ASTM-F838 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

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



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1.1 This test method determines the bacterial retention characteristics of membrane filters for liquid filtration using Brevundimonas diminuta as the challenge organism. This test method may be employed to evaluate any membrane filter system used for liquid sterilization.

1.2 This test method is not intended to be used in performance of product- and process-specific validation of the bacterial retention characteristics of membrane filters to be used in pharmaceutical or biopharmaceutical sterilizing filtration, or both. Process- and product-specific bacterial retention validation should be carried out using the intended product manufacturing process parameters and the product solution or surrogate as the carrier fluid.

1.3 The values stated in SI units are to be regarded as standard.

1.3.1 Exception—The inch-pound values given for units of pressure are to be regarded as standard; SI unit conversions are shown in parentheses.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Significance and Use

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 filter will be challenged uniformly across the membrane surface to assure it 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.


bacterial retention; liquid filtration; membrane filters;; ICS Number Code 07.100.20 (Microbiology of water)

To find similar documents by ASTM Volume:

11.02 (Water (II))

14.02 (General Test Methods; Forensic Psychophysiology; Forensic Sciences; Terminology; Conformity Assessment; Statistical Methods; Nanotechnology; Forensic Engineering; Manufacture of Pharmaceutical Products)

14.04 (Laboratory Apparatus; Degradation of Materials; SI; Oxygen Fire Safety)

To find similar documents by classification:

07.100.20 (Microbiology of water Examination of biological properties of water, see 13.060.70)

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Document Number


Revision Level




Modification Type

Editorially changed

Publication Date

Aug. 1, 2018

Document Type

Test Method

Page Count

6 pages

Committee Number