ISO 13408-2:2018
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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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
4.1 General
4.2 Management responsibility
4.3 Procurement of filters
5 Sterilizing filter characterization
5.1 General
5.2 Microbial removal effectiveness
5.3 Material effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 General
6.2 Risk management
6.3 Process characterization
6.4 Equipment characterization
7 Fluid definition
7.1 General
7.2 Microbiological quality
8 Process definition
8.1 General
8.2 Filter definition and characterization
8.2.1 General
8.2.2 Compatibility between the filter and fluid
8.2.3 Filter use
8.3 Filtration process definition
8.4 Integrity testing process definition
9 Validation
9.1 General
9.2 Validation of fluid-specific microbial retention by sterilizing filters for liquids
9.2.1 General
9.2.2 Test organism
9.3 Validation of the integrity test for sterilizing filters for liquids
9.4 Validation of filter interactions with the process fluid
9.5 Validation of the sterilization of filter system
9.6 Validation of fluid-specific microbial retention by sterilizing filters for gases
9.6.1 General
9.6.2 Aerosol retention
9.6.3 Validation of physical integrity testing
9.6.4 Compatibility and service life
9.6.5 Validation of the sterilization of the filter system for gases
10 Routine monitoring and control
11 Product release from sterilizing filtration
12 Maintaining process effectiveness
12.1 General
12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification
12.5 Assessment of change
Annex A (informative) Guidance on the application of this document
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
4.1 General
4.2 Management responsibility
4.3 Procurement of filters
5 Sterilizing filter characterization
5.1 General
5.2 Microbial removal effectiveness
5.3 Material effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 General
6.2 Risk management
6.3 Process characterization
6.4 Equipment characterization
7 Fluid definition
7.1 General
7.2 Microbiological quality
8 Process definition
8.1 General
8.2 Filter definition and characterization
8.2.1 General
8.2.2 Compatibility between the filter and fluid
8.2.3 Filter use
8.3 Filtration process definition
8.4 Integrity testing process definition
9 Validation
9.1 General
9.2 Validation of fluid-specific microbial retention by sterilizing filters for liquids
9.2.1 General
9.2.2 Test organism
9.3 Validation of the integrity test for sterilizing filters for liquids
9.4 Validation of filter interactions with the process fluid
9.5 Validation of the sterilization of filter system
9.6 Validation of fluid-specific microbial retention by sterilizing filters for gases
9.6.1 General
9.6.2 Aerosol retention
9.6.3 Validation of physical integrity testing
9.6.4 Compatibility and service life
9.6.5 Validation of the sterilization of the filter system for gases
10 Routine monitoring and control
11 Product release from sterilizing filtration
12 Maintaining process effectiveness
12.1 General
12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification
12.5 Assessment of change
Annex A (informative) Guidance on the application of this document
Bibliography