An isolator is a controlled environment that is defined by fixed walls, floor,and ceiling. Transfers of materials into and out of the environment as well as the interaction technologies are separated by barriers such as gloves, sleeves, and airlocks.
A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding clean room air and personnel). There are two major types of isolators: Closed isolator systems exclude external contamination from the isolator's critical zone by accomplishing material transfer via aseptic connection to auxiliary equipment, rather than use of openings to the surrounding environment. Closed systems remain sealed throughout operations. Open isolator systems are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g., using continuous overpressure) to exclude the entry of external contamination into the isolator.