Enzyme indicators: Rapid and quantitative evaluation in the H₂O₂ decontamination process

Function, use, and significance for H₂O₂ decontamination

Pharmaceutical production is subject to the highest standards of microbiological safety. Especially in aseptic processes, such as those used in isolators, no microbiological contamination must be detected. A key step is effective bio-decontamination, which is validated by biological indicators as standard. This method is reliable, but faces challenges. On one hand, only one qualitative result (growth / no growth) can be produced with a cycle. In addition, detection with biological indicators requires an incubation period of seven days for final results.

When new H₂O₂ decontamination cycles are developed or existing ones are adapted, the seven-day incubation period presents challenges for manufacturers. This is where modern approaches such as enzyme indicators add value. Enzyme indicators can be evaluated directly after the decontamination cycle and provide a quantitative result. 

These properties make enzyme indicators well suited for decontamination cycle optimization and parameter determination as they complement biological indicators.

In the video you will learn how enzyme indicators work, what their advantages are compared to the classic method with biological indicators, and how both methods can be used in combination.