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ISO 13408-1:2023

M00003444

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

standard by International Organization for Standardization, 08/01/2023

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Full Description

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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Published: 08/01/2023 File Size: 1 file , 3.9 MB Note: This product is unavailable in Ukraine, Russia, Belarus