International Standard
ISO 13408-1:2023
Aseptic processing of health care products — Part 1: General requirements
Reference number
ISO 13408-1:2023
Edition 3
2023-08
© ISO 2024
International Standard
Read sample
Published (Edition 3, 2023)

ISO 13408-1:2023

Format
Language
CHF 194
Convert Swiss francs (CHF) to your currency

Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2023-08
    Stage
    : International Standard published [60.60]
  • Edition
     : 3
    Number of pages
     : 72
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
  • RSS updates

Life cycle

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)

  2. Store
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.080
  7. 11.080.01
  8. ISO 13408-1:2023