The Role Of Biological Indicators For Hydrogen Peroxide Vapor Technology

By Dr Lynne Murdoch, Bioquell UK Ltd

Biological indicators (BIs) have become the industry standard for verification of hydrogen peroxide vapor (HPV) decontamination efficacy. This white paper discusses BIs for use with HPV and some of the factors associated with inconsistent performance of BIs used to assess HPV bio-decontamination cycles.

Biological indicators (BIs) are defined loosely as a characterized strain and population of a microorganism that can be used to monitor the efficacy of a decontamination process. They continue to be considered the ‘gold standard’ as they demonstrate the ability of the chosen method to inactivate highly resistant microorganisms. The strain, preparation and presentation of the BI vary, depending on the process the BI is designed for. This article will concentrate on BIs designed for hydrogen peroxide vapor (HPV) bio-decontamination.

There is an increasing issue with inconsistency in BI batches and so-called ‘rogue’ BIs. Batch variability in BIs leads to false positives, and although less easily detected, false negatives. Inaccurate or unexpected results when re-validating HPV cycles can potentially have huge consequences on the BI users. Impacts range from having to repeat cycles to scrapping of product and shutdown of facilities, all of which could pose a significant financial impact upon the user.