ABSTRACT
Aseptic environments present many limiting, restrictive conditions and requirements to the equipment that is intended to operate in them. This chapter considers the effects of these conditions and restrictions on the equipment, the effect of the equipment on the environment, and describes some specific approaches that engineers use in designing package filling equipment to accommodate these concerns. Clean rooms or isolation chambers are used to provide aseptic environments for package filling. The presence of a person in a clean room generates significantly high levels of particulates, even though the people are conventionally gowned for clean room operation. Introducing sterile containers and packaging components into the aseptic environment is a design issue that varies with the component, the process, and the type of enclosure. The high demands of pharmaceutical asepsis and its validation have made achieving effective results in isolation technology applications very challenging.
