By Emilie Gautriaud, Keith T. Stafford, Jennifer Adamchuk, Mark W. Simon and Duan Li Ou, Saint-Gobain, Northboro R&D Center
Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination. Such treatments may also affect the molecular structure of the silicone rubber, causing changes in the physical properties and performance of the material. Several studies on this topic have been reported; however, a systematic investigation has not been performed on the effect of standard sterilization procedures on commercial silicone rubbers commonly used in this industry. To date, most investigations have focused on the treatment of unfilled silicone polymer under ideal radiation conditions, the results of which cannot be directly correlated with the effect of realistic sterilization conditions on commercial tubing, hose and connection components. This report may be used as a material selection guide for process engineers working in pharmaceutical manufacture facilities, as well as a tool for selecting sterilization procedures that are compatible with specific silicone tubing and hose products.