For more than 65 years, Dow Corning has drawn upon the versatility and biocompatibility of silicones to help its customers develop and manufacture innovative pharmaceutical and biopharmaceutical products. Yet today’s Pharmaceutical and BioPharma companies face a range of challenges that demand new ways of thinking - ones that incorporate Quality by Design, reduce the risk of contamination and improve processing efficiencies. Sentinel and Dow Corning have an ultimate goal to provide solutions to meet the regulatory requirements of our industry. 

All Dow Corning molded assemblies are manufactured under GMP principles in an FDA inspected and ISO-Registered Production Facility. All products are produced from Dow Corning’s USP Class VI-compliant Silastic® BioMedical Grade Elastomers to the industry’s highest quality standards. 

FDA Food Grade Materials (21 CFR 177.2600) 
Assemblies and Tubing Manufactured in Compliance with: 
US Pharmacopeia <381> (Elastomeric Closures for Injections) 
European Pharmacopoeia 3.1.9 (Silicone Elastomer for Closures and Tubing) 
Sanitary 3-A standards 

During manufacture, Dow Corning follows strict contamination control policies in accordance with GMP principles to ensure consistent product purity and quality. Validated monitoring of air, critical surfaces and equipment verifies compliance to these policies.