ASTM_E_1115-112017.pdf

E1115-11(2017)antimicrobial properties of gloves9.Procedure7.6 Test Formulation-Directions for use of active test9.1 After subjects have refrained from using antimicrobialsformulation should be utilized if available.If not available,usefor at least one week,perform wash with cleansing washdirections provided in this test method(see 11.1.3).formulation(see 7.4)using methodology outlined in 10.17.7 Water-Sterile deionized water or equivalent(Specifi-10.4.Subjects are not to have washed their hands on this daycation D1193,Type IID).2 h prior to baseline determination.After washing,determine7.8 Sampling Fluid-Dissolve 0.4 g KH2PO 10.1 gfirst estimate of baseline bacterial population by samplingNa2HPO4.1.0 g isooctylphenoxypolyethoxyethanol(forhands and enumerating the bacteria in the sampling fluid.Thisexample,Triton X-100),and appropriately validated neutraliz-is Day I of Baseline Period.Repeat this baseline determi-ers in 1 L distilled water.Adjust pH to 7.81 with 0.1 N HCInation procedure on Days 3 and 7.Days 3 and 5.or Days 5 andor 01.N NaOH.Dispense to achieve a final volume of 75+17 of Baseline Periodto obtain three estimates of baselinemL and sterilize.population.After obtaining the first and second estimates of thebaseline populations,select subjects who exhibited at each7.9 Dilution Fluid-Sterile Butterfields buffer or othersampling time counts 21 x 10 per hand.The three estimates ofsuitable diluent adjusted to pH 7.2 0.1 with effectivethe baseline population obtained for each of the selectedneutralizer for the test material.Adjust pH with 0.1 N HCI orsubjects are averaged to obtain the mean baseline counts.0.1 N NaOH.See Test Methods E10549.2 A basic random bacterial recovery sampling plan should7.10 Agar-Soybean-casein Digest agar(USP 32)or otherbe followed.The number of subjects and sampling timessolid media appropriately validated to support growth of thedepend on the test formulation but must establish the onset andtest organism with appropriate neutralizers if needed.extent of the bacterial suppression and the duration of suppres-Nore 6-Inadequate neutralization may result in false interpretation ofsion below the baseline counts.Equal numbers of subjectsthe test data.The use of excess chemical neutralizers may exert a toxiceffect on the recovery of bacterial cells.The goal,therefore,is to stopshould be assigned per sampling time,test formulation andantimicrobial activity as early as possible in the sampling/plating process.hand.A typical balanced randomization plan for testing a blockIf it can be demonstrated that antimicrobial activity is quenched orof six subjects follows with sampling at 0 h,3 h(optional).andinactivated in the sampling fluid then.to reduce the chance of possible6 h.toxic effects,inactivators should not be added to the dilution fluid orplating media.Subject NoPost Scrub Sampling Time,h0-h3-h6-h7.11 Scrub Sponge and Nail Cleaner Stick-Such as E-Zleft handright handScrub 16010 or any equivalent may be used.2left handright hand0right handleft hand8.Subjectsnight handleft hand6left handright hand8.1 Recruit a sufficient number(see X1.1)of healthy sub-right handleft handjects who have no clinical evidence of dermatoses,openIf only 0 h and 6 h post scrub samples are collected the 0 hwounds,or other skin disorders.Exclude any individualwill be randomized to the right or left hand.receiving antibiotic therapy and any individual sensitive to9.2.1 The number of subjects per block may vary but mustnatural rubber or latex or to a component of the formulation(s)be divisible by two and by the number of sampling times inbeing tested.order to assign equal number of left and right hands to each8.2 Instruct the subjects to avoid contact with antimicrobialsampling time.products(other than the test formulation(s)as dispensed for9.3 No sooner than 24 h and no longer than 96 h aftereach scrub)for the duration of the test and for at least one weekcompletion of the baseline determination,subjects performprior to the test.This restriction includes antimicrobial-scrub with the test formulation.The starting interval should becontaining antiperspirants,deodorants,shampoos,lotions,same for all subjects participating in the study.According todishwashing liquids and soaps,and also such materials asthe random sampling plan,determine the bacterial populationsacids,bases,and solvents.Bathing in biocide treated pools,hoton the subjectshands at the assigned sampling times aftertubs,or spas should be avoided.Subjects are provided with ascrubbing.Determine bacterial population by sampling handskit of non-antimicrobial personal care products for exclusiveand enumerating the bacteria in the sampling fluid as specifieduse during the test and rubber gloves to be worn when contactin Sections 13 and 14.with antimicrobials agents cannot be avoided.9.4 If measurement of cumulative effect is desired,thehands are sampled one more time after performing 11 addi-Peterson.A.F.The Microbiology of the Hands:Evaluating the Effects ofSurgical Scrubs,Developments in Industrial Microbiology.Vol 14.1973.pp.tional scrubs with the active test formulation over a 5 day125-130.period.Repeat the treatment procedure with the test formula-Horowitz.W.(Ed.).2006 Official Methods of Analysis of AOAC International,tion one additional time after the sampling on Day I and treat2006.18th Ed.Revision I.Ch 17.p.4.Sec.17.2.01(m).AOAC.Washington.D.C.three additional times on Day 2.Day 3 and Day 4 with at leastThe sole source of supply of the apparatus known to the committee at this timeis E-Z Scrub 160,Cat.No.371603,manufactured by Becton Dickinson Div.,a 1-h interval between scrub treatments.On day 5 perform oneFranklin Lakes,NJ 07417-1884.If you are aware of alternative supplicrs,pleasescrub treatment prior to sampling.provide this information to ASTM International Headquarters.Your comments willreceive careful consideration at a meeting of the responsible technical committee.9.5 In summary,measurement of immediate activity is madewhich you may attend.following a single scrub.Persistent activity may be measuredE1115-11(2017)12.Surgical Scrub Technique When Bacterial Samples15.2 To determine the activity of the test formulation,allAre Not Specifiedcounts of colony forming units per hand should be converted to12.1 Perform technique as described in Section 11,exceptcommon(base10)logarithms.At each sampling time log10omit 11.1.3.10.Subjects dry hands with clean paper towelsreductions should be calculated.after final rinse of hands.16.Method of Statistical Analysis13.Bacterial Recovery16.1 Prior to initiating the statistical analyses,the subjectsfirst and second baseline count for each hand are to be13.1 At each specified sampling time,(for example,examined to determine if they meet the qualification criterionimmediate,3h,6h)aseptically add 75 mL of sampling fluid(1.0 x 10 CFU/hand).with neutralizer(see 7.8)to the gloved hand to be sampled andsecure the glove above the wrist.16.2 Check for Significant Difference Between Right andLeft Hand Bioburdens at Baseline-The source data for the13.2 Within one minute of donning gloves,uniformly mas-baseline analysis are the 3-day average log values for thesage all surfaces of the hand for 1 min 5 s,paying particularright and left hands of each subject.Potential differencesattention to the fingers and flipping the hand after 30 s to ensurebetween right and left hand bioburdens at the baseline areboth the palm and back of the hand are thoroughly massaged.examined using a two-factor,subject x hand,analysis of13.3 Aseptically retrieve a 3 to 5 mL sample of the fluid invariance procedure.the glove by pulling the glove away from the wrist,inserting a16.3 Activity-The mean log1 reductions and the 95%pipet into the finger region of the glove,and withdrawing theconfidence intervals for the test formulation(s)after 1 or 5 daysfluid.of usage are to be calculated for each sampling time.Log1013.4 Rinse hands under running tap water to remove re-reductions for each subject are calculated as average baselinesidual sampling fluid.log1o of a hand minus log10 of the post-treatment count for that13.5 The first dilution of sampling fluid is to be made inhand.dilution fluid with appropriate neutralizer within 1 min and16.3.1 Persistent Activity(Within-treatments)-Analysis of10 s of completing the massage.The plating of the recoveredvariance techniques are to be performed to evaluate differencessampling solution is completed within 30 min after sampling.between sampling intervals in a given day.Log1o reductionvalues from baseline are used in this analysis.14.Enumeration of Bacteria in Sampling Fluid16.3.2 Cumulative Activity(Within-treatments)-Analysisof variance techniques are to be performed to calculate14.1 Enumerate the bacteria in the sampling fluid by micro-biological techniques such as surface inoculation techniquedifferences between similar sampling times on different testdays.(that is,comparing 6 h,Day 5 to 6 h,Day 1).Log(spread plating or spiral plating)or pour-plate technique.reduction values from baseline are used in this analysis.14.2 Prepare sample dilutions in Dilution Fluid(see 7.9).Use Soybean-Casein Digest Agar(see 7.10).Plate in duplicate.17.Internal Reference Standard14.3 Incubate plated sample at 30 2C for 48 to 72 h17.1 To measure the validity of the test method within abefore reading.Standard plate counting procedures are to bestudy an internal reference formulation and a negative controlused.should be evaluated.14.4 Calculate for each hand sampled at each sampling time18.Precision and Biasthe average number of colony forming units(CFUs)recovered.18.1 A precision and bias statement can not be made for thistest method at this time.15.Determination of Reduction Obtained15.1 For each post-treatment sampling time determine19.Keywordschanges from baseline counts obtained with the test formula-19.1 antimicrobial;efficacy;glove juice;handwash;health-tion.care;surgical scrubCopyright ASTM 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