NF EN ISO 13408-2 : 2018

This document specifies sterilizing filtration requirements for aseptic processing of health products, conducted in accordance with ISO 13408-1. It also provides filter users with recommendations for general requirements for the configuration, validation, and routine operations of a sterile filtration process. This document does not concern the elimination of viruses. Sterilizing filtration does not apply to fluids voluntarily containing particles larger than the pore size of the filter (eg whole bacterial cell vaccines). This document does not apply to High Efficiency Particulate Air (HEPA) filters. This document does not specify requirements for the development, the validation and routine control of a process for the elimination of spongiform encephalopathy proliferation agents, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been made in specific countries for the treatment of materials potentially contaminated by these agents.