ABSTRACT
The last 30 years of aseptic processing have witnessed a substantial number of process improvements that have markedly reduced the incidence of microbial contamination. The changes were myriad but largely focused on one overarching objective—minimizing the impact of the greatest contributor to contamination—the gowned aseptic processing operator. This entry discusses sterility by design, provides regulatory and historical perspective, and sterility assurance for aseptic processing.
