ASTM_E_2362_-_15.pdf

Designation:E236215Standard Practice forEvaluation of Pre-saturated or Impregnated Towelettes forHard Surface Disinfection1This standard is issued under the fixed designation E2362;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.1.Scope1.1 This practice is designed to evaluate the antimicrobialactivity of pre-saturated or impregnated towelettes when usedas a hard surface disinfectant.1.2 It is the responsibility of the investigator to determinewhether Good Laboratory Practices(GLPs)are required andto follow them when appropriate.1.3 This practice should be performed only by those trainedin microbiological techniques.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 Appropriate modifications to the practice may be re-quired when testing organisms not specified herein.1.6 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 to determine theapplicability of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D1193 Specification for Reagent WaterE1054 Test Methods for Evaluation of Inactivators of Anti-microbial Agents2.2 Federal Standard40 CFR,Part 160 Good Laboratory Practice Standards33.Terminology3.1 carrier,na transportable surface onto which a testorganism will be inoculated and dried.The carrier will betreated with the test substance and subcultured for survivors.3.2 CFU,ncolony forming units3.3 disinfectant,na physical or chemical agent or processthat destroys pathogenic or potentially pathogenic microorgan-isms in/on surfaces or objects.3.4 impregnated,adjsaturated with test substance.3.5 neutralizer,na component used to render an activeagent incapable of destroying organisms by chemical orphysical means.3.6 pre-saturated,adjto be filled or impregnated with testsubstance prior to the time of its intended use.3.7 towelette,nA paper,cloth or non-woven blend mate-rial used as a transporter for a cleaning and/or disinfectionagent.4.Summary of Practice44.1 A towelette impregnated or pre-saturated with a testsubstance is used to treat a carrier which has been inoculatedwith a test organism after an aliquot of a test organism has beeninoculated,evenly distributed to an inoculation area of ap-proximately one square inch(approximately 625 mm),anddried onto the carrier.The carrier is wiped using the pre-saturated or impregnated towelette simulating the applicationof the test substance and then held for a pre-determined contacttime.After the specified contact time,the test substanceremaining on the carrier is neutralized and the carrier issubcultured to recover surviving test organism.5.Significance and Use5.1 This practice may be used to determine if a pre-saturatedor impregnated towelette demonstrates antimicrobial effective-ness as a disinfectant on hard surfaces.This practice providessurvivor results in the form of a qualitative endpoint(growth1This practice is under the jurisdiction of ASTM Committee E35 on Pesticides,Antimicrobials,and Alternative Control Agents and is the direct responsibility ofSubcommittee E35.15 on Antimicrobial Agents.Current edition approved Oct.1,2015 Published October 2015.Originallyapproved in 2004.Last previous edition approved in 2009 as E2362 09.DOI:10.1520/E2362-15.2For 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.3Available from the Superintendent of Documents,U.S.Government PrintingOffice,Washington D.C.204024United States Environmental ProtectionAgency,Standard Operating Procedurefor Disinfectant Towelette Test Against Staphylococcus aureus,Pseudomonasaeruginosa,and Salmonella enterica,EPA/OPP Microbiology Laboratory,Ft.Meade,MD.SOP#MB09-05,Revised 1/30/13.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 positive versus growth negative).The results generated byfollowing this practice do not provide for specific quantitativereductions.6.Apparatus6.1 Incubatorany calibrated incubator that maintains atemperature specific for propagation of organisms.(forexample,bacteria and mycobacteria at 36 6 1 C and fungi at27.5 6 2.5 C).6.2 Sterilizerany suitable,calibrated steam sterilizer thatproduces the conditions of sterilization is acceptable.6.3 Test Toweletteswith instructions for use.6.4 Timer(Stop-clock)a calibrated timer that displays minand s.6.5 Spectrophotometercalibrated to 650 nm.6.6 Mixera vortex mixer is recommended.6.7 pH metera calibra