted as a polymer supplier for multiple
healthcare applications
Dynaflex™ G2711 Thermoplastic Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-08/versaflex-machine-cover-case-study-one-pager.pdf
RE S P IRATORY
DE VICE
MANUFACT URE R
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/2025-02/case study snapshot-Ostomy bag-G2705.pdf
PowerPoint Presentation
M E D I C A L D E V I C E
M A N U FA C T U R E R
O S T O M Y B A G S E A L S
• Comply with ISO 10993 and FDA Class II medical device
regulations
• Offer Good sealing performance
• Provide technical supports for processing
recommendations
• Deliver a high compression set materials to improve
comfort
• Provided a medical-grade TPE to help the
customer meet necessary regulatory
specifications and gain market share
• Provided technical support during design
and the manufacturing process for EVA
bonding
• Delivered soft-touch feel and excellent
sealing performance
Versaflex HC Thermoplastic Elastomers -
G2705 Formulation
KEY REQUIREMENTS
WHY AVIENT?
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。
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