Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

Importancia y uso:

5.1 This test method is designed to assess the retentivity of a sterilizing filter under standard challenge conditions.

5.1.1 A challenge of 10⁷ bacteria per cm² of effective filtration area is selected to provide a high degree of assurance that the method has sufficient sensitivity to detect oversized pores and that the filter will quantitatively retain large numbers of organisms. The model challenge organism, B. diminuta, is widely considered to be a small bacterium and is recognized as an industry standard for qualifying sterilizing filters. Other species may represent a worst-case test in terms of ability to penetrate a filter. This test does not provide assurance that filters can completely retain such bacteria.

5.1.2 The analytical procedure utilized in this test method provides a method to assign a numerical value to the filtration efficiency of the filter being evaluated under standard filtration conditions. For the purpose of product sterility assurance, additional process-specific studies should be performed.

Subcomité:

E55.14

Referida por:

D8422-21

Volúmen:

14.01

Número ICS:

07.100.20 (Microbiology of water)

Palabras clave:

bacterial retention; liquid filtration; membrane filters;