The Technology of Isolators
At the same time, the technological issues relating to the new types of emerging APIs, the High Potent Active Pharmaceutical Ingredients (HPAPIs) and oncologic molecules, the Cytostatics/Cytotoxics are addressed. The plant engineering and process knowledge grow and skills in safety matters are developed in relation to the high activity of High Potent molecules with respect to very low dosages. In keeping with its pioneering tradition, the first isolator was engineered, built and assembled, and became operational starting from 2001. This technology that originates from the nuclear sector, for the containment of radiations, was re-engineered for the safe micronization of HPAPIs. Starting from the 2000s, the development of the isolator technology led to the creation of a generation of machines that allow the scale up from R&D batch sizes to commercial ones regardless of the volumes produced.