Human operators pose the greatest risk to product contamination during “conventional cleanroom” aseptic processing. Many different barriers of varying capabilities have been used to separate operators from critical sites during aseptic processing with the objective of reducing the probability of a contaminated unit. These range from simple flexible curtains used on many traditional aseptic processing lines to advanced aseptic processing in isolators.
A Restricted Access Barrier System (RABS) is an advanced aseptic processing system that can be utilized in many applications in a fill-finish area. RABS provides an enclosed environment to reduce the risk of contamination to product, containers, closures, and product contact surfaces compared to the risks associated with conventional cleanroom operations. RABS can operate as “doors closed” for processing with very low risk of contamination similar to isolators or permit rare “open door interventions” provided appropriate measures are taken.