ASTM F838 - 15ae1 - Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

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ASTM F838 - 15ae1

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

Status : Current   Published : November 2018

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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.




Standard NumberASTM F838 - 15ae1
TitleStandard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
StatusCurrent
Publication Date15 November 2018
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Bacterial retention; liquid filtration; membrane filters
ICS07.100.20
PublisherASTM
FormatA4
DeliveryYes
Pages6
File Size122 KB
Price£40.00


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