ASTM E3178-18
(Practice)Standard Practice for Evaluating Static and Cidal Chemical Decontaminants against Bacillus Spores using Centrifugal Filtration Tubes
Standard Practice for Evaluating Static and Cidal Chemical Decontaminants against <emph type="bdit">Bacillus</emph> Spores using Centrifugal Filtration Tubes
SIGNIFICANCE AND USE
5.1 The practice can be used to evaluate coupon materials of any composition, insofar as the coupon can be small enough to fit inside filter units mentioned in 4.1.
5.2 This practice defines procedures that are quantitative, scalable, rapid, sensitive, and safe, while minimizing labor and addressing statistical confidence (1, 2).
5.2.1 Quantitative—The total number of spores per coupon is determined by dilution-plating, and all spores remaining on the coupon are assayed for activity in the extraction tube to provide confidence that all the spores were accounted for.
5.2.2 Statistical Confidence—The use of five independent preparations of spore inocula for a statistical n of 5.
5.2.3 Sensitivity—Allows for complete detection of all culturable spores inoculated on a coupon, including the spores that remain attached to the coupon.
5.2.3.1 The limit of detection is dependent on the culturability of fully matured spores to germinate, outgrow and divide in the presence of the extraction medium (1% tryptic soy broth, 100 mM L-Alanine, 1 mM inosine, 0.05% Tween 80) and/or on tryptic soy agar.
5.2.3.2 Results presented in Refs (1, 3) (and currently unpublished results) indicate that these media, combined with the test temperatures and conditions described herein will generate results with a high level of practical confidence for detecting culturable Bacillus spores.
5.2.4 Safety—Inoculated coupons are contained within filter units.
5.2.5 Simplicity of Testing—Tests and extractions are performed in the same filter unit to minimize coupon handling steps.
5.2.6 Scalable and Rapid—A maximum of 36 samples can be processed in 1 h by two technicians; a total of 300 samples have been processed by six technicians in 5 h (1, 2).
5.2.7 Wide application for numerous Bacillus species and strains. The method has also been modified and used for vegetative bacteria and viruses as well (1, 2).
SCOPE
1.1 This practice is used to quantify the efficacy of liquid or solid decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials. This practice can distinguish between bactericidal and bacteriostatic chemicals within decontamination mixtures. This is important because many decontaminants contain both reactive compounds and high concentrations of bacteriostatic surfactants. All test samples are directly compared to pre-neutralized controls, un-inoculated negative growth controls, and solution controls on the same day as the test in order to increase practical confidence in the inactivation data.
1.2 This procedure should be performed only by those trained in microbiological techniques, are familiar with antimicrobial (sporicidal) agents and the application instructions of the antimicrobial products.
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 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, 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
Relations
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: E3178 − 18
Standard Practice for
Evaluating Static and Cidal Chemical Decontaminants
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against Bacillus Spores using Centrifugal Filtration Tubes
This standard is issued under the fixed designation E3178; 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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1.1 This practice is used to quantify the efficacy of liquid or 2.1 ASTM Standards:
soliddecontaminantson Bacillussporesdriedonthesurfaceof E1054Test Methods for Evaluation of Inactivators of Anti-
coupons made from porous and non-porous materials. This microbial Agents
practicecandistinguishbetweenbactericidalandbacteriostatic E2756Terminology Relating toAntimicrobial andAntiviral
chemicals within decontamination mixtures. This is important Agents
3,4
because many decontaminants contain both reactive com- 2.2 CFR Standards:
pounds and high concentrations of bacteriostatic surfactants. Title 7 (Agriculture) CFR, Part 331Possession, Use, and
All test samples are directly compared to pre-neutralized Transfer of Select Agents and Toxins
controls, un-inoculated negative growth controls, and solution Title 9 (Animals and Animal Products) CFR, Part 121Pos-
controls on the same day as the test in order to increase session, Use, and Transfer of Select Agents and Toxins
practical confidence in the inactivation data. Title 42 (Public Health) CFR, Part 73Select Agents and
Toxins
1.2 This procedure should be performed only by those
trained in microbiological techniques, are familiar with anti-
3. Terminology
microbial(sporicidal)agentsandtheapplicationinstructionsof
3.1 For definitions of terms used in this Practice, see
the antimicrobial products.
Terminology E2756.
1.3 The values stated in SI units are to be regarded as
3.2 Definitions of Terms Specific to This Standard:
standard. No other units of measurement are included in this
3.2.1 decontaminant, n—a physical or chemical agent or
standard.
process that inactivates pathogenic or potentially pathogenic
1.4 This standard may involve hazardous materials,
microorganisms in or on surfaces or objects.
operations, and equipment. This standard does not purport to
3.2.2 endospore, n—a dormant, robust and non-
address all of the safety concerns, if any, associated with its
metabolically active structure produced by certain types of
use. It is the responsibility of the user of this standard to
bacteria from the Firmicutes phylum.
establish appropriate safety, health, and environmental prac-
tices and determine the applicability of regulatory limitations 3.2.3 exosporium, n—the outermost structural layer of mac-
robacillus spores including Bacillus anthracis, Bacillus th-
prior to use.
1.5 This international standard was developed in accor- uringiensis and Bacillus cereus.
dance with internationally recognized principles on standard-
3.2.4 macrobacillus, n—a Bacillus species that produces
ization established in the Decision on Principles for the
endospores that possess an exosporium including Bacillus
Development of International Standards, Guides and Recom-
anthracis, Bacillus thuringiensis and Bacillus cereus.
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
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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
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This practice is under the jurisdiction ofASTM Committee E35 on Pesticides, the ASTM website.
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Antimicrobials, and Alternative Control Agents and is the direct responsibility of United States Select Agent Program administered by the Center for Disease
Subcommittee E35.15 on Antimicrobial Agents. Control(CDC)and/ortheUnitedStatesDepartmentofAgriculture(USDA),Animal
Current edition approved Oct. 1, 2018. Published January 2019. DOI: 10.1520/ and Plant Health Inspection Service (APHIS)https://www.selectagents.gov/
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F3178–18 https://www.access.gpo.gov
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E3178 − 18
3.2.5 microbacillus, n—a Bacillus species that produces 4.8 The number of culturable surviving spores from decon-
endospores that do not possess an exosporium including tamination tests is divided by the extraction percentage to
-1
Bacillus subtilis and Bacillus atroph
...
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