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2023 Aseptic Conference

SES203b - New Insights on the Practical Use of Enzyme Indicators

‐ Mar 7, 2023 12:30pm

The application of biological indicators for development and validation of H2O2 biodecontamination cycles for barrier systems is common across the industry, despite their drawbacks like significant variability together with necessary incubation times. Enzyme indicators are a recent supplementary type of indicators, which are based on the decomposition of an enzyme (thermostable adenylate kinase, tAK) by H2O2. Initial experience with the use of these new indicators is currently being gained throughout the industry. However, there are still significant knowledge gaps on how to apply the indicators.

In this presentation, new experimental results that contribute to a better understanding of the indicators will be discussed. A more detailed analysis of the contributions to the variability of the results, the influence of temperatures, storage conditions, the timing of the reading after exposure and the degree of inactivation of the indicator will be given.

These results lead to a better understanding of the possibilities and limitations for the use of enzyme indicators. Practical questions such as "When to do what?" can be answered with a better data basis. This will further facilitate the use of enzyme indicators as a complementary tool to biological indicators with the goal of faster development of safer processes.


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