40088 - High Consistency Rubber 20 Durometer, Molding Grade - 2 LBS

DESCRIPTION  Applied Silicone Corporation Implant Grade High Consistency Addition Cure Molding Systems HCRA(M) are two part platinum catalyzed silicone elastomers designed for use in processes where high strength molded parts are desired. This material is specially formulated for a long potlife and a molding cure profile. HCRA(M) 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 which are strained through a 400 mesh (25 micron) screen to ensure freedom from particulate contamination.  The stringent biocompatibility requirements imposed upon these materials make this series of elastomers ideally suited for use in critical medical devices. Custom formulation for radiopacity, color, etc. is available upon request. Important characteristics include: • Long mixed life for molding applications • Blendable to modify durometer • No volatile cure by-products • Optional post cure • Non-tacky surface • Non-blooming • No peroxide residues • Tested under FDA protocol as a substitute to replace discontinued Dow Corning Medical Grade Silicone for long term implantation.  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. APPLICATIONS  Applied Silicone Implant Molding Grade HCRA(M) High Consistency Addition Cure Silicone Elastomer Systems are 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 twenty-four hours to prevent structuring and premature crosslinking. Store mixed material in a freezer to extend the working time. Cure is typically achieved in three minutes at 150ºC. Post cure is recommended to stabilize physical properties. Typical postcure is one hour at 165ºC. 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(M) begins to cure in about eight hours at room temperature. Mill 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 twenty-four hours. Mixed material can be stored at lower temperatures to extend pot life.   LOT TESTING  Each production lot is certified as having passed Cytotoxicity and physical properties. Other testing is available upon request.  TYPICAL PROPERTIES    These are typical values and are not intended for use in preparing specifications. TEST RESULTS COMPRESSION MOLDED 10 MINUTES @ 240ºF: 40088 40089 40090 40092 HCRA-20M HCRA-35M HCRA-50M HCRA-80M DUROMETER, SHORE A UNITS 20 35 55 80 TENSILE STRENGTH, psi 1430 1600 1500 1250 ELONGATION, % 1300 1000 820 590 TEAR STRENGTH, ppi 180 200 220 280 SPECIFIC GRAVITY 1.12 1.12 1.15 1.22 TENSION SET, % 35 9 8 15 APPEARANCE TRANSLUCENT, COLORLESS, TRANSLUCENT TRANSLUCENT 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.