NEW PRODUCT
PRODUCT INFORMATION SHEET

APPLIED SILICONE CORPORATION 

FLUOROSILICONE DISPERSION IN PCE/BA, IMPLANT GRADE

A membrane is generally formed by coating processes such as dipping, casting, spraying, knife coating, or brushing.  After evaporation of the solvent, the silicone is cured by application of heat and a strong, elastic membrane is formed.

This product is supplied either as a one-part, ready to be used catalyzed dispersion, or as a two-part product (silicone-solvent mixture) and a silicone cross-linking compound.

This dispersion is designed to exhibit high thixotropy providing exceptional build at low processing viscosities.

This material is intended for long term medical contact or implantation.  Manufacturing of this material is performed under stringent quality control that is fully traceable per ISO 9001. 

Applied Silicone recommends that product designers using this material contact Applied Silicone Corporation's Regulatory Affairs to determine what test results are available before incorporating this material into a medical device.  the user of this material must independently determine that any medical product incorporating this material is safe and effective.

The one-part product is shipped ready to use.  For the two part-system, the recommended ratio mixture is is 2.7 grams of crosslinker per 1000 grams of 18% solids (1.5 parts crosslinker per 100 parts solids).  The use of improper solvent mixtures may lead to partial insolubility and coagulation of dispersion.  Dilute in 95% PCE and 5% BA, if necessary. The dispersion-crosslinker mixture can then be applied to a mold or substrate.

When multiple coats are applied, most of the solvent should be evaporated before a subsequent coat is applied.  Typically, rapid air circulation readily removes solvent vapors.  The ambient temperature should not exceed 30°C to prevent bubbling.  High humidity combined with evaporative cooling can lead to water condensation at the surface.

After the last coat is applied and most of the solvent has evaporated, the material is cured by application of heat.  Time and temperature requirements will be dependent on the particular application and should be determined by the user.  As a guideline, thirty minutes at 130°C is recommended.

A Material Safety Data Sheet (MSDS) is supplied with the shipment. The dispersion contains the solvent perchloroethylene which a health hazard. The dispersion should not come into contact with eyes, skin, or clothing.  Care must be taken to limit employee exposure to solvent vapors.  Use dispersion with adequate ventilation.  Keep away from open flame, sources of sparks and heat.  When transferring dispersion, ground all vessels.  The user is urged to be familiar with the properties of perchloroethylene and butyl acetate.

Since contamination can result in an unreliable cure, it is important to avoid contamination of the product, any containers which hold it, and any material to which it is applied.  Certain materials such as tin, sulfur and amine compounds will cause inhibition or neutralization of the curing agent.  Never use latex gloves to handle this material.

Applied Silicone Corporation warrants that this product shall meet applicable specifications and descriptions for a period of six months from the date of shipment when supplied uncatalyzed and stored in the original sealed container below 30°C.

The dispersion is a health hazard and must be stored and transported in accordance with applicable federal, state, and local regulations.

The dispersion is available in 1-gallon cans, 5-gallon cans, and 55-gallon drums. The crosslinker is packaged separately in glass or plastic bottles. Suggested retest date of the two-part system: Six months from the date of shipment.

Upon request, this product can be supplied with the crosslinker added at the factory.  Suggested retest date of this one-part system: Six weeks. 

Applied Silicone Corporation warrants that this product meets applicable descriptions and specifications for a period of six months from shipment. No other warranties, expressed or implied, are intended. This product was designed for sophisticated users. The user must carefully review literature for uses where adverse effects are reported for certain applications of silicone in medical devices. The user of this material must independently determine that any product incorporating this material is safe and effective. The user of this material must thoroughly test any application consistent with industry requirements and/or standards.  Applied Silicone Corporation disclaims any expressed or implied warranty against the infringement of any patent. Any suggestion of use by Applied Silicone should not be taken as inducement to infringe on any particular patent.

 Revised 12.17.02