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/2022-03/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/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/products/polymer-colorants/healthcare-colorants
Based on polysulfone resins and tested to ISO 10993, this line of opaque and transparent colorants is specifically formulated to achieve high heat resistance in healthcare applications.
Formulated with raw materials tested to ISO, USP, EP, and ICH Q3D protocols, the portfolio includes standard color ranges to speed up time to market and custom color solutions tailored to customer requirements.
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.
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.