ABSTRACT

Advanced aseptic processing technologies (AAPT) began to appear in the manufacture of drugs and biologics in the late 1980s. The first of these systems were simple (comparatively speaking) adaptations of the flexible (polyvinyl chloride) wall isolators, which had been introduced for sterility testing only a few years before. From the beginning what attracted forward-thinking individuals to aseptic processing inside isolators was the potential of reduced contamination through the separation of human operators from the manufacturing environment. It did not take long in the implementation process for those same technologists to realize that reduced contamination was a reality of isolator technology rather than mere potential.