Dow Corning Healthcare Product Selection Guide
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Dow Corning Healthcare Product Selection Guide Advancing healthcare through material innovations Dow Corning Healthcare Selection Guide

• Trustworthy Practices: We adhere to current good manufacturing practices and specifications – Pharmacopoeia compliant, Drug Master Files, Technical Files, and ISO 9001:2000 standards. • Reliable Source of Supply: Dow Corning’s integrated supply chain and comprehensive documentation ensure traceability of our materials. • Consistent Quality: Our silicone healthcare materials are manufactured in a dedicated, U.S. FDA-registered (CFN 1816403) and inspected facility. Our healthcare materials are manufactured to meet critical cGMP principles. • Registration Support: Dow Corning manufactures...

Healthcare Solutions from Dow Corning Dow Corning has a reputation for providing one of the most expansive lines of silicon-based materials in the healthcare industry – materials that have demonstrated their safety and benefits in a wide range of healthcare applications. • Topical Excipients for Drug Delivery • Silicone Adhesives • Elastomers (Rubbers) • Device Adhesives and Encapsulants • Tubing and Molded Assemblies • Fluids, Emulsions, and Dispersions • Antifoams and Antifoam Emulsions Solutions That Go Beyond Building on our strength in silicon-based technology and our more than 40...

Topical Excipients (Silky Touch) The Silky Touch products are silicon-based excipients that can improve the bioavailability of the active drug, the aesthetics and the processability of topical pharmaceutical formulations (creams, emulsions, gels, ointments, lotions, sprays and stick formulations). To assure consistent quality in pharmaceutical formulations, Dow Corning® brand topical excipient products are packaged and tested at the Healthcare Industries Materials Site utilizing principles of GMP guidelines for Active Pharmaceutical Ingredients (APIs). Regulatory Status Ph. Eur. (EP)...

Typical Properties† Nonvolatile Content Relative Density Dynamic Viscosity mPa.s How to read the selector guide charts The charts on pages 4 through 19 of this brochure 0.59-0.71 contain two or three of the following sections: Regulatory Status: This section includes select governmental regulations and organizational standards to which the various materials comply as indicated by the presence of the • symbol. The compliance may have been achieved through testing or by other regulation-specified provision. Biocompatibility Tests: This section includes select biological qualification...

Silicone Adhesives Regulatory Status To assure consistent quality for pharmaceutical drug delivery and wound applications, pressure sensitive adhesive and soft skin adhesive products are manufactured, packaged, and tested at the Healthcare Industries Materials Site utilizing principles of GMP guidelines for Active Pharmaceutical Ingredients (APIs). Typical Applications Solvent-based non-sensitizing, non-irritating, pressuresensitive adhesive formulations • Adhesion of dressings, prosthetics, and other devices to the body FDA Material Application File Technical1 and FDA Drug Master File...

Typical Properties† Solids Content Peel Adhesion Tack Solvent Solution Viscosity at 25°C Rheology – Eta* at 0.01 rad/s at 30°C Very High High Heptane or Ethyl Acetate Heptane or Ethyl Acetate Ethyl Acetate Ethyl Acetate Penetration (62.5 g probe weight) Appearance Pot Life7 at Room Temperature Viscosity at 25°C mPa.s Specifications Writers: These values are not intended for use in preparing specifications. Please contact your local Dow Corning sales office prior to writing specifications on these products. 60% PSA solids in ethyl acetate. Time from initial mixing to double viscosity.

Elastomers (Rubbers) To assure consistent quality for medical device and pharma­ ceutical applications, elastomers from Dow Corning are manufactured, packaged, and tested at the Healthcare Industries Materials Site utilizing principles of GMP guidelines for both Active Pharmaceutical Ingredients (APIs) and Medical Devices. Regulatory Status Volatile Matter Substances Soluble in Hexane Ph. Eur. (EP) Monograph 3.1.9. Silicone Elastomer for Closures and Tubing Technical File FDA Regulation 21 CFR 177.2600 (Food Grade) Biocompatibility Tests Cytotoxicity Mutagenicity/Genotoxicity Hemolysis Skin...

Typical Properties† Relative Density Tear Strength, Die B Elongation Tensile Strength, Die C Durometer Hardness, Shore A Writers: These values are not intended for use in preparing specifications. Please contact your local Dow Corning sales office prior to writing specifications on these products. Continued on next page. Dow Corning Healthcare Selection Guid

Elastomers (Rubbers) Continued from previous page. To assure consistent quality for medical device and pharma­ ceutical applications, elastomers from Dow Corning are manufactured, packaged, and tested at the Healthcare Industries Materials Site utilizing principles of GMP guidelines for both Active Pharmaceutical Ingredients (APIs) and Medical Devices. Regulatory Status Volatile Matter Substances Soluble in Hexane Ph. Eur. (EP) Monograph 3.1.9. Silicone Elastomer for Closures and Tubing Technical File FDA Regulation 21 CFR 177.2600 (Food Grade) Biocompatibility Tests Cytotoxicity...

Typical Properties† Relative Density Durometer Hardness, Shore A MPa (psi) Writers: These values are not intended for use in preparing specifications. Please contact your local Dow Corning sales office prior to writing specifications on these products. Dow Corning Healthcare Selection Guid

Device Adhesives and Encapsulants To assure consistent quality for medical device and pharma­ ceutical applications, elastomers from Dow Corning are manufactured, packaged, and tested at the Healthcare Industries Materials Site utilizing principles of GMP guidelines for both Active Pharmaceutical Ingredients (APIs) and Medical Devices. Regulatory Status Volatile Matter Substances Soluble in Hexane FDA Regulation 21 CFR 177.2600 (Food Grade) Ph. Eur. (EP) Monograph 3.1.9. Silicone Elastomer for Closures and Tubing Biocompatibility Tests Cytotoxicity Mutagenicity/Genotoxicity Hemolysis Skin...