ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements

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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.
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Status: Active ChangeNumber: 2 InternationalClassificationCodeOfStandards: 11.080.01 TechnicalCommittee: ISO/TC 198 ActivatedDate: 23.10.2018 PagesCount: 45 Language: en

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