https://www.avient.com/sites/default/files/2023-07/Versaflex HC _ Versaflex HC BIO - BT Series Product Overview.pdf
KEY CHARACTERISTICS
• Meets critical need for thermal weldability
and kink resistance
• Minimizes extractables during processing
• Provides excellent tensile strength
• Complies with USP VI and ISO 10993-4, -5, -11
certifications
• Suitable for gamma and autoclave
sterilization methods
• Bio-based grade option formulated with nearly
40% Gen 1 biomass content
PRODUCT OVERVIEW
1.844.4AVIENT
www.avient.com
Copyright © 2023, Avient Corporation.
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?rtype[]=1164
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?ind[]=21537
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?sust[]=1139
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
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.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Colorants and Formulations Special Effects Application Bulletin_0.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
• Available as pre-colored formulation or
concentrate and for use in different polymers
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
* Design note: Effect colors require careful consideration of part design and
polymer flow paths to minimize visible flow lines.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Medical Devices 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 reducing risk of change
• Non-phthalate and formulated without animal-
derived substances
• Available for use in a wide range of polymers
including polyolefins, styrenics, polycarbonate
and alloys, polyester, POM
• Functionality can be combined with colorants
into convenient combination concentrates and
ready-to-use formulations
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
FUNCTIONALITY TARGET APPLICATIONS
DRUG
DELIVERY
DEVICES
SYRINGES &
NEEDLES DIAGNOSTICS CATHETERS
Clarifying PP
Sorbitol-free for transparent
applications with reduced migration
and improved thermal stability
Lubricant—
permanent/
non-migrating
Fast acting reduction in friction
for wide variety of polymers such
as PP, ABS, POM, PC
Protection from
UV in transparent
applications for PP,
PE, PETG, COP
UV blocking in 290-450nm with
no impact on clarity; can be
combined with colors (e.g., amber)
Antistatic ready-to-
use solution for PP,
ABS, PC/ABS
Permanent/non-migrating;
fast decay time independent
of % relative humidity
Gamma/e-beam
sterilization
protection of the
polymer
Preserving the properties of
PP and COC/COP; reduction
in yellowing using Color
Compensation Technology (CCT)
Reduced material
consumption/cycle
time—nucleation
Fast acting new generation
nucleant for PE and PP; improved
thermal and mechanical properties
allows wall thinning; reduction of
tolerance/dimensional problems
between different colors
Laser marking
replacing ink
printing/labels
Solvent-free, high-speed
identification for Nd/YAG laser
for PE,PP, ABS, PC, POM
Antioxidants for
PE, PP, TPE
Thermal protection during
converting/downstream sterilization
Brand protection/
anticounterfeit Covert and non-covert systems
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Pharma Pkg 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, reducing risk of change
• Non-phthalate and formulated without animal-
derived substances
• Available for use in a wide range of polymers
including polyolefins, styrenics, polycarbonate
and alloys, polyester, POM
• Functionality can be combined with colorants
into convenient combination concentrates or
formulations
REGULATORY SUPPORT
• Pre-tested raw materials:
- 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
* FDA/EU compliance information available upon request
FUNCTIONALITY TARGET APPLICATIONS EBM/IBM
CONTAINERS CLOSURES FILM COMBINATION
DEVICES
Clarifying PP Sorbitol-free—possibilities in
packaging ocular solutions
Slip/torque reduction Slip for PE, PP films, processing aid,
torque reduction for closures
Protection from UV in
transparent packaging
for PP, PE, PETG, COP
UV blocking in 290–450nm with
no impact on clarity
Antistatic ready-to-use
solution for PE films e.g.
https://www.avient.com/sites/default/files/2022-12/Mevopur Laser Marking Additives Application Bulletin.pdf
KEY CHARACTERISTICS
• Designed for Nd:YAG lasers operating between
1060-1070 nm
• Available for different polymers including
PP, PE, PC, PBT, POM, ABS, MABS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Can be designed for dark marking on natural
or white/light colored background or light
marking on black/dark background
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.
https://www.avient.com/sites/default/files/2022-07/MEVOPUR Chemical Foaming Agents Application Bulletin_CN.pdf
主要特性
根据ISO 13485规定的程序生产
变更控制记录的级别高于CAS编号级别,降低
变更风险
可用于常规注塑机和挤出设备—由技术支持团
队提供设置支持
可用于聚烯烃、苯乙烯和共聚物
可与着色剂联用
注册药品管理档案(III类)和/或医疗器械主
文件
食品接触声明符合美国FDA和EU规范
法规支持
原材料根据以下法规测试:
- ISO 10993-1
- USP第、章(包含VI级)
- 欧洲药典,各论3.1.3/3.1.5章节(聚烯烃包
装材料)
- 美国药典(聚乙烯)
- 杂质元素符合ICH Q3D要求
轻量化
1.844.4AVIENT
www.avient.com
版权所有© 2022埃万特公司。
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。