Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003, IDT)
This Malaysian Standard 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.
This Malaysian Standard 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).
Published
• (none) / (none) / (none)
PDF
07/06/2019
20
NSC 18 - Medical Devices and Facilities for Healthcare
