S I L I C O N E S Wacker Silicones For Medical Confidential

Why Silicones? Extremely versatile polymer Excellent properties Used in multiple forms Proven in many markets and applications Industrial Textiles Transportation Construction Consumer Lubricants/Coatings Healthcare Electrical/Electronics Personal care …and many more Global and sustainable supply

Silicon (Si) Naturally occurring metalloid chemical element 8th most common element by mass 2nd 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

Silicone Polymers 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…

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

Medical Silicone Elastomers Silicone rubber: thermoset elastomer Covalent bonds between macromolecules form 3D polymer network One part polymers – vulcanized solid silicone elastomer Two part polymers – two part liquid silicone elastomer Cross-linking systems Condensation Radical initiated Addition Physical properties controlled by cross-link density Fillers reinforce cross-linked matrix (usually fumed silica)

Medical Market Channel Silicone Polymer Manufacturer Distributor Compounder Processor There are many potential players that make up the market channel for medical grade silicone. It is important to note however, that the market channel for thermoset elastomers is often vastly different than that of thermoplastic elastomers. The difference in the supply chain is due to the inability of thermoset polymers to be reprocessed under heat conditions, (such as melt compounding). Due to the chemical structure, silicone must be manufactured, functionalized and processed in a heat absent, viscous state prior to the formation of the final part. Therefore, this limits the number of players within the silicone market channel to those with thermoset compatible equipment and capabilities.   With that being said, the first player within the medical silicone market channel is the silicone polymer manufacturer, also known as the raw material supplier. Many polymer manufacturers offer functionalized (and in many cases custom) silicone polymers that have been tailored to have a range of hardness and flow, along with other characteristics, including colors and radiopacity. In many cases, these silicone materials are then sold directly to an extrusion processor, injection molder or original equipment manufacturer (OEM) in liquid, foam, gel or adhesive form without being further modified. Other players within this market channel include silicone distributors and compounders, who may blend the material with other polymers or ingredients to meet end application requirements. These intermediary suppliers will then distribute to the same three potential customers (extrusion processer, molding processor or OEM). The number of players comprised within the silicone market channel may vary based on end user requirements, as well as internal capabilities of both the raw material supplier and the OEM. Medical Device Manufacturer For Internal Use Only

Medical Silicone Elastomer Advantages Wide durometer range Low TG Hi Purity Chemically inert High molecular weight High permeability Intrinsic stability Sterilizable (steam, gamma, EtO) No extractables Low modulus Biocompatible Foamable Non-irritating/non-sensitizing Good elastomeric properties Clear High temperature resistance Good hemocompatability Non-allergenic No plasticizers

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

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

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

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

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)

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 17.04.2018 Silpuran® v. Elastosil® Product Selection SILPURAN should be selected if the application requires: Reference to a Device Master File at the FDA 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

Silpuran™ HCR Silicone Product Families

Silpuran® Products for Medical Devices 17.04.2018 Silpuran® Products for Medical Devices

Processing Silicone Elastomers Solid Silicone Rubber Liquid Silicone Rubber Extrusion  Coextrusion Compression Molding Transfer Molding Injection Molding Doctor Blade Calendaring Low-Pressure Filling

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