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NBN EN ISO 13408-1:2024
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
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Summary
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.
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.
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 04/24/2024 |
| Cancellation Date | 10/31/2024 |
| Page Count | 101 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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24/04/2024
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Most Recent
19/07/2013
Superseded
Historical
29/07/2011
Superseded
Historical