Use of EIs in Vapour Phase Hydrogen Peroxide Decontamination Cycle Optimisation and Rapid Validation

Abstract

AstraZeneca investigated the use of Enzymatic Indicators (EIs) in order to optimise their Sterility Testing Isolator gassing cycles. The quantitative nature of the EI data has enabled identification and successful validation of an optimised cycle, which has halved the original gassing cycle, leading to reduced costs, reduced periods of Isolator downtime and increased overall productivity. When completing the validation, the EI data was also used to provide greater confidence in the instance of erroneous Biological Indicator results, and as such has also expedited validation of a new ‘wet’ vaporised H2O2 generator. In addition, the EI data provided increased data across the sterility isolator chamber, allowing for confidence that sufficient cycle decontamination is achieved in all challenge locations, and as such there is no risk of BI failures upon requalification. EIs are therefore regarded as a beneficial companion for BI data when looking to optimise productivity of current isolators, and when used for validation of new equipment.