https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Pharma Pkg 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 • Non-phthalate and formulated without animal- derived substances • Available for use in a wide range of polymers including polyolefins, styrenics, polycarbonate and alloys, polyester, POM • Functionality can be combined with colorants into convenient combination concentrates or formulations REGULATORY SUPPORT • Pre-tested raw materials: - 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) • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request FUNCTIONALITY TARGET APPLICATIONS EBM/IBM CONTAINERS CLOSURES FILM COMBINATION DEVICES Clarifying PP Sorbitol-free—possibilities in packaging ocular solutions Slip/torque reduction Slip for PE, PP films, processing aid, torque reduction for closures Protection from UV in transparent packaging for PP, PE, PETG, COP UV blocking in 290–450nm with no impact on clarity Antistatic ready-to-use solution for PE films e.g. for API handling Permanent/non-migrating; fast decay time independent of % relative humidity Antistatic masterbatch for PE films Cost effective, long-lasting, migrating type but with biological evaluation Gamma/e-beam sterilization protection of the polymer Preserving the properties of PP and COC/COP.
https://www.avient.com/sites/default/files/2022-12/Mevopur Laser Marking Additives Application Bulletin.pdf
KEY CHARACTERISTICS • Designed for Nd:YAG lasers operating between 1060-1070 nm • Available for different polymers including PP, PE, PC, PBT, POM, ABS, MABS • 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 • Can be designed for dark marking on natural or white/light colored background or light marking on black/dark background 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.
https://www.avient.com/sites/default/files/2025-08/Cesa Flame Retardant Additives Product Bulletin.pdf
Manufacturers have the ability to design and validate to meet UL criteria: • UL 94 V-0 • UL 94 HB • UL 94 V-1 • UL 94 5VA • UL 94 V-2 • UL 94 5VB • ASTM E-84 (Class A, B, C) Avient’s Corporate Technology Analytical testing lab participates in UL’s Total Certification Program and their Client Test Data Program, helping manufacturers reduce time to market by integrating the product certification process in a comprehensive program.
https://www.avient.com/sites/default/files/2021-09/avient-hong-kong-holding-certificate-of-change-of-name-aug-2-2021.pdf
公公公公 司司司司 更更更更 改改改改 名名名名 稱稱稱稱 證證證證 明明明明 書書書書 CERTIFICATE OF CHANGE OF NAME 本 人 謹 此 證 明 I hereby certify that POLYONE HONG KONG HOLDING LIMITED 已 藉 特 別 決 議 更 改 其 名 稱 , 該 公 司 根 據 having by special resolution changed its name, is n ow incorporated under the 香 港 法 例 第 622 章《 公 司 條 例 》註 冊 的 名 稱 現 為 Companies Ordinance (Chapter 622 of the Laws of Hon g Kong) in the name of Avient Hong Kong Holding Limited 本 證 明 書 於 二二二二 OOOO 二二二二 一一一一 年 八八八八 月 二二二二 日 發 出 。
https://www.avient.com/sites/default/files/2021-09/cai-biopolymers-brochure-2021.pdf
Use of Biopolymers in Packaging Types Introduction to Biopolymers Less Frequently Used More Frequently Used Single Use Bottles Single Use Cups, Tubs & Trays Clothing Packaging Bags Pre-packed Fruit Bags Vegetable Bags Coffee Capsules Carrier Bags Fruit Labels Fast Food Trays (closed system) Teabags Biowaste Bags To ensure compliance with requirements and regulations, suitable certification is of crucial importance.
Avient is a TÜV Austria certified masterbatch supplier and can help support and secure the full certification process of a final part.
In compliance with certification requirements, Avient biocolorants can offer a large spectrum of color possibilities supporting differentiation and appeal at consumer level.
https://www.avient.com/sites/default/files/2022-02/MEVOPUR Bio-based Solutions Application Bulletin_JP.pdf
規制対応 • • • 評価試験: - ISO 10993-1 - USP および (Class VI) - 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ レフィン系包装材) - USP (ポリエチレン) - ICH Q3Dに準拠した元素不純物分析 DMF(Type III)および Device Master File 登 録済み 米国FDAおよびEUの食品接触規格 ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。
a) 米国食品医薬品局(FDA)または国際標準化機構(ISO)により「インプラント」機器として分類される医療機器、または米国薬局方(USP)または ISO 規格で定義される「パーマネント」 機器、または (b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または (c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。
https://www.avient.com/sites/default/files/2021-12/Chemically Resistant Materials Whitepaper.pdf
MATERIAL BRIEF DESCRIPTION FR PC/ABS Flame retardant, chemical resistance, high ESCR FR PC/PET Flame retardant, impact modified, chemical resistant FR PC/PBT Skin-contact biocompatible, flame retardant, high chemical resistance FR Copolyester Flame retardant, chemical resistant, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8910 Unfilled PK blend, BPA-free, high chemical resistance, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8920 FR Non-halogenated flame retardant PK blend, BPA-free, high chemical resistance, may incorporate agency rated materials to meet USP Class VI or ISO 10993 requirements Edgetek™ ET8900 CR Unfilled PK blend, high chemical resistance Edgetek™ ET8900 HI CR High impact PK blend, high chemical resistance Edgetek™ ET8920 FR CR Non-halogenated flame retardant PK blend, high chemical resistance Table 2.
https://www.avient.com/sites/default/files/resources/TRA%2520-%25202016%2520Annual%2520Report%2520for%252017%2520Tideman.pdf
Business Number: 898451794 Mailing Address: Address Line 1: 17 Tideman Drive City, Province/Territory, Postal Code: Orangeville Ontario L9W3K3 Country: Canada Facility Name: Orangeville Compound NAICS Code: 326198 NPRI ID: 4358 Physical Address: Address Line 1: 17 Tideman Drive City, Province/Territory, Postal Code: Orangeville Ontario L9W3K3 Country: Canada Latitude: 43.91230 Longitude: 80.11300 Number or Permit Number: ON9820023 Government Department, Agency, or Program Name: Ontario MOE Hazardous Waste Generator Number Number or Permit Number: 07786DZLMV Government Department, Agency, or Program Name: Certificate of Approval Air Number or Permit Number: 56265DFQF2 Government Department, Agency, or Program Name: Certificate of Approval Industrial Sewage Works Contact Type Technical Contact, Company Coordinator Name: Brian Greer about:/V003/Html http://www.canada.gc.ca/home.html http://www.servicecanada.gc.ca/eng/home.shtml http://www.canada.gc.ca/aboutgov-ausujetgouv/depts/menu-eng.html https://ec.ss.ec.gc.ca/auth/en/Services about:blank# about:blank# about:blank# about:/V003/Logout_Deconnexion http://ec.gc.ca/default.asp?
No Did the facility complete any pollution prevention activities in the current NPRI reporting year No Report Submission and Electronic Certification NPRI Electronic Statement of Certification Specify the language of correspondence English Comments (optional) I hereby certify that I have exercised due diligence to ensure that the submitted information is true and complete.
https://www.avient.com/sites/default/files/2023-12/Versaflex OM TPEs for Sealing Ring of Blood Lancet.pdf
BLOOD LANCET MANUFACTURER S E A L I N G R I N G • Compliance with strict regulations for medical materials • Excellent sealing performance • Good compression set • Provided a recycled TPE solutions compared to silicone without increasing system cost • Delivered a TPE that complied with ISO 10993-4 & -5 and USP Class VI • Supported a change to an injection molded material to ease production and enhance assembly capabilities Versaflex™ HC TPEs – OM1040-1 Grade KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2022-11/Versaflex CL-Serum collection cartridge-Application Snapshot.pdf
A LIFE SCIENCE COMPANY S E R U M C O L L E C T I O N C A R T R I D G E • Excellent clarity • Good bonding and peel strength onto PP • Heat resistance • Meet sterilization needs • Easy processing • Formulated transparent Shore 50A TPE with excellent adhesion onto PP and good sealing performance • Met regulatory requirements for USP Class VI and ISO 10993-4,5 • Provided a short lead time and on-site technical service Versaflex™ CL Thermoplastic Elastomers KEY REQUIREMENTS WHY AVIENT?