ASTM F838-20
Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

Standard No.

ASTM F838-20

Release Date

2020

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F838-20

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 can be used to evaluate any membrane filter system used for liquid sterilization. 1.2 This test method is not intended to be used in performance of productand process-specific validation of the bacterial retention characteristics of membrane filters to be used in pharmaceutical or biopharmaceutical sterilizing filtration, or both. Processand 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.

ASTM F838-20 Referenced Document

• ASTM D1193 Standard Specification for Reagent Water

ASTM F838-20 history

• 2020 ASTM F838-20 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
• 2015 ASTM F838-15ae1 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
• 2015 ASTM F838-15a Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
• 2015 ASTM F838-15 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
• 2005 ASTM F838-05(2013) Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
• 2005 ASTM F838-05 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
• 1983 ASTM F838-83(1993) Standard Test Method for Determining Bacterial Retention Of Membrane Filters Utilized For Liquid Filtration