Celanese Healthcare Market and Applications Market, Materials, Requirements and Applications 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 1
Celanese is a global technology and specialty materials company Advanced Engineered Materials Specialty thermoplastics used in automotive, electrical, electronics, more Acetyl Intermediates Acetic acid, vinyl acetate monomer, and additional intermediate chemistries 2013 Net Sales: $6.5B Employees: 7,400 Manufacturing Locations: 26 Consumer Specialties Cellulose derivatives like acetate tow for filters Food ingredients including sweeteners, preservatives Industrial Specialties Emulsion polymers for paint, adhesives, nonwovens, carpets EVA polymers for flexible packaging, medical solutions 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 2
Celanese s integrated product portfolio Building Blocks Differentiated Intermediates Specialty Products Acetyl Intermediates Emulsion polymers EVA polymers Industrial Specialties Acetic Acid VAM Cellulose derivatives Food ingredients Consumer Specialties Raw Materials Anhydride and esters Engineered Materials Affiliates Advanced Engineered Materials Methanol, Olefin, & Acetone Derivatives Specialty Derivatives 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 3
Celanese s major end-use segments Global presence and diverse applications in growth segments Consumer & Industrial Adhesives 10% Food & Beverage 2% Paints & Coatings 11% Textiles 5% Automotive 15% Construction 2% Consumer & Medical Applications 11% Chemical Additives 7% Paper & Packaging 5% Note: End-use percentages based on Celanese 2012 net sales with strategic affiliates proportional revenue and Celanese internal management estimates. Filter Media 19% Industrial Performance Applications 7% Other 5% 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 4
Celanese s recent brand launch Moving to a Simplified, Unified Celanese Brand On March 31st On October 1 st, Celanese announced it is simplifying its brand architecture to capture in a single brand the full suite of our technology, resources, products and solutions Our vision represents Celanese s depth and breadth of industry and chemistry knowledge, the capabilities to innovate for our customers, the dedication to creating value, and a commitment to partnerships to help our customers succeed We believe the phrase that best describes Celanese is The chemistry inside innovation. - Mark Rohr, Chairman & CEO 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 5
Celanese s commitment to employee and process safety OSHA Incident Rate Per 200,000 hours 0.72 Lost-time Incident Rate Per 200,000 hours 0.19 0.15 0.36 0.35 0.05 0.1 0.09 2005 2010 2011 2012 Contractor Incident Rate Per 200,000 hours 2005 2010 2011 2012 Process Safety Incident Rate Per 200,000 hours 1.32 0.172 0.202 0.48 0.31 0.29 0.094 2007 2010 2011 2012 2010 2011 2012 We design and operate our facilities to provide our employees with a safe workplace and to minimize the potential for any adverse impacts on health and the environment. Each employee is accountable for safe work practices and responsible environmental conduct. Guiding Principles on Safety 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 6
Celanese s commitment to sustainability and environmental stewardship Energy Intensity Mbtu/Lb Greenhouse Gas Intensity MT/MT 3.95 3.01 3.08 2.98 0.85 0.48 0.49 0.47 2005 2010 2011 2012 Waste Intensity MT/MT 0.057 0.022 0.024 0.021 2005 2010 2011 2012 Volatile Organic Carbon Intensity Kg/MT 0.66 0.40 0.40 0.37 2005 2010 2011 2012 2005 2010 2011 2012 We're working together to grow sustainably by improving continuously and offering solutions that make a difference, for our customers and the world. Mark Rohr, Chairman and CEO 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 7
Celanese Advanced Engineered Materials (AEM) Transportation Fuel systems Safety systems Structural / mechanical components Aesthetics Drug delivery systems Medical implants Medical Source: Celanese internal estimates for 2013 41% 3% AEM 2013 Net Sales $1.35B 11% Industrial Fluid handling Building & Construction Office equipment 22% 23% Consumer Consumer & Appliances Durables Cookware Water purification Sporting goods Electrical & Electronics Communication High brightness LEDs Connectors Products Are Used in a Diversified Set of End Applications 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 8
Global Network Strong Global Presence Winona, MN Florence, KY Bishop, TX Auburn Hills, MI Wilmington, NC Shelby, NC Oberhausen, Germany Industriepark Hoechst, Frankfurt, Germany Kaiserslautern, Germany Sulzbach, Germany Al Jubail, Saudi Arabia Beijing, China Guangzhou, China Hong Kong Seoul, Korea Tochigi, Japan Tokyo, Japan Fuji City, Japan Nanjing, China Shanghai, China Nantong, China Taipei, Taiwan Dafa, Taiwan Kuantan, Malaysia Singapore Suzano, Brazil São Paulo, Brazil Celanese Strategic Affiliates Ventures of Affiliates Celanese Engineered Materials A Global Footprint 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 9
Introduction: Why are Pharma Applications So Much More Sensitive? Toxicology Biocompatibility Extractables Single and Multiple Use Sterilization Drug contact Etc.... These properties ensure the product performance and quality during its intended use Patient safety The Influence of the Polymer on the Application Must be Understood, Established and Continuously Proven 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 10
Celanese Medical Technology (MT ) Grades Raw Material Supplier End-user OEM Patient Safety and Patient Satisfaction Molder/ Device- Manufacturer Close cooperation between the end-user, molder/device manufacturer and raw material supplier at the very beginning of the product design stage is necessary for a cost and time effective application development/time to market. 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 11
Celanese MT Grades Service Package Material compliance to FDA and EU requirements Long-term supply assurance without change of formulation Animal- and latex-free formulations Certified biocompatibility (USP 23 Class VI / ISO 10993, etc.) FDA Drug Master File FDA Device Master File Individual analytical tests per lot / delivery (purity control) where appropriate Expanded certificate of inspection Change management to GMP-principles Reduce the Barriers to Register Your Device Achieve a New Level of Proven Material Quality 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 12
Celanese Delivers a Complete Portfolio of Engineering Polymers Celanex thermoplastic polyester (PBT) Celstran, Compel and Factor long fiber reinforced thermoplastics (LFRT) Celstran continuous fiber reinforced thermoplastic (CFR-TP) Fortron polyphenylene sulfide (PPS) GUR ultra-high molecular weight polyethylene (UHMW-PE) Hostaform and Celcon acetal copolymer (POM) Impet thermoplastic polyester (PET) Riteflex thermoplastic polyester elastomer (TPC-ET) Thermx polycyclohexylene dimethylene terephthalate (PCT) Vandar thermoplastic polyester alloy (PBT) Vectra and Zenite liquid crystal polymers (LCP) 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 13
Celanese Maintains Leading Position in Engineered Materials Service temperature High-Performance Polymers (HPP) (TI 1 > 150 C) Engineering Polymers (ETP) (TI 1 90 150 C) Engineering Polymers LCP Vectra /Zenite PPS Fortron PCT Thermx PET Impet PBT Celanex PBT Alloy Vandar TPC-ET Riteflex POM Hostaform /Celcon UHMW-PE GUR Long Fiber and Continuous Fiber Reinforced Thermoplastics* LFRT Celstran, Factor Compel Basic Polymers Amorphous Partially crystalline CFR-TP Celstran Tapes, Rods and Profiles TI 1 = Temperature Index * with Matrix Polymers: PP, PA, PPS, PBT, POM and others on request 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 14
Celanese MT Product Portfolio Hostaform MT and Hostaform acetal copolymer (POM) Drug delivery systems Metal gear replacement Snap fittings Tribological systems Sliding mechanisms Clips and clamps Functional parts with high dimensional precision and stability Housings Dental instrumentation Surgical instrumentation components Orthopedic trial sizers Celanex MT and Celanex thermoplastic polyester (PBT) Drug delivery systems Metal gear replacement Functional parts with high dimensional precision and stability Tribological systems Sliding mechanisms Snap fittings Clips and clamps 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 15
Celanese MT Product Portfolio GUR ultra-high molecular weight polyethylene (UHMW-PE) Acetabular liners for THA Tibial inserts for TKA Bearing components for shoulder and other joints Endoprosthetics Cervical disks for spine Fortron MT polyphenylene sulfide (PPS) Surgical instrumentation Sterilization trays Metal replacement Nonwovens used for filtration Vectra MT liquid crystal polymer (LCP) Surgical instrumentation Surgical stapler cartridges Dental devices Sterilization trays Pharmaceutical packaging Complete air and moisture barriers Integrated 3D circuits Riteflex thermoplastic polyester elastormer (TPC-ET) Advanced wound care Extruded catheter tubing Surgical gowns, drapes and bedding Surgical instrumentation 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 16
Specific Material Properties: Resistance Against Radiation LCP PS PPS PE Vectra Fortron PET PEI ABS HIPS PC PSU PVC, flex. PE-UHM W PBT PA (10,11) GUR Celanex PVC, rigid SEBS HDPE LSR PA (6,12) PP, st ab. PM M A PP POM PTFE Hostaform Source: Ageless Processing Technologies, KJH 12/96 0 500 1000 1500 Dose in kgy in Ambiant Air at Which Elongation Decreases by 25% 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 17
Specific Material Properties: Permeation Properties HDPE PP EVA/PE PS PCL BOPP COC LDPE PVC plastized PC Celluloseacetate Fortron PPS Hostaform POM PEN PET Celanex PBT PAN PA6 Vectra LCP PVDC EVOH Celluose 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 18
Applications: Overview Drug Delivery Systems Dry powder inhalers Nebulizers MDIs aerosol valves Insulin injection pens Needle-less syringes Materials Hostaform POM, Celanex PBT Hostaform POM, Celanex PBT Hostaform POM, Celanex PBT Hostaform POM, Celanex PBT Vectra LCP Medical Devices Minimal Invasive Surgery (MIS) Clamps Materials Vectra LCP, Fortron PPS Hostaform POM 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 19
Case Studies and Performance Driven Product Solutions 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 20
Applications: Diabetes Care Insulin Pens Requirements Exact and reproducible dosing Low friction forces and low wear Application of an abrasion-free scale Lowest emissions Solution Hostaform MT and Celanex MT PBT for highest precision and low creep behavior Slide and wear tests with customer specific parameters Lasermarkable Hostaform for white letters on black background color Hostaform MT for highest purity Hostaform MT POM Celanex MT PBT Vectra MT LCP 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 21
Applications: Diabetes Care Insulin Pens Requirements Good slide and wear properties Precision Abrasion-free lasermarking Low creep behavior Lowest emissions Hostaform C 9021 10/9005 Laserblack 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 22
Applications: Dry Powder Inhaler Requirements Precise dosing No reaction of polymer with drug Low actuating forces Squeak-free operation No animal origin additives Food compliant Drug Master File listing (DMF) Solution Hostaform MT POM Celanex MT PBT Vectra MT LCP Tight partnership between designer, pharma company and manufacturer achieves a quick time-to-market Hostaform MT POM and Celanex MT PBT with additional tests per lot 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 23
Applications: Dry Powder Inhaler Requirements Good slide and wear properties Precision Food compliant Drug Master File (DMF) listing Minimal emissions Long-term supply Hostaform MT8U01 Celanex 2401 MT 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 24
Applications: Dry Powder Inhaler Requirements USP 23 Class VI Low coefficient of friction High precision Creep resistance Resilience Celcon MT24U01 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 25
Applications: Surgical Instruments Requirements Multiple-use applications with repeated sterilization High mechanical loads Use of different disinfectants Biocompatibility to human tissue Solution Vectra MT LCP and Fortron MT PPS with high resistance against gamma, e-beam and heat sterilization Vectra MT LCP for thin-wall molding with high stiffness Outstanding chemical resistance to a wide range of disinfectants USP Class VI / ISO 10993 tests done on polymer accordingly Fortron MT PPS Vectra MT LCP 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 26
Applications: Surgical Instruments Requirements Very good chemical resistance to many different chemicals Stable mechanical properties after numerous sterilizations Good adhesion to metal inserts Compliant to USP and ISO standards Very good creep behavior Forceps Fortron MT 9140 L4 black 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 27
Applications: Surgical Instruments Requirements Flow in thin, long wall sections High strength in thin walls to resist deformation during staple closure Precise dimensions to position staple perfectly Reproducibility FDA Sterilizability Colorability Stapler Cartridges Vectra A130 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 28
Applications: Surgical Instruments Requirements High stiffness and strength Good chemical resistance Stable mechanical properties after numerous sterilization cycles Rib Spreader Blocks and Blades Vectra A130 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 29
Applications: Fiber Applications Application Conveyor for paper production Blood filter Purification filter Result Celanese polymers for several technologies: Monofilaments Multifilament Staple fibers Meltblown nonwovens Spunbond nonwovens Adjustment of Celanese polymers to the processing conditions of the customer Hostaform MT POM Celanex MT PBT Vectra MT LCP Fortron MT PPS 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 30
Applications Fiber Applications Reasons for Celanex PBT Meltblown process Outstanding flowability FDA- and EU-Food compliance Biocompatibility Easy modification of surface Excellent mechanical and adhesive filter effect Case Study: Fresenius BioR Bloodfilter Celanex MT 2008 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 31
Applications: Miscellaneous Requirements FDA conforming USP 23 Class VI Creep resistance Resilience Sterilizable Clamps for Umbilical Cord Hostaform C 9021 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 32
Performance Driven Solutions Tribology Disposable syringes Inhalers Hose clamps Insulin pens, finger prickers,.. Gearwheels, couplings, bearing journals 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 33
Celanese Headquarters Florence, KY Physical Testing Laboratory Mechanical Major Tests: Tensile, flex, compression fatigue, friction Highlights: - Instruments/software - Robotic systems - Temperature capabilities Impact Major Tests: Izod, Charpy, Gardner, multiaxial impact, tensile impact Highlights: - Screening tools - Temperature capabilities - Non-routine techniques Physical Major Tests: Abrasion, color, yellowness, haze, gloss, hardness, density, specific gravity, water absorption Highlights: - Coordinated activities - Problem-solving tools DTUL Major Tests: Deflection temperature under load, Vicat softening temperature Highlights: - Centralized Celanese lab - Advanced capabilities to 350 C Electrical Major Tests: Arc resistance, comparative tracking index, dielectric constant/dissipation factor, dielectrics strength, surface/volume resistivity Highlights: - Screening tools - Unique capabilities Fibers/Films Major Tests: Low load mechanical testing of fibers, films and rods Highlights: - Small quantity samples - Low load sensitivity - Temperature capabilities - Non-routine techniques Aging Studies Major Tests: UL Heat Aging Studies Air, Water or Chemical aged Highlights: - Track how properties change with time and temperature Non-Routine Major Tests: Developed in collaboration with customers Highlights: - Versatile instrumentation - Knowledgeable operators - Powerful problem solving tool 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 34
Celanese Technical Service Offerings Application Development Support Celanese offers technical support for each stage of application development from concept through to commercialization Structural and mold filling analyses (CAE) Part and tool design, gating and material suggestions Material and testing laboratories Development molding laboratory (three injection machines): 110 ton (4 oz) Mannesmann Demag 250 ton (10 and 15 oz barrels) Engel 375 ton (20 oz) Cincinnati Milacron 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 35
Celanese Healthcare Market Expertise Celanese Advantages We have been successfully serving the healthcare technology market for close to 20 years. Celanese has developed USP Class VI Medical Technology resins. We strive to achieve strategic partnerships with the OEM and the converter reduces development time and cost. Celanese has been able to achieve a strong position in drug delivery systems (inhalers, insulin pens, etc.). We offer technical support (CAE Structural and Mold Filling Analysis, Development Engineering Support, Process Support, etc.). 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 36
Medical / Healthcare Market Celanese Support Thank you for your interest Let us know how we can help you further 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 37
Disclaimer 2014 Celanese or its affiliates. All rights reserved. This publication was printed based on Celanese s present state of knowledge, and Celanese undertakes no obligation to update it. Because conditions of product use are outside Celanese s control, Celanese makes no warranties, express or implied, and assumes no liability in connection with any use of this information. Nothing herein is intended as a license to operate under or a recommendation to infringe any patents. Celanese, registered C-ball design and all other trademarks herein with, TM, SM, unless otherwise noted, are trademarks of Celanese or its affiliates. Fortron is a registered trademark of Fortron Industries LLC. Contact Information Americas 8040 Dixie Highway, Florence, KY 41042 USA Product Information Service t: +1-800-833-4882 t: +1-859-372-3244 Customer Service t: +1-800-526-4960 t: +1-859-372-3214 e: info-engineeredmaterials-am@celanese.com Europe Am Unisys-Park 1, 65843 Sulzbach, Germany Product Information Service t: +(00)-800-86427-531 t: +49-(0)-69-45009-1011 e: info-engineeredmaterials-eu@celanese.com Asia 4560 Jinke Road, Zhang Jiang Hi Tech Park Shanghai 201203 PRC Customer Service t: +86 21 3861 9266 f: +86 21 3861 9599 e: info-engineeredmaterials-asia@celanese.com 2014 Celanese MED-005R1 AM 03/14 Celanese Healthcare Market and Applications 38