ASTM_E_2614_-_15.pdf

Designation:E261415Standard Guide forEvaluation of Cleanroom Disinfectants1This standard is issued under the fixed designation E2614;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 identifies important factors to consider whenselecting a disinfectant for use in a cleanroom or similarcontrolled environment and recommends test methods suitablefor evaluating disinfectants.The proper selection of disinfect-ing agent combined with qualification testing is a key elementof a successful disinfection program.Regulatory guidance suchas United States Pharmacopoeia Chapter,“Disinfec-tants and Antiseptics”and the FDA Guidance for Industry,“Sterile Drug Products Produced by Aseptic ProcessingCur-rent Good Manufacturing Practice”address the necessity ofdisinfectant effectiveness testing but do not clearly defineacceptable test methods.1.2 An understanding of microbiology and microbiologicaltechniques is essential.Knowledge in the following areas isrecommended:microorganisms,antimicrobialproducts(disinfectants,sporicides,and decontamination agents),thechemistry of disinfection,mechanism of activity of disinfec-tants on cells,application procedures,cleanroom surfaces,andenvironmental conditions within a cleanroom.This informa-tion is available in several published texts listed in thebibliography.1.3 The theoretical basis for disinfectant activity is notaddressed in this guide.An understanding of the effect ofdisinfectant concentration on microbial reduction(concentra-tion exponent)and kinetics is desirable in determining theuse-dilution of different disinfectants and in using dilution toneutralize a disinfectant for efficacy testing.USP chapter provides further information on this topic.1.4 This guide is written for the cleanroom environment,although many of the principles outlined in this standard areapplicable to manufacturing and processing environmentsoutside of the cleanroom.1.5 Evaluation of disinfectants for biofilm control is outsidethe scope of this document.2.Referenced Documents2.1 ASTM Standards:2E2111 Quantitative Carrier Test Method to Evaluate theBactericidal,Fungicidal,Mycobactericidal,and SporicidalPotencies of Liquid ChemicalsE2197 Quantitative Disk Carrier Test Method for Determin-ing Bactericidal,Virucidal,Fungicidal,Mycobactericidal,and Sporicidal Activities of ChemicalsE2315 Guide for Assessment of Antimicrobial Activity Us-ing a Time-Kill Procedure2.2 BSI Standards:3BS EN 1040 Chemical disinfectants and antiseptics.Quan-titative suspension test for the evaluation of basic bacte-ricidal activity of chemical disinfectants and antiseptics.Test method and requirements(phase 1)BS EN 1276 Chemical disinfectants and antiseptics.Quan-titative suspension test for the evaluation of bactericidalactivity of chemical disinfectants and antiseptics used infood,industrial,domestic and institutional areas.Testmethod and requirements(phase 2,step 1)BS EN 1650 Chemical disinfectants and antiseptics.Quan-titative suspension test for the evaluation of fungicidal oryeasticidal activity of chemical disinfectants and antisep-tics used in food,industrial,domestic and institutionalareas.Test method and requirements(phase 2,step 1)BS EN 13704 Chemical disinfectants.Quantitative suspen-sion test for the evaluation of sporicidal activity ofchemical disinfectants used in food,industrial,domesticand institutional areas.Test method and requirements(phase 2,step 1)BS EN 13697 Chemical disinfectants and antiseptics.Quan-titative non-porous surface test for the evaluation ofbactericidal and/or fungicidal activity of chemical disin-fectants used in food,industrial,domestic and institutionalareas.Test method and requirements without mechanicalaction(phase 2,step 2)1This specification is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is under the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved May 1,2015.Published July 2015.Originally approvedin 2008.Last previous edition approved in 2008 as E261408.DOI:10.1520/E2614-15.2For 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 British Standards Institute(BSI),389 Chiswick High Rd.,London W4 4AL,U.K.,http:/www.bsi-.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 2.3 Other Standards:AOAC International,Official Methods of Analysis,Chapter6Disinfectants,18th Edition,20054ISO 14644-1 Cleanrooms and associated controlled environ-ments-Part 1:Classification of air cleanliness5Unit