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。
https://www.avient.com/sites/default/files/2021-09/mevopur-colors-for-needle-hubs-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
可将颜色与添加剂相结合,以增强产品性能
和防护性能
法规支持
经过预测试的原材料:
- 美国药典(USP)23,第87和88章(VI类)
萃取和生物学评价
- ISO 10993,第4、5、10、11和18部分,
萃取和生物学评价
- 美国药典和欧洲药典中针对USP 、
ICH Q3D可萃取金属和EP3.1聚烯烃的测试的
其他监管支持信息
FDA器械主文件
食品接触符合FDA/EU*要求
针头的标称外径
(mm) 颜色说明 RAL 潘通色号 透明产品代码 不透明产品代码
0.4 中灰色 7035 423 C PP7M665125 PP7M665127
0.45 褐色 8017 7588 C PP8M665294 PP8M665296
0.5 橘黄色 2003 173 C PP2M665298 PP2M665300
0.55 中紫色 4005 7676 C PP4M665290 PP4M665292
0.6 深蓝色 5010 288 C PP5M665894 PP5M665896
0.7 黑色 9005 黑色 C PP9M664950 PP9M664952
0.8 深绿色 6001 7483 C PP6M665687 PP6M665689
0.9 黄色 1021 115 C PP1M665211 PP1M665213
1.1 乳白色 1015 7401 C PP0M665290 PP0M665292
1.2 粉色 3015 502 C PE3M665725 PP3M665727
适用医疗保健使用限制—见下文。
https://www.avient.com/sites/default/files/2024-05/Responsible Care_14001 Global Cert_Avient_2024.pdf
Avient Corporation - Lomas de Zamora, Argentina
AV .
De Martorell, 124
Sant Andreu, Barcelona 8740
65536-116900Certificate No:
Page 42 of 53
ABS Quality Evaluations, Inc. 1701 City Plaza Drive, Spring, TX 77389, U.S.A.
Avient Corporation - Santa Clara, Mexico
Plásticos 28 int B102
Santa Clara Coatitla, Ecatepec de Morelos,
Estado de México 55540
México
65536-117323Certificate No:
Page 43 of 53
ABS Quality Evaluations, Inc. 1701 City Plaza Drive, Spring, TX 77389, U.S.A.
https://www.avient.com/sites/default/files/2022-01/Avient S.à r.l._extract CoC_2021.12.27.pdf
Corporate seat Luxemburg
Date of deed of incorporation 04-07-2018
Registered in Registre de Commerce et des sociétés
Luxemburg, Luxembourg
under number B226205
Company
Trade name Avient S.à r.l., Netherlands branch
Company start date 24-07-2018
Activities SBI-code: 46769 - Wholesale of other intermediary products
SBI-code: 46696 - Wholesale of packaging
SBI-code: 4941 - Freight transport by road (no removal services)
Employees 0
Establishment
Establishment number 000040405362
Trade name Avient S.à r.l., Netherlands branch
Visiting address Uranusweg 3, 8938AJ Leeuwarden
Date of incorporation 24-07-2018
Activities SBI-code: 46769 - Wholesale of other intermediary products
SBI-code: 46696 - Wholesale of packaging
SBI-code: 4941 - Freight transport by road (no removal services)
For further information on activities, see Dutch extract.
https://www.avient.com/resources/safety-data-sheets?page=4598
98885W1MX WILFLEX ONE FLUO BLUE
https://www.avient.com/sites/default/files/2023-11/Responsible Care_14001 Global Cert_Avient.pdf
Garibaldi 2405
Lomas de Zamora, Buenos Aires 1832
Argentina
Activity: Manufacture of Colour and Additive Concentrates, Thermoplastic
Resins and Specialty Compounds
Activity: Design and Manufacture of Colorants and Additives Concentrates
Facility: Avient Colorants SA
Parc Scientifique Fleming, Fond Jean Pâques 1
Louvain-La-Nueve, Walloon Brabant 1348
Belgium
Facility: Avient Corporation - Maipu, Chile
Camino a Melipilla 15.170
Maipu, Región Metropolitana de Santiago 9250000
Chile
Activity: Design and Manufacture of Colour and Additive Concentrates,
Activity: Design and Manufacture of Colorants and Additives Concentrates
Facility: Avient Corporation - Lahore, Pakistan
Plot no. 135, Kitaar, Bund Road
Off Multan Road, Thokar Niaz Baig.
De Martorell, 124
Sant Andreu, Barcelona 8740
Facility: Avient Corporation - Santa Clara, Mexico
Plásticos 28 int B102
Santa Clara Coatitla, Ecatepec de Morelos,
Estado de México 55540
México
Activity: Design and Manufacture of Colour and Additive Concentrates,
Activity: Design and Manufacture of Colorants and Additives for Plastics
Facility: Avient Corporation - Shanghai (Xinzhuang), China
No. 88, Lane 4377 Jindu Road
Minhang District
Shanghai 201108
Facility: Avient Corporation - Shenzhen, China
No. 1, Qihang Industry Park, Haoxiang Road
Shajing Town, Baoan
Shenzhen, Guangdong Province 518104
Facility: Avient Corporation - Rania, India
Survey No.344/1-2-3
Rania Works, Sakarda Bhadarwa Road
Rania, Gujarat 391780
Facility: Avient Corporation - Riyadh, Saudi Arabia
2nd Industrial City, Al-Kharj Road
P.O.
Toluca 2000
Toluca, Estado de México 50233
México
Facility: Avient Corporation - Vashere, India
Renaissance Industrial & Warehousing Complex
Unit No.
https://www.avient.com/sites/default/files/2023-11/ISO14001 Global Cert_Avient.pdf
Garibaldi 2405
Lomas de Zamora, Buenos Aires 1832
Argentina
Activity: Manufacture of Colour and Additive Concentrates, Thermoplastic
Resins and Specialty Compounds
Activity: Design and Manufacture of Colorants and Additives Concentrates
Facility: Avient Colorants SA
Parc Scientifique Fleming, Fond Jean Pâques 1
Louvain-La-Nueve, Walloon Brabant 1348
Belgium
Facility: Avient Corporation - Maipu, Chile
Camino a Melipilla 15.170
Maipu, Región Metropolitana de Santiago 9250000
Chile
Activity: Design and Manufacture of Colour and Additive Concentrates,
Activity: Design and Manufacture of Colorants and Additives Concentrates
Facility: Avient Corporation - Lahore, Pakistan
Plot no. 135, Kitaar, Bund Road
Off Multan Road, Thokar Niaz Baig.
De Martorell, 124
Sant Andreu, Barcelona 8740
Facility: Avient Corporation - Santa Clara, Mexico
Plásticos 28 int B102
Santa Clara Coatitla, Ecatepec de Morelos,
Estado de México 55540
México
Activity: Design and Manufacture of Colour and Additive Concentrates,
Activity: Design and Manufacture of Colorants and Additives for Plastics
Facility: Avient Corporation - Shanghai (Xinzhuang), China
No. 88, Lane 4377 Jindu Road
Minhang District
Shanghai 201108
Facility: Avient Corporation - Shenzhen, China
No. 1, Qihang Industry Park, Haoxiang Road
Shajing Town, Baoan
Shenzhen, Guangdong Province 518104
Facility: Avient Corporation - Rania, India
Survey No.344/1-2-3
Rania Works, Sakarda Bhadarwa Road
Rania, Gujarat 391780
Facility: Avient Corporation - Riyadh, Saudi Arabia
2nd Industrial City, Al-Kharj Road
P.O.
Toluca 2000
Toluca, Estado de México 50233
México
Facility: Avient Corporation - Vashere, India
Renaissance Industrial & Warehousing Complex
Unit No.
https://www.avient.com/sites/default/files/2024-05/ISO14001 Global Cert_Avient_2024.pdf
Garibaldi 2405
Lomas de Zamora, Buenos Aires 1832
Argentina
Activity: Manufacture of Colour and Additive Concentrates, Thermoplastic
Resins and Specialty Compounds
Activity: Design and Manufacture of Colorants and Additives Concentrates
Facility: Avient Colorants SA
Parc Scientifique Fleming, Fond Jean Pâques 1
Louvain-La-Nueve, Walloon Brabant 1348
Belgium
Facility: Avient Corporation - Maipu, Chile
Camino a Melipilla 15.170
Maipu, Región Metropolitana de Santiago 9250000
Chile
Activity: Design and Manufacture of Colour and Additive Concentrates,
Activity: Design and Manufacture of Colorants and Additives Concentrates
Facility: Avient Corporation - Lahore, Pakistan
Plot no. 135, Kitaar, Bund Road
Off Multan Road, Thokar Niaz Baig.
De Martorell, 124
Sant Andreu, Barcelona 8740
Facility: Avient Corporation - Santa Clara, Mexico
Plásticos 28 int B102
Santa Clara Coatitla, Ecatepec de Morelos,
Estado de México 55540
México
Activity: Design and Manufacture of Colour and Additive Concentrates,
Facility: Avient Corporation - Shanghai (Xinzhuang), China
No. 88, Lane 4377 Jindu Road
Minhang District
Shanghai 201108
Facility: Avient Corporation - Shenzhen, China
No. 1, Qihang Industry Park, Haoxiang Road
Shajing Town, Baoan
Shenzhen, Guangdong Province 518104
Facility: Avient Corporation - Rania, India
Survey No.344/1-2-3
Rania Works, Sakarda Bhadarwa Road
Rania, Gujarat 391780
Facility: Avient Corporation - Riyadh, Saudi Arabia
2nd Industrial City, Al-Kharj Road
P.O.
Toluca 2000
Toluca, Estado de México 50233
México
Facility: Avient Corporation - Vashere, India
Renaissance Industrial & Warehousing Complex
Unit No.
https://www.avient.com/sites/default/files/2024-12/ISO 22000-2024. Avient Sta. Clara 308865_en_46389 %2811%29.pdf
View PDF
The SQS herewith attests that the organisation named below has a management system that meets the requirements of
the normative base mentioned.
70
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Certificate
Avient Colorants MX S.A. de C.V.
Plasticos 28, int B102
Santa Clara Coatitla
55540 Ecatepec de Morelos, Estado de México
Mexico
Scope
Category I
Production of customer specific Masterbatches for
Food packaging materials on the dedicated extrusion
lines.
https://www.avient.com/sites/default/files/2024-12/Terms and Conditions of Sale for Czech Republic %28Czech Translation%29.pdf
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