ISO 13408-1 specifies and provides guidance on the general requirements for processes, programs and procedures for the development, verification and routine control of the manufacturing process for aseptically processed healthcare products.
ISO 13408-1 contains requirements and guidance on general aseptic handling. Specific requirements and guidance on the various special processes and methods associated with filtration, lyophilization, clean-in-place (CIP) technologies, sterilization-in-place (SIP) and isolator systems are provided in other parts of ISO 13408.
Aseptic processing is an activity consisting of many unit operations that must be combined effectively to maintain sterility. The purpose of the aseptic process definition is to gain a comprehensive understanding of the integration of the different elements required. Based on the definition of aseptic handling, an assessment of the risks of aseptic processing will be made. Methods and procedures to control these risks will be defined and implemented.
The aseptic process description should consider the entire process and provide a rationale explaining how each element involved in the processing contributes to obtaining and maintaining a sterile product.
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