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/2024-12/ISO 9001_Chinese_Changzhou.pdf
质量管理体系认证认证
证书编号:04624Q15809R1S
兹证明:
法博莱恩纱线(常州)有限公司
统一社会信用代码:91320412MA1NMF5W4P
质量管理体系符合:
GB/T 19001-2016 / ISO 9001:2015 标准
证书覆盖范围:
纺织品(纱线)、玻璃制品(纱线)的包覆加工
注册地址/实际地理地址:江苏省常州西太湖科技产业园兰香路 8 号研发车间
5 厂房
颁证日期:2024-10-26
有效期至:2027-10-25
初次颁证日期:2021-10-28
证书编号
受审核方
组织机构代码
认证范围
注册地址
生产办公地址
注册日期
有效期至
初次颁证日期
二维码
https://www.avient.com/content/name-change-details
Sucursal en España
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.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations for Needle Hubs Application Bulletin.pdf
Mevopur™ Healthcare Colorants and Formulations
for Needle and Catheter Hubs
APPLICATION BULLETIN
* FDA/EU compliance information available upon request
To help our customers meet healthcare industry
standards, Avient offers a range of standard colors
for needle hubs, canula hubs and wings matching
the color coding of the ISO 6009 standard.
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
• Color can be combined with additives to
enhance performance and protection
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 Device Master File
• Food contact established with FDA/EU*
NOMINAL
OUTSIDE
DIAMETER OF
NEEDLE (MM)
COLOR
DESCRIPTION RAL PANTONE TRANSPARENT
PRODUCT CODE
OPAQUE
PRODUCT
CODE
0.4 Medium Grey 7035 423 C PP7M665125 PP7M665127
0.45 Brown 8017 7588 C PP8M665294 PP8M665296
0.5 Orange 2003 173 C PP2M665298 PP2M665300
0.55 Medium Purple 4005 7676 C PP4M665290 PP4M665292
0.6 Deep Blue 5010 288 C PP5M665894 PP5M665896
0.7 Black 9005 Black C PP9M664950 PP9M664952
0.8 Deep Green 6001 7483 C PP6M665687 PP6M665689
0.9 Yellow 1021 115 C PP1M665211 PP1M665213
1.1 Cream 1015 7401 C PP0M665290 PP0M665292
1.2 Pink 3015 502 C PE3M665725 PP3M665727
Healthcare use limitations apply—see below.
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/resources/safety-data-sheets?page=5092
Geon(TM) DB4842B ISO STABLE HI VISC
155-191-119-1 FIBERLOC 81530
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/resources/safety-data-sheets?page=4228
ISO PURPLE TPU
UV FL YELLOW 1
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/sites/default/files/2022-07/Avient 2021 Sustainability Report 7-26-22.pdf
Kutno, Poland 1.
Sustainability Report | 2021 58
Product Excellence
Avient subscribes to several ISO Management Systems to ensure continual improvement.
Strategic Partnerships and Alliances
Our Environmental Partners
Sustainability Report | 2021 61
https://endplasticwaste.org/en/news?