BSI BS EN ISO 13408-1:2024

Current Revision
Aseptic processing of health care products -- General requirements

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BSI BS EN ISO 13408-1:2024

Aseptic processing of health care products -- General requirements

PUBLISH DATE 2024
PAGES 94
BSI BS EN ISO 13408-1:2024

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.

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