ASTM F1608-21
(Test Method)Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
SIGNIFICANCE AND USE
5.1 The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test is useful in assessing the relative potential of a particular porous material in contributing to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following:
5.1.1 The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions.
5.1.2 The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package.
5.1.3 The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems).
5.1.4 The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions.
SCOPE
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.
1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.
1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards.
1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.
General Information
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Standards Content (Sample)
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.
Designation: F1608 − 21
Standard Test Method for
Microbial Ranking of Porous Packaging Materials (Exposure
1
Chamber Method)
This standard is issued under the fixed designation F1608; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This test method is used to determine the passage of
ization established in the Decision on Principles for the
airborne bacteria through porous materials intended for use in
Development of International Standards, Guides and Recom-
packagingsterilemedicaldevices.Thistestmethodisdesigned
mendations issued by the World Trade Organization Technical
to test materials under conditions that result in the detectable
Barriers to Trade (TBT) Committee.
passage of bacterial spores through the test material.
1.1.1 Around-robin study was conducted with eleven labo-
2. Referenced Documents
ratories participating. Each laboratory tested duplicate samples
2
2.1 ASTM Standards:
of six commercially available porous materials to determine
E691Practice for Conducting an Interlaboratory Study to
theLogReductionValue(LRV)(seecalculationinSection12).
Determine the Precision of a Test Method
Materialstestedunderthestandardconditionsdescribedinthis
testmethodreturnedaveragevaluesthatrangefromLRV1.7to
3. Terminology
4.3.
3.1 Definitions:
1.1.2 Results of this round-robin study indicate that caution
3.1.1 porous packaging material, n—a material used in
should be used when comparing test data and ranking
medical packaging which is intended to provide an environ-
materials,especiallywhenasmallnumberofsamplereplicates
mentalandbiologicalbarrier,whileallowingsufficientairflow
are used. In addition, further collaborative work (such as
to be used in gaseous sterilization methods (for example,
described in Practice E691) should be conducted before this
ethylene oxide, steam, gas plasma).
test method would be considered adequate for purposes of
setting performance standards.
4. Summary of Test Method
1.2 This test method requires manipulation of microorgan-
4.1 Samples of porous materials are subjected to an aerosol
isms and should be performed only by trained personnel. The
of Bacillus atrophaeus spores within an exposure chamber.
U.S. Department of Health and Human Services publication
Spores which pass through the porous sample are collected on
Biosafety in Microbiological and Biomedical Laboratories
membrane filters and enumerated. The LRV is calculated by
(CDC/NIH-HHS Publication No. 84-8395) should be con-
comparing the logarithm of the number of spores passing
sulted for guidance.
throughtheporousmaterialwiththelogarithmofthemicrobial
1.3 The values stated in SI units are to be regarded as
challenge.
standard. No other units of measurement are included in this
4.2 Standard Set of Conditions—This test method specifies
standard.
a standard set of conditions for conducting the exposure
1.4 This standard does not purport to address all of the
chambertestmethod.Astandardsetofconditionsisrequiredto
safety concerns, if any, associated with its use. It is the
enable evaluation of materials between laboratories. The con-
responsibility of the user of this standard to establish appro-
ditions stated in this test method were chosen for several
priate safety, health, and environmental practices and deter-
reasons. First, it is difficult to maintain an aerosol of spores
mine the applicability of regulatory limitations prior to use.
over long periods of time. (Also, if the spore challenge time is
long, the cost of the test increases). Second, to determine the
differences between materials, it is necessary to test the
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onPrimary
Barrier Packaging and is the direct responsibility of Subcommittee F02.15 on
2
Chemical/Safety Properties. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Oct. 1, 2021. Published November 2021. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1995. Last previous edition approved in 2016 as F1608–16. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F1608-21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1608 − 16 F1608 − 21
Standard Test Method for
Microbial Ranking of Porous Packaging Materials (Exposure
1
Chamber Method)
This standard is issued under the fixed designation F1608; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging
sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of
bacterial spores through the test material.
1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six
commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials
tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.
1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials,
especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice
E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards.
1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S.
Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-
HHS Publication No. 84-8395) should be consulted for guidance.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
1
This test method is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary Barrier Packaging and is the direct responsibility of Subcommittee F02.15 on
Chemical/Safety Properties.
Current edition approved May 1, 2016Oct. 1, 2021. Published June 2016November 2021. Originally approved in 1995. Last previous edition approved in 20092016 as
F1608 – 00 (2009).F1608 – 16. DOI: 10.1520/F1608-16.10.1520/F1608-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F1608 − 21
3. Terminology
3.1 Definitions:
3.1.1 porous packaging material, n—a material used in medical packaging which is intended to provide an environmental and
biological barrier, while allowing sufficient air flow to be used in gaseous sterilization methods (for example, ethylene oxide,
steam, gas plasma).
4. Summary of Test Method
4.1 Samples of porous materials are subjected to an aerosol of Bacillus atrophaeus spores within an exposure chamber. Spores
which pass through the porous sample are collected on membrane filters and enumerated. The LRV is calculated by comparing the
logarithm of the number of spores passing through the porous material with the logarithm of the microbial challenge.
4.2 Standard Set of Conditions—This test method specifies a standard set of conditions for conducting the exposure chamber test
method. A standard set of conditions is required to enable evaluation of materials between laboratori
...
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