Single-use devices allow today’s bioprocess manufacturer decreased time-to-market and reduced manufacturing costs on new drug developments. Localized sterilization of fluid transfer connection points provides a distinct advantage over mechanical seal type single-use connectors by providing a verifiable SAL.
Even though steam is readily accepted and used as a sterilant, it has some major handling and recurring system cost disadvantages, especially as a localized sterilant for single-use devices. Alternately, some low temperature gaseous sterilants like Ethylene Oxide and Vaporized Hydrogen Dioxide offer definite advantages over steam, but are toxic and require more stringent process controls.
Of all the low temperature gaseous sterilization methods, Ozone gas offers significant advantages. It can be easily produced and controlled, is safe to handle, and environmentally friendly. The validation of localized sterilization for single-use devices using ozone should be greatly minimized because of the FDA approval of ozone as a sterilant for reusable medical devices.