EHEDG Guidelines

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Doc. 19 A method for assessing the bacterial impermeability of hydrophobic membrane filters

Second Edition, June 2012 - Research has shown that hydrophobic membrane filters, with a pore size of 0.22 mm, do not retain micro-organisms under all process conditions. Investigations were conducted in risk assessment of sterilising hydrophobic membrane filters, evaluating the performance of the filters under a range of operating conditions. To validate the bacterial retention ability of sterilising grade hydrophobic membrane filters, a bacterial aerosol challenge test methodology was developed.

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