ABSTRACT
The use of advanced aseptic processing equipment has gained wide acceptance over the past several years as an alternative to the conventional clean room for the testing and manufacture of sterile health care products. The availability of an automated, reproducible decontamination process significantly contributed to this technology shift. The Parenteral Drug Association (PDA) has defined an aseptic isolator as a sealed enclosure supplied with air through a microbially retentive filtration system (HEPA minimum) and is able to be reproducibly decontaminated prior to use (1).
