Insights for the Use of Enzyme Indicators in Hydrogen Peroxide Bio-Decontamination Cycle Validation

Enzyme Indicators (EIs) are strips of purified thermostable adenylate kinase (tAK) that are currently used across the world in the pharmaceutical industry to quantitatively assess the bio-decontamination efficacy of hydrogen peroxide (H₂O₂). Adoption of EIs in the hydrogen peroxide bio-decontamination cycle validation has increased across the pharmaceutical industry because of the numerous advantages they have over current assessment tools such as biological indicators (BIs). These benefits include a rapid result, reduced variation, and simplified handling due to the reduced contamination risk incurred from not using viable organisms. A number of pharmaceutical industry validation teams who have successfully integrated EI technology into their validation strategy realized that it would be advantageous to have an EI industry working group to look together at the adoption of the technology and bring a standardization of the validation approach. This paper provides a comprehensive approach to analyzing and applying EI use following the extensive compilation of data and methods from leading global pharmaceutical companies, including the points that are to be considered for handling, use, and data analysis of EIs within the steps of bio-decontamination validation.