Avoiding Product Oxidation With Hydrogen Peroxide In Pharmaceutical Isolators

By Dr. Felix Heise, Merck and Dr. Thomas Kosian, Syntegon

Thanks to scientific and technical advances, groundbreaking developments are taking place in biotechnologically produced drugs, for example for the treatment of cancer, autoimmune diseases, or rare diseases affecting only a small patient population. However, these highly efficacious and sometimes very toxic drugs require special safety precautions and hermetically sealed production processes to protect humans and pharmaceuticals from each other. At the same time, especially newly developed drugs which are often produced in smaller batches require a high degree of flexibility and modularity. Integrated air management and optimized bio-decontamination play a fundamental role in the flexible integration of isolators into existing building and clean room concepts, while ensuring safe production processes.

Isolators are highly popular in aseptic manufacturing. But they also entail risks, for example through the effects of hydrogen peroxide (H₂O₂) which is used for decontamination. In this article, Thomas Kosian from Syntegon and Felix Heise from Merck (EMD Serono) explain how these risks can be counteracted with profound and targeted analyses.