https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
KEY CHARACTERISTICS • Manufactured under change control principles beyond CAS number (similar level as MEVOPUR concentrates), reducing risk of change • Free from animal-derived substances and phthalates • Suitable for blown film, injection molding, blow molding and extrusion REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP chapters , including Class VI, a requirement for ophthalmic and nasal drugs - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities - USP and USP light transmission • Registered Drug Master File (Type III) • Food contact compliance established with FDA/EU* APPLICATION BULLETIN CARRIER MATERIAL PIGMENT CONTENT/TYPE LIGHT FASTNESS THERMAL STABILITY PRODUCT CODE 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 Healthcare use limitations apply—see below. Avient products have not been designed for nor are they promoted or intended for use in: (a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under US Pharmacopoeia (USP) or ISO standards; or (b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or (c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.
https://www.avient.com/sites/default/files/resources/TRA%2520-%25202016%2520Plan%2520Summary.pdf
Contacts Public Contact First Name: * Brian Last Name: * Greer Position: * EHS Manager Telephone: * 5192150535 Ext Fax Email: * brian.greer@polyone.com Person responsible for the Toxic Substance Reduction Plan preparation First Name: * Darryl Last Name: * Chartrand Position: * Senior Air Quality Technologist Telephone: * 4164999000 Ext 73642 Fax 4164994687 Email: * darryl.chartrand@ch2m.com Employees Employees Number of Fulltime Employees: * 16 Copy of Certifications of Plan Copy of Certifications of Plan Upload Document A copy of the certification statement(s) from the Highest Ranking Employee and the Licensed Planner(s), for the Toxic Substance Reduction Plan for which the Plan Summary is being submitted are required. Please upload a single document containing all certifications. Do not upload any certification statements that are dated after December 31.
https://www.avient.com/sites/default/files/2021-01/tax-certificate-avient-pakistan-private-limited.pdf
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。
https://www.avient.com/sites/default/files/2021-01/clariant-plastics-coatings-usa-llc-de-amendment-change-of-name-jan-15-2021.pdf
Delaware The First State Page 1 5799827 8100 Authentication: 202256240 SR# 20210072080 Date: 01-11-21 You may verify this certificate online at corp.delaware.gov/authver.shtml I, JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF DELAWARE, DO HEREBY CERTIFY THE ATTACHED IS A TRUE AND CORRECT COPY OF THE CERTIFICATE OF AMENDMENT OF “CLARIANT PLASTICS & COATINGS USA LLC”, CHANGING ITS NAME FROM "CLARIANT PLASTICS & COATINGS USA LLC" TO "AVIENT COLORANTS USA LLC", FILED IN THIS OFFICE ON THE ELEVENTH DAY OF JANUARY, A.D. 2021, AT 10:39 O`CLOCK A.M. AND I DO HEREBY FURTHER CERTIFY THAT THE EFFECTIVE DATE OF THE AFORESAID CERTIFICATE OF AMENDMENT IS THE FIFTEENTH DAY OF JANUARY, A.D. 2021.
https://www.avient.com/sites/default/files/2024-12/AVNT Investor Day 2024 Presentation.pdf
All Rights Reserved 2024 33 Drug delivery devices CATALYZE THE CORE M ARKET DRIVERS & NEEDS • Regulatory compliance • Reliable material quality and uninterrupted supply • Supply chain risk mitigation • Global reach $6B ADDRESSABLE MARKET A V I E N T E N D M A R K E T S , A P P L I C A T I O N S AVIENT VALUE PROPOSITION • ISO 13485 accredited sites • Globally approved raw material portfolio • Strict change management • Global supply Auto injectors Syringes Inhalers OTHER APPLICATONS • In-vitro diagnostics • Remote monitoring • Pharma packaging • Catheters • Medical equipment Copyright © .
https://www.avient.com/sites/default/files/2021-01/w9-avient-corporation-july-2020.pdf
October 2018) Department of the Treasury Internal Revenue Service Request for Taxpayer Identification Number and Certification Go to www.irs.gov/FormW9 for instructions and the latest information. Social security number – – or Employer identification number – Part II Certification Under penalties of perjury, I certify that: 1. Certification instructions.
https://www.avient.com/sites/default/files/2021-01/w-9-clariant-plastics-coatings-usa-llc-july-20201.pdf
Certification instructions. You must sign the certification. You may cross out item 2 of the certification. 4.
https://www.avient.com/sites/default/files/2020-07/versaflex-hc-syringe-plunger-english.pdf
Versaflex HC - Syringe Plunger - English SYRINGE MANUFACTURER D I S P O S A B L E S Y R I N G E P L U N G E R • USP VI and ISO 10993-4,5 compliant • Sterilize by gamma & EtO • Long-term sealing performance • Low coefficient of friction (COF) • Consistent performance across barrel sizes • Provided a formulated solution that met rigorous medical application requirements • Improved global supply continuity • Increased process efficiency by replacing previous thermoset material with TPE Versaflex™ HC 2110-57B KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2022-01/Dynaflex-Disposable syringe tip cap-Application snapshot.pdf
SYRINGE MANUFACTURING D I S P O S A B L E S Y R I N G E T I P C A P • Excellent sealing and resealing performance • No DEHP or natural rubber latex added during processing • Can be sterilized by EtO • Compliance with ISO 10993-4&5, USP Class VI Dynaflex™ Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?