ABSTRACT
This chapter will focus on a microbiology reviewer’s observationson the evolution of the barrier system for aseptic processing of pharmaceuticals and the development of standards for their use. Some related information will be provided in this chapter that considers isolation systems for laboratory use, and isolators for sterility testing. Discussion of barrier systems will include restricted access barrier systems (RABS) and isolator systems (isolators). Some observations are offered on microbiological measurement of environments used for pharmaceutical manufacturing. The scientific review philosophy and the regulatory experience form the basis of this perspective.
