Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, IDT)
This Malaysian Standard 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.
This standard 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 MS ISO 13408.
Published
• (none) / (none) / (none)
PDF
26/01/2021
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NSC 18 - Medical Devices and Facilities for Healthcare
