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ISO 13408-1:2023

Aseptic processing of health care products — Part 1: General requirements

Standard Details

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
Standard Type: Main
Document No: ISO 13408-1:2023
Document Year: 2023
Pages: 72
Edition: 3
  • Section Volume:
  • ISO/TC 198. Sterilization of health care products
  • ICS:
  • 11.080.01 Sterilization and disinfection in general

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ISO 13408-1:2023
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