2650059

DANSK DS/EN ISO 13408-2 [ Withdrawn ]

Aseptic processing of health care products – Part 2: Filtration

standard by Dansk Standard , 08/16/2011

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Full Description

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).

Product Details

Edition:: 11
Published:: 08/16/2011
Number of Pages:: 26
File Size:: 1 file , 380 KB
Product Code(s):: DS-026, DS-026

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