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/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。
https://www.avient.com/sites/default/files/2021-12/Chemically Resistant Materials Whitepaper.pdf
MATERIAL BRIEF DESCRIPTION
FR PC/ABS Flame retardant, chemical resistance, high ESCR
FR PC/PET Flame retardant, impact modified, chemical resistant
FR PC/PBT Skin-contact biocompatible, flame retardant, high chemical resistance
FR Copolyester
Flame retardant, chemical resistant, may incorporate agency-rated materials
to meet USP Class VI or ISO 10993 requirements
Trilliant™ HC8910 Unfilled PK blend, BPA-free, high chemical resistance, may incorporate
agency-rated materials to meet USP Class VI or ISO 10993 requirements
Trilliant™ HC8920 FR
Non-halogenated flame retardant PK blend, BPA-free, high chemical resistance, may
incorporate agency rated materials to meet USP Class VI or ISO 10993 requirements
Edgetek™ ET8900 CR Unfilled PK blend, high chemical resistance
Edgetek™ ET8900 HI CR High impact PK blend, high chemical resistance
Edgetek™ ET8920 FR CR Non-halogenated flame retardant PK blend, high chemical resistance
Table 2.
https://www.avient.com/sites/default/files/2022-02/MEVOPUR Bio-based Solutions Application Bulletin_JP.pdf
規制対応
•
•
•
評価試験:
- ISO 10993-1
- USP および (Class VI)
- 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ
レフィン系包装材)
- USP (ポリエチレン)
- ICH Q3Dに準拠した元素不純物分析
DMF(Type III)および Device Master File 登
録済み
米国FDAおよびEUの食品接触規格
ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。
a) 米国食品医薬品局(FDA)または国際標準化機構(ISO)により「インプラント」機器として分類される医療機器、または米国薬局方(USP)または ISO 規格で定義される「パーマネント」
機器、または
(b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または
(c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。
https://www.avient.com/sites/default/files/2022-03/MEVOPUR Chemical Foaming Agents Application Bulletin_JP.pdf
主な特徴
•
•
•
•
•
•
ISO 13485の管理基準化で製造。
規制対応
•
•
•
評価試験*:
- ISO 10993-1
- USP および (Class VI)
- 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ
レフィン系包装材料)
- USP (ポリエチレン)
- ICH Q3Dに準拠した元素不純物分析
DMF(Type III)および Device Master File 登
録済み
米国FDAおよびEUの食品接触規格
軽量化
ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。
a) 米国食品医薬品局(FDA)または国際標準化機構(ISO)により「インプラント」機器として分類される医療機器、または米国薬局方(USP)または ISO 規格で定義される「パーマネント」
機器、または
(b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または
(c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。
https://www.avient.com/sites/default/files/2024-02/Gravi-Tech REC Recycled Formulations Product Bulletin.pdf
KEY CHARACTERISTICS
• Customized density offering a wide range of
specific gravities (1.2–11 gm/cm3)
• Based on recycled resin from PIR and PCR
sources
• Broad modulus range, from very flexible to very
rigid grades
• Corrosion resistance that withstands oxidization
for long-term use and benefit
• Chemical resistance can be adapted depending
on base resin as required
• Provides visual surface effects, aesthetics, and
cool touch
• Design flexibility and processing ease
MARKETS AND APPLICATIONS
Applications in packaging and consumer goods in
which a more sustainable solution is preferred:
• Cosmetic caps and closures
• Perfume caps
• Spirit bottle caps
• Luxury boxes
• Handles and knobs
SUSTAINABILITY BENEFITS
• Formulated with recycled resin from
post-industrial recycled (PIR) and/or
post-consumer recycled (PCR) sources including
ocean bound plastic waste
• Reduces waste and supports the circular
economy
• Reduces carbon footprint compared to fossil
feedstock alternatives
• Simplifies manufacturing and lowers costs
versus metal
PRODUCT BULLETIN
CHARACTERISTICS UNITS
Gravi-Tech REC-CI
GT5200-5089 PT
Natural
Gravi-Tech REC
GT5200-5075
Black X2
Gravi-Tech REC
GT5200-5078
Black
Gravi-Tech REC
GT5200-5079
Black
Gravi-Tech REC
GT5200-5060
Black
Gravi-Tech REC
GT5200-5057
Black
Base Resin
Ocean Bound
rPP
rPP rPP rPP rPP rPP
Recycled Content/Filler g/cm >98% PIR+PCR 60% PIR/Mineral
>95%
PIR/Mineral
>95%
PIR+PCR/Mineral
30% PIR/Mineral 30% PIR/Mineral
Density (ISO 1183) g/ccm 1.2 1.2 1.2 1.2 1.9 2.0
CHARACTERISTICS UNITS
Gravi-Tech REC
GT7300-5034 X2 FD
Natural
Gravi-Tech REC
GT7300-5036
Black
Gravi-Tech REC
GT7300-5025
Black
Gravi-Tech REC
GT6000-5032
Black
Gravi-Tech REC
GT6000-5031
Black
Base Resin ABS rABS/ABS rABS rPA6 rPA6
Recycled Content/Filler g/cm 50% PIR/Mineral 65% PIR/Mineral 10% PIR/Mineral 20% PIR/Mineral 20% PIR/Mineral
Density (ISO 1183) g/ccm 1.5 1.5 2.2 2.7 2.8
AVAILABLE GRADES
Copyright © 2024, Avient Corporation.
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.