Celanese. Engineered Materials. Tapping Materials Innovation for New Product Development Opportunities Solving Unmet Needs in the Marketplace

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1 Celanese Engineered Materials Tapping Materials Innovation for New Product Development Opportunities Solving Unmet Needs in the Marketplace Don DeMello Field Development Engineer MD&M Philadelphia Oct

2 Outline Celanese overview Value of dedicated medical technology grades Semi-crystalline product families for medical devices Medical trend focus New low tribology solutions that deliver noise free & low friction ease of operation in drug delivery devices Medical trend focus - Lightweighting & space reducing polymer solutions enabling the next generation of wearable & portable devices Conclusions 2

3 Celanese Outline Overview 3

4 Celanese is a Global Technology and Specialty Materials Company Engineered Materials Specialty thermoplastics used in medical, automotive, electrical, electronics, more Acetyl Intermediates Acetic acid, vinyl acetate monomer, and additional intermediate chemistries Celanese is a company of world-class chemists, material and polymer scientists, engineers, operators and professionals across the globe Consumer Specialties Industrial Specialties Cellulose derivatives like acetate tow for filters Food ingredients including sweeteners, preservatives EVA polymers for flexible packaging, medical solutions, drug delivery Emulsion polymers for paint, adhesives, nonwovens, carpets

5 Celanese Engineered Materials in Medical Global leader in medical engineering polymers Drug Delivery Devices Inhalers Injection devices Implants and implanted devices Surgical instruments Decades experience supplying to highly regulated medical devices 20 years in drug delivery devices GUR UHMW-PE in orthopedic implants for almost 50 years Market needs based technology development Longterm commitment necessary for medical device markets 5

6 Engineered Materials Medical Application Examples Insulin pens (POM, PBT, LCP) Dry powder inhalers (POM, PBT, LCP, PPS) Artificial hip joints (UHMW-PE) Surgical instruments (PPS, LCP) Safety syringes (POM) Cannula disposal unit (POM, PBT) Diagnostics (POM, PBT, LCP) Surgical stapler cartridges (LCP) Orthotic component (UHMW-PE) Microelectronic devices (LCP) Polymers advance complex designs & manufacturing productivity

7 Value of Dedicated Medical Technology Grades 8

8 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 9

9 Material Flow from Raws to Consumer Change control agreements Technical support Raw materials Polymer supplier Molder/assembly Brand owner/oem Consumer Regulatory support Celanese medical grade materials are designed to meet quality and safety in the medical device industry 10

10 Advantages of Medical Technology Service Package Long-term supply assurance Management of Change - Two year notification of change commitment* Certified biocompatibility (USP 23 Class VI / ISO 10993, etc.) Food contact compliance (US FDA and EU) Animal and latex-free formulations US FDA Drug & Device Master file listing Production according to GMP principles Additional analytical & individual batch testing Expended certificate of inspection Support in regulatory approval process *requires customer QAC Reduce barriers to register your device Achieve a new level of proven material quality 11

11 Note on FDA Drug & Device Master Files In order to support customers in medical markets: We have performed pharmacopeia testing on our products and have set up Drug (DMF) and Device (MAF) Master Files at the FDA. File contains extensive information about our products: Exact formulations Where/how manufactured All toxicology studies Upon customer request, we authorize FDA personnel to review our files to support the customers applications. 12

12 Semi-Crystalline Product Families for Medical Devices 13

13 Service temperature Semi-Crystalline Resins for Medical Devices High-Performance Polymers (HPP) (TI 1 > 150 C) Engineering Polymers (ETP) (TI C) Basic Polymers TI 1 = Temperature Index Amorphous Semi-crystalline Engineering Polymers LCP PPS PCT PET PBT PBT Alloy TPC-ET Elastomer POM UHMW-PE Long Fiber and Continuous Fiber Reinforced Thermoplastics LFRT CFR-TP Semi-crystalline resins for processability, chemical, mechanical, tribology 14

14 Applications: Diabetes Care Insulin Pens Requirements Exact and reproducible dosing Low friction forces and low wear Application of an abrasion-free scale Low emissions Solution Hostaform MT POM and Celanex MT PBT for high precision, low friction & low creep behavior Slide and wear tests with customer specific parameters Hostaform lasermarkable POM for white letters on black background color Hostaform MT POM Celanex MT PBT Vectra MT LCP 18

15 Applications: Dry Powder Inhalers 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) Minimal emissions Hostaform MT POM Celanex MT PBT Vectra MT LCP Solution Tight relationship among designer, pharma company and manufacturer achieves a quick time-to-market Hostaform MT POM and Celanex MT PBT with additional tests per lot 19

16 Medical Trend Focus New Low Tribology Solutions that Deliver Noise Free & Low Friction Ease of Operation in Drug Delivery Devices 22

17 Introduction to Hostaform MT SlideX POM Copolymer The growing market for medical drug delivery devices requires innovative material solutions which offer improved technical properties, easy processability and increased patient comfort The new Hostaform MT SlideX POM grades were developed in response to the market requirement for Hostaform POM grades with excellent sliding properties (low friction and wear) and low noise, for the development of complex mechanical drug delivery and lancing devices 23

18 Hostaform MT SlideX Video 24

19 Advantages of Hostaform MT SlideX for Low Tribology Devices Medical Technology service package & compliance Excellent performing medical POM grades with tribological modifier Two new grades: Hostaform MT SlideX 1203 (medium flow) Hostaform MT SlideX 2404 (high flow) Improved friction and wear performance versus POM, PET, PP and steel etc. Mechanical performance comparable to unmodified Hostaform POM Low noise during sliding due to low stick-slip phenomenon Non-migrating tribological additive No running-in effects (works smoothly from the first movement) Low breakaway forces Suitable for dry run applications (no further lubrication necessary) Potential benefit where mold deposit issues exist Non-squeaking POM/POM possibilities Elimination of post siliconization process 25

20 How Do We Test For Friction? Stick-Slip Test Equipment Ball on Plate Configuration F N : normal force = 5-30N A: surface area a: acceleration F R : friction force F H : static friction force v r : sliding speed = 1-10mm/s F N a, F R, F H Checked with: C&E matrix Gage R&R Control chart A v r 26

21 coefficient of friction Stick-Slip Test Ball-on-Plate Configuration Typical cycle of Stick-Slip test Static & dynamic coefficient of friction / F = 12.5 N Static CoF Dynamic CoF POM vs. POM Stick Slip, Noise mm/s 2 mm/s 1 mm/s cycles sliding speed 27

22 coefficient of friction Stick-Slip Test Ball-on-Plate Configuration Typical cycle of Stick-Slip test Static & dynamic coefficient of friction / F = 12.5 N Static CoF Dynamic CoF POM vs. POM 0.2 POM vs. PBT 0 8 mm/s 2 mm/s 1 mm/s cycles sliding speed 28

23 coefficient of friction Hostaform MT SlideX 1203 is on a Similar Level as External Siliconization Typical cycle of Stick-Slip test Static & dynamic coefficient of friction / F = 12.5 N 0.20 Static CoF Dynamic CoF 0.15 POM vs. itself POM vs. itself + silicone oil direct lubrication 0.00 POM vs. MT Slidex cycles v = 2 mm/s (surface effects, 20 cycles) v = 8 mm/s (running-in effects, 130 cycles) Long-term performance Potential material to be used without external lubrication 29

24 Coefficient of Friction Stick-Slip Test Ball-on-Plate Configuration Hostaform MT SlideX 1203 vs Thermoplastics & Metals F = 30 N, v = 8 mm/s, Cycles = 850, T = 23 C Static CoF Dynamic Cof Low coefficient of friction for a wide range of plastics and metals 30

25 Width of abrasion in mm Stick-Slip Test Ball-on-Plate Configuration Unmodified Hostaform (ball) vs Various Hostaform MT grades (plate) F = 30 N, v = 8 mm/s, after 1000 cycles POM + PTFE POM + PTFE MT SlideX 2404 POM slip modified POM unmodified 0 3 MT SlideX Dynamic coefficient of friction POM slip modified Noise Rating no noise risk (1-3) low noise risk (4-5) high noise risk (6-10) Excellent performance at low sliding speed: Low friction and no noise risk with Hostaform MT SlideX grades 31

26 Hostaform MT SlideX 1203 Tribological Test Results Block-on-shaft test of Hostaform POM slip & wear grades Abrasion volume relative to unmodified POM Test Conditions Material shaft: Steel Shaft diameter: 65 mm Roughness Rz: 0,8 µm Load F N. : 3,1 N Sliding velocity: 136 m/min Test duration: 60 h Distance: Ca. 490 km MT Slidex 1203 POM MT + 8F02 PTFE C9021 POM + + 2% 2% Silicone Oil MT POM 8U01 Oil Lowest wear rates of Hostaform MT SlideX 1203 at high sliding speed 32

27 m Breakaway Force First movement of two compressed plastic surfaces to overcome the static friction 0.45 Static friction (breakaway force) MT 8U01 POM vs POM vs. MT 8U01 MT 8U01 POM vs POM vs. MT 8F02 + PTFE MT 8U01 POM vs MT vs. MT Slidex 2404 SlideX MT 8U01 POM vs MT vs. MT Slidex 1203 SlideX E sliding velocity [m/s] Hostaform MT SlideX 1203 exhibits lowest breakaway force 33

28 Medical Trend Focus Lightweighting & Space Reducing Polymer Solutions Enabling the Next Generation of Wearable & Portable Devices 34

29 Value of Liquid Crystal Polymers in Compact & Lightweight Medical Devices Designers are looking for advanced polymer solutions to pack more technology into tighter and lighter spaces for patient comfort and concealment LCPs are valuable for patch pump designs, diagnostic devices, insulin pen internals, surgical staple cartridges & instruments Vectra LCP polymers are a natural fit for pushing the envelope on thin wall designs to free up more internal space without sacrificing product strength, stiffness, and dimensional control LCP resins increase in strength & stiffness with thin wall designs due to their unique rod-like molecular orientation Due to their extreme shear flow behavior, complex thin wall designs that can t be filled with other resins can be filled with LCP Thin wall design enables fast cycle times for higher productivity & reduced material use, important for single/limited use products 35

30 LCP vs Semi-Crystalline Morphology Nematic Liquid Crystal Random Coil Melt LCP Semi-Crystalline Solid State Extended Chain Structure High Chain Continuity High Mechanical Properties Inherent Property Anisotropy Lamellar Structure Low Chain Continuity Lower Mechanical Properties LCP maintains same molecular order in both the melt & solid phase 36

31 Liquid Crystal Polymers are Very Unique in the World of Engineering Resins Melting range rather than a sharp melting point and very low heat of fusion resulting in low cycle time for molding productivity High chain continuity, ordered molecular structure in both melt & solid phase Flows extremely well under shear within the melting range Inherently flame resistant without need for FR additives Food contact compliant, suitable for medical biocompatibility with MT grades High heat deflection temperatures up to 340 C Reinforcement reduced anisotropy increases load bearing capability Excellent barrier property to oxygen and moisture, one of the best resins Excellent chemical resistance Sterilizable: steam, EtO, gamma, H2O2 plasma 37

32 30% GF LCP Spiral Flow vs Other 30-40% GF Resins LCP, E series PPS PCT PPA PET FR Spiral Flow (Inches) Each molded at manufacturer s recommended conditions and three injection pressures normalized to 30K psi. Cavity thickness = in. Higher flow = thinner walls and complex parts 38

33 Flow Length (mm) LCP Molding How Shear Helps Flow Injection Speed vs. Flow Length (0.1 mm Test Bar) Injection speed is a function of shear Low MV at high shear Long flow length Minimize filling pressure LCP 30%GF E series PPS 40% GF Injection Speed (mm/sec) 39

34 Flex Modulus, MPa Paradigm Shift How Design Can Change Material Properties Flex Modulus vs. Wall Thickness % GF LCP E series Thickness, mm 40

35 Tensile strength, MPa Paradigm Shift How Design Can Change Material Properties Mechanical properties are proportionally better in thinner wall sections than thick ones. Effect of wall thickness on strength for 30%GF LCP, E series mm 3.2mm 1.6mm 0.8mm 0.7mm 0.6mm Test bar thickness Push your designs further, thin walls can improve mechanical properties 41

36 Laser Direct Structuring Technology Selective metallization of thermoplastic injection molded parts by Laser-Direct- Structuring (LDS) Manufacturing process that combines the speed, precision and flexibility of the laser with the benefits of a short and economically advantaged process chain: 3 step process: Application Example Hearing Aids Photo: Siemens LDS Process Requirements: Thin wall Selective plating Micro structure Material: Vectra LDS LCP 3D form factor Component rationalization 43

37 Conclusions 44

38 Product Development Support Accelerate Your New Product Introductions New Product Opportunity Generation Prototype Part Design Testing Modeling & Simulation Part Validation Use your resin supplier s polymer expertise and application experience to help optimize designs for high performance, early and often in the development timeline 46

39 Summary Celanese offers Broad medical material portfolio for drug delivery devices Supported by technical experience, mechanical & regulatory data New Hostaform MT SlideX POM Best performing medical POM grades with tribological modifier Mechanical performance comparable to unmodified POM Vectra MT LCP for lightweighting & thinwall wearable devices Medical grade LCP that improves in strength & stiffness for <1mm thick parts Extreme flow, low mold shrink for complex designs with tight tolerance requirements Successful medical device design is enhanced by Examining component interactions & material options at concept or early design stage Material knowledge and custom technical data to help designers push performance Early collaboration of OEM/design house + molder/contract manufacturer + resin supplier Selecting the most appropriate medical grade materials for complex mechanical drug delivery devices early in the project can facilitate a successful launch and decrease risk of failure 47

40 Disclaimer 2015 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 222 W. Las Colinas Blvd., Suite 900N, Irving, TX USA Product Information Service t: t: Customer Service t: t: e: info-engineeredmaterials-am@celanese.com Europe The New Atrium, 6th floor, Strawinskylaan ZX Amsterdam, The Netherlands Product Information Service t: +(00) t: +49-(0) e: info-engineeredmaterials-eu@celanese.com Asia 4560 Jinke Road, Zhang Jiang Hi Tech Park Shanghai PRC Customer Service t: f: e: info-engineeredmaterials-asia@celanese.com 48

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