ASTM E1883-02(2007)
(Test Method)Standard Test Method for Assessment of an Antibacterial Handwash Product by Multiple Basin Wash Technique
Standard Test Method for Assessment of an Antibacterial Handwash Product by Multiple Basin Wash Technique
SCOPE
1.1 This test method covers determining the effectiveness of an antibacterial handwash for reducing the level of aerobic bacterial flora on the hands, following an extended period of use.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 In this test method metric units are used for all applications, except for distance. In this case, inches are used and metric units follow in parentheses.
1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. (Title 21 CFR, Part 50).
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
General Information
Relations
Buy Standard
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E1883 − 02(Reapproved 2007)
Standard Test Method for
Assessment of an Antibacterial Handwash Product by
Multiple Basin Wash Technique
This standard is issued under the fixed designation E1883; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Terminology
1.1 This test method covers determining the effectiveness of 3.1 Definitions:
an antibacterial handwash for reducing the level of aerobic 3.1.1 active ingredient—a substance performing a function
bacterial flora on the hands, following an extended period of definded by this method.
use.
3.1.2 active test formulation—a formulation with an active
ingredient.
1.2 A knowledge of microbiological techniques is required
for these procedures.
3.1.3 control test formulation—a formulation without an
active in this test method. Frequently a bland soap.
1.3 In this test method metric units are used for all
applications, except for distance. In this case, inches are used
3.1.4 neutralization—Aprocess that results in quenching or
and metric units follow in parentheses.
inactivation of the antimicrobial activity of a formulation. This
may be achieved with dilution of the formulation or with the
1.4 Performance of this procedure requires the knowledge
use of chemical agents, called neutralizers.
of regulations pertaining to the protection of human subjects.
(Title 21 CFR, Part 50). 3.1.5 neutralizer—a procedure or chemical agent used to
inactivate,neutralize,orquenchthemicrobiocidalpropertiesof
1.5 This standard does not purport to address all of the
an antimicrobial agent.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- 3.1.6 resident microorganisms—microorganisms that live
priate safety and health practices and determine the applica- and multiply on skin, forming a permanent population.
bility of regulatory limitations prior to use.
3.1.7 test formulation—a formulation containing an active
ingredient.
2. Referenced Documents
3.1.8 transient microorganisms—microorganisms that con-
2.1 ASTM Standards:
taminate but do not normally permanently colonize skin.
D1193 Specification for Reagent Water
E1054 Test Methods for Evaluation of Inactivators of Anti- 4. Summary of Test Method
microbial Agents
4.1 This hand degerming protocol is a modification of the
Cade Handwashing Procedure, that is a serial basin hand wash
2.2 Other Standard:
4,5
Title 21 Code of Federal Regulations (CFR), Part 50 sampling technique.
4.1.1 Two baseline bacterial counts will be determined for
Protection of Human Subjects: Informed Consent Verifi-
cation & Part 56, Institutional Review Boards thehandsandapost-usagecountwillbedoneaftertwelvedays
of antibacterial handwash usage. The samples are collected
from basin wash water following one or more 60 second
washes with a bar soap that does not contain an antimicrobial.
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides and Alternative Control Agents and is the direct responsibility of At each sampling interval samples may be collected from the
Subcommittee E35.15 on Antimicrobial Agents.
first and or fifth hand wash in a series of five washes.
Current edition approved Nov. 1, 2007. Published November 2007. Originally
4.1.2 The data will be used to calculate the reduction of
approved in 1997. Last previous edition approved in 2002 as E1883 – 02. DOI:
bacterial flora resulting from the use of the antibacterial test
10.1520/E1883-02R07.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on Cade, A.R., “A Method for Testing Degerming Efficacy of Hexachlorophene
the ASTM website. Soaps,” Journal of the Society of Cosmetic Chemistry , Vol. 2: 1951, pp 181–291.
3 5
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments, Price, P.B., “The bacteriology of normal skin: a new quantitative test applied to
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:// a study of the bacterial flora and disinfectant action of mechanical cleansing,”
www.access.gpo.gov. Journal Infection Control, Vol. 63:1938, pp 301–318.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1883 − 02 (2007)
handwashproductasdescribedwithintheprotocol.Reductions 7.6 Bland cleansing formulation, a mild, non-antimicrobial
in bacterial populations calculated from baseline and post- solid or liquid cleanser. (The Investigator may choose to use
treatment samples collected after the first basin wash are the product vehicle.)
reflective of the antimicrobial test soaps ability to reduce the
NOTE 1—This formulation should be used during the washout period
population of transient organisms on the hands. Reductions in
and for all sample collection washes.
bacterial populations calculated from baseline and post-
7.7 Sterile High Purity Water—Specification D1193, Type
treatment samples collected after the fifth basin wash are
III, or better.
reflective of the antimicrobial test soaps ability to reduce the
population of resident flora on the hands.
8. Subjects
5. Significance and Use
8.1 Number of subjects—Sample size calculations should be
done to determine the number of subjects necessary to find
5.1 This procedure should be used for in vivo evaluation of
statistically significant differences (reductions) from baseline.
the performance of antibacterial handwash products that are
The number of subjects required depends on the statistical
intended to reduce the skin micro flora following repeated use.
confidence required for the expected results, the variability
Activity against the combined transient and resident micro
encountered in the data collection (for example, variability in
flora may be assessed. Historically counts from the first basin
4,6
reductions from baseline), and the expected efficacy of the test
are considered to be transients. The latter measurement is
product (for example, its expected reduction from baseline).
probably more meaningful as the resident population is more
This number of subjects (n) can be estimated from the
stable.
following equation:
5.1.1 This test method is applicable for testing all forms of
topical antimicrobial handwash formulations.
~Z 1Z !
α/2 β
n.S (1)
F G
D
6. Apparatus
where:
6.1 Colony Counter—Any of several types may be used.
S = estimate of variance (of reduction from baseline
6.2 Incubator—Any incubator that can maintaining a tem-
based on in-house data pool),
perature of 30-35 °C may be used.
Z = cumulative probability of the standard normal distri-
α/2
bution,
6.3 Sterilizer—Any suitable steam sterilizer that can pro-
duce the conditions of sterility is acceptable. =1.96 for α=0.05,
Z = power of the test= 0.842 for β= 0.80, and,
β
6.4 Timer (Stop-Clock)—One that can be read for hours and
D = expected efficacy (expected reduction from baseline).
minutes.
8.2 Recruiting—Recruit a sufficient number of healthy adult
6.5 Water Bath—Any bath of appropriate size and capable
human volunteers who have no clinical evidence of derma-
of maintaining temperature at 45 6 2°C.
toses, open wounds, hangnails or other skin disorders that may
6.6 Wash Basins—Sterile metal, plastic, or porcelain basins
affect the integrity of the test.
capable of containing approximately 3 L. Alternatively, non-
8.2.1 Individuals, such as hospital, nursing home, day-care
sterile containers may be used if lined with a low bioburden
center workers, or others who work in environments that may
plastic bag.
offer exposures to bacteria not expected in the general popu-
lation should be excluded as subjects.
7. Materials and Reagents
8.3 Instruction of Volunteers—Instruct the volunteers to
7.1 Bacteriological Pipettes,5.0and2.2or1.1mLcapacity.
avoid contact with antimicrobials (other than the test formula-
7.2 Test Tubes, or equivalent.
tion)forthedurationofthetestandforatleasttwoweeksprior
to the first baseline sampling. This restriction includes sham-
7.3 Test Formulation—Directionsforuseoftestformulation
poos, lotions and soaps, and such materials as acids, bases, and
should be included if available.
solvents. Bathing in biocide treated pools, hot tubs, and spas
7.4 Dilution Fluid—Butterfield’s phosphate buffer, or other
should be avoided.
suitable diluent, adjusted to pH 7.2 6 0.1 with effective
8.3.1 Volunteers are to be provided with a kit of non-
neutralizer if required.Adjust pH with 0.1 N HCl or 0.1 N Na
antimicrobial personal care products for exclusive use during
OH (See Test Methods E1054.)
the test and protective gloves to be worn when contact with
7.5 Plating Medium—Soybean-Casein Digest Agar Me-
antimicrobial can not be avoided. Polypropolyene gloves
dium, or commercially available equivalent with appropriate
should be used for applying material such as makeup,
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:E1883–97 Designation:E1883–02 (Reapproved 2007)
Standard Test Method for
Assessment of an Antibacterial Handwash Product by
Multiple Basin Wash Technique
This standard is issued under the fixed designation E 1883; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 Thistestmethodcoversdeterminingtheeffectivenessofanantibacterialhandwashforreducingthelevelofaerobicbacterial
flora on the hands, following an extended period of use.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 In this test method metric units are used for all applications, except for distance. In this case, inches are used and metric
units follow in parentheses.
1.4
1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. (Title
21 CFR, Part 50).
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2.1 ASTM Standards:
D 1193 Specification for Reagent Water
E 1054Practices for Evaluating Inactivators of Antimicrobial Agents Used in Disinfectant, Sanitizer, Antiseptic, or Preserved
Products Test Methods for Evaluation of Inactivators of Antimicrobial Agents
2.2 Other Standard:
Title 21 Code of Federal Regulations (CFR), Part 50 Protection of Human Subjects: Informed Consent Verification & Part 56,
Institutional Review Boards
3. Terminology
3.1 Definitions:
3.1.1 active ingredient—a substance added to a formulation specifically for inhibition or inactivation of microorganisms. —a
substance performing a function definded by this method.
3.1.2 active test formulation—a formulation with an active ingredient.
3.1.3 control test formulation—a formulation without an active in this test method. Frequently a bland soap.
3.1.4 neutralization—inactivation of the antibacterial of the test material. This can be achieved through dilution of active test
formulations to levels too low to have an antibacterial activity, or through the use of chemical agents, called neutralizers, to
eliminate antibacterial activity. —Aprocess that results in quenching or inactivation of the antimicrobial activity of a formulation.
This may be achieved with dilution of the formulation or with the use of chemical agents, called neutralizers.
3.1.5 neutralizer—a procedure or chemical agent used to inactivate, neutralize, or quench the microbiocidal properties of an
antimicrobial agent.
3.1.6 resident microorganisms—microorganisms that live and multiply on skin, forming a permanent population.
This test method is under the jurisdiction of ASTM Committee E-35 on Pesticides and is the direct responsibility of Subcommittee E35.15 on Antimicrobial Agents .
Current edition approved May 10, 1997. Published January 1998.
This test method is under the jurisdiction ofASTM Committee E35 on Pesticides andAlternative ControlAgents and is the direct responsibility of Subcommittee E35.15
on Antimicrobial Agents.
Current edition approved Nov. 1, 2007. Published November 2007. Originally approved in 1997. Last previous edition approved in 2002 as E 1883 – 02.
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 11.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
Annual Book of ASTM Standards, Vol 11.04.
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1883–02 (2007)
3.1.6
3.1.7 test formulation—a formulation containing an active ingredient.
3.1.8 transient microorganisms—microorganisms from the environment that contaminate but do not normally permanently
colonize skin.
4. Summary of Test Method
4.1 This hand degerming protocol is a modification of the Cade Handwashing Procedure, that is a serial basin hand wash
,
4 5
sampling technique.
4.1.1 Two baseline bacterial counts will be determined for the hands and a post-usage count will be done after twelve days of
antibacterial handwash usage. The samples are collected from basin wash water following one or more 60 second washes with a
bar soap that does not contain an antimicrobial.At each sampling interval samples may be collected from the first and or fifth hand
wash in a series of five washes.
4.1.2 The data will be used to calculate the reduction of bacterial flora resulting from the use of the antibacterial test handwash
product as described within the protocol. Reductions in bacterial populations calculated from baseline and post-treatment samples
collected after the first basin wash are reflective of the antimicrobial test soaps ability to reduce the population of transient
floraorganisms on the hands. Reductions in bacterial populations calculated from baseline and post-treatment samples collected
afterthefifthbasinwasharereflectiveoftheantimicrobialtestsoapsabilitytoreducethepopulationofresidentfloraonthehands.
5. Significance and Use
5.1 Thisprocedureshouldbeusedfor in vivoevaluationoftheperformanceofantibacterialhandwashproductsthatareintended
to reduce the skin micro flora following repeated use. Activity against the combined transient and resident micro flora may be
,
assessed. Historically counts from the first basin are considered to be transients. . The latter measurement is probably more
meaningful as the resident population is more stable.
5.1.1This test method is applicable for testing all forms of topical antimicrobial handwash formulations.
5.2Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. The
latter measurement is probably more meaningful as the resident population is more stable.
5.1.1 This test method is applicable for testing all forms of topical antimicrobial handwash formulations.
6. Apparatus
6.1 Colony Counter— Any of several types may be used.
6.2 Incubator—Any incubator capable of maintaining a temperature of 35 6 2°C may be used. —Any incubator that can
maintaining a temperature of 30-35 °C may be used.
6.3 Sterilizer—Anysuitablesteamsterilizercapableofproducingtheconditionsofsterilization.—Anysuitablesteamsterilizer
that can produce the conditions of sterility is acceptable.
6.4 Timer (Stop-Clock)—One that can be read for hours and minutes.
6.5 Water Bath—Any bath of appropriate size and capable of maintaining temperature at 45 6 2°C.
6.6 Wash Basins— Sterile metal, plastic, or porcelain basins capable of containing approximately 3 L.Alternatively, non-sterile
containers may be used if lined with a low bioburden plastic bag.
7. Materials and Reagents
7.1 Bacteriological Pipettes, 5.0 and 2.2 or 1.1 mL capacity.
7.2 Test Tubes, or equivalent.
7.3 Test MaterialsTest Formulation— Directions for use of test formulation should be included if available.
7.4 Dilution Fluid— Butterfield’s phosphate buffer,or equivalent, containing an antimicrobial inactivator specific for the test
formulation. (See Test Methods E1054 or other suitable diluent, adjusted to pH 7.2 6 0.1 with effective neutralizer if required.
Adjust pH with 0.1 N HCl or 0.1 N Na OH (See Test Methods E 1054.)
7.4.1Butterfield’s Phosphate Buffer Stock Solution—Dissolve34gofKH PO in500mLofdistilledwater,adjusttopH7.2with
2 4
approximately 75 mL of 1N NaOH, and dilute to 1 L. Store under refrigeration.
7.4.2Dilution Fluid— Dilute 1.25 mLof Butterfield’s Phosphate Buffer stock solution to 1 Lwith distilled water (antimicrobial
inactivator may be added prior to adding water). Adjust to pH 7.2, dispense in appropriate volumes, and sterilize at 121°C.
Cade, A.R., “A Method for Testing Degerming Efficacy of Hexachlorophene Soaps,” Journal of the Society of Cosmetic Chemistry , Vol. 2: 1951, pp 181–291.
Roth, R.R., Williams, D.J., “Microbial Ecology of the Skin” Annual Review of Microbiology, Vol. 42: 1988, pp. 441–64.
Price, P.B., “The bacteriology of normal skin: a new quantitative test applied to a study of the bacterial flora and disinfectant action of mechanical cleansing,” Journal
Infection Control, Vol. 63:1938, pp 301–318.
Title 21, Code of Regulations (CFR), Part 50, Protection of Human Subjects: Informed Consent Verification, Available from U.S. Government Printing Office,
Superintendent of Documents, Washington, DC 20402.
Roth, R.R., Williams, D.J., “Microbial Ecology of the Skin” Annual Review of Microbiology, Vol. 42: 1988, pp. 441–64.
Presterilized/disposable bacteriological pipettes are available from most laboratory supply houses.
Butterfield, C.T., “The selection of a Dilution Water for Bacteriological Examinations.” J. bacteriol. 23: 355–368. 1931.
E1883–02 (2007)
7.5 Plating Medium— Soybean-casein digest agar, or equivalent. — Soybean-Casein Digest Agar Medium, or commercially
available equivalent with appropriate neautralizers if needed.
7.6 Baseline Cleaning WashBland cleansing formulation , a mild, non-antimicrobial solid or liquid cleanser. (The Investigator
may choose to use the product vehicle.)
NOTE1—Soap 1—This formulation should be used during the washout period and for all sample collection washes.
7.7 Sterile High Purity Water—Specification D 1193, Type III, or better.
8. Panelists Subjects
8.1 Number of Panelists—Thenumberofpanelistrequireddependsuponthelevelofstatisticalsignificancerequiredforthetest
results, the variability encountered in the study, and the relative efficacy of the antibacterial agent being evaluated. Panelists are
selected from a group of adults who agree to the following test restrictions and for whom an initial estimate of the baseline
population has been established. This group, from which the test panelist are to be selected, should be approximately 1.5 times
larger than the proposed test panel. Number of subjects—Sample size calculations should be done to determine the number of
subjects necessary to find statistically significant differences (reductions) from baseline. The number of subjects required depends
on the statistical confidence required for the expected results, the variability encountered in the data collect
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.