ABSTRACT
INTRODUCTION The development of isolators and RABS (restricted access barrier systems) was started at the end of the 1980s and beginning of the 1990s, almost in parallel.
While isolators were developed for critical operations based on the experience gained in the nuclear power industry, RABS development took conventional clean room technologies one step further. Early on, the main obstacles to the introduction of isolators were the challenges in validating the “sterilization” or, rather, decontamination cycles for the units. When this issue was solved, the development focused more on rapid decontamination for better utilization of the lines by achieving quick turnaround. For RABS, the challenge lay in the missing definition of RABS with widely different ways of operating the various RABS designs.
