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BSI BS EN ISO 13408-6:2021

Aseptic processing of health care products -- Isolator systems
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BSI BS EN ISO 13408-6:2021

Aseptic processing of health care products -- Isolator systems

PUBLISH DATE 2021
PAGES 48
BSI BS EN ISO 13408-6:2021
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. This document does not specify requirements for restricted access barrier systems (RABS). 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. 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. This document does not define biosafety containment requirements.
SDO BSI: British Standards Institution
Document Number ISO 13408-6
Publication Date May 24, 2021
Language en - English
Page Count 48
Revision Level
Supercedes
Committee CH/198
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