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ΕΛΟΤ EN ISO 13408-1 Ε3

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

ΕΛΟΤ EN ISO 13408-1 Ε3

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

100,00 €

Abstract

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.

Info

Publication Date

2024-05-27

Greek Title

Ασηπτική επεξεργασία προϊόντων ιατρικής φροντίδας - Μέρος 1: Γενικές απαιτήσεις

English Title

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

Standard Stage

Techincal Body

Y

Related Documents

EN ISO 13408-1:2024 - Identical
ISO 13408-1:2023 - Identical
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