ASTM International - ASTM F838-15ae1

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

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Organization: ASTM International
Publication Date: 30 September 2015
Status: active
Page Count: 6
ICS Code (Microbiology of water): 07.100.20
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... View More

scope:

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.

Document History

September 30, 2015
Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
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...
ASTM F838-15ae1
September 30, 2015
Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
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...
May 1, 2015
Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
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...
June 1, 2013
Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
5.1 Since all sterilizing filtration processes are performed under positive pressure, this test method is designed to assess the retentivity of a sterilizing filter under process conditions. 5.1.1 A...
January 1, 2005
Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
1.1 This test method determines the bacterial retention characteristics of membrane filters for liquid filtration using Pseudomonas diminuta as the challenge organism. This test may be employed to...
January 1, 1993
Standard Test Method for Determining Bacterial Retention Of Membrane Filters Utilized For Liquid Filtration (Withdrawn 2002)
1.1 This test method determines the bacterial retention characteristics of membrane filters for liquid filtration using Pseudomonas diminuta as the challenge organism. This test may be employed to...
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