ABSTRACT
The ECSs play a central role in preventing microbial
contamination into sterile products delivered by the
parenteral route. Maintenance of the product’s sterility
during manufacturing is of particular importance when
products are aseptically manufactured as there is no
subsequent process step, such as terminal sterilization,
that provides a higher degree of sterility assurance. The
industry recognizes the potential for microbial cross
contamination risks associated with the manipulation
of sterile products or sterile process devices and com-
ponents. The risk increases while the sterile product or
components are directly exposed to the environment.
The highest risk for cross contamination is perceived at
those steps where personnel is close or intervene in
handling sterile product or components in operations
of the so-called “aseptic process.” The design of a
comprehensive ECS that covers the facilities used for
the formulation and packaging of sterile products
presupposes a clear understanding of the principles
outlined above. On those bases, a careful selection of
methodologies and structural components directed to the
control are necessary for controlling and in some cases
eliminating the microbial cross contamination risk. The
