ISO 13408-1:2023 | Aseptic processing of health care products

ISO 13408-1:2023 | Aseptic processing of health care products

ID 20758 | 13.11.2023 / Preview attached

ISO 13408-1:2023 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 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.

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Fonte: ISO

Allegati (Riservati) Abbonati Normazione

Allegati

	Descrizione	Lingua	Dimensioni	Downloads
	Preview ISO 13408-1 2023 Abbonati Normazione	EN	222 kB	0