SILICONES Wacker Silicones For Medical Why Silicones Extremely

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SILICONES Wacker Silicones For Medical

SILICONES Wacker Silicones For Medical

Why Silicones? Extremely versatile polymer • Excellent properties • Used in multiple forms •

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

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

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

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

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 Market Channel Silicone Polymer Manufacturer Distributor Compounder Processor Medical Device Manufacturer Confidential

Medical Silicone Elastomer Advantages • • • Page 8 Wide durometer range Hi Purity

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

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

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

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

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

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

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)

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™ LSR Silicone Product Families Confidential

Silpuran™ HCR Silicone Product Families Confidential

Silpuran™ HCR Silicone Product Families Confidential

Silpuran® Products for Medical Devices Confidential

Silpuran® Products for Medical Devices Confidential

Processing Silicone Elastomers Processing Liquid Silicone Rubber Extrusion Coextrusion Compression Molding Transfer Molding Injection

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

Thank You !

Thank You !