ADVANCED MEDICAL POLYMERS FOR THE LIFE OF YOUR PROGRAM Medical Product Portfolio 1
OUR MEDICAL TECHNOLOGY POLYMERS MT PORTFOLIO OFFERS DESIGN FREEDOM AND ADVANCED PERFORMANCE Offering advanced polymer solutions in such diverse areas as diagnostics, orthopedic implants, medical supplies and drug packaging and delivery, we provide a wide range of solutions for your medical product development program. We back up our high-performance products with comprehensive support in design assistance, analytical testing, finite element modeling and Moldflow analysis. Our MT polymers have available Drug and Device Master Files, USP Class VI and ISO 10993 biocompatibility to help support your regulatory approvals. As a trusted global leader in medical technology polymers, we offer total solutions with global reach, local resources, design and application development support, and over 40 years of technical expertise in the medical industry. Celanese enables you to outpace the exacting demands of today s medical products with advanced engineered materials. A portfolio of advanced engineered polymer solutions Manufacturing and long-term supply guarantee Extensive research and development capabilities Processing guidance and support Design and Regulatory Support Strong History of Material Innovations for Medical Products Celanese high-performance MT polymers are robust, easy to process and assure long-term performance, retaining precise dimensions in even the most intricate components. Our polymer benefits include high mechanical properties and resistance to chemicals, with many grades designed to withstand sterilization by usual methods. Couple that with the ability to reduce total manufacturing costs by consolidating multiple parts into a single unit, and you ve got a solid material advantage in all things medical. Responsibility, Commitment and Understanding We are a trusted and reliable development partner to the medical industry with a long-term supply commitment to provide advanced high-quality and biocompatible polymer technologies with superior dimensional stability, mechanical properties, chemical resistance and ease of processing, backed by unmatched technical expertise. High product purity Consistent formulation Long-term supply assurance Change management Production according to GMP principles Drug and Device Master File listing Food contact compliance (FDA and EU) Biocompatibility Free from additives derived from animal sources Not available on some grades Not available on some grades 2 3
Celanese Engineered Materials for Medical Applications Material Description Typical Medical Applications Grade Description Hostaform MT and Hostaform acetal copolymer (POM) Thermally stable High chemical resistance Excellent impact resistance Suitable for repeat steam sterilization cycles Sliding properties High hardness and rigidity Spring properties 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) Ideal sliding and Drug delivery systems wear behavior Metal gear replacement High dimensional stability Functional parts with high dimensional Good chemical resistance to precision and stability polar and non-polar solvents Tribological systems Gamma-resistance up to 50kGy Sliding mechanisms Snap fittings Clips and clamps GUR ultra-high molecular weight polyethylene (UHMW-PE) Extremely high impact strength Acetabular liners for THA Low coefficient of friction Tibial inserts for TKA Extremely high abrasion resistance Bearing components for shoulder High strength and other joints Gamma stable for crosslinking Endoprosthetics and sterilization Cervical disks for spine Fortron MT polyphenylene sulfide (PPS) High dimensional stability Excellent chemical resistance Heat resistance up to 240 C Gamma, EtO and Steam Sterilizable Suitable for repeat steam sterilization cycles Vectra MT liquid crystal polymer (LCP) Extremely high rigidity in thin walled designs High impact strength Very high heat resistance Suitable for repeat steam sterilization cycles High dimensional stability Replication of very fine parts with extremely high precision Surgical instrumentation trays Metal replacement Nonwovens used for filtration Surgical instrumentation Surgical stapler cartridges Dental devices trays Pharmaceutical packaging Complete air and moisture barriers Integrated 3D circuits Thin-Wall Sections or Long Flow Lengths Thick-Wall Section Parts Excellent Impact Resistance High Strength with Flexibility High Strength with Rigidity High Elongation at Yield >6% 25% Very Low Friction or Noise Hostaform MT and Hostaform acetal copolymer (POM) MT 2U01 Stiff flowing for extrusion and thick walled parts MT 8U01 Standard flow, unfilled MT U01 Easy flow, unfilled MT U03 Easy flow, unfilled, increased stiffness MT 24U01 Very easy flow, unfilled MT 8R02 Standard flow, slip modified Tribological MT R01 Easy flow, slip modified Tribological MT 8F01 Standard flow, PTFE modified Tribological MT 8F02 Standard flow, PTFE modified Tribological MT 24F01 Very easy flow, PTFE modified Tribological MT 8U05 Standard flow, fluoresces under UV light UV Visibility MT SlideX 03 Standard flow with tribological modification Tribological MT SlideX 2404 Easy flow with tribological modification Tribological High Dimensional Stability High Temperature Operation HDT >100 C HDT >200 C Cryogenic Operation ETO Gamma Steam EU Food Contact US Drug/Device Masterfile USP Class 6 Biocompatibility ISO 10993 Barrier Properties Coloration Injection Molding Compression Molding Extrusion Film Production Machining Special Applications Celanex MT and Celanex thermoplastic polyester (PBT) 2401 MT Standard flow unfilled Gamma Resistant 2402 MT Easy flow unfilled Gamma Resistant 2404 MT Standard flow, PTFE modified Tribological 2405 MT Standard flow, slip modified Laser marking Gamma Resistant and Tribological Black with white marking Laser Markable White with black marking Laser Markable GUR ultra-high molecular weight polyethylene (UHMW-PE) 1020 Implant grade Tribological 1050 Implant grade Tribological 1020-E Implant grade + vitamin E Tribological 1050-E Implant grade + vitamin E Tribological Fortron MT polyphenylene sulfide (PPS) MT 9140L4 Standard flow, 40% glass fiber filled MT 9140L6 Easy flow, 40% glass fiber filled MT 9320C0 Unfilled high viscosity Vectra MT liquid crystal polymer (LCP) MT 1300 Unfilled MT 1310 Glass fiber filled MT 4310 Easy flow + glass fiber MT 4350 Easy flow with mineral filler MT 1335 Glass fiber + PTFE KEY: Excellent Match Good Match Possible Match Not Appropriate Contact us for recommendations 4 5
Celanese Medical Products Data Sheet HOSTAFORM POM HOSTAFORM POM CELANEX PBT MT 2U01 MT 8U01 MT U01 MT U03 MT 24U01 MT 8R02 MT R01 MT 8F01 MT 8F02 MT 24F01 MT 8U05 MT SlideX 03 MT SlideX 2404 2401 MT 2402 MT 2404 MT 2405 MT Density g/cm 3 ISO 1183 1.41 1.41 1.41 1.41 1.41 1.4 1.41 1.44 1.52 1.44 1.41 1.40 1.40 1.31 1.31 1.34 1.31 Volume melt flow index 10 min ISO 1133 2.2 8 24 8.5 Moisture absorption at 23 C until saturation % ISO 62 0.65 0.65 0.65 0.65 0.65 0.65 0.65 0.65 0.6 0.6 8.5 6 Tensile stress at yield (50mm/min) MPa ISO 527-2/1A 62 64 65 70 65 62 65 58 48 58 64 58 55 60 60 56 60 Tensile strain at yield (50mm/min) % ISO 527-2/1A 9 9 9 8 7.5 9 9 9 7 9 7 4 4 7 10 Tensile modulus MPa ISO 527-2/1A 2600 2850 2900 3100 2900 2700 2900 2600 2500 2600 2850 2650 2550 2600 2700 2600 2500 Charpy impact strength at 23 C kj/m 2 ISO 179/1eU 220 180 150 0 0 140 60 80 180 160 160 NB 135 Charpy ched impact strength at 23 C kj/m 2 ISO 179/1eA 8.5 6.5 6 6 5.5 8 6.5 5.2 4 4 6.5 6 5.5 6 5 3.3 5 Heat deflection temperature HDT/A (1.8 MPa) C ISO 75-1/2 101 104 106 107 106 82 102 102 98 100 104 93 90 55 60 55 50 Heat deflection temperature HDT/B (0.45 MPa) C ISO 75-1/2 150 160 Vicat softening point VST/B/50 C ISO 306 151 150 151 158 151 151 145 146 150 151 144 190 190 190 190 Consumer articles regulations and BfR recommendations yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes FDA regulation CFR Vol. 21 177 /Food contact ification FCN 2470 2470 2470 2470 2470 2470 2470 2470 2470 2470 2470 2470 1660 1660 1660 1660 Drug Master File (DMF) 11559 11559 11559 11559 11559 11559 11559 11559 11559 11559 11559 11559 Device Master File (MAF) 1079 1079 1079 1079 1079 1079 1079 1079 1079 1079 1079 1079 21 8 13 25 20 40 21 19 10033 1) 10033 1) 10033 1) 10033 1) 10047 2) 10047 2) 10047 2) 10047 2) 1078 1) 1078 1) 443 2) 443 2) 1078 1) 443 2) 1078 1) 443 2) USP Class VI yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes Cytotoxicity yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes Ethylene oxide Superheated steam 1/134 C Gamma radiation German Federal Institute for Risk Assessment German Federal Institute for Risk Assessment 6 7
Celanese Medical Products Data Sheet GUR UHMW-PE 1020 1050 1020-E 1050-E Density g/cm 3 ISO 1183 0.93 0.93 0.93 0.93 Volume melt flow index 10 min ISO 1133 NA NA NA NA Moisture absorption at 23 C until saturation % ISO 62 < 0.01 < 0.01 < 0.01 < 0.01 Tensile stress at yield (50mm/min) Tensile modulus MPa MPa ISO 527-1 and 527-2 19.0 19.0 19.0 19.0 ISO 527-1 and 527-2 680 600 620 580 Charpy impact strength at 23 C kj/m 2 ISO 179/1eU no break no break no break no break Charpy double ched impact strength at 23 C kj/m 2 ISO 11542-2 230 170 230 170 HDT/A (1.8 MPa) C ISO 75-1/2 42 42 42 42 Vicat softening point VST/B/50 C ISO 306 80 80 80 80 Consumer articles regulations and BfR recommendations yes yes yes yes FDA regulation CFR Vol. 21 177 / Food contact ification FCN 1520 (2.1; 2.2) 1520 (2.1; 2.2) yes yes Drug Master File (DMF) 10904 10904 10904 1520 (2.1; 2.2) 10904 1520 (2.1; 2.2) Device Master File (MAF) 588 588 588 588 USP Class VI yes yes yes yes Cytotoxicity yes yes yes yes Ethylene oxide Superheated steam 1/134 C Gamma radiation These products show no yield point. The number given is stress at 50% elongation. German Federal Institute for Risk Assessment Celanese Medical Products Data Sheet FORTRON PPS MT 9140L4 MT 9140L6 MT 9320C0 Density g/cm 3 ISO 1183 1.65 1.65 1.35 Reinforcing material glass fiber glass fiber without Concentration of reinforced materials Weight % Volume melt flow index ISO 3451, Part 1 40 40 0 10 min ISO 1133 NA NA NA Moisture absorption at 23 C until saturation % ISO 62 0.02 0.02 0.02 Tensile stress at break (5mm/min) MPa ISO 527-2/1A 195 195 90 Tensile strain at break (5mm/min) % ISO 527-2/1A 1.9 1.9 8 Tensile modulus (1mm/min) MPa ISO 527-2/1A 14700 14700 3500 Charpy impact strength at 23 C kj/m 2 ISO 179/1eU 53 53 Charpy ched impact strength at 23 C kj/m 2 ISO 179/1eU 10 10 HDT/B (0.45 MPa) C ISO 75-1/2 HDT/C HDT/C HDT/C Consumer articles regulations and BfR recommendations yes yes yes FDA regulation CFR Vol. 21 177 / Food contact ification FCN FN 40 FN 40 FN 40 Drug Master File (DMF) 14844 14844 14844 Device Master File (MAF) 1097 1097 1097 USP Class VI yes yes yes Cytotoxicity yes yes yes Ethylene oxide Superheated steam 1/134 C / / / Gamma radiation German Federal Institute for Risk Assessment 8 9
Celanese Medical Products Data Sheet VECTRA LCP MT 1300 MT 1310 MT 4310 MT 4350 MT 1335 Density g/cm 3 ISO 1183 1.40 1.62 1.61 1.74 1.620 Reinforcing material without glass fiber glass fiber mineral filled glass/ptfe Concentration of reinforced materials Weight % Volume melt flow index ISO 3451, Part 1 0 30 30 40 35 10 min ISO 1133 NA NA NA NA NA Moisture absorption at 23 C until saturation % ISO 62-4 0.003 0.04 0.03 0.005 Tensile stress at break (5mm/min) MPa ISO 527-2/1A 182 190 150 105 171 Tensile strain at break (5mm/min) % ISO 527-2/1A 3.4 2.1 1.6 3.2 3.3 Tensile modulus MPa ISO 527-2/1A 10600 15000 15000 9800 11000 Charpy impact strength at 23 C kj/m 2 ISO 179/1eU 267 33 43 58 38 Charpy ched impact strength at 23 C kj/m 2 ISO 179/1eA 95 26 22 6 26 HDT/A (1.8 MPa) C ISO 75-1/2 187 235 276 230 230 HDT/B (0.45 MPa) C ISO 75-1/2 250 250 Vicat softening point VST/B/50 C ISO 306 145 160 195 195 146 Consumer articles regulations and BfR recommendations yes yes yes yes yes FDA regulation CFR Vol. 21 177 / Food contact ification FCN FCN 103 FCN 103 FCN 103 FCN 103 FCN 103 Drug Master File (DMF) 8464 8464 8464 8464 8464 Device Master File (MAF) 315 315 315 315 315 USP Class VI yes yes yes yes yes Cytotoxicity yes yes yes yes yes Ethylene oxide Superheated steam 1/134 C Gamma radiation Full Regulatory Support Celanese understands the increasing regulatory demands found throughout the global medical market and can help provide solutions that comply with all necessary requirements. Our regulatory support is designed to provide you with what is needed to comply with the required regulatory demands and thereby shorten your time to market. Our available MT polymers include: US FDA Drug and Device Master Files USP Class VI Certifications ISO 10993 Biocompatibility Food Contact Compliance US/EU RoHS Manufactured without animal-derived additives, phthalates, and latex REACH compliant Stable, Secure Supply Commitment The medical industry demands long-term security of supply and Celanese delivers. We are committed to longterm supply and security of supply with advanced change ification and change management processes. Benefits include: Stringent process controls with quality-centric focus Anti-counterfeiting technologies available No change formulations available Advanced Medical Polymers for the Life of Your Program Please contact our segment industry experts. We can help make material recommendations to overcome obstacles with polymer solutions for all industry segments: Implants Drug delivery Injection Inhalers Dry powder Metered dose Instruments and devices Catheters and tubing Caps, closures and packaging Global Availability with Local Support Contact us now and we ll help with your medical innovations and products celanese.com/engineered-materials Americas 800-833-4882 or info-engineeredmaterials-am@celanese.com Asia +86 21 3861 9266 or info-engineeredmaterials-asia@celanese.com Europe +(00)-800-86427-531 or info-engineeredmaterials-eu@celanese.com German Federal Institute for Risk Assessment 10 11
ENGINEERED MATERIALS celanese.com/engineered-materials 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 2003 PRC Customer Service t: +86 21 3861 9266 f: +86 21 3861 9599 e: info-engineeredmaterials-asia@celanese.com 2016 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 identified herein with, TM, SM, unless otherwise ed, are trademarks of Celanese or its affiliates. Fortron is a registered trademark o Fortron Industries LLC. MED-013-MedicalProductsPortfolio-Bro-EN-r1-0216