ASTM_E_2111_-_12.pdf

Designation:E211112Standard Quantitative Carrier Test Method toEvaluate the Bactericidal,Fungicidal,Mycobactericidal,andSporicidal Potencies of Liquid Chemicals1This standard is issued under the fixed designation E2111;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.INTRODUCTIONThe need for better tests to assess the microbicidal activity of chemicals was recognized(1)2andseveral simpler and quantitative test methods have been developed for working with a wide variety ofmicroorganisms(2).The test method described here uses glass vials as carriers;the same basic set ofmaterials and procedures can be used to test the potency of liquid microbicides against vegetativebacteria,fungi,mycobacteria,and bacterial spores.However,the test method is not appropriate for usewith viruses because of the relatively high levels of eluate dilutions required and the need formembrane filtration.Further evaluation of products under more stringent test conditions may benecessary for their registration.Performance standards for the categories of products to be tested andthe specific types of organism(s)to be used may also vary depending on the regulatory agency.1.Scope1.1 This test method is designed for use in product devel-opment and for the generation of product potency data.Thistest method permits the loading of each carrier with a knownvolume of the test organism.The incorporation of controls canalso determine the initial load of colony forming units(CFU)of organisms on the test carriers and any loss in CFU after themandatory drying of the inoculum.1.2 This test method is designed to have survivors and alsoto be used with a performance standard.The surviving micro-organisms on each test carrier are compared to the mean of noless than three control carriers to determine if the performancestandard has been met.To allow proper statistical evaluation ofresults,the size of the test inoculum should be sufficiently largeto take into account both the performance standard and theexperimental variation in the results.For example,if anarbitrary performance standard of 6-log10reduction in theviability titer of the test organism is used,and an inoculum sizeof 107CFU,then theoretically a maximum of ten survivors percarrier is permitted;however,because of experimentalvariability,the exact target may need to be higher than 106CFU/carrier,thus fewer survivors would be permitted.1.3 This test method should be performed by persons withtraining in microbiology and in facilities designed andequipped for work with infectious agents at the appropriatebiosafety level(3).1.4 In this test method,SI units are used for all applications,except for distance,in which case inches are used and SI unitsfollow.1.5 It is the responsibility of the investigator to determinewhether Good Laboratory Practice Regulations(GLPs)arerequired and to follow them where appropriate(40 CFR Part160 for EPA submissions and 21 CFR Part 58 for FDAsubmissions).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 determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:3D1129 Terminology Relating to WaterD1193 Specification for Reagent WaterE1054 Test Methods for Evaluation of Inactivators of Anti-microbial Agents1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of SubcommitteeE35.15 on Antimicrobial Agents.Current edition approved May 15,2012.Published June 2012.Originallyapproved in 2000.Last previous edition approved in 2005 as E2111 05.DOI:10.1520/E211112.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.3For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 E2197 Quantitative Disk Carrier Test Method for Determin-ing Bactericidal,Virucidal,Fungicidal,Mycobactericidal,and Sporicidal Activities of ChemicalsE2756 Terminology Relating to Antimicrobial and AntiviralAgents2.2 CFR Standards:440 CFR Part 16021 CFR Part 583.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 carrier,ninanimate surface or object inoculated withthe test organism.3.1.2 eluate,neluent,which contains the recovered organ-ism(s).3.1.3 eluent,nany solution that is harmless to the testorganism(s)and that is added