Vapor hydrogen peroxide as alternative to dry heat microbial reduction

Abstract

The Jet Propulsion Laboratory (JPL), in conjunction with the NASA Planetary Protection Officer, has selected vapor phase hydrogen peroxide (VHP) sterilization process for continued development as a NASA approved sterilization technique for spacecraft subsystems and systems. The goal was to include this technique, with an appropriate specification, in NASA Procedural Requirements 8020.12 as a low-temperature complementary technique to the dry heat sterilization process. The VHP process is widely used by the medical industry to sterilize surgical instruments and biomedical devices, but high doses of VHP may degrade the performance of flight hardware, or compromise material compatibility. The goal for this study was to determine the minimum VHP process conditions for planetary protection acceptable microbial reduction levels. Experiments were conducted by the STERIS Corporation, under contract to JPL, to evaluate the effectiveness of vapor hydrogen peroxide for the inactivation of the standard spore challenge, Geobacillus stearothermophilus. VHP process parameters were determined that provide significant reductions in spore viability while allowing survival of sufficient spores for statistically significant enumeration. In addition to the obvious process parameters of interest: hydrogen peroxide concentration, number of injection cycles, and exposure duration, the investigation also considered the possible effect on lethality of environmental parameters: temperature, absolute humidity, and material substrate. This study delineated a range of test sterilizer process conditions: VHP concentration, process duration, a process temperature range for which the worst case D-value may be imposed, a process humidity range for which the worst case D-value may be imposed, and the dependence on selected spacecraft material substrates. The derivation of D-values from the lethality data permitted conservative planetary protection recommendations.