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  • ASTM
    F838-05(2013) Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
    Edition: 2013
    $103.58
    Unlimited Users per year

Description of ASTM-F838 2013

ASTM F838 - 05(2013)

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

Active Standard ASTM F838 | Developed by Subcommittee: E55.03

Book of Standards Volume: 14.02




ASTM F838

Significance and Use

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 challenge of 10 7 bacteria per cm 2 of effective filtration area is orders of magnitude higher than one would expect to encounter in a sterilizing filtration process. This level was selected in order to provide a high degree of assurance that the filter would quantitatively retain large numbers of organisms. This concept is important, in view of the requirement to provide a quantitative assessment in validating a sterilization process.

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. This value, coupled with a knowledge of the number and types of organisms (bioburden) indigenous to the process, may then be utilized to determine the probability of obtaining a sterile filtrate. Conversely, the numerical value of the filtration efficiency may be used when one must meet a specified probability of sterility assurance to calculate the volume of fluid that may be filtered in order to maintain that level of assurance.

1. Scope

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 method may be employed to evaluate any membrane filter system used for liquid sterilization.

1.2 This standard may involve hazardous materials, operations, and equipment. 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 and health practices and determine the applicability of regulatory limitations prior to use.


2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D1193 Specification for Reagent Water


ICS Code

ICS Number Code 07.100.20 (Microbiology of water)


DOI: 10.1520/F0838

ASTM International is a member of CrossRef.

ASTM F838

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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