ABSTRACT
Aseptic processing is one of the most challenging production methods in pharmaceutical manufacturing. The environment in which the sterile drug is exposed must meet the highest air quality standards throughout processing. Only this level of control can assure that each unit produced is free of microorganisms and therefore safe for consumer use. The history of aseptic processing is replete with incidents in which a loss of environmental control led to the production of non-sterile parenteral or ophthalmic drugs. Published data shows that non-sterility problems continue to occur rather frequently in industry. People are by far the greatest source of contamination in an aseptic processing operation. Poor aseptic technique or cleanroom behaviors can lead to a rapid loss of environmental control. Such behaviors can effectively negate the advantages of an otherwise well-designed operation. It is therefore important to ensure that all aseptic interventions are meticulously executed and that strict standards of cleanroom behavior are observed at all times.
