International Standard
ISO 13408-1:2023
Aseptic processing of health care products — Part 1: General requirements
Reference number
ISO 13408-1:2023
ISO 13408-1:2023
Edición 3
2023-08
2023-08
© ISO 2024
International Standard
Resumen
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2023-08Etapa: Norma Internacional publicada [60.60]
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Edición: 3Número de páginas: 72
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Comité Técnico :ISO/TC 198ICS :11.080.01
- RSS actualizaciones
Ciclo de vida
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Anteriormente
RetiradaISO 13408-1:2008
RetiradaISO 13408-1:2008/Amd 1:2013
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Ahora
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