ASTM_E_1327_-_07_2012e1.pdf

Designation:E132707(Reapproved 2012)1Standard Test Method forEvaluation of Antimicrobial Handwash Formulations byUtilizing Fingernail Regions1This standard is issued under the fixed designation E1327;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1NOTEEditorial changes were made throughout the document in November 2012.1.Scope1.1 This test method can be used to determine the effective-ness of antimicrobial handwashing agents(including handrubs)in the reduction of transient bacterial flora with particularemphasis on the fingernail region.1.2 A knowledge of microbiological techniques is requiredfor these procedures.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.For more specifichazard statements,see 7.5.2.Referenced Documents2.1 ASTM Standards:2E1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE2276 TestMethodforDeterminingtheBacteria-Eliminating Effectiveness of Hygienic Handwash andHandrub Agents Using the Fingerpads of AdultsE1838 Test Method for Determining the Virus-EliminatingEffectiveness of Hygienic Handwash and Handrub AgentsUsing the Fingerpads of Adults3.Summary of Test Method3.1 This test method,involving an improved method ofrecovering bacteria from hands,is used to study the effects ofantimicrobial handwashes including health care personnelhandwash products.The group of volunteer panelists need notrefrain from using topical antimicrobials(such as deodorantsoaps)before participating in the study.All subjects wash theirhands with a nonantimicrobial hand soap prior to testing toremove any residual hand lotions and to lower the numbers ofresident skin flora.Activity of products is measured bycomparing the numbers of marker bacteria recovered fromartificially contaminated fingernail regions after use of thehandwashing formulations to the numbers recovered from theartificially contaminated but unwashed fingernail regions.Broth cultures of Serratia marcescens(a red pigmented bac-terial species)and Escherichia coli(which produces fluores-cent colonies on a special agar medium)are used as testbacteria.A spore suspension of Bacillus subtilis may beutilized to study(1)degree of physical removal by handwash-ing techniques,and(2)the recovery and precision aspects ofthe test method.4.Significance and Use4.1 The procedure should be used to test the degermingeffectiveness of antimicrobial hand washing products used byhealth care personnel that are intended for frequent use,andthat are intended to reduce the level of contamination acquiredthrough contact with contaminated objects or people.4.2 Performance of these procedures requires the knowl-edge of regulations pertaining to the protection of humansubjects(Ref 1).35.Apparatus5.1 Colony CounterAny of several types may be used,forexample,Quebec Colony Counter.5.2 IncubatorsOne incubator capable of maintaining atemperature of 25 6 2C(this temperature is required to ensurepigment production of Serratia);a second incubator capable ofmaintaining 37 6 2C used for E.coli and B.subtilisincubation is acceptable.5.3 Water BathCapable of maintaining temperature of 806 2C for heat shocking of B.subtilis spores is needed.1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved Oct.1,2012.Published November 2012.Originallyapproved in 1990.Last previous edition approved in 2007 as E1327 07.DOI:10.1520/E1327-07R12E01.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The boldface numbers in parentheses refer to a list of references at the end ofthis standard.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.4 SterilizerAny suitable steam sterilizer capable of pro-ducing the conditions of sterilization is acceptable.5.5 TimerAny stop-watch that can be read in minutes andseconds is required.5.6 Handwashing SinkA sink of sufficient size to permitpanelists to wash without touching hands to sink surface orother panelists is needed.5.6.1 Water Faucet(s),to be located above the sink at aheight that permits the hands to be held higher than the elbowduring the washing procedure.5.6.2 Tap Water Temperature Regulator and TemperatureMonitor,to monitor and regulate water temperature o