ASTM_E_2897_-_12.pdf

Designation:E289712Standard Guide forEvaluation of the Effectiveness of Hand Hygiene TopicalAntimicrobial Products using ex vivo Porcine Skin1This standard is issued under the fixed designation E2897;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.INTRODUCTIONUse of ex vivo animal skin models such as pigskin has widely been used as surrogate for humanskin.Pigskin model is a safe,inexpensive,accurate,and reliable platform of testing antisepticefficacy.2,3,4The test guide described here utilizes sterilized pigskin to evaluate the effectiveness ofhand hygiene topical antimicrobial products.The pigskin substrate is used to overcome limitationsposed by exposure of human subjects to potentially pathogenic microorganisms,while offering thebenefit of applicability to a wide variety of hand-washing conditions that cannot be simulated in testtubes.The microbial reduction is the difference in log10value obtained from artificially contaminatedpigskins after use of test formulation to the log10value obtained from contaminated pigskins notexposed to the test formulation.1.Scope1.1 This guide is designed to demonstrate the effectivenessof hand hygiene topical antimicrobial products using pigskin asa surrogate model.1.2 Knowledge of microbiological techniques is requiredfor these procedures.1.3 This standard guide can be used to evaluate topicalantimicrobial handwash or handrub formulations.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 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:5E1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE1174 Test Method for Evaluation of the Effectiveness ofHealth Care Personnel Handwash FormulationsE1874 Test Method for Recovery of Microorganisms FromSkin using the Cup Scrub Technique3.Terminology3.1 Definitions:3.1.1 antimicrobial ingredient,na substance added to aformulation specifically for the inhibition or inactivation ofmicroorganisms.3.1.2 neutralization,nthe process for inactivating orquenching the activity of a microbicide,often achieved throughphysical(for example,filtration or dilution)or chemical means.3.1.3 resident microorganisms,nmicroorganisms that sur-vive and multiply on the skin,forming a stable population.3.1.4 transient microorganisms,nmicroorganisms thatcontaminate the skin but do not form a stable population.3.1.5 test organism,nan applied inoculum of an organismthat has characteristics which allow it to be readily identified.The test organism is used to simulate a transient topical1This 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 Nov.15,2012.Published November 2012.DOI:10.1520/E2897-12.2Woolwine,J.D.,and Gerberding,J.L.,“Effect of Testing Method on ApparentActivities of Antiviral Disinfectants and Antiseptics,”Antimicrobial Agents andChemotherapy,Vol 39,1999,pp.921923.3Bush,L.W.,Benson,L.M.,and White,J.H.,“Pigskin as a Test Substrate forEvaluating Topical Antimicrobial Activity,”J.Clinical Microbiology,Vol 24,1986,pp.343348.4McDonnel,G.,Haines,K.,Klein,D.,Rippon,M.,Walmsley,R.,and Pretzer,D.,“Clinical Correlation of a Skin Antisepsis Model,”J.Microbiological Methods,Vol 35,1999,pp.3135.5For 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 microbial contaminant.It may also be referred to as a markerorganism,bacterial simulant,or bacterial contaminant.3.1.6 test substance,na leave-on or wash-off product orformulation which incorporates antimicrobial ingredient(s).4.Summary of Guide4.1 This guide describes procedures for testing using non-living pigskin substrates that have been shaved to remove thehair and sterilized using gamma radiation prior to use intesting.The specific procedures allow use of a test microor-ganism of the investigators choice.Activity of a test substanceis measured by comparing the number of test microorganismsrecovered from artificially contaminated pigskins after use ofan antimicrobial formulation to the number of test microorgan-isms recovered from contaminated pigskins not exposed