ABSTRACT
INTRODUCTION Isolators, glove boxes, and restricted access barrier systems (RABS) technology are widely accepted as solutions to enhance product safety, protection of staff and facility from potent materials, and for cost-effective production of aseptic and powder drugs. Whichever specific technology used, we can loosely define these solutions as “aseptic processing systems” (APS). Currently, APS are in operation around the world in a variety of settings. The main users of APS are still large pharmaceutical and biotechnology companies that have had prior experience with this technology, and usually APS are used for minimizing the potential for false-positive result during product sterility testing. As the technologies involved in APS are becoming more commonplace, and as new process and product needs arise that require isolation, more companies are exploring and adopting the use of APS technology.
