ISO 13408-1:2008

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

Датум објављивања: 10. 6. 2008.

95.99 Повучен 15. 8. 2023.

Опште информације

Тренутна фаза: 95.99 Effective date: 15. 8. 2023.

Иницијатор: ISO

Припада: ISO/TC 198

Врста: Међународни стандард

ICS: 11.080.01

Језик: енглески француски

Куповина

Статус: Повучен

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Апстракт

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.