ASTM F1608-00(2009)
(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
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 are useful in assessing the relative potential of a particular porous material to contribute 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:
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.
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.
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).
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 LRV. 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 condsidered 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 and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
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Designation: F1608 − 00(Reapproved 2009)
Standard Test Method for
Microbial Ranking of Porous Packaging Materials (Exposure
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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 2. Referenced Documents
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2.1 ASTM Standards:
1.1 This test method is used to determine the passage of
E177Practice for Use of the Terms Precision and Bias in
airborne bacteria through porous materials intended for use in
ASTM Test Methods
packagingsterilemedicaldevices.Thistestmethodisdesigned
E691Practice for Conducting an Interlaboratory Study to
to test materials under conditions that result in the detectable
Determine the Precision of a Test Method
passage of bacterial spores through the test material.
1.1.1 Around-robin study was conducted with eleven labo-
3. Terminology
ratories participating. Each laboratory tested duplicate samples
3.1 Definitions:
of six commercially available porous materials to determine
3.1.1 porous packaging material, n—a material used in
the LRV. Materials tested under the standard conditions de-
medical packaging which is intended to provide an environ-
scribed in this test method returned average values that range
mentalandbiologicalbarrier,whileallowingsufficientairflow
from LRV 1.7 to 4.3.
to be used in gaseous sterilization methods (for example, EO,
1.1.2 Results of this round-robin study indicate that caution
steam, gas plasma).
should be used when comparing test data and ranking
materials,especiallywhenasmallnumberofsamplereplicates
4. Summary of Test Method
are used. In addition, further collaborative work (such as
4.1 Samples of porous materials are subjected to an aerosol
described in Practice E691) should be conducted before this
of Bacillus subtilis var. niger spores within an exposure
test method would be condsidered adequate for purposes of
chamber. Spores which pass through the porous sample are
setting performance standards.
collected on membrane filters and enumerated. The logarithm
1.2 This test method requires manipulation of microorgan- reduction value (LRV) is calculated by comparing the loga-
isms and should be performed only by trained personnel. The rithm of the number of spores passing through the porous
U.S. Department of Health and Human Services publication material with the logarithm of the microbial challenge.
Biosafety in Microbiological and Biomedical Laboratories
4.2 Standard Set of Conditions —This test method specifies
(CDC/NIH-HHS Publication No. 84-8395) should be con-
a standard set of conditions for conducting the exposure
sulted for guidance.
chambertestmethod.Astandardsetofconditionsisrequiredto
enable evaluation of materials between laboratories. The con-
1.3 The values stated in SI units are to be regarded as
ditions stated in this test method were chosen for several
standard. No other units of measurement are included in this
reasons. First, it is difficult to maintain an aerosol of spores
standard.
over long periods of time. (Also, if the spore challenge time is
1.4 This standard does not purport to address all of the
long, the cost of the test increases). Second, to determine the
safety concerns, if any, associated with its use. It is the
differences between materials, it is necessary to test the
responsibility of the user of this standard to establish appro-
materials under conditions which allow passage of bacterial
priate safety and health practices and determine the applica-
spores. If a material does not allow any passage of spores, all
bility of regulatory limitations prior to use.
that can be stated is that it has better resistance to penetration
than the severity of the challenge conditions. Third, it is
necessary to have a large spore challenge level to be able to
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ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible
Barrier Packaging and is the direct responsibility of Subcommittee F02.15 on
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Chemical/Safety Properties. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Oct. 1, 2009. Published November 2009. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1995. Last previous edition approved in 2004 as F1608–00(2004). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F1608-00R09. the ASTM website.
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F1608 − 00 (2009)
detect the passage of spores
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