Standard

SN EN ISO 13408-1:2024

Attuale

Le modifiche e le versioni esistenti o nuove devono essere acquistate separatamente.

Lingua
Servizi

Astratto

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.

Specifiche dei prodotti

  • Standard da INB
  • Pubblicato:
  • Efficace:
  • Versione: 2
  • Tipo di documento: EN
  • Pagine
  • Publisher SNV
  • Distributor SNV
  • ICS 11.080.01
  • National Committee INB/NK 171

Relazioni con i prodotti