Applied's Medical Implant Grade Responsive Silicone Gel System, PN 40004 is a two part system of pure silicone polymers designed for use in fabricating medical devices where softness, cohesiveness, and resiliency are desired. 

This product is supplied in two parts: base and crosslinker.  When mixed in the ratio of three parts by weight base to one part by weight crosslinker and cured by application of heat, a soft, responsive, and cohesive gel results.  The cured gel is clear, colorless, and odorless, and can be controlled within a limited range by varying the crosslinker/base ratio.  Heat cure cycles can be varied to suit the user's requirements.  Important characteristics include: 

• Suitable for gel filled devices
• Optically clear when cured
• Customer control of final products

This material was designed to pass USP Class VI and testing is based on the May 1993 FDA Guidelines Supplement to the CFR 90300204.  A sample from each manufactured lot is subjected to an MEM Tissue Culture test.  Additional testing is available on request. 

An FDA Master File reference including formulation, manufacturing methods, testing and toxicology is available. 

The users 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. 
 

This product was designed to be mixed in the ratio of 1.0 parts by weight crosslinker to 3.0 parts by weight base.  The firmness of the cured gel may be increased, i.e., a lower penetration value, by increasing the proportion of crosslinker in the mix.  The firmness may be decreased, i.e., a high penetration value, by decreasing the proportion of crosslinker in the mix.  Applied Silicone can adjust gel firmness to meet customer requirements.  Excess crosslinker will lead to reduce gel fracture strength.

The mixture is then dispensed to fill the desired form.  As particular applications warrant and permit, the mixture may be placed under vacuum to consolidate and remove air bubbles before, or after, the filling process. 

The mixture is then 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, full cure is achieved after 3.5 hours at 165°C.  The cure temperature can be adjusted to suit particular applications.  Lower cure temperatures will require greater time to achieve full cure. 
 
 

A material safety data sheet is supplied with the shipment.  Contact with the eye may cause temporary eye discomfort.  Avoid contact with eyes. 

Accurate measuring and complete mixing are important factors in obtaining consistent results.  Contamination by trace amounts of various compounds can result in an unreliable cure and/or yellowing of the gel.  Therefore, it is important to avoid contamination of the gel and any surface/material to which the gel is exposed.  All metering and mixing equipment, as well as any form into which the material is introduced, should be thoroughly clean.  Organic rubbers often contain compounds which can interfere with the cure of the gel and should be avoided.  Any mold, form, or substrate to which this material is intended to be applied should be tested to determine that the cure of the product is not affected. 
 

This product is available in 1 gallon bottles, 5 gallon pails, and 55 gallon drums. 

This product should be stored under cool dry conditions.  Containers should be sealed. 

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 stored in the original container below 30°C. 
 

DISCLAIMER 
 
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 11.08.07