ASTM E1115-2002 Standard Test Method for Evaluation of Surgical Hand Scrub Formulations《外科手用擦洗剂配方评估的试验方法》.pdf

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1、Designation: E 1115 02Standard Test Method forEvaluation of Surgical Hand Scrub Formulations1This standard is issued under the fixed designation E 1115; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A n

2、umber in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method is designed to measure the reduction ofmicrobial flora on the skin. It is intended for determining bothimmediate and p

3、ersistent microbial reductions, after single orrepetitive treatments, or both. It may also be used to measurecumulative antimicrobial activity after repetitive treatments.1.2 A knowledge of microbiological techniques is requiredfor these procedures.1.3 In this method, metric units are used for all a

4、pplications,except for distance, in which case inches are used and metricunits follow in parentheses.1.4 Performance of this procedure requires the knowledgeof regulations pertaining to the protection of human subjects.21.5 This standard does not purport to address all of thesafety concerns, if any,

5、 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:3D 1193 Specification for Reagent WaterE 1054 Practic

6、es for Evaluating Inactivators of Antimicro-bial Agents Used in Disinfectant, Sanitizer, Antiseptic, orPreserved Products2.2 Other Documents:21 CFR Parts 50 and 564AATCC Test Method 147 1993 Antibacterial Assessment ofTextile Materials: Parallel Streak Method5Horowitz, W. (Ed.), 2000, Official Metho

7、ds of Analysis ofAOAC International 17th Ed., Ch 17, p. 4, Sec. 17.2.01(m). Assoc. of Off. Anal. Chemist, Washington, D.C.United States Pharmacopeia, 25, 2001, United States Phar-macopeial Convention, Inc., Rockville, MD. Chapter 61“Microbial Limits Test”3. Terminology3.1 Definitions:3.1.1 active in

8、gredienta substance added to a formulationspecifically for the inhibition or inactivation of microorgan-isms.3.1.2 cleansing washa non-antimicrobial wash intendedto remove gross soil or residues from the hands of the subjectsprior to collecting baseline samples.3.1.3 cleansing wash formulation6a liq

9、uid castile soap orother liquid soap with neutral pH which does not contain anantimicrobial.3.1.4 cumulative effecta progressive decrease in the num-ber of microorganisms recovered following repeated applica-tions.3.1.5 internal reference formulationa formulation withdemonstrated performance charact

10、eristics within the labora-tory.3.1.6 neutralizationa process that results in quenching orinactivation of the antimicrobial activity of a formulation. Thismay be achieved through dilution of the formulation or throughthe use of chemical agents called neutralizers.3.1.7 persistenceprolonged or extend

11、ed antimicrobial ac-tivity that prevents or inhibits the proliferation or survival ofmicroorganisms after treatment.3.1.8 sampling fluida buffered solution that aids in recov-ery of microorganisms from the skin and neutralization of theactive ingredient in test and internal reference formulations.3.

12、1.9 test formulationa formulation containing an activeingredient(s).4. Summary of Test Method4.1 This test method is conducted on subjects selected froma group of volunteers who have refrained from using anyantimicrobials for at least two weeks prior to initiation of thetest. Subjects are selected f

13、rom this group on the basis of highinitial bacterial count,$ 1 3 105CFU/per hand as determined1This test method is under the jurisdiction of ASTM Committee E35 onPesticides and is the direct responsibility of Subcommittee E35.15 on AntimicrobialAgents.Current edition approved February 10, 2002. Publ

14、ished May 2002. Originallypublished as E 1115 86. Discontinued June 2000 and reinstated with revision asE111502.221 CFR Ch. 1, Parts 50 and 56.3For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards vo

15、lume information, refer to the standards Document Summary page onthe ASTM website.4United States Code of Federal Regulations.5Technical Manual of the American Association of Textile Chemists andColorists, P.O. Box 12215, Research Triangle Park, NC 27709.6Johnsons Baby Wash Head toToeyJohnsons and Jo

16、hnsons Inc., Skillman,NJ 085589418.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.by baseline measurements of the bacteria on their hands usingthe recovery techniques in this method.4.2 The selected subjects perform a simulated surg

17、ical scrubunder the supervision of an individual competent in aseptictechnique. One hand of each subject is sampled immediatelyafter the scrub (within 1 min), and the other hand, 6 h afterscrubbing. Only one hand of a subject is sampled at a specifiedtime. Optionally, another sampling time, 3 h for

18、example, canbe added between the immediate and 6 h sampling times. If thisis desired, the panel size must be increased by 50 % to obtainthe same number of data points at each designated samplinginterval. Also, a sampling time randomization must be gener-ated such that one-third of the hands are samp

19、led at eachsampling interval with only one hand of a subject beingsampled at a sampling time interval.4.3 If demonstration of cumulative activity is desired,eleven additional scrubs are performed over a 5-day period,one additional time on Day 1, three times on Days 2, 3, and 4and once on Day 5. The

20、hands are sampled again after the lastscheduled scrub.NOTE 1The researcher should be cautioned that components ofchemical neutralizer systems such as lecithin and polysorbate 80 mayinterfere in the determination of cumulative effect on the skin.7,8,95. Significance and Use5.1 The procedure in this t

21、est method should be used toevaluate the activity of the test formulation in reducing thebacterial population of the hands immediately after a single useand to determine persistent activity (inhibition of growth) after6 h. Optionally, measurements of persistent activity after a 3 hperiod and measure

22、ments of cumulative activity may be madeafter repetitive uses over a five day period.6. Apparatus6.1 Colony CounterAny of several types may be used, forexample, Quebec Colony Counter.6.2 IncubatorAny incubator that can maintain a tempera-ture of 30 6 2C may be used.6.3 SterilizerAny suitable steam s

23、terilizer that can pro-duce the conditions of sterility is acceptable.6.4 Timer (stop-clock)That can be read for minutes andseconds.6.5 Hand Washing SinkA sink of sufficient size to permitsubjects to wash without touching hands to sink surface orother subjects.6.5.1 Water Faucet(s)To be located abov

24、e the sink at aheight that permits the hands to be held higher than the elbowsduring the washing procedure. (It is desirable for the height ofthe faucet(s) to be adjustable.)6.6 Tap Water Temperature Regulator and TemperatureMonitorTo monitor and regulate water temperature to 40 62C.7. Reagents and

25、Materials7.1 Petri Dishes100 by 15 mm. Required for performingStandard Plate Count.107.2 Bacteriological Pipets10.0 and 2.2 or 1.1-mL capac-ity.117.3 Water-Dilution BottlesAny sterilizable container hav-ing a 150 to 200-mL capacity and tight closures may be used.127.4 Cleansing Wash FormulationA for

26、mulation withoutan active ingredient.7.5 Gloves for SamplingLoose-fitting, unlined, powder-free latex gloves which do not demonstrate antimicrobialactivity, or equivalent glove. An equivalent is a glove com-posed of any material that is unlined, does not leak and doesnot demonstrate antimicrobial ac

27、tivity.Azone of inhibition testsuch as AATCC Test Method 147 may be used to evaluate theantibacterial activity.7.6 Test FormulationDirections for use of active testformulation should be utilized if available. If not available, usedirections provided in this test method (see 11.3).7.7 WaterSterile de

28、ionized water or equivalent (Specifi-cation D 1193, Type III).7.8 Sampling Fluid13Dissolve 0.4 g KH2PO4, 10.1 gNa2HPO4and 1.0 g isooctylphenoxypolyethoxyethanol13in 1L of water. Adjust to obtain a final pH 7.8 6 0.1. Dispense toachieve a final volume of 75 6 1 mL into water dilutionbottles, or other

29、 suitable containers, and sterilize. Optionally,the sampling fluid may be sterilized before dispensing intosterile containers. The ability of the sampling fluid to neutralizeor quench the antimicrobial activity of the test formulationmust be validated (see Practices E 1054). The validation testshoul

30、d be conducted in vivo in accordance with how thesurgical hand scrub study is conducted. If the sampling fluiddoes not quench the antimicrobial activity of the test formula-tion and the internal reference formulation, an antimicrobialinactivator should be included if required.7.9 Dilution FluidButte

31、rfields buffered phosphate dilu-ent14adjusted to pH 7.2 6 0.1 (or other suitable diluent) andcontaining an antimicrobial inactivator if required.7.10 Soybean-Casein Digest Agar, or equivalent15Containing an antimicrobial inactivator if required.NOTE 2Inadequate neutralization may result in false int

32、erpretation of7Bently, M.V., Kedor,E.R., Vianna, R.F., Collett, J.H., Influence of lecithin andurea on the in vitro permeation of hydrocortisone acetate through skin from hairlessmouse. International Journal of Pharmaceutics. Vol. 146: 255262.8Kato, A., Ishibahi, Y., Effect of egg yolk lecithin on t

33、ransdermal delivery ofbunazosin. Journal of Pharmacy and Pharmacology. Vol 39: 399400.9Rejendran D., Sivabalan, M., Dhanaraj, S.A., Ponnusankar,S., Dube,R., Suresh,B., Trandermal delivery of prazoosin HCL with nonionic surfactants. IndianJournal of Pharmaceutical Sciences. Vol. 150153.10Pre-steriliz

34、ed/disposable plastic petri dishes are available from most locallaboratory supply houses.11Pre-sterilized/disposable bacteriological pipets are available from most locallaboratory supply houses.12Dilution bottles of 160-mL capacity having a screw-cap closure are availablefrom Corning Glass Co., Kimb

35、le Glass Co., or most local laboratory supply houses.13Peterson, A. F., “The Microbiology of the Hands: Evaluating the Effects ofSurgical Scrubs,” Developments in Industrial Microbiology, Vol 14, 1973, pp.125-130.14Horowitz, W. (Ed.) 2000, Offcial Methods of Analysis of AOAC International17th Ed., C

36、h 17, p. 4, Sec. 17.2.01 (m). Assoc. of Off. Anal. Chemist, Washington,D.C.15United States Pharmacopeia, 23, 1995, United States Pharmacopeial Conven-tion, Inc., Rockville, MD. Chapter 61 “Microbial Limits Test.”E1115022the test data. The use of excess chemical neutralizers may exert a toxiceffect o

37、n the recovery of bacterial cells. The goal, therefore, is to stopantimicrobial activity as early as possible in the sampling/plating process.If it can be demonstrated that antimicrobial activity is quenched orinactivated in the sampling fluid then, to reduce the chance of possibletoxic effects, ina

38、ctivators should not be added to the dilution fluid orplating media.7.11 Scrub Sponge and Nail Cleaner StickSuch as E-ZScrub 16016or any equivalent may be used.8. Subjects8.1 Sample size calculations should be done to determinethe number of subjects necessary to find statistically significantdiffere

39、nces (reductions) from baseline. The number of subjectsrequired depends on the statistical confidence required for theexpected results, the variability encountered in the data collec-tion (that is, variability in reductions from baseline), and theexpected efficacy of the test product (that is, its e

40、xpectedreduction from baseline). This number of subjects (n) can beestimated from the following equation:n . S25FZa/21 Zb!2D2 Gwhere:S2= estimate of variance (of reduction from baselinebased on in-house data pool),Za/2= cumulative probability of the standard normal dis-tribution = 1.96 for a = 0.05,

41、Zb= power of the test = 0.842 for b = 0.80, andD = expected efficacy (expected reduction from base-line).8.2 Recruit a sufficient number of healthy subjects who haveno clinical evidence of dermatoses, open wounds, or other skindisorders. Exclude any individual receiving antibiotic therapyand any ind

42、ividual sensitive to natural rubber or latex or to acomponent of the formulation(s) being tested.8.3 Instruct the subjects to avoid contact with antimicrobials(other than the test formulation as dispensed for each scrub) forat least two weeks prior to obtaining the first baseline samplingand for the

43、 duration of the test. This restriction includesantimicrobial-containing antiperspirants, deodorants, sham-poos, lotions, dishwashing liquids and soaps, and also suchmaterials as acids, bases, and solvents. Bathing in biocidetreated pools, hot tubs, or spas, is not permitted. Subjectsshould be provi

44、ded with a kit of non-antimicrobial personalcare products for exclusive use during the test and rubbergloves to be worn when contact with antimicrobials agentscannot be avoided.9. Procedure9.1 After subjects have refrained from using antimicrobialsfor at least two weeks, perform wash with cleansing

45、washformulation (see 7.4) using methodology outlined in 10.1-10.4.Subjects are not to have washed their hands on this day 2 hprior to baseline determination. After washing, determine firstestimate of baseline bacterial population by sampling handsand enumerating the bacteria in the sampling fluid. T

46、his is Day1 of “Baseline Period.” Repeat this baseline determinationprocedure on Days 3 and 7, Days 3 and 5, or Days 5 and 7 of“Baseline Period” to obtain three estimates of baseline popu-lation. After obtaining the first and second estimates of thebaseline populations, select subjects who exhibited

47、 at eachsampling time counts $1 3 105per hand. The three estimatesof the baseline population obtained for each of the selectedsubjects are averaged to obtain the mean baseline counts.9.2 A basic random sampling plan should be followed. Thenumber of subjects and sampling times depend on the testformu

48、lation but must establish the onset and extent of thebacterial suppression and the duration of suppression below thebaseline counts. Equal numbers of subjects should be assignedper sampling time, test formulation and hand. A typicalbalanced randomization plan for testing a block of six subjectsfollo

49、ws with sampling at 0 h, 3 h (optional), and 6 h.Subject No. Post Scrub Sampling Time, h0-h 3-h 6-h1 left hand right hand2 left hand right hand3 right hand left hand4 right hand left hand5 left hand right hand6 right hand left handIf only 0 h and 6 h post scrub samples are collected the 0 hwill be randomized to the right or left hand.9.2.1 The number of subjects per block may vary but mustbe divisible by two and by the number of sampling times inorder to assign equal number of left and right hands to eachsampling time.9.3 No sooner than 24