ASTM E2752-2010(2015) Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products《评估抑菌个人清洁用品剩余效力的标准指南》.pdf

《ASTM E2752-2010(2015) Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products《评估抑菌个人清洁用品剩余效力的标准指南》.pdf》由会员分享，可在线阅读，更多相关《ASTM E2752-2010(2015) Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products《评估抑菌个人清洁用品剩余效力的标准指南》.pdf（4页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: E2752 10 (Reapproved 2015)Standard Guide forEvaluation of Residual Effectiveness of AntibacterialPersonal Cleansing Products1This standard is issued under the fixed designation E2752; the number immediately following the designation indicates the year oforiginal adoption or, in the case

2、 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 is designed to demonstrate the effectivenessof an antibacterial personal cleansin

3、g product in reducing thenumbers of a marker organism (representing transients) bothimmediately and after prolonged exposure to (cleansing) wash-ing when used as recommended under simulated use condi-tions. The method demonstrates the effect of residual antibac-terial activity by means of inhibition

4、 of proliferation of bacteriaon the skin after the contact period. Antimicrobial activity iscompared with a vehicle or to a baseline organism count.1.2 A knowledge of microbiological techniques is requiredfor these procedures.1.3 Performance of this procedure requires the knowledgeof regulations per

5、taining to the protection of human subjects(21 CFR Parts 50 and 56).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 may involve hazardous materials,operations, and equipment. This standard does not purport

6、toaddress all of the safety concerns, if any, associated with itsuse. It is the responsibility of the user of this standard toestablish appropriate safety and health practices and deter-mine the applicability of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E1054 Tes

7、t Methods for Evaluation of Inactivators of Anti-microbial AgentsE1874 Test Method for Recovery of Microorganisms FromSkin using the Cup Scrub Technique2.2 Federal Document:321 CFR Parts 50 and 56 Code of Federal Regulations:Protection of Human Subjects; Institutional ReviewBoards3. Terminology3.1 D

8、efinitions of Terms Specific to This Standard:3.1.1 marker organism, nan applied inoculum of an or-ganism that has characteristics that allow it to be readilyidentified or differentiated. Marker organisms are used tosimulate transient microorganisms.3.1.2 occlusion, ncovered and sealed from the outs

9、ideenvironment.3.1.3 occlusive chamber, na covering that protects thesampling surface without contacting the sampling surface.3.1.4 personal cleansing products, nproducts used forpersonal hygiene such as soaps, hand sanitizers, towelettes,body washes, and so forth.3.1.5 transient organisms, norganis

10、ms from the environ-ment that contaminate but do not normally permanentlycolonize skin.3.1.6 vehicle, na formulation for delivery of the antimi-crobial agent.4. Summary of Test Method4.1 This guide is conducted on a group of volunteer subjectswho refrained from using oral and topical antimicrobials

11、for atleast one week.4.2 The test sites are washed multiple times with thecleansing product or vehicle. After washing, the sites areinoculated with a marker organism and occluded for a specifiedperiod of time after which the sites are sampled and enumer-ated for the marker organism.Activity of the c

12、leansing productis measured by comparing microbial counts from treated sitesto those derived from the sites treated with vehicle or to anuntreated baseline organism count.1This guide is under the jurisdiction of ASTM Committee E35 on Pesticides,Antimicrobials, and Alternative Control Agents and is t

13、he direct responsibility ofSubcommittee E35.15 on Antimicrobial Agents.Current edition approved Oct. 1, 2015. Published November 2015. Originallyapproved in 2010. Last previous edition approved in 2010 as E275210. DOI:10.1520/E275210R15.2For referenced ASTM standards, visit the ASTM website, www.ast

14、m.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.3DLA Document Services Building 4/D 700 Robbins Avenue Philadelphia, PA19111-5094 http:/quicksearch.dla.mil/Copyright ASTM I

15、nternational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15. Significance and Use5.1 The procedure is used to evaluate personal cleansingproducts containing antibacterial ingredients that are intendedto reduce the number of organisms on intact skin. It also ma

16、ybe used to demonstrate the effect of residual antibacterialactivity by means of inhibition of the proliferation of bacteriaon the skin after contact.6. Apparatus6.1 Colony CounterUse any of several types.6.2 IncubatorAny incubator capable of maintaining asuitable temperature 62C.6.3 SterilizerAny s

17、uitable steam sterilizer capable of pro-ducing the conditions of sterilization.6.4 Timer (Stop Clock)One that displays hours and min-utes.6.5 TableAny elevated surface, such asa1by2-mtablewith mattress or similar padding to allow the subject to recline,when applicable.6.6 Handwashing SinkA sink of s

18、ufficient size to permitpanelist to wash without touching hands to the sink surface orother panelist.6.7 Water Faucet(s)To be located above the sink at aheight that permits the hands to be held higher than the elbowsduring the washing procedure.6.8 Tap Water Temperature Regulator and TemperatureMoni

19、torTo monitor and regulate water temperature.7. Reagents and Materials7.1 Bacteriological PipettesSterile, of appropriate capac-ity.NOTE 1Presterilized/disposable bacteriological pipettes are availablefrom most laboratory supply houses.7.2 Water Dilution BottlesAny sterilizable container hav-ing a 1

20、00 to 200-mL capacity and tight closure.NOTE 2Milk dilution bottles of 160-mLcapacity have a screw-cappedclosure and are available from most local laboratory supply houses.7.3 Scrub CupsSterile cylinders, height approximately 2.5cm, inside diameter of convenient size. Useful sizes range fromapproxim

21、ately 1.5 to 4.0 cm.7.4 Teflon Policeman or Rubber PolicemanCan be fash-ioned in the laboratory or purchased.7.5 PipettorWith disposable tips capable of delivering 10L.7.6 Graduated CylindersSterile, of appropriate capacity.7.7 BeakersSterile, of appropriate capacity.7.8 Occlusive ChamberFor coverin

22、g inoculated test sites.NOTE 3Occlusive chambers or plastic weigh boats of appropriate sizeavailable from laboratory supply houses7.9 Adhesive DressingFor securing the occlusive cham-ber.NOTE 4Adhesive dressings such as adhesive tape, surgical tape, orothers secural devices.7.10 Bacterial CulturesSu

23、ch as Staphylococcus aureusATCC 27217 or Escherichia coli ATCC 11229, or others asappropriate.7.11 Test FormulationsWith directions for use.7.12 Sampling and Dilution FluidSterile Butterfieldsphosphate buffered water, containing an antimicrobial inacti-vator specific for the test formulation as dete

24、rmined by TestMethod E1054.7.13 Plating MediumSoybean-casein digest agar orequivalent as appropriate with neutralizers, as determined byTest Method E1054.7.14 Sterile Culture Tubes, or equivalent with closures ofappropriate capacity.8. Test Control and Baseline Skin Sites8.1 Select skin sites approp

25、riate for target flora and the testmaterials intended use. Where possible, a contralateral site isrecommended for application of the vehicle or for the micro-organism count control.NOTE 5Forearms are a convenient site for most applications.9. Subjects9.1 Number of SubjectsThe number of subjects requ

26、ireddepends on the statistical confidence for the expected testresults, the variability encountered in the study, and the relativeefficacy of the antibacterial agent evaluated.9.1.1 Recruit a sufficient number of healthy adult volunteerswho have no clinical evidence of dermatoses, open wounds, oroth

27、er skin disorders that affect the integrity of the test.9.2 Instruct the subjects to avoid contact with antimicrobialsfor at least one week prior to the test. This restriction includesantimicrobial-containing antiperspirants, deodorants,shampoos, lotions, and soaps, also such material as acids bases

28、and solvents. Bathing in biocide-treated pools, hot tubs, spas,and so forth, should be avoided. Provide volunteers with a kitof non-antimicrobial personal care products for exclusive useduring the test. Volunteers must wear rubber gloves whencontact with antimicrobial agents cannot be avoided.10. Pr

29、ocedure10.1 Treatment(s) Application Procedure:10.1.1 Application of test material is assigned by a prede-termined randomized application schedule. Each subject willhave an active and a vehicle or no vehicle treatment site.10.1.2 Application of test and vehicle material consists ofan equal number of

30、 washes. For demonstration of residualactivity, more than one test material application may berequired. Schedule applications at least one hour apart.10.1.3 Perform all washes under supervision of a techniciantrained in the methodology. The following are suggestedtreatment procedures for evaluating

31、two rinse-off products, abar soap product, and a liquid soap product; and two no-rinseproducts, a liquid gel product and a pre-wetted towelette.10.1.4 Bar Soap Products and VehicleCheck, record, andmaintain the temperature of the water at 35 to 38C before eachwash. Water flow should be 4L/min. Remov

32、e all jewelry fromhands and wrists prior to start of wash procedure. Subjects canE2752 10 (2015)2wash their own arms. The start time of each wash should berecorded. The following wash procedure is recommended.10.1.4.1 Subjects wash their left arm first with the assignedtest product or vehicle formul

33、ation:(1) Wet the volar surface of the forearm under the runningwater.(2) Wet the appropriate bar of soap under the runningwater.(3) The subjects rub the bar on their forearm, using anup-and-down motion from the wrist to the elbow, for 15 s.(4) Then set the bar down and continue to rub the lather on

34、their forearm using the same up-and-down motion from thewrist to the elbow, for an additional 45 s.(5) Rinse the forearm for 15 s. Do not rub!(6) Pat the forearm dry using a paper towel. Do not rub!(7) Repeat steps 1 to 6 on their right forearm with the otherformulation.10.1.4.2 The above wash proce

35、dure is conducted a total ofnine (9) times. There will be three (3) washes each day on thefirst, second, and third days of the study. The washes are to beat least one (1) hour apart.10.1.5 Liquid Soap Products and VehicleCheck, record,and maintain the temperature of the water at 35 to 38C beforeeach

36、 wash. Water flow should be 4L/min. Remove all jewelryfrom hands and wrists prior to start of wash procedure.Subjects can wash their own arms. The start time of each washshould be recorded. The following wash procedure is recom-mended.10.1.5.1 Subjects wash their left arm first with the assignedtest

37、 product or vehicle formulation:(1) Wet the volar surface of the forearm under the runningwater.(2) 1.8 mL of liquid soap product is dispensed from asyringe onto the volar surface of the forearm.(3) The subjects rub the liquid soap on their forearm, usingan up-and-down motion from the wrist to the e

38、lbow, for 45 s.(4) They rinse their forearm for 15 s. Do not rub!(5) Pat the forearm dry using a paper towel. Do not rub!(6) Repeat steps 1 to 5 on the right forearm with the otherformulation.10.1.5.2 The above wash procedure is conducted a total ofnine (9) times. There are three (3) washes each day

39、 on the first,second, and third days of the test period. The washes are to beat least one (1) hour apart.10.1.6 No-Rinse, Liquid Gel, and PlaceboRemove alljewelry from hands and wrists prior to start of procedure. Thetime of treatment should be recorded at the start of application.Subjects can treat

40、 their own arms. The start time of eachtreatment should be recorded. The following procedure isrecommended.10.1.6.1 Subjects left forearm is treated first with theassigned test product or vehicle formulation:(1) 1.8 mL of product is dispensed from a syringe onto thevolar surface of the forearm.(2) T

41、he subjects rub the formulation on their forearm, usingan up-and-down motion from the wrist to the elbow, for 15 s.(3) Allow subjects forearm to air dry.(4) Repeat steps 1 to 3 on the right forearm with the otherformulation.10.1.6.2 The above procedure is conducted a total of three(3) times at least

42、 one (1) hour apart.10.1.7 Pre-Wetted Towelette or Wipe Product and VehicleRemove all jewelry from hands and wrists prior to start ofprocedure. The time of treatment should be recorded at the startof wiping. A technician will wipe each subjects arm. Thetechnician will wear gloves for this procedure.

43、 The start time ofeach treatment should be recorded. The following procedure isrecommended.10.1.7.1 Subjects left forearm is treated first with theassigned test product or vehicle formulation:(1) The technician will unfold the test towelette and wipethe forearm in an up-and-down motion for 15s.(2) T

44、he technician will flip the towelette and wipe theforearm with the opposite side of the towelette in an up-and-down motion for another 15 s.(3) Allow subjects forearm to air dry.(4) Repeat steps 1 to 3 on the right forearm with the otherformulation.10.1.7.2 The above wipe procedure is conducted a to

45、tal ofthree (3) times at least one (1) hour apart.10.2 Evaluation ProcedureResidual activity is assessed atany selected time after the last treatment application, forexample, 1 hour, 6 hours, 24 hours, and so forth, by measuringthe survival of marker bacteria applied under occlusion to thetreated sk

46、in sites after pre-selected exposure times, forexample, 30 minutes, two hours, or five hours depending onstudy objectives. The following is an example of a procedurefor assessing residual activity 24 h after the last treatment usingexposure times of 30 min,2hand5h.10.2.1 Approximately 24 h after the

47、 final treatmentapplication, three (3) evenly spaced circular test sites aremarked along the midsection of the volar aspect of eachforearm, avoiding the area on the wrist and elbow crease. Thelower site is near the wrist and the upper site is near the elbow.Mark the sites by pressing a 3.0 cm inside

48、 diameter glasscylinder, inked with a stamp pad, against the skin.10.2.2 Using a micro pipettor (section 7.5), inoculate thecenter of each circular site with 10 L of the bacterial cultureto obtain 106to 107colony forming units (CFUs) of S. aureus.A sterile, disposable, inoculating loop is used to ev

49、enly spreadthe inoculum within the center of the test site while remaining4 to 5 mm from the marked edge. The culture is prepared asdescribed in section 10.5.10.2.3 Each inoculated site is immediately occluded bycovering it with an occlusive chamber (section 7.8) andsecured to the skin with an adhesive dressing (section 7.9).10.3 Harvesting of the Surviving OrganismsAll inocu-lated sites are sampled for surviving organisms. One (1) testsite on each arm is harvested at each of the three (3) timeperiods 30 6 5min,2h6 5 min, and 5 h 6