Standard

NS-EN ISO 13408-1:2024

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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.

Document information

  • Standard from SN
  • Published:
  • Edition: 2024-04
  • Version: 1
  • Document type: NAT
  • ICS 11.080.01
  • National Committee CEN/TC 204

Legal references

EU law: 2017/745, 2017/746

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