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。
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/2025-04/CCG PVDF Extrusion_Molding Case Study.pdf
https://www.avient.com/products/polymer-additives/processing-enhancement-additives/colorant-chromatics-pvdf-processing-aids
Slide 1: Wire & cable oem
https://www.avient.com/sites/default/files/2025-05/Smartbatch Shampoo _ Conditioner OEM Case Study Snapshot.pdf
https://www.avient.com/products/polymer-colorants/color-additive-combination-masterbatches/smartbatch-combination-colorants-additives
Slide 1: Consumer packaged goods company
https://www.avient.com/sites/default/files/2025-05/Cesa Stat Pet Food Packaging Case Study Snapshot.pdf
https://www.avient.com/products/polymer-additives/processing-enhancement-additives/cesa-stat-antistatic-additives
Slide 1: Flexible packaging company
https://www.avient.com/sites/default/files/2023-11/ISO 9001 2015_Hickory NC.pdf
1616267 Certification Effective Date: April 1, 2021
Issue Date: March 30, 2021 Certificate Expiry Date: March 31, 2024
________________________________________________________________________________
ISO 9001
Registered by:
QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada.
https://www.avient.com/sites/default/files/2021-04/trilliant-hc8900-medical-device-housing-case-study.pdf
DEVICE
MANUFACTURER
M E D I C A L D E V I C E H O U S I N G
• Improved chemical resistance compared to PC/ABS,
PC/PET & COPE
• Flame retardant (FR) rating of V-1 at 0.75 mm
• Zero BPA & non-halogenated FR material
• Available in standard hospital grade pre-colors
• Provided a cost-effective material with superior
chemical resistance to traditional materials
• Formulated a medical-grade, semi-crystalline
blend to support regulatory testing and
approvals
• Demonstrated superior property retention and
crack resistance after exposure to hospital-
grade disinfectants, including Virex® Tb,
helping to extend the device life
Trilliant™ HC8900 Thermoplastics
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-09/case-study-one-pager-hybrid-5g-cable.pdf
OFC
MANUFACTURER
5 G H Y B R I D C A B L E
J A C K E T I N G & I N S U L A T I O N
• Fire performance: reduce smoke and fume production,
high flame and char resistance
• Reduce development time
• Meet required standards: UL 1581 (Class XL) mechanical
properties , UL 1685 (flame test/smoke parameters), FT2
& FV2 (VW1)
• Accelerated speed to market, reducing
development time to three months
• Instilled confidence and proved material
expertise as solutions passed extensive
testing ahead of competition
• Optimized cable manufacture process and
line speed following trials at customers
facility
ECCOH 5549/1 LDD & Syncure™ S100FH
KEY REQUIREMENTS
WHY AVIENT?
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/2024-10/Complet LFT - Moisture Resistant Nylon - Snowmobile Running Board case study.pdf
https://www.avient.com/products/long-fiber-technology/complet-moisture-resistant-nylons
Slide 1: Snowmobile OEM
https://www.avient.com/sites/default/files/2024-03/CCG Application Snapshot_Airline components manufacturer_Final.pdf
All Rights Reserved
https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-pes/psu/ppsu-colorants
Slide 1: Airline components manufacturer