SILICONES Wacker Silicones For Medical Why Silicones Extremely
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SILICONES Wacker Silicones For Medical
Why Silicones? Extremely versatile polymer • Excellent properties • Used in multiple forms • Proven in many markets and applications • Industrial Transportation Consumer Healthcare Personal care • Page 2 Textiles Construction Lubricants/Coatings Electrical/Electronics …and many more Global and sustainable supply Confidential
Silicon (Si) • Naturally occurring metalloid chemical element 8 th most common element by mass 2 nd most abundant element in Earth’s crust after oxygen Very high melting point Excellent heat insulator Basis of synthetic silicon-based polymers (a. k. a. Silicone) • Silicates extensively in commercial applications Ceramics Glass Portland cement Concrete Semi-conductor electronics Page 3 Confidential
Silicone Polymers Page 4 • Frederick Kipping coined word term in 1901 • Inert synthetic polymer compound • Silicon + carbon, hydrogen, oxygen via chemical process • 2, 000+ forms: liquids, solids, semi-viscous, pastes, greases, oils… Confidential
Medical Grade Silicone Long history in medical and pharmaceutical applications • Tested for biocompatibility • USP Class VI ISO 10993 • Three categories Non-implantable Short term implantable Long term implantable • Key medical forms Elastomers Fluids Adhesives Gels Page 5 Confidential
Medical Silicone Elastomers • Silicone rubber: thermoset elastomer Covalent bonds between macromolecules form 3 D polymer network One part polymers – vulcanized solid silicone elastomer Two part polymers – two part liquid silicone elastomer • Cross-linking systems Condensation Radical initiated Addition • • Page 6 Physical properties controlled by cross-link density Fillers reinforce cross-linked matrix (usually fumed silica) Confidential
Medical Market Channel Silicone Polymer Manufacturer Distributor Compounder Processor Medical Device Manufacturer Confidential
Medical Silicone Elastomer Advantages • • • Page 8 Wide durometer range Hi Purity High molecular weight Intrinsic stability No extractables Biocompatible Non-irritating/non-sensitizing Clear Good hemocompatability No plasticizers • • • Low TG Chemically inert High permeability Sterilizable (steam, gamma, Et. O) Low modulus Foamable Good elastomeric properties High temperature resistance Non-allergenic Confidential
Wacker Silpuran™ Silicone Elastomers • • Medical Grade Solid (HCR) and liquid (LSR) silicone rubber Biocompatible – inert; microbe growth resistant Biodurable – non degradable Good chemical resistance Sterilizable - single and multi use Good weathering resistance High transparency Confidential
Silpuran™ Medical Silicones - Purity • Excellent purity – filled/packaged in clean rooms (class 8) • LSR mixing in dedicated clean room (restricted access) • 50 micron filtering (individually sealed strainer sieves) • HCR grades packaged in antistatic in-liner (sealed to avoid contamination) • Specially trained staff to minimize contamination Confidential
Silpuran™ Medical Silicones - Care • Good Manufacturing Practices (GMP) operations • Batch to batch consistency • Batch records and histories • Change control management • Highest product safety standards • Individual control of shipping units before entering cleanroom • Visual control during manufacturing process • Reference to a device Master File at the FDA Confidential
Silpuran™ Medical Silicones - Quality • Wacker ISO certifications ISO: 2008 ISO 14001: 2004 • Plant management responsible for cleanroom standard • Integrated process control system • Annual qualification of clean room class • Annual FMEA and implementation of measures • Customers informed of product spec. changes Confidential
Silpuran™ Certifications • Biocompatibility testing USP Class VI ISO 10993 • Compliance with EU Pharmacopoeia 3. 1. 9 (Silicone elastomers for closures and tubing) • Suitable for food contact requirements of FDA CFR 21 177. 2600 (Rubber articles intended for repeated use) Confidential
Silpuran® v. Elastosil® Product Selection USP Class VI and ISO 10993: All SILPURAN grades meet these standards. Testing was done on each grade / durometer and paperwork references specific product / durometer. Many ELASTOSIL grades meet these standards. Testing was done on one durometer for each series with results extended to all durometers. Device Master File at FDA: SILPURAN products supported ELASTOSIL products no longer supported / available
Silpuran® v. Elastosil® Product Selection SILPURAN should be selected if the application requires: a) Reference to a Device Master File at the FDA b) Products specifically designed for Healthcare needs If neither a or b apply, then ELASTOSIL or SILPURAN can be selected Always talk with us to decide which material family is the best option for new opportunities !
Silpuran™ LSR Silicone Product Families Confidential
Silpuran™ HCR Silicone Product Families Confidential
Silpuran® Products for Medical Devices Confidential
Processing Silicone Elastomers Processing Liquid Silicone Rubber Extrusion Coextrusion Compression Molding Transfer Molding Injection Molding Doctor Blade Calendaring Low-Pressure Filling Page 19 Solid Silicone Rubber
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