Isolator technology is taking on an increasingly important role, particularly in the manufacture of biopharmaceutical products and new forms of therapy including ATMP. To work under aseptic conditions, hydrogen peroxide (H2O2) is often used for decontamination. In addition to the established chemical and biological indicators (CI & BI), enzyme indicators (EI) are also increasingly coming into focus. EI are based on the inactivation of an enzyme by H2O2. The remaining activity is measured using an ATP-based bioluminescence measurement. Initial studies show good agreement with classic biological indicators, which suggests promising potential.
Enzyme-based indicators, based on the denaturation of an enzyme by H2O2, offer a promising alternative. The remaining activity is measured using ATP bioluminescence. This method provides faster, quantitative results and can specifically support the development and validation of the decontamination processes.