Alcance
This document specifies the requirements for and provides guidance on the specification, selection,qualification, bio-decontamination, validation, operation and control of isolator systems related toaseptic processing of health care products and processing of cell-based health care products.This document does not specify requirements for restricted access barrier systems (RABS).This document does not supersede or replace national regulatory requirements such as GoodManufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to nationalor regional jurisdictions.This document does not specify requirements for isolators used for sterility testing; however, some ofthe principles and information in this document could be applicable to this application.This document does not define biosafety containment requirements.