https://www.avient.com/sites/default/files/2023-05/Mevopur Healthcare Colorants and Formulations Amber for Pharma Application Bulletin.pdf
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.
https://www.avient.com/sites/default/files/2020-10/tpe-injection-molding-guide.pdf
A material is shear dependent when its viscosity is higher at low shear rates (such as extrusion) and lower at high shear rates (as in injection molding). To aid in release, the cavity or core may be coated with a release coating such as PTFE impregnated nickel after it has been given a sandblast or EDM finish. 8 Sprue and Sprue Puller Design The sprue should have sufficient draft, from 1º to 3º to minimize drag and sprue sticking. Hot Runner System Gates Valve Gates Valve gates offer the best solution for high production parts where surface quality is critical, such as medical and cosmetic products.
https://www.avient.com/sites/default/files/2022-07/Lewiston 308872_en_13485_21%5B43%5D.pdf
Lewiston, ME, 04240 United States of America Scope Avient CAI Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market. Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45484 Validity 01.03.2022 – 28.02.2025 Issue 01.03.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.
https://www.avient.com/sites/default/files/2023-10/308659_en_46154.pdf
Ltd. 30, Hsing Pang Road 33068 Taoyuan Taiwan Scope Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market. Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 46154 Validity 12.01.2022 – 11.01.2025 Issue 12.01.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland F.
https://www.avient.com/sites/default/files/2022-11/WPC Sheet Decking Application Snapshot.pdf
WOOD PLASTIC COMPOSITE (WPC) MFG S H E E T A N D D E C K I N G • Lightweighting solution offering energy savings and manufacturing efficiencies • Reduced downtime associated with poor quality rejections • Consistent and uniform cell structure in decking material • Compatibility with mono-core extrusion formula (rice hull bio-filler and virgin PVC) when used with a chemical foaming additive • Density control of 0.60-0.65 g/cc in production • Provided a CFA solution that offered energy savings, process optimization, and extended manufacturing run times • Enabled improved performance results and enhanced process control • Allowed tighter tolerance control with uniform cell structure, eliminating voids and surpassing density target ($100K savings) • Increased productivity and aesthetic finish with secondary operations (sanding) KEY REQUIREMENTS Excelite™ Chemical Foaming Additives (CFA) WHY AVIENT?
https://www.avient.com/sites/default/files/2024-12/ISO 22000-2024. Avient Sta. Clara 308865_en_46389 %2811%29.pdf
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/2021-04/versaflex-hc-bt218-biopharmaceutical-tubing-case-study.pdf
MEDICAL TUBING EXTRUDER B I O P H A R M A C E U T I C A L T U B I N G • Low leachables & extractables • Great tensile performance and kink resistance • Good thermal weldability • Excellent clarity and medical blue tint • ISO 10993-4 & 5, USP Class VI & Animal Derivative Free (ADF) • Supplied drop-in material replacement to overcome supply constraints of incumbent TPE • Offered a lower extractable profile than comparable materials in the market • Enabled easy material transition without changes in tooling or thermal welding machine settings • Formulated solution with proprietary additives to provide clarity and prevent yellowing after sterilization Versaflex™ HC BT218 Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2025-01/Stethoscope Dispersions Case Study Snapshot.pdf
MEDICAL DEVICE MANUFACTURER S T E T H O S C O P E S • Provide a silicone paste colorant dispersion for liquid silicone rubber (LSR) to use in stethoscope ear tips • Create a custom-colored vinyl plastisol formulation for stethoscope tubing • Harmonize color across materials to meet specific process and performance requirements • Deliver effective communication and cross-functional collaboration • Offered dependable silicone paste colorants that allowed for comfort and easy sterilization • Provided a colored vinyl plastisol to reduce tackiness and support product longevity • Collaborated internally to align all materials and provide color consistency across components • Supported fast color changes and met quality specifications through constant communication and technical expertise Silcopas Silicone Paste Colorants and CORE Vinyl Plastisols for Healthcare KEY REQUIREMENTS WHY AVIENT? https://www.avient.com/products/vinyl-formulations/vinyl-plastisols-organosols/core-vinyl-plastisols-healthcare https://www.avient.com/products/polymer-colorants/colorant-dispersions/colorants-liquid-silicone-rubber Slide 1: Medical device manufacturer
https://www.avient.com/sites/default/files/2025-01/ISO 13485 Shanghai %28ZhangJiang%29%2C China.pdf
240625-2017-AQ-RGC-NA-PS Initial certification date: 14 September 2017 Valid: 08 February 2025 – 07 February 2028 This is to certify that the management system of PolyOne-Shanghai, China 88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode: 91310000607342402D) has been found to conform to the Quality Management System standard: ISO 13485:2016 This certificate is valid for the following scope: Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates Used for the Plastic Parts of Medical Devices http://www.dnv.com
https://www.avient.com/sites/default/files/resources/PolyOne%2520IR%2520Presentation%2520-%2520Seaport%2520Global%2520Transports%2520%2526%2520Industrials%2520Confer....pdf
T H E N E W P O L Y O N E : A S P E C I A L T Y G R O W T H C O M P A N Y Growing leadership position in attractive markets Innovation, technology and service are differentiators Capital management is a strength: Record-setting cash generation to continue for years Expand ROIC while increasing invested capital Proven acquisition strategy with robust pipeline Commercial investments are fueling momentum and generating organic growth SEGMENT HIGHLIGHTS PolyOne Corporation 17 C O L O R , A D D I T I V E S & I N K S PolyOne Corporation 18 Solid Colorants Performance Additives Screen Printing Inks Liquid Colorants 27% 14% Textiles Building & Electrical & Operating Income & MarginRevenue by Region C O L O R , A D D I T I V E S & I N K S 2 0 1 7 R E V E N U E | $ 8 9 3 M I L L I O N $4 $25 $104 $139 0.9% 5.5% 12.2% 15.5% 16.0% 18.0% 100 110 120 130 140 150 PolyOne Corporation 19 32% 46% 1% Mexico Brazil S P E C I A L T Y E N G I N E E R E D M A T E R I A L S PolyOne Corporation 20 Engineered Formulations Advanced Composites Thermoplastic Elastomers 20% 19% Electrical & 13% Building & S P E C I A L T Y E N G I N E E R E D M A T E R I A L S Revenue by Region Operating Income & Margin 2 0 1 7 R E V E N U E | $ 6 2 4 M I L L I O N PolyOne Corporation 21 $21 $57 $78 0.1% 5.1% 9.3% 12.5% 28% 48% 22% P E R F O R M A N C E P R O D U C T S & S O L U T I O N S PolyOne Corporation 22 Specialty Vinyl Solutions Healthcare Formulations Smart Device Materials Flame Retardant Polymers Building & 30% 15%Appliance Electrical & 1% Mexico 77% Latin America P E R F O R M A N C E P R O D U C T S & S O L U T I O N S Operating Income & MarginRevenue by Region 2 0 1 7 R E V E N U E | $ 7 2 1 M I L L I O N $40 $33 $56 $77 4.6% 3.6% 7.2% 10.7% 16.0% 0 100 PolyOne Corporation 23 D I S T R I B U T I O N E N D M A R K E T S & S U P P L I E R S PolyOne Corporation 24 23% Healthcare 22% Electrical & Building & $20 $25 $63 $73 2.9% 5.9% 6.3% 1.0% 3.0% 5.0% 7.0% 15 25 35 45 55 65 75 Operating Income & Margin 2017 Revenue | $1.2 Billion http://www.avient.com/Pages/VariationRoot.aspx http://www.avient.com/Pages/VariationRoot.aspx T A R G E T E N D M A R K E T S & A P P L I C A T I O N E X A M P L E S PolyOne Corporation 25 Thermally Conductive Chemical Resistant Polymer Colorants Elastomeric Grips and Handles Structural Composites Antimicrobial Technologies Anti-Counterfeiting Target End Markets… Healthcare Catheter Technologies Under-hood Components Target End Markets… Automotive Interior Structural Sound & Vibration Management Roof Systems Air Management Electronics and Cameras Lighting Exterior / Interior Trim Braces & Brackets Fasteners Seals & Flaps Target End Markets… Consumer Thermally Conductive Polymer Colorants Elastomeric Grips and Handles Structural Composite Oxygen Scavenger Laser Marking Additives Antistatic Technologies UV Light Barrier Technologies Cap & Closure Colorants Process Optimization Antioxidant Technologies Density Modified Target End Markets… Packaging Impart weight, sound and metallic finish to caps and closures for cosmetics and spirits applications Elevate quality and prestige perceptions among high-end consumers Eliminate time and cost associated with secondary operations and assembly Luxury Packaging GravitechTM Density Modified Polymers Eliminate costs by increasing pigment density Enhance color performance without altering form and formulation Increase design capabilities by reducing weight and layer thickness Optimize Color Usage OnColorTM Super Concentrates Inhibit microbial growth on polymer surfaces Enhance value or products and devices Highly versatile concentrate with the ability to be incorporated into a wide variety of products Combat Bacteria Formation WithStandTM Antimicrobial Technology Durable, long-lasting products stand up to the most aggressive disinfectants Minimize environmental stress cracking and discoloration One of the broadest medically approved polymer and colorant portfolios Medical Device Housings Chemically Resistant Engineered Polymers Color & Design Services Greater control of color development and supply chain Work across entire design process from concept to commercialization Inspire creativity in the use of polymer materials, colors, and effects Innovative brand differentiation Faster development timelines Outdoor Applications Leading provider of high performance specialty materials for the recreational and sports & leisure industry Well positioned across all segments to address market needs Metal to Polymer Conversion Lightweighting Thermal Management Impact Performance ColorMatrix Fiber Colorant Solutions Proprietary advanced liquid color formulations and equipment enable greater efficiency and productivity Eliminates aqueous dyeing and its associated wastewater treatment Solid Color Concentrates Extrusion-spun fibers colored via solid masterbatch Fiber Colorants High flame retardancy to meet strict UL standards Greater processing and design flexibility Specialized additives provide long term color stability Diffusive lens materials improve light dispersion Smart Home Devices ResilienceTM Vinyl Solutions 1 Reconciliation of Non-GAAP Financial Measures (Unaudited) (Dollars in millions, except per share data) Senior management uses comparisons of adjusted net income from continuing operations attributable to PolyOne common shareholders, adjusted earnings per share (EPS) attributable to PolyOne common shareholders and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) to assess performance and allocate resources because senior management believes that these measures are useful in understanding current profitability levels and that current levels may serve as a base for future performance.