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ISO - 13408-1

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

active, Most Current
Organization: ISO
Publication Date: 1 August 2023
Status: active
Page Count: 84
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

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 History

13408-1
August 1, 2023
Aseptic processing of health care products — Part 1: General requirements
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...
May 1, 2013
Aseptic processing of health care products - Part 1: General requirements AMENDMENT 1
A description is not available for this item.
June 15, 2008
Aseptic processing of health care products - Part 1: General requirements
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing...
August 1, 1998
Aseptic Processing of Health Care Products - Part 1: General Requirements
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for the validation and control of aseptically processed health care...

References

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