IMPACT OF STERILIZATION METHODS ON SILICONE HOSES: A COMPARATIVE STUDY

HELGA SAGER; MANUEL SOLARI; MARÍA R GÓMEZ; DINA LEVIN; LESLIE ARAGÓN; VALERIA BONADA; CHIEN WANG

Bonn

Congreso; 18th World Sterilization Congress; 2017

Deutsche Gesellschaft fur sterilgutversorgung e.V.

Silicone rubber based hoses and tubing for transporting air or fluids are widely used in hospitals in worldwide. As biopharmaceutical devices, they require conditions such as sterilizable, non-reactive and non-toxic properties. Additional beneficial properties of silicone are being flexibility, translucency and high resistance to extreme temperature that makes it an ideal material for developing new medical devices. Chemically, silicone is an elastomer formed by monomers of siloxane. More precisely, it consists of an inorganic silicon-oxygen backbone chain with organic side groups attached to the Si atoms. By using inputs not typically associated with allergenic responses, and avoiding introduction of migratory plasticizers, silicone elastomers are tending to replace the traditionally lower cost materials such as PVC and latex. While cleaning and sterilization processes are essential for sanitizing the rubber parts of medical devices, they often have an adverse effect on the integrity of the material. Several silicone qualities or grades are used in healthcare industry depending on the final vulcanization process applied and therefore, differential chemical, thermal or/and mechanical resistance properties are available. Nevertheless, most of the manufacturers recommend the single use or its replacement after the product physical properties change, without a clear indication of its real lifetime. Therefore, ambiguities of rather discharging the hoses after several recycling or continuing it reuse are always an issue to discuss in hospital sterilization service. In this work, the inner surface of peroxide-cured silicone hoses was studied by Scanning Electron Microscopy and Infrared Spectroscopy with the aim of monitoring the progressive changes of chemical and physical properties after several reprocessing cycles (by steam, ethylene oxide and peroxide sterilization procedures). Also their mechanical properties were studied and discussed in order to established a recommendation for it reuse.