ISO 13408-6:2021

Aseptic processing of health care products -- Part 6: Isolator systems
Autor: ISO
Código ICS: 11.080.01


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.

Especificaciones de la Norma
Fecha de Publicación 13/04/2021
Título Secundario Traitement aseptique des produits de santé -- Partie 6: Systèmes isolateurs
Páginas Técnicas 25
Idioma Inglés