ISO 13408-1:2008

Aseptic processing of health care products — Part 1: General requirements

Datum objavljivanja: 10. 6. 2008.

95.99 Povučen 15. 8. 2023.

Опште информације

Trenutna faza: 95.99 Effective date: 15. 8. 2023.

Inicijator: ISO

Pripada: ISO/TC 198

Vrsta: Međunarodni standard

ICS: 11.080.01

Jezik: engleski francuski

Kupovina

Status: Povučen

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Apstrakt

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.
ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.