NF EN ISO 13408-2

NF EN ISO 13408-2

May 2018
Standard Current

Aseptic processing of health care products - Part 2 : sterilizing filtration

ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.ISO 13408-2:2018 is not applicable to removal of viruses.Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2018

Number of pages

48 p.

Reference

NF EN ISO 13408-2

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-117-2

Print number

1

International kinship

ISO 13408-2:2018

European kinship

EN ISO 13408-2:2018
Sumary
Aseptic processing of health care products - Part 2 : sterilizing filtration

ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.

ISO 13408-2:2018 is not applicable to removal of viruses.

Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).

ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.

ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Replaced standards (1)
NF EN ISO 13408-2
September 2011
Standard Cancelled
Aseptic processing of health care products - Part 2 : filtration

ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Éléments du système qualité
  • 5 Caractérisation des filtres stérilisants
  • 6 Caractérisation du processus et de l'équipement
  • 7 Définition du fluide
  • 8 Définition du processus
  • 9 Validation
  • 10 Surveillance et contrôle de routine
  • 11 Libération du produit après filtration stérilisante
  • 12 Maintien de l'efficacité du processus
  • Annexe A Recommandations relatives à l'application du présent document
  • Bibliographie
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