Aseptic processing of health care products – Part 2: Filtration (ISO 13408-2:2003)
Abstract
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).
DIN EN ISO 13408-2:2011-09 (E)
Aseptic processing of health care products – Part 2: Filtration (ISO 13408-2:2003)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 General requirements ……………………………………………………………………………………………………..7
5 Selection of filters and filter assemblies based on filter manufacturer’s data ……………………7
6 Fluid-specific selection criteria based on filter user’s data ……………………………………………….7
7 Filtration process ……………………………………………………………………………………………………………8
7.1 Process parameters ………………………………………………………………………………………………………..8
7.2 Validation of fluid-specific microbial retention by filters …………………………………………………..9
8 Filtration system design ………………………………………………………………………………………………..11
9 Routine process ……………………………………………………………………………………………………………12
10 Process documentation ………………………………………………………………………………………………..12
11 Maintenance and change control …………………………………………………………………………………..13
12 Operator training …………………………………………………………………………………………………………..13
Annex A (informative) Basic information and quality certificates for filter cartridges ……………………..14
Bibliography …………………………………………………………………………………………………………………………………18