https://www.avient.com/news/avient-announces-industry-first-carbon-negative-and-carbon-neutral-thermoplastic-elastomers
Avient follows the ISO 14067:2018 standard to calculate PCF values and utilizes global formulation expertise, green manufacturing processes, and sourcing & logistics competence to achieve such low or negative values.
https://www.avient.com/sites/default/files/2022-07/REMAFIN EP White Masterbatches for Pharma Application Bulletin_CN.pdf
主要特性
生产符合高于CAS编号级别的变更控制原则
(与MEVOPUR母粒类似),降低变更风险
不含动物源性物质和邻苯二甲酸盐
适用于吹膜、注塑、吹塑和挤出
注册药品主文件(III型)
食品接触符合FDA/EU*要求
法规支持
原材料根据以下法规测试:
- ISO 10993-1
- USP第、章,包括VI级别,符合眼
科和鼻腔用药物要求
- 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
- USP和USP,透光率
载体材料 耐光性 热稳定性 产品代码颜料含量/类型
HDPE 50% TiO2
8 300°C PH00075525
LLDPE 60% TiO2
8 300°C PL00075542
LLDPE 70% TiO2
8 300°C PL00075545
PP 50% TiO2
8 300°C PP00075717
适用医疗保健使用限制—见下文。
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/2021-09/mevopur-colors-and-additives-for-ivd-devices-application-bulletin-cn.pdf
主要特性
在三个通过ISO 13485认证的医疗生产线生
产全球统一的配方,提供全球一致性和供应
链保障
变更控制记录不限于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
可用作各种聚合物的母粒或即用型配方
为方便起见,可在一个产品中实现功能性和颜
色的组合
法规支持
经过预测试的原材料:
- ISO 10993-1
- USP 第、章(VI类)
- USP (指南),6.2.3 可萃取元素;
USP
- ICHQ3D/USP 2 可萃取金属
- 欧洲药典 3.1 聚烯烃(如适用)
FDA发布的注册药品主文件(III类)和/或医疗
器械主文件
为符合(新)法规(如IVDR)的批准或过渡提
供文档支持
适用医疗保健使用限制—见下文。
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/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/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/2023-12/Jeddah Saudi Arabia ISO 45001.pdf
Limited
PO Box 2137, Jeddah 22758, Saudi Arabia
Has been assessed and found to meet the requirements of
ISO 45001:2018
This certificate is valid for the following scope of operations:
Production and Supply of Color and Additive Master Batches
Authorised by: Stan Wright
Director
Date of Certificate Issue: 30 December 2021
Certificate Valid Until: 29 December 2024
Recertification audit before 30 November 2024.
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/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/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?