<p>This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.</p>
<p>This document does not specify requirements for restricted access barrier systems (RABS).</p>
<p>This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.</p>
<p>This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.</p>
<p>This document does not define biosafety containment requirements.</p>
Registration number (WIID)
72836
Scope
<p>This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.</p>
<p>This document does not specify requirements for restricted access barrier systems (RABS).</p>
<p>This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.</p>
<p>This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.</p>
<p>This document does not define biosafety containment requirements.</p>
