Sani-Tech® Ultra White Paper

For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion. To address these concerns, chemists and material experts within Saint-Gobain spent the last few years developing a silicone material that minimizes all potential contaminants. The product, Sani-Tech® Ultra, has the lowest extractable level of any commonly used fluid transfer material and addresses the concerns of the industry with the most comprehensive body of testing available. Lot traceable, manufactured and packaged in a ISO Class VII clean room, Sani-Tech® Ultra is the next generation of silicone materials for pharmaceutical production.

The main sources of extractables in silicone rubber are low molecular weight siloxane molecules. These siloxane molecules come from impurities within the raw materials used in the silicone rubber manufacturing process. In theory all of the extractables can be removed from silicone rubber using a non-polar organic solvent such as hexane at its boiling temperature. The amount of total extractables in Sani-Tech® Ultra is measured following the procedure defined in European Pharmacopoeia 3.1.9; this procedure is an extremely aggressive extraction procedure compared to applications where Sani-Tech® Ultra is used.