ISO 13408-2 Aseptic Handling of Health Care Products - Sterilization Filtration

Material Testing

ISO 13408-2 Aseptic Handling of Health Care Products - Sterilization Filtration

ISO 13408-2 specifies requirements for sterilization filtration as part of the aseptic processing of healthcare products conducted in accordance with ISO 13408‑1. It also guides filter users regarding the general requirements for the setup, validation and routine operation of a sterilization filtration process.

ISO 13408-2 Aseptic Handling of Health Care Products - Sterilization Filtration

ISO 13408-2 does not apply to the removal of viruses. Sterilization filtration does not apply to liquids that intentionally contain particles larger than the pore size of the filter (eg bacterial whole cell vaccines). ISO 13408-2 does not apply to high efficiency particulate air (HEPA) filters.

ISO 13408-2 does not specify requirements for the development, validation, and routine control of a process for eliminating 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.

EUROLAB assists manufacturers with ISO 13408-2 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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