Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau die Einführung und Anwendung eines Managementsystems gemäß DIN EN ISO 50001:2018 für den Geltungsbereich: Entwicklung und Produktion von technischen Thermoplasten; an den Standorten gemäß Anlage.

Park, Pudong, Shanghai, China, 201203 has been found to conform to the Environmental Management System standard: ISO 14001:2015 This certificate is valid for the following scope: Design and Manufacture of Masterbatch

Versaflex HC - Syringe Plunger - Spanish FABRICANTE DE JERINGAS É M B O L O D E J E R I N G A D E S E C H A B L E • Cumplir con las normas USP VI e ISO 10993-4,5 • Esterilización con gamma y EtO • Rendimiento de sellado a largo plazo • Bajo coeficiente de fricción (COF) • Rendimiento uniforme en jeringas de diferentes diámetros • Ofreció una solución formulada que cumple con los requerimientos rigurosos de una aplicación médica • Mejoró la continuidad del suministro global • Aumentó la eficiencia del proceso al sustituir el material termoestable anterior con un TPE Versaflex™ HC 2110-57B REQUERIMIENTOS CLAVE ¿POR QUÉ AVIENT?

RESPIRATORY DEVICE MANUFACTURER C P A P M A C H I N E C O V E R • Good aesthetics with high COF for grip functionality • Chemically bondable to FR PC/ABS down to 1mm • NCS S 9000-N color suitable for UV laser marking to white • Good scratch and mar resistance • Good chemical resistance to detergents, alcohols and bleach • Pass VOCs & out-gassing in accordance to ISO 18562-3/2:2017 • Customized formulation to balance mar resistance, flow, and laser marking whiteness and clarity • Collaborated on tooling improvements to widen processing window and increase yield rate • Provided application development and on- site technical support to manage short shot, sink marks, burn marks and air trap Customized VersaflexTM TPEs WHY AVIENT?

ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 65567 Effective Date: 08 September 2023 Expiration Date: 07 September 2026 Revision Date: 08 September 2023 Dominic Townsend, President This certificate may be found on the ABS QE Website (www.abs-qe.com).

Page 1 / 1 has been assessed and certified as meeting the requirements of ISO 14001:2015 For the following activities The Design and Manufacturing of Plastic Color Concentrated, Plastic Additive Concentrated and Pigment Powder for Thermoplastic & Rubber Industries.

主な特徴 • • • • • • ISO 13485の管理基準化で製造。 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 レフィン系包装材料) - 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 軽量化 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。

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing 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 as pre-colored formulation or concentrate and for use in different polymers 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 * Design note: Effect colors require careful consideration of part design and polymer flow paths to minimize visible flow lines.

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing 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 • Standard concentrates in a PE carrier and on request in PP • Pre-colored formulations can be supplied in specific resins selected for the application 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) • Food contact established with FDA/EU* APPLICATION BULLETIN DRUG TYPE COLOR DESCRIPTION PANTONE REFERENCE AVIENT PRODUCT CODE PE BASED Adrenergic agonist combinations Light Green 373 C PE6M176349 Adrenergic agonists Purple 2583 C PE4M176057 Anti-infectives Tan 467 C PE8M176130 Anti-inflammatory, nonsteroidal Grey Cool Grey 4 C PE7M176184 Anti-inflammatory, steroids Pink 197 C PE3M176237 Anti-inflammatory, immunomodulators Olive Green 5763 C On request Beta-blockers Yellow Yellow C PE1M176160 Beta-blocker combinations Dark Blue 281 C PE5M176272 Carbonic anhydrase inhibitors Orange 1585 C PE2M176089 Cytotoxic Black 6 C PL9M176008 Miotics Dark Green 348 C PE6M176267 Mydriatics and cycloplegics Red 1797 C PE3M176236 Prostaglandin analogues Turquoise 326 C PE5M176273 Healthcare use limitations apply—see below.

KEY CHARACTERISTICS • Customized density offering a wide range of specific gravities (1.2–11 gm/cm3) • Based on recycled resin from PIR and PCR sources • Broad modulus range, from very flexible to very rigid grades • Corrosion resistance that withstands oxidization for long-term use and benefit • Chemical resistance can be adapted depending on base resin as required • Provides visual surface effects, aesthetics, and cool touch • Design flexibility and processing ease MARKETS AND APPLICATIONS Applications in packaging and consumer goods in which a more sustainable solution is preferred: • Cosmetic caps and closures • Perfume caps • Spirit bottle caps • Luxury boxes • Handles and knobs SUSTAINABILITY BENEFITS • Formulated with recycled resin from post-industrial recycled (PIR) and/or post-consumer recycled (PCR) sources including ocean bound plastic waste • Reduces waste and supports the circular economy • Reduces carbon footprint compared to fossil feedstock alternatives • Simplifies manufacturing and lowers costs versus metal PRODUCT BULLETIN CHARACTERISTICS UNITS Gravi-Tech REC-CI GT5200-5089 PT Natural Gravi-Tech REC GT5200-5075 Black X2 Gravi-Tech REC GT5200-5078 Black Gravi-Tech REC GT5200-5079 Black Gravi-Tech REC GT5200-5060 Black Gravi-Tech REC GT5200-5057 Black Base Resin Ocean Bound rPP rPP rPP rPP rPP rPP Recycled Content/Filler g/cm >98% PIR+PCR 60% PIR/Mineral >95% PIR/Mineral >95% PIR+PCR/Mineral 30% PIR/Mineral 30% PIR/Mineral Density (ISO 1183) g/ccm 1.2 1.2 1.2 1.2 1.9 2.0 CHARACTERISTICS UNITS Gravi-Tech REC GT7300-5034 X2 FD Natural Gravi-Tech REC GT7300-5036 Black Gravi-Tech REC GT7300-5025 Black Gravi-Tech REC GT6000-5032 Black Gravi-Tech REC GT6000-5031 Black Base Resin ABS rABS/ABS rABS rPA6 rPA6 Recycled Content/Filler g/cm 50% PIR/Mineral 65% PIR/Mineral 10% PIR/Mineral 20% PIR/Mineral 20% PIR/Mineral Density (ISO 1183) g/ccm 1.5 1.5 2.2 2.7 2.8 AVAILABLE GRADES Copyright © 2024, Avient Corporation.