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.
Preview
Previsualice esta norma en nuestra Plataforma de navegación en línea (OBP)
Informaciones generales
-
Estado: PublicadoFecha de publicación: 2023-08Etapa: Norma Internacional publicada [60.60]
-
Edición: 3Número de páginas: 72
-
Comité Técnico :ISO/TC 198ICS :11.080.01
- RSS actualizaciones
Ciclo de vida
-
Anteriormente
RetiradaISO 13408-1:2008
RetiradaISO 13408-1:2008/Amd 1:2013
-
Ahora
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)