ASTM_E_2752_-_10_2015.pdf

Designation:E275210(Reapproved 2015)Standard Guide forEvaluation of Residual Effectiveness of AntibacterialPersonal Cleansing Products1This standard is issued under the fixed designation E2752;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 guide is designed to demonstrate the effectivenessof an antibacterial personal cleansing product in reducing thenumbers of a marker organism(representing transients)bothimmediately and after prolonged exposure to(cleansing)wash-ing when used as recommended under simulated use condi-tions.The method demonstrates the effect of residual antibac-terial activity by means of inhibition of proliferation of bacteriaon the skin after the contact period.Antimicrobial activity iscompared with a vehicle or to a baseline organism count.1.2 A knowledge of microbiological techniques is requiredfor these procedures.1.3 Performance of this procedure requires the knowledgeof regulations pertaining to the protection of human subjects(21 CFR Parts 50 and 56).1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 This standard may involve hazardous materials,operations,and equipment.This standard does not purport toaddress all of the safety concerns,if any,associated with itsuse.It is the responsibility of the user of this standard toestablish appropriate safety and health practices and deter-mine the applicability of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE1874 Test Method for Recovery of Microorganisms FromSkin using the Cup Scrub Technique2.2 Federal Document:321 CFR Parts 50 and 56 Code of Federal Regulations:Protection of Human Subjects;Institutional ReviewBoards3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 marker organism,nan applied inoculum of an or-ganism that has characteristics that allow it to be readilyidentified or differentiated.Marker organisms are used tosimulate transient microorganisms.3.1.2 occlusion,ncovered and sealed from the outsideenvironment.3.1.3 occlusive chamber,na covering that protects thesampling surface without contacting the sampling surface.3.1.4 personal cleansing products,nproducts used forpersonal hygiene such as soaps,hand sanitizers,towelettes,body washes,and so forth.3.1.5 transient organisms,norganisms from the environ-ment that contaminate but do not normally permanentlycolonize skin.3.1.6 vehicle,na formulation for delivery of the antimi-crobial agent.4.Summary of Test Method4.1 This guide is conducted on a group of volunteer subjectswho refrained from using oral and topical antimicrobials for atleast one week.4.2 The test sites are washed multiple times with thecleansing product or vehicle.After washing,the sites areinoculated with a marker organism and occluded for a specifiedperiod of time after which the sites are sampled and enumer-ated for the marker organism.Activity of the cleansing productis measured by comparing microbial counts from treated sitesto those derived from the sites treated with vehicle or to anuntreated baseline organism count.1This guide 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 November 2015.Originallyapproved in 2010.Last previous edition approved in 2010 as E275210.DOI:10.1520/E275210R15.2For 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.3DLA Document Services Building 4/D 700 Robbins Avenue Philadelphia,PA19111-5094 http:/quicksearch.dla.mil/Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.Significance and Use5.1 The procedure is used to evaluate personal cleansingproducts containing antibacterial ingredients that are intendedto reduce the number of organisms on intact skin.It also maybe used to demonstrate the effect of residual antibacterialactivity by means of inhibition of the proliferation of bacteriaon the skin after contact.6.Apparatus6.1 Colony CounterUse any of several types.6.2 IncubatorAny incubator capable of maintaining asuitable temperature 62C.6.3 SterilizerAny suitable steam sterilizer capable of pro-ducing the conditions of sterilization.6.4 Timer(Stop Clock)One that displays hours and min-utes.6.5 TableAny elevated surface,such as a 1 by 2-m tablewith mattress or similar padding to allow the subject to recline,whe