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ASTM E3363-23

Standard Test Method for Quantitative Performance Evaluation of Antimicrobial Towelettes
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ASTM E3363-23

Standard Test Method for Quantitative Performance Evaluation of Antimicrobial Towelettes

PUBLISH DATE 2023
PAGES 20
ASTM E3363-23

1.1 This test method quantitatively determines the effectiveness of various sizes of antimicrobial towelettes in treating hard, non-porous surfaces against Pseudomonas aeruginosa and Staphylococcus aureus.

1.2 This test method may be used to evaluate towelettes for antimicrobial efficacy against additional microorganisms (with necessary modifications).

1.2.1 This test method does not differentiate between chemical inactivation of the test microbe and mechanical removal of inoculum from a surface; rather, product efficacy is considered a combination of both attributes of a towelette-based formulation.

1.3 This test method involves the use of hazardous materials, chemicals, and infectious microorganisms and therefore should be performed only by those trained in microbiological techniques in facilities designed and equipped for work with infectious agents at the appropriate biosafety level, a BSL-2 or higher laboratory; specifications provided in the “Biosafety for Biomedical and Microbiological Laboratories” (BMBL), 6th edition (BMBL).

1.4 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP Standards—For example, 40 CFR, Part 160 of FIFRA) are required and to follow them when appropriate.

1.5 Strict adherence to the protocol is necessary for the validity of the test results.

1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7 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.

1.8 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.

1.1 Thistestmethodquantitativelydeterminestheeffectivenessofvarioussizesofantimicrobialtowelettesintreatinghard,non-poroussurfacesagainstPseudomonasaeruginosaandStaphylococcusaureus.1.2 Thistestmethodmaybeusedtoevaluatetowelettesforantimicrobialefficacyagainstadditionalmicroorganisms(withnecessarymodifications).1.2.1 Thistestmethoddoesnotdifferentiatebetweenchemicalinactivationofthetestmicrobeandmechanicalremovalofinoculumfromasurface;rather,productefficacyisconsideredacombinationofbothattributesofatowelette-basedformulation.1.3 Thistestmethodinvolvestheuseofhazardousmaterials,chemicals,andinfectiousmicroorganismsandthereforeshouldbeperformedonlybythosetrainedinmicrobiologicaltechniquesinfacilitiesdesignedandequippedforworkwithinfectiousagentsattheappropriatebiosafetylevel,aBSL-2orhigherlaboratory;specificationsprovidedinthe“BiosafetyforBiomedicalandMicrobiologicalLaboratories”(BMBL),6thedition(BMBL).1.4 ItistheresponsibilityoftheinvestigatortodeterminewhetherGoodLaboratoryPractices(GLPStandards—Forexample,40CFR,Part160ofFIFRA)arerequiredandtofollowthemwhenappropriate.1.5 Strictadherencetotheprotocolisnecessaryforthevalidityofthetestresults.1.6 ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.7 Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafety,health,andenvironmentalpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.1.8 ThisinternationalstandardwasdevelopedinaccordancewithinternationallyrecognizedprinciplesonstandardizationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecommendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.
5.1 TheplasticPetriplate(carrier)providesaclosedsystemforenumerationandeasyapplicationofapre-saturatedorimpregnatedantimicrobialtowelettebyananalyst.5.2 Aliquotingofsterile5 %non-heat-inactivatedfetalbovineserum(five10µLspots)ontosoiledcarriersandinoculationoffinaltestsuspensionontotreatedcarriers(five10 µLspots)isconductedusingatemplateandapositivedisplacementpipette,therebyensuringapreciseinoculumlevelanduniformdistributionofsoilandfinaltestsuspension.5.3 Asingletoweletteistestedper2-carrierset,eliminatingthelikelihoodofcrosscontaminationbetweencarriers.5.4 Thecorkscrew-patternedcircularmotionoftheproductapplication(wipeoutsidetoinside,wipeinsidetooutsideusingthewipingtemplate;seeAnnexA3–AnnexA6)ensuresuniformcoverageandcontactofdisinfectantwiththeinoculatedsurface.5.5 Theadditionofneutralizertothetreatedcarriersattheendofthecontacttimeresultsinneutralizationofthetestsubstance.Thisstandardtestmethodprovidesaprocedureforperformingneutralizationverificationtoconfirmthatthemicrobicidal,microbistatic,orbothtypesofactivityofatestsubstancehasbeenreducedby50 %attheendofthecontacttime(seeAnnexA1forneutralizationverificationprocedure).5.6 Thedesignofthisstandardtestmethodminimizesanylossofviableorganismsthroughcarrierwash-off.5.7 Itisoptionaltoadjust(dilutioninPBS)theinoculumtoachievedesiredcontrolcountsof5.0 log10CFU/carrierto6.5 log10CFU/carrier.5.8 Include,whereapplicable,comparisonsofthetesttoothersimilarproceduressuchasPracticesE1054andE2362.
SDO ASTM: ASTM International
Document Number E3363
Publication Date Sept. 1, 2023
Language en - English
Page Count 20
Revision Level 23
Supercedes
Committee E35.15
Publish Date Document Id Type View
Sept. 1, 2023 E3363-23E01 Revision
Sept. 1, 2023 E3363-23 Revision