Vaporized hydrogen peroxide sterilization of freeze dryers.

Abstract

The feasibility of using vapor hydrogen peroxide (VHP) as an alternative to steam sterilization has been examined using a pilot plant freeze dryer equipped with a prototype vapor generator. Specific objectives of the study discussed in this presentation were to: 1. Identify critical process variables affecting the lethality of VHP to Bacillus stearothermophilus spores, particularly within dead legs in the system. 2. Measure the efficacy of system degassing after sterilization. 3. Determine the effect of repeated sterilization cycles on the integrity of elastomeric components of the freeze dryer. Penetration of adequate concentrations of hydrogen peroxide vapor into small diameter piping, such as tubing connected to pressure gauges, is the most challenging aspect of VHP sterilization of freeze dryers. Prior to equipment modifications, spore strips placed within such dead legs remained positive irrespective of the number of gas/degas pulses and system pressure. Equipment modifications necessary to effect complete kill of biological indicators placed in system dead legs is discussed. Results of this study support the conclusion that vaporized hydrogen peroxide shows promise as an alternative sterilization method for freeze dryers.