https://www.avient.com/sites/default/files/2023-12/Certificado ISO 9001 Avient Brasil-UPdated.pdf
Francisco Nakasato, 1700
Bairro São Roque das Chaves
Itupeva, SP 13295-000
Brasil
ISO 9001:2015
O Sistema de Gestão da Qualidade é aplicável a:
Certificado No: 49862
Data de Expiração Anterior: 09 Abril 2020
Data de Aprovação Original: 16 Abril 2014
Data de Certificação: 13 Abril 2020
Data Efetiva: 06 Abril 2023
Data de Expiração: 09 Abril 2026
Data de Emissão: 06 Abril 2023 Dominic Townsend, Presidente
DEVELOPMENT, PRODUCTION, SALES AND TECHNICAL ASSISTANCE OF LIQUID COLORANTS, COLORS
CONCENTRATES AND ADDITIVES FOR THE PLASTICS, FIBERS AND RUBBER MARKET IN GENERAL
DESENVOLVIMENTO, PRODUÇÃO, VENDAS E ASSISTÊNCIA TÉCNICA DE COLORANTES LÍQUIDOS,
CONCENTRADOS DE CORES E ADITIVOS PARA O MERCADO DE PLÁSTICOS, FIBRAS E BORRACHAS EM GERAL.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives_Laser Welding Additives for 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
• Available as additive concentrates, ready-to-use
additive formulations or ready-to-use additive/
colorant formulations for 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
* FDA/EU compliance information available upon request; exceptions may occur
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-10/Stat-Tech TPE Static Dissipative _ Electrically Conductive Thermoplastic Elastomers Product Overview_A4.pdf
These include:
• Industrial – Conveyor belts (food production
and pharmaceutical industries) and controls
(joy sticks, machinery handles and knobs,
corrugated bellows, tool grips)
• Electrical and electronic devices – Seals and
gaskets, radars and sensors
• ADAS components – Camera systems,
navigation systems, vehicle control systems,
infotainment systems
PRODUCT OVERVIEW
STAT-TECH SOLUTIONS
KEY TECHNICAL PROPERTIES
Material
Description
Base
Resin Color Hardness
Range
Surface
Resistivity (Ω)
Key
Characteristics
ST0100-5003 ESD FD White
VN8904 GP0F025721 TPU White 85 ShA 108 to 109 High elongation, static conductive,
FDA compliance
ST0100-5006 ESD X2 Natural TPU Natural 85 ShA 107 to 109 High elongation, static conductive
ST0200-5001 ESD Natural X1 TPE Natural 40 ShD 107 to 109 High elongation, permanent anti-static,
static conductive
SST0200-5004 ESD Black TPE Black 40 ShA 103 to 105 Electrically conductive,
static dissipative, lower hardness
ST0200-5002 EC ES Black TPE Black 60 ShA 100 to 102 Electrically conductive, high elongation
ST0200-5009 EC Black TPE Black 60 ShA 100 to 102 Electrically conductive, high elongation
Property Unit
Standard
Test
Methods
ST0100-5003
ESD FD White
VN8904
GP0F02571
ST0100-
5006
ESD X2
Natural
5001 ESD
Natural X1
5004 ESD
Black
5002 EC
ES Black
5009 EC
Black
Base Resin TPU TPU TPE TPE TPE TPE
Physical Properties
Hardness Shore ISO 48-4 85A 85A 50D 40A 60 A 60A
Density ISO 1183 1.19 1.15 1 1.01 0.965 1.21
Mechanical Properties
Tensile Strength (Break) Mpa DIN 53404 10 15 15 4 5.7 2.5
Elongation, Break % DIN 53504 600 650 500 300 400 250
Electrical Properties
Surface Resistivity Ω IEC 60093 108 to 109 107 to 109 107 to 109 103 to 105 100 to 102 100 to 102
Volume Resistivity Ω.cm IEC 60093 108 to 109 107 to 109 107 to 109 103 to 105 100 to 102 100 to 102
Color White Natural Natural Black Black Black
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2020-08/gravi-tech-closures-case-study-spanish.pdf
De
hecho, un informe llamado “El empaque importa”
(Packaging Matters™) realizado en 2015 por la compañía
MeadWestvaco, indica que más del 25% de los
consumidores de bebidas alcohólicas dicen que el
empaque es “muy” o “extremadamente” impactante en
su decisión de compra de un producto.
El cambio de moldeado de metal a moldeado por
inyección también permitiría el ahorro en el costo de
procesamiento y un aumento en la libertad
de diseño.
EL IMPACTO
El equipo del productor de empaques cambió al material
Gravi-Tech y registró inmediatamente un ahorro en
costos de 35% debido a costos menores en el material
y procesamiento.
https://www.avient.com/sites/default/files/2020-07/gls-tpe-bayer-cap-spanish.pdf
GLS TPE - Bayer Cap - Spanish
BAYER®
T A P A S O B R E - M O L D E A D A
C O N E L A S T Ó M E R O
T E R M O P L Á S T I C O ( T P E )
• Fácil de sujetar y abrir
• Requerimientos de diseño:
• Logotipo en relieve
• Color específico de la marca
• Optimiza el espacio en los estantes y reduce el embalaje
• Funcionalidad de embalaje mejorada,
tanto para el usuario (diseño ergonómico)
como en el estante (mejor apilamiento y
menos embalaje)
• Se ofreció una formulación de valor
agregado que permitió al cliente ampliar la
diferenciación de la marca en el mercado
Elastómero termoplástico GLS™
REQUERIMIENTOS CLAVE
¿POR QUÉ AVIENT?
https://www.avient.com/sites/default/files/2022-09/ColorMatrix Lactra SX Product Bulletin_Spanish.pdf
Lactra
SX permite bloquear la luz en botellas PET de una
sola capa y ofrece la ventaja adicional de la libertad
de diseño.
La oxidación inducida por la luz produce reacciones
de degradación en los productos lácteos y una
disminución en la calidad nutricional.
Tradicionalmente, los productos lácteos líquidos
UHT se envasaban en cajas de cartón laminado,
bolsas o en botellas de polietileno de alta densidad
(HDPE) y polietileno tereftalato (PET) multicapa.
https://www.avient.com/sites/default/files/2020-09/versaflex-pf-technical-bulletin-sept-2020.pdf
TECHNICAL BULLETIN
VERSAFLEX™ PF
Tack Layer for
Surface Protective Films
Properties Versaflex PF
MD6727
Versaflex PF
MD6741
Versaflex PF
MD6649
Versaflex PF
9512
Versaflex PF
MD6666
Versaflex PF
MD6748
Versaflex PF
MD6700
Features Low Tack Low Tack; Used for tailoring tack
with MD6700 Low-Medium Tack Value Offering Medium Tack
Low Gel/Residuals Low Tack Build High Tack
Peel Strength Low Low-Medium Medium Medium-High Medium-High High High
Applications Optical Films Home Appliances Plastics Construction/Bare Metals Finished Metals Steel/Painted Metals Bare Metals
MFR @ 190°C/2.16 kg -- 4.5 17 5.4 21 4.8 6.5
MFR @ 230°C/2.16 kg 10 20 -- -- -- -- --
Specific Gravity, g/cc 0.92 0.91 0.92 0.92 0.94 0.94 0.94
Hardness, Shore A 50 49 37 38 37 31 30
G' @ 23°C, Pa 28.0 x 105 10.4 x 106 8.3 x 105 -- 9.9 x 105 11.8 x 105 10.0 x 105
DMA Tg, °C -29 -30 -9 10 11 15 21
LDPE/Versaflex PF Film1 180° Peel, N/25mm
Stainless Steel
after 20 min @ 25°C 0.5 2.2 3.2 6.1 6.7 8.5 8.6
after 7 days @ 25°C 0.6 2.7 4.3 5.5 8.2 8.3 10.3
PMMA2
after 20 min @ 25°C 1.1 1.7 3.8 4.9 6.9 8.3 8.8
after 20 min @ 75°C 2.8 4.1 5.1 6.9 9.0 10.7 11.8
after 7 days @ 75°C 4.0 4.4 5.9 9.8 8.4 9.8 10.3
Polycarbonate3
after 20 min @ 25°C 1.4 2.2 3.8 6.8 6.3 8.4 7.0
after 20 min @ 75°C 3.4 4.8 6.7 8.8 8.8 10.0 11.8
after 7 days @ 75°C 4.6 6.5 7.5 10.6 11.6 10.6 13.8
1 Film thickness: 51 micron LDPE/25 micron Versaflex PF
2 Arkema Plexiglas™ V052-100 (Plexiglas is a trademark of Arkema France Corp.)
3 Sabic Lexan™ L52-111 (Lexan is a trademark of Sabic Innovative Plastics)
PHYSICAL PROPERTIES OF SELECTED VERSAFLEX PF TACK LAYER FORMULATIONS
PRODUCT DESCRIPTION
Versaflex™ PF formulations are specially
developed for the manufacture of co-extruded
surface protective films that apply easily, maintain
tack with minimal build, peel smoothly and
remove completely with little-to-no residue or
ghosting.
BENEFITS OF VERSAFLEX PF FOR
SURFACE PROTECTIVE FILMS:
• Customizable tack
• Single-step manufacturing process (co-
extrusion)
• Low volatile organic compound (VOC)
emissions during manufacturing
• Eliminates secondary coating and drying
operations
• Eliminates hazardous liquid chemicals
compared to solvent systems
• Reduces converting costs versus coating
• Reduces energy consumption
MARKETS AND APPLICATIONS
Versaflex PF formulations, customizable
based on desired level of tack, are co-extruded
with protective films to provide just the right
amount of protection during the fabrication,
assembly, shipment, storage and installation of
finished goods in many industries and end-use
applications including:
• Optical films and display panels for consumer
electronics
• Home appliances
• Construction and building materials
• Furniture and cabinetry
• Automotive and other transportation
100/0 90/10 80/20 70/30 60/40 40/60 30/70 20/80 10/90 0/100
0.9
1.1
2.0
2.4
2.8
3.7
3.8
4.9
0
1
2
3
4
5
6
7
8
6.5
1.6
MD6727
MD6748
MD6700
MD6666
9512
MD6649
MD6741
0
2
4
6
8
10
12
% of MD6741/MD6700
Degree of tack can be customized for substrate surfaces.
TAILORING TACK BY BLENDING VERSAFLEX PF
Film Thickness:
39 micron LDPE/13 micron Versaflex PF
F = Final tack after 7 days @ 25° C i = Initial tack after 20 mins @ 25° C
Pe
S
tr
en
gt
h
on
S
te
, N
/2
5m
m
Pe
S
tr
en
gt
h
on
S
te
, N
/2
5m
m
PEEL STRENGTH ON STAINLESS STEEL
Film Thickness:
51 micron LDPE/25 micron Versaflex PF
www.avient.com
Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2022-08/MEVOPUR Special Effect Colors Application Bulletin_CN.pdf
主要特性
在三个经ISO 13485认证的生产设施生产,在
全球范围内提供质量稳定一致的产品,并增加
供应稳定性
变更控制记录的级别高于CAS编号级别,降低
变更风险
不含动物源性物质和邻苯二甲酸盐
可用作预着色配方或母粒,用于不同的聚合物
注册药品管理档案(III类)和/或医疗器械主
文件
食品接触符合FDA/EU**要求
法规支持
原材料根据以下标准检测:
- ISO 10993-1和美国药典 生物学
评估
- 欧洲药典3.1.3/3.1.5(聚烯烃)
- 美国药典(聚乙烯)
- ICH Q3D 杂质元素
* 设计备注:选择效果颜色时需要仔细考虑零件设计和聚合物流动路径,
从而尽可能减少可见流线。
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。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用:
(1) 接触人体组织或体液长达30天或更长时间;
(2)“整形”(整容或重建)手术;
(3) 生殖植入物或任何节育器械;或者
(4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
https://www.avient.com/sites/default/files/2022-10/5_PolyOne GMP Certificate%5B97%5D.pdf
For and on behalf of BSI
Theuns Kotze, Managing Director – IMETA Assurance
Last Assessment Date: 2022/06/25
Latest issue Date: 2022/08/24
Expiry Date: 2023/08/17
BSI Group India Private Limited T: +91 11 2692 9000
(CIN U74899DL1999PTC101381 info.in@bsigroup.com
The Mira Corporate Suites bsigroup.com/en-IN
Plot 1&2, Ishwar Nagar,
Mathura Road New Delhi-110065, India
Good Manufacturing Practices
mailto:info.in@bsigroup.com
https://www.avient.com/sites/default/files/2023-01/Mevopur Standard Colors Product Bulletin _ Color Card.pdf
KEY CHARACTERISTICS
• Globally harmonized formulations are
manufactured at four ISO 13485 certified
medical sites, providing global consistency
and increased security of supply
• Documented change control available
• A range of standard colors eliminates color
matching to expedite development time
• The portfolio includes compliant colors for
use in:
- Needle hub applications: ISO 6009
- Ophthalmic container closures
(American Academy of Ophthalmology)
REGULATORY SUPPORT
• A library of pre-tested raw materials including:
- 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*
HEALTHCARE APPLICATIONS
• Medical devices such as catheters, surgical and
dental instruments, and drug delivery devices
• Pharmaceutical packaging including vials
and bottles
• Diagnostics for blood analysis or In Vitro
Diagnostics (IVD)
PRODUCT BULLETIN & COLOR CARD
* FDA/EU compliance information available upon request; exceptions may occur
Color Pantone
Reference PE Base PP Base Transparent
PP Base PEBA Base PC Base Transparent
PC Base* ABS Base*
White — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206
Yellow 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958
Orange 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939
Red 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037
Pink 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039
Violet 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978
Light Blue 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402
Mid Blue 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404
Dark Blue 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406
Light Green 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070
Bluish Green 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068
Medium Green 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072
Dark Gray 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297
Mid Gray Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295
Beige 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871
Brown 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869
Black Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896
Colors may vary from actual color shown.