Isolator

Barrier technologies that separate operators from the Grade A zone in aseptic processing. An isolator is a sealed enclosure that is decontaminated, usually with vaporized hydrogen peroxide, and accessed only through gloves and transfer ports. A RABS has a rigid barrier with glove ports and controlled interventions, can be opened under defined conditions and sits in a Grade B room. EU GMP Annex 1 expects barrier technology to be considered for aseptic processing and alternatives to it to be justified. Japanese documents often name the two together when describing filling lines.