ASTM F1608-00(2004)
(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:
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 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 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 2004)
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 E177 Practice for Use of the Terms Precision and Bias in
ASTM Test Methods
1.1 This test method is used to determine the passage of
E691 Practice for Conducting an Interlaboratory Study to
airborne bacteria through porous materials intended for use in
Determine the Precision of a Test Method
packagingsterilemedicaldevices.Thistestmethodisdesigned
to test materials under conditions that result in the detectable
3. Terminology
passage of bacterial spores through the test material.
3.1 Definition:
1.1.1 Around-robin study was conducted with eleven labo-
3.1.1 porous packaging material, n—a material used in
ratories participating. Each laboratory tested duplicate samples
medical packaging which is intended to provide an environ-
of six commercially available porous materials to determine
mentalandbiologicalbarrier,whileallowingsufficientairflow
the LRV. Materials tested under the standard conditions de-
to be used in gaseous sterilization methods (for example, EO,
scribed in this test method returned average values that range
steam, gas plasma).
from LRV 1.7 to 4.3.
1.1.2 Results of this round-robin study indicate that caution
4. Summary of Test Method
should be used when comparing test data and ranking materi-
4.1 Samples of porous materials are subjected to an aerosol
als, especially when a small number of sample replicates are
of Bacillus subtilis var. niger spores within an exposure
used.Inaddition,furthercollaborativework(suchasdescribed
chamber. Spores which pass through the porous sample are
in Practice E691) should be conducted before this test method
collected on membrane filters and enumerated. The logarithm
would be condsidered adequate for purposes of setting perfor-
reduction value (LRV) is calculated by comparing the loga-
mance standards.
rithm of the number of spores passing through the porous
1.2 This test method requires manipulation of microorgan-
material with the logarithm of the microbial challenge.
isms and should be performed only by trained personnel. The
4.2 Standard Set of Conditions—This test method specifies
U.S. Department of Health and Human Services publication
a standard set of conditions for conducting the exposure
Biosafety in Microbiological and Biomedical Laboratories
chambertestmethod.Astandardsetofconditionsisrequiredto
(CDC/NIH-HHS Publication No. 84-8395) should be con-
enable evaluation of materials between laboratories. The con-
sulted for guidance.
ditions stated in this test method were chosen for several
1.3 This standard does not purport to address all of the
reasons. First, it is difficult to maintain an aerosol of spores
safety concerns, if any, associated with its use. It is the
over long periods of time. (Also, if the spore challenge time is
responsibility of the user of this standard to establish appro-
long, the cost of the test increases). Second, to determine the
priate safety and health practices and determine the applica-
differences between materials, it is necessary to test the
bility of regulatory limitations prior to use.
materials under conditions which allow passage of bacterial
2. Referenced Documents spores. If a material does not allow any passage of spores, all
2 that can be stated is that it has better resistance to penetration
2.1 ASTM Standards:
than the severity of the challenge conditions. Third, it is
necessary to have a large spore challenge level to be able to
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible
detect the passage of spores through the entire range of
Barrier Materials and is the direct responsibility of Subcommittee F02.15 on
commercially available porous packaging materials. The stan-
Chemical/Safety Properties.
dard conditions stated in this test method are based upon these
Current edition approved Oct. 1, 2004. Published October 2004. Originally
approved in 1995. Last previous edition approved in 2000 as F1608–00. DOI: factors. (Additional information may be found in the Refer-
10.1520/F1608-00R04.
ences section). However, since many factors influence the
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
determination of an appropriate porous material (outlined in
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
5.1.1-5.1.4), each user may modify these conditions (that is,
Standards volume information,
...
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