Silicone Solutions for Medical Device Applications Proven Performance. Trusted Expertise. Explore new frontiers in healthcare Medical care has made unprecedented advances in the last 30 years, and the new technology you are developing continues to transform healthcare. Innovation in material science is a key part of that transformation, and Dow Corning continues to be a source of innovative materials that help you discover new directions in medical device design. We offer a versatile portfolio of high-performance medical-grade silicone elastomers, adhesives and fluids — and the trusted, technical, process and regulatory expertise to help you select the right material for your application. Elastomers ■ High consistency rubbers ■ Liquid silicone rubbers Adhesives ■ Pressure sensitive adhesives ■ Soft skin adhesives ■ Curable adhesives for device bonding Coatings ■ Fluids and emulsions for coating and siliconization High Consistency Rubber (HCR) HCRs are millable thermoset silicone elastomers that can be extruded continuously to form a desired size and shape before curing. Silicone tubing is an example. Benefits Innovation Meets Expertise You want to explore new directions and create the next generation of medical device technology. You have a powerful ally with Dow Corning. When we are part of your team, you’re backed by our expertise and our culture of discovery and innovation, which has been nurtured by six decades of proven performance. You’ll find a depth of knowledge not just in silicone chemistry, but in the medical device industry, process technology and regulatory compliance. Product Description Typical Applications Two-part (1:1 by weight), platinum-catalyzed, enhanced tear-resistance silicone elastomers •Fabrication of molded medical/surgical/ diagnostic devices and components HCR Silastic® BioMedical Grade Elastomers •DMF (drug master file) access available upon request •Excellent batch-to-batch reproducibility for critical applications • Manufactured in a dedicated healthcare facility •Fabrication of extruded parts ® Silastic BioMedical Grade Bases •DMF (drug master file) access available upon request •Must add peroxide Two-part (1:1 by weight), platinum-catalyzed, enhanced tear-resistance silicone elastomers Dow Corning® C6 Series Elastomers •Highly reproducible and stable materials •Fabrication of extruded parts • Manufactured in a dedicated healthcare facility •Fabrication of molded medical/surgical/ diagnostic devices and components • Improved cost efficiency Dow Corning® C6 Series Elastomers One-part, high-consistency rubber base •Must add peroxide Dow Corning® QP1 Elastomers •Choice of cure systems (peroxide/platinum) • Manufactured under ISO quality system requirements •Fabrication of extruded parts One-part, high-consistency rubber base •Base, must add curatives Dow Corning® C6 Series Elastomers •Low hysteresis •Lower hysteresis for demanding applications (i.e. peristaltic pump tubing) Two-part (1:1 by weight), platinum-catalyzed, enhanced tear-resistance silicone elastomers •Fabrication of molded medical/surgical/ diagnostic devices and components •Fabrication of extruded parts •Fabrication of molded medical/surgical/ diagnostic devices and components Select European Pharmacopeia 3.1.9 Cytotoxicity Mutagenicity/Genotoxicity Hemolysis Skin Sensitization Pyrogenicity (USP) 90-Day Implant 30-Day Implant 7-Day Implant USP Class V and VI Substance Soluble in Hexane Volatile Matter Food Grade Compliance* Hardness, Shore A Tensile Strength (MPa/psi) Elongation at Break (%) Tear Strength, Die B (kN/m/ppi) Relative Density Biocompatibility Testing Silastic® Q7-4720 BioMedical Grade ETR Elastomer1 • • • • • • • • • • • • 23 8.9/1300 1310 31.6/180 1.11 Silastic® Q7-4735 BioMedical Grade ETR Elastomer1 • • • • • • • • • • • • 36 9.3/1350 1180 36.8/210 1.12 Silastic® Q7-4750 BioMedical Grade ETR Elastomer1 • • • • • • • • • • • • 50 10.0/1450 930 45.6/260 1.16 Silastic® Q7-4765 BioMedical Grade ETR Elastomer1 • • • • • • • • • • • • 65 8.0/1160 900 45.6/260 1.20 Silastic® Q7-4780 BioMedical Grade ETR Elastomer1 • • • • • • • • • • • • 77 7.8/1130 660 42.1/240 1.20 Silastic® Q7-4535 BioMedical Grade ETR Elastomer1, 2 • • • • • • • • • • • • 36 8.1/1180 830 24.6/140 1.12 Silastic® Q7-4550 BioMedical Grade ETR Elastomer1, 2 • • • • • • • • • • • • 48 9.3/1360 680 31.6/180 1.16 Silastic® Q7-4565 BioMedical Grade ETR Elastomer1, 2 • • • • • • • • • • • • 67 7.9/1150 620 38.6/220 1.20 Dow Corning® C6-135 Elastomer • • • • • • • • 36 8.2/1200 1120 35.1/200 1.12 Dow Corning® C6-150 Elastomer • • • • • • • • 50 10.6/1540 980 42.1/240 1.16 Dow Corning® C6-165 Elastomer • • • • • • • • 61 8.0/1170 940 42.1/240 1.21 Dow Corning® C6-180 Elastomer • • • • • • • • 77 7.2/1050 610 38.6/220 1.21 Dow Corning® C6-235 Elastomer2 • • • • • • • • 37 7.5/1100 810 21.1/120 1.12 Dow Corning® C6-250 Elastomer2 • • • • • • • • 49 8.2/1200 530 26.3/150 1.16 Dow Corning® C6-265 Elastomer2 • • • • • • • • 66 8.2/1200 560 35.1/200 1.20 Dow Corning® QP1-30 Silicone Elastomer3 • • • • 28 9.5/1390 790 12.3/70 1.09 Dow Corning® QP1-50 Silicone Elastomer3 • • • • 48 11.8/1720 545 15.8/90 1.13 Dow Corning® QP1-60 Silicone Elastomer3 • • • • 57 13.0/1890 535 21.1/120 1.16 Dow Corning® QP1-70 Silicone Elastomer3 • • • • 68 12.6/1835 470 24.6/140 1.20 Dow Corning® C6-350 LH Elastomer • • • • 49 8.5/1240 730 38.6/220 1.15 Products • • • • *Contact your Dow Corning representative for area-specific information Use of this material for implantation ≥ 30 days requires indemnification 1.0 parts Di(2,4-Dichlorobenzoil) peroxide compounded with 100 parts base molded 5 min at 115 °C (240 °F) 3 1.2 parts Di(2,4-Dichlorobenzoil) peroxide compounded with 100 parts base molded 5 min at 115 °C (240 °F) 1 2 Liquid Silicone Rubber (LSR) Innovation Meets Expertise You want to explore new directions and create the next generation of medical device technology. You have a powerful ally with Dow Corning. When we are part of your LSRs are pumpable thermoset team, you’re backed by our expertise and our culture silicone elastomers that can be of discovery and innovation, nurtured by six decades of processed by molding equipment. proven performance. You’ll find a depth of knowledge not They are ideal for intricate designs just in silicone chemistry, but in the medical device industry, and close-tolerance parts. process technology and regulatory compliance. Benefits Product Description Typical Applications LSR Silastic® BioMedical Grade Liquid Silicone Rubber • High-quality, consistent materials for critical applications • Manufactured in a dedicated healthcare facility Two-part (1:1 by weight), platinum-catalyzed, liquid silicone rubber materials •DMF (drug master file) access available upon request • Injection molding of precision and intricate parts of medical devices (O-rings, stoppers and closures) •Mesh or fabric coating • Improved molding performance • Formulated to significantly reduce mold fouling • Enhance throughput and limit cleaning and change-outs over time • Improved mechanical properties like tear strength and compression set • Highly reproducible and stable materials • Manufactured in a dedicated healthcare facility Two-part (1:1 by weight), platinum-catalyzed, liquid silicone rubber materials Dow Corning® C6 Series LSR • Improved molding performance • Injection molding of precision and intricate parts of medical devices (O-rings, stoppers and closures) •Mesh or fabric coating •Implantation applications ≤ 29 days • Formulated to significantly reduce mold fouling • Enhance throughput and limit cleaning and change-outs over time • Improved mechanical properties like tear strength and compression set • No need for post cure to stabilize physical properties • Manufactured in a dedicated healthcare facility • Formulated to reduce mold fouling, resulting in longer run times before cleaning •Less downtime and greater cost efficiency •Improved mold release •No need for post cure • No need for post cure to stabilize physical properties Two-part (1:1 by weight), platinum-catalyzed, liquid silicone rubber materials ® Dow Corning QP1 LSR • Injection molding of precision and intricate parts of medical devices (O-rings, stoppers and closures) •Mesh or fabric coating •Implantation applications ≤ 29 days • High batch-to-batch consistency means fewer adjustments • Low viscosity material flows into intricate molds at lower pressures • Wider process window • Shortens process cycle time • Formulated to significantly reduce mold fouling • Enhance throughput and limit cleaning and change-outs over time • Greater molding consistency Select European Pharmacopeia 3.1.9 Cytotoxicity Mutagenicity/Genotoxicity Hemolysis Skin Sensitization Pyrogenicity (USP) 90-Day Implant 30-Day Implant 7-Day Implant USP Class V and VI Substance Soluble in Hexane Volatile Matter Food Grade Compliance* Hardness, Shore A Tensile Strength (MPa/psi) Elongation at Break (%) Tear Strength, Die B (kN/m/ppi) Relative Density Biocompatibility Testing Silastic® 7-6830 BioMedical Grade Liquid Silicone Rubber1 • • • • • • • • • • • • 30 8.8/1280 790 24.1/140 1.13 1 Products • • • • • • • • • • • • 40 9.8/1430 700 36.8/210 1.13 Silastic® Q7-4840 BioMedical Grade Liquid Silicone Rubber1 • • • • • • • • • • • • 44 9.4/1370 540 36.8/210 1.12 1 Silastic Q7-4850 BioMedical Grade Liquid Silicone Rubber • • • • • • • • • • • • 50 10.1/1470 630 45.1/260 1.15 1 • • • • • • • • • • • • 60 8.8/1280 540 50.9/290 1.10 Silastic® 7-4870 BioMedical Grade Liquid Silicone Rubber1 • • • • • • • • • • • • 66 9.5/1380 420 47.4/270 1.15 Silastic® Q7-7840 BioMedical Grade Liquid Silicone Rubber1 • • • • • • • • • • • • 40 9.3/1360 750 30.7/175 1.14 ® 1 • • • • • • • • • • • • 50 9.0/1310 660 48.2/275 1.13 ® 1 Silastic Q7-7870 BioMedical Grade Liquid Silicone Rubber • • • • • • • • • • • • 67 9.4/1370 415 45.6/260 1.14 Dow Corning® C6-530 Liquid Silicone Rubber • • • • • • • • 30 8.2/1190 830 26.3/150 1.13 Dow Corning® C6-540 Liquid Silicone Rubber • • • • • • • • 40 8.9/1290 740 42.1/240 1.13 Dow Corning® C6-550 Liquid Silicone Rubber • • • • • • • • 50 10.4/1520 660 44.7/255 1.14 Dow Corning C6-560 Liquid Silicone Rubber • • • • • • • • 60 8.8/1280 540 50.9/290 1.10 Dow Corning® C6-570 Liquid Silicone Rubber • • • • • • • • 65 9.1/1320 440 54.4/310 1.15 Dow Corning® C6-740 Liquid Silicone Rubber • • • • • • • • • 40 8.6/1250 680 30.7/175 1.14 Dow Corning® C6-750 Liquid Silicone Rubber • • • • • • • • • 50 8.8/1280 610 42.1/240 1.13 Dow Corning® C6-770 Liquid Silicone Rubber • • • • • • • • • 67 9.3/1360 450 42.1/240 1.14 Dow Corning® QP1-20 Liquid Silicone Rubber • • • • • 20 5.6/810 650 18.4/105 1.12 Dow Corning QP1-30 Liquid Silicone Rubber • ▲ • • • 30 5.7/830 625 18.4/105 1.13 Dow Corning® QP1-40 Liquid Silicone Rubber • ▲ • • • 40 7.5/1090 580 31.6/180 1.14 Dow Corning® QP1-45 Liquid Silicone Rubber • ▲ • • • 45 7.8/1140 485 38.6/220 1.13 Dow Corning® QP1-50 Liquid Silicone Rubber • ▲ • • • 50 8.6/1260 510 41.2/235 1.13 Dow Corning® QP1-60 Liquid Silicone Rubber • ▲ • • • 60 9.6/1400 460 50.9/290 1.14 ® • ▲ • • • 68 9.7/1420 405 44.7/255 1.14 ® Dow Corning QP1-75 Liquid Silicone Rubber • • • • • 73 8.9/1300 400 15.8/90 1.16 Dow Corning® QP1-230 Liquid Silicone Rubber • • • • • 30 6.8/990 630 15.8/90 1.12 ® Silastic 7-6840 BioMedical Grade Liquid Silicone Rubber ® ® Silastic 7-4860 BioMedical Grade Liquid Silicone Rubber Silastic Q7-7850 BioMedical Grade Liquid Silicone Rubber ® ® Dow Corning QP1-70 Liquid Silicone Rubber Dow Corning QP1-240 Liquid Silicone Rubber • ▲ • • • 40 8.0/1160 540 36.8/210 1.11 Dow Corning® QP1-250 Liquid Silicone Rubber • ▲ • • • 50 8.2/1200 495 47.4/270 1.12 Dow Corning® QP1-260 Liquid Silicone Rubber • ▲ • • • 60 8.6/1400 390 50.1/290 1.12 • • • • • 68 9.5/1390 325 54.4/310 1.14 ® ® Dow Corning QP1-270 Liquid Silicone Rubber 1 Use of this material for implantation ≥ 30 days requires indemnification * Contact your Dow Corning representative for area-specific information ▲ Biocompatibility potential based on test data from analogous materials Adhesives Pressure sensitive adhesives (PSAs) and soft skin adhesives (SSAs) can be used for wearable monitoring devices, wound care products, medical device attachments, external prosthetic devices and specialty cosmetic applications. Benefits Innovation Meets Expertise You want to explore new directions and create the next generation of medical device technology. You have a powerful ally with Dow Corning. When we are part of your team, you’re backed by our expertise and our culture of discovery and innovation, nurtured by six decades of proven performance. You’ll find a depth of knowledge not just in silicone chemistry, but in the medical device industry and process technology. Product Description Typical Applications Processing Methods PSA • Biocompatibility (non-irritating and non-sensitizing) Dow Corning® MG Series Pressure Sensitive Adhesives for Medical Devices • High adhesion and conformity to skin One-part, polycondensed polydimethylsiloxane/silicate resin adhesives • Adhesion for extended wear time Volatile solvent-based silicone adhesives • High gas and moisture permeability • Available in a range of tack options, solvent types and solid contents to help meet application needs and processing constraints Uses conventional tape coating equipment • Non-sensitizing adherence of medical devices/appliances (colostomy, ileostomy, surgical dressings/pads, external prosthetic devices and patient monitoring) One-part, polycondensed polydimethylsiloxane/silicate resin adhesive • Transfer coating • Brushing process Can be applied using conventional hot melt coating equipment Hot melt silicone adhesive Elastomer Dow Corning® Soft Filling Elastomer • Transparent • Low viscosity Two-part (1:1 by weight), platinum-catalyzed, soft fillerless elastomer • Filling material for external foam prostheses and pressure cushions Two-part (1:1 by weight), platinum-catalyzed, soft fillerless elastomeric adhesive • Non-sensitizing, gentle adhesion to skin (wound care and scar therapies) SSA Dow Corning® MG Series Soft Skin Adhesives • Transparent • Low viscosity Knife over roll coating process is recommended • Specification writers: These values are not intended for use in preparing specifications. Please contact a Dow Corning representative prior to writing specifications on these products. • Adhesion promoters are available. Please contact your Dow Corning representative for details. • • • • • • • • • 2000 Not Applicable 100 Not Applicable Melt Viscosity at 185 °C (cP) Solvent Type FDA Drug Master File System Toxicity Pyrogenicity (USP) 59 Not Applicable 30300 21 Medium 700 21 High 670 16 590 9 Very High 245-275 0.1 500 320 90 0.6 0.11 • 500 320 90 0.6 0.11 ▲ • 2900 2900 135 1.1 0.03 ▲ • 5100 5100 140 1.9 0.05 • • • Dow Corning® MG7-9800 Soft Skin Adhesive • • • Dow Corning® MG7-9850 Soft Skin Adhesive ▲ ▲ Dow Corning® MG7-9900 Soft Skin Adhesive ▲ ▲ Based on test results on adhesive solids on biocompatibility test data from analogous materials Ethyl Acetate Not Applicable 700 470 Dow Corning® MG7-9700 Soft Skin Adhesive ▲ Based 2500 Medium 470 • • Ethyl Acetate Shear (kg) • Peel Adhesion (g/cm) • Dow Corning® 7-9600 Soft Filling Elastomer 1 64 siloxane Not Applicable Nominal Tack Value Sensitive Adhesive1 90 • • • Release (N/2.5cm) Dow Corning® MG-2410 Silicone Pressure 32 Adhesion (N/2.5cm) Sensitive Adhesive1 Viscosity at 25 °C (cP) Dow Corning® MG-2502 Silicone Pressure methyldi- Penetration After Cure (mm/10) Sensitive Adhesive1 Solid Content (%) Dow Corning® MG-2402 Silicone Pressure • Viscosity Part B (mPa·s) Sensitive Adhesive • Hexa• Viscosity Part A (mPa·s) 1 Skin Sensitization Dow Corning® MG-2401 Silicone Pressure Skin Irritation Products Mutagenicity/Genotoxicity Cytotoxicity Biocompatibility Testing Not Applicable Contact Dow Corning Every day, you face complex challenges. Our global team of experts is ready to help with material, processing or regulatory issues. Let us know how we can help you at dowcorning.com/healthcare. Your Global Connection Dow Corning has sales offices and manufacturing facilities worldwide, as well as full-service, global technical support. Contact us today by visiting dowcorning.com/ContactUs. Images: AV22941, AV06729, AV20294, AV18539, AV13681, AV18540, AV12392, AV19192, AV02278, AV06484, AV06727, AV24799 LIMITED WARRANTY INFORMATION – PLEASE READ CAREFULLY The information contained herein is offered in good faith and is believed to be accurate. However, because conditions and methods of use of our products are beyond our control, this information should not be used in substitution for customer’s tests to ensure that our products are safe, effective and fully satisfactory for the intended end use. Suggestions of use shall not be taken as inducements to infringe any patent. Dow Corning’s sole warranty is that our products will meet the sales specifications in effect at the time of shipment. Your exclusive remedy for breach of such warranty is limited to refund of purchase price or replacement of any product shown to be other than as warranted. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, DOW CORNING SPECIFICALLY DISCLAIMS ANY OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY. DOW CORNING DISCLAIMS LIABILITY FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES. Dow Corning and Silastic are registered trademarks of Dow Corning Corporation. We help you invent the future is a trademark of Dow Corning Corporation. ©2016 Dow Corning Corporation. All rights reserved. AMPM390-15 Form No. 52-1225-01