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DESCRIPTION Applied Silicone Corporation Implant Grade High Consistency Addition Cure Extrudable HCRA 4750 is a two part platinum catalyzed silicone elastomer designed for use in processes where high strength extruded or molded parts are desired. This material is specially formulated for rapid vulcanization in short dwell cure ovens. HCRA 4750 contains 100% by weight of dimethyl silicone elastomer when cured. This product is supplied in two components consisting of equal amounts of Part A and Part B. The stringent biocompatibility requirements imposed upon this material make this elastomer ideally suited for use in critical implantable medical devices. Custom formulation for radiopacity, color, and other requirements are available upon request. Important characteristics include: • Good pot-life
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BIOCOMPATIBILITY This material was designed and tested to meet ISO 10993 requirements for long term implantation. A sample from each manufactured lot is subjected to an MEM Tissue Culture test. Additional testing is available upon request. FDA Master File references, including formulation, manufacturing methods, testing and toxicology are available. |
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APPLICATIONS Applied Silicone Implant Grade High Consistency Addition Cure Extrudable HCRA 4750 is designed to be mixed in equal parts using standard rubber processing techniques such as two roll milling. Care must be taken to work in a clean area with clean equipment, as traces of foreign materials can poison the catalyst, and inhibit the cure. For optimum results, freshen both parts separately on a two roll mill before mixing them. Do not allow material temperature to exceed 30ºC during milling. Mixed material should be used within four hours to prevent structuring and premature cross-linking. Store mixed material in a freezer to extend the working time. HAV cure is typically achieved in three seconds at 593ºC. Post-cure is recommended to stabilize physical properties. Typical post-cure is one hour at 165ºC. |
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PRECAUTIONS Accurate measuring and complete mixing are important factors in obtaining consistent results. Contamination by trace amounts of compounds containing sulfur, amines, and organometallic salts can result in an unreliable cure of the material. Organic rubbers and tin catalyzed silicones often contain compounds which can interfere with the cure of this material and should be avoided. HCRA begins to cure in about 120 minutes at room temperature. Mix components and use promptly for best results. Clean equipment thoroughly to avoid cured residue which may result in crumbs of elastomer being picked up by the next lot causing "gels" and imperfections. Mix only what is intended
for use. Mixed shelf life at room temperature is approximately four hours. Mixed material can be stored at lower temperatures to extend
pot life.
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PACKAGING AND STORAGE Packaging is available in 50 pound kits. This material should be stored under cool and dry conditions. Containers should be sealed to avoid contamination. Suggested retest is at six months from the date of shipment. |
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LOT TESTING Each production lot is certified as having Cytotoxicity and physical properties. Other testing is available upon request. |
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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 08.19.98 |
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