UNE-EN ISO 13408-1:2024
Current
The latest, up-to-date edition.
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
Hardcopy , PDF
Spanish, Castilian, English
27-11-2024
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes,programs and procedures for development, validation and routine control of aseptic processing ofhealth care products.This part of ISO 13408 includes requirements and guidance relative to the overall topic of asepticprocessing.Specific requirements and guidance on various specialized processes and methods related to sterilizingfiltration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolatorsystems are given in other parts of ISO 13408.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
101
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| ISO 13408-1:2023 | Identical |
| EN ISO 13408-1:2024 | Identical |
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