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

2. 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

3. 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

4. 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…

5. 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

6. 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)

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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
(Rubber articles intended for repeated use)

14. 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

15. Silpuran® v. Elastosil® Product Selection
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 !

16. Silpuran™ LSR Silicone Product Families

17. Silpuran™ HCR Silicone Product Families

18. Silpuran® Products for Medical Devices
Silpuran® Products for Medical Devices

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

20. Thank You !
Confidential