It specifies requirements and provides guidance on equipment, processes, programs and procedures for the control and validation of lyophilization as an aseptic process. This part of ISO 13408 applies to processes where sterilizing agents are delivered to internal surfaces of equipment that may come into contact with the product.
This part of ISO 13408 does not apply to processes where equipment is disassembled and delivered to the sterilizer. This part of ISO 13408 is not a substitute for national regulatory requirements such as good manufacturing practices or mandatory requirements, particularly those relating to national or regional jurisdictions.
This part of ISO 13408 does not specify requirements for the development, validation and routine control of a process for inactivating agents that cause spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been made in certain countries for the handling of materials potentially contaminated with these agents.
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