Technological Outlook

Abstract

In the pharmaceutical industry, more products are coming to production from biotechnological research. Their market volume increases disproportionately, which is also reflected in the dimensions and capacity of the isolator units required for fill-finish production steps. These products usually react very sensitive to external influences and cannot be terminally sterilized, therefore an aseptic preparation method with controlled environment is required. The isolator provides for it over the classical method of preparation in the clean room or with a simple barrier system such as open RABS, advanced technology options. Due to the strict physical separation of process and product on the one hand and the operator on the other hand, many atmospheric conditions are created and maintained. As an example, very low O₂ concentrations or low humidity for the processing of oxygen-sensitive or moisture-sensitive products are mentioned.