ASTM E1883-02(2015)
(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
SIGNIFICANCE AND USE
5.1 This procedure should be used for in vivo evaluation of the performance of antibacterial handwash products that are intended 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.4 ,6 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.
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).
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E1883 − 02 (Reapproved 2015)
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 cation & Part 56, Institutional Review Boards
1.1 This test method covers determining the effectiveness of
3. Terminology
an antibacterial handwash for reducing the level of aerobic
3.1 Definitions:
bacterial flora on the hands, following an extended period of
3.1.1 active ingredient—a substance performing a function
use.
defined by this method.
1.2 A knowledge of microbiological techniques is required
3.1.2 active test formulation—a formulation with an active
for these procedures.
ingredient.
1.3 In this test method metric units are used for all
3.1.3 control test formulation—a formulation without an
applications, except for distance. In this case, inches are used
active in this test method. Frequently a bland soap.
and metric units follow in parentheses.
3.1.4 neutralization—a process that results in quenching or
1.4 Performance of this procedure requires the knowledge
inactivation of the antimicrobial activity of a formulation. This
of regulations pertaining to the protection of human subjects.
may be achieved with dilution of the formulation or with the
(Title 21 CFR, Part 50).
use of chemical agents, called neutralizers.
1.5 The values stated in SI units are to be regarded as
3.1.5 neutralizer—a procedure or chemical agent used to
standard. No other units of measurement are included in this
inactivate,neutralize,orquenchthemicrobiocidalpropertiesof
standard.
an antimicrobial agent.
1.6 This standard does not purport to address all of the
3.1.6 resident microorganisms—microorganisms that live
safety concerns, if any, associated with its use. It is the
and multiply on skin, forming a permanent population.
responsibility of the user of this standard to establish appro-
3.1.7 test formulation—a formulation containing an active
priate safety and health practices and determine the applica-
ingredient.
bility of regulatory limitations prior to use.
3.1.8 transient microorganisms—microorganisms that con-
2. Referenced Documents
taminate but do not normally permanently colonize skin.
2.1 ASTM Standards:
4. Summary of Test Method
D1193 Specification for Reagent Water
E1054 Test Methods for Evaluation of Inactivators of Anti-
4.1 This hand degerming protocol is a modification of the
microbial Agents
Cade Handwashing Procedure, that is a serial basin hand wash
4,5
2.2 Other Standard:
sampling technique.
Title 21 Code of Federal Regulations (CFR), Part 50
4.1.1 Two baseline bacterial counts will be determined for
Protection of Human Subjects: Informed Consent Verifi-
thehandsandapost-usagecountwillbedoneaftertwelvedays
of antibacterial handwash usage. The samples are collected
1 frombasinwashwaterfollowingoneormore60-swasheswith
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
a bar soap that does not contain an antimicrobial. At each
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
sampling interval samples may be collected from the first and
Current edition approved Oct. 1, 2015. Published November 2015. Originally
or fifth hand wash in a series of five washes.
approved in 1997. Last previous edition approved in 2007 as E1883 – 02(2007).
DOI: 10.1520/E1883-02R15.
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 Cade, A.R., “A Method for Testing Degerming Efficacy of Hexachlorophene
Standards volume information, refer to the standard’s Document Summary page on Soaps,” Journal of the Society of Cosmetic Chemistry, Vol. 2: 1951, pp 181–291.
the ASTM website. Price, P.B., “The bacteriology of normal skin: a new quantitative test applied to
Available from U.S. Government Publishing Office, 732 N. Capitol St., NW, a study of the bacterial flora and disinfectant action of mechanical cleansing,”
Washington, DC 20401-0001, http://www.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 (2015)
4.1.2 The data will be used to calculate the reduction of 7.5 Plating Medium—Soybean-Casein Digest Agar
bacterial flora resulting from the use of the antibacterial test Medium, or commercially available equivalent with appropri-
handwashproductasdescribedwithintheprotocol.Reductions ate neautralizers if needed.
in bacterial populations calculated from baseline and post-
7.6 Bland cleansing formulation, a mild, non-antimicrobial
treatment samples collected after the first basin wash are
solid or liquid cleanser. (The Investigator may choose to use
reflective of the antimicrobial test soaps ability to reduce the
the product vehicle.)
population of transient organisms on the hands. Reductions in
NOTE 1—This formulation should be used during the washout period
bacterial populations calculated from baseline and post-
and for all sample collection washes.
treatment samples collected after the fifth basin wash are
7.7 Sterile High Purity Water—Specification D1193, Type
reflective of the antimicrobial test soaps ability to reduce the
III, or better.
population of resident flora on the hands.
8. Subjects
5. Significance and Use
8.1 Number of subjects—Sample size calculations should be
5.1 This procedure should be used for in vivo evaluation of
done to determine the number of subjects necessary to find
the performance of antibacterial handwash products that are
statistically significant differences (reductions) from baseline.
intended to reduce the skin micro flora following repeated use.
The number of subjects required depends on the statistical
Activity against the combined transient and resident micro
confidence required for the expected results, the variability
flora may be assessed. Historically counts from the first basin
4,6
encountered in the data collection (for example, variability in
are considered to be transients. The latter measurement is
reductions from baseline), and the expected efficacy of the test
probably more meaningful as the resident population is more
product (for example, its expected reduction from baseline).
stable.
This number of subjects (n) can be estimated from the
5.1.1 This test method is applicable for testing all forms of
following equation:
topical antimicrobial handwash formulations.
~Z 1Z !
α/2 β
n.S (1)
F G
D
6. Apparatus
6.1 Colony Counter—Any of several types may be used. Where:
S = estimateofvariance(ofreductionfrombaselinebased
6.2 Incubator—Any incubator that can maintaining a tem-
on in-house data pool),
perature of 30 to 35°C may be used.
Z = cumulative probability of the standard normal
α/2
6.3 Sterilizer—Any suitable steam sterilizer that can pro-
distribution,
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
of maintaining temperature at 45 6 2°C.
dermatoses, open wounds, hangnails or other skin disorders
6.6 Wash Basins—Sterile metal, plastic, or porcelain basins
that may 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
avoid contact with antimicrobials (other than the test formula-
7.1 Bacteriological Pipettes,5.0and2.2or1.1mLcapacity.
tion)forthedurationofthetestandforatleasttwoweeksprior
7.2 Test Tubes, or equivalent.
to the first baseline sampling. This restriction includes
7.3 Test Formulation—Directionsforuseoftestformulation
shampoos, lotions and soaps, and such materials as acids,
should be included if available.
bases, and solvents. Bathing in biocide treated pools, hot tubs,
7 and spas should be avoided.
7.4 Dilution Fluid—Butterfield’s phosphate buffer, or other
8.3.1 Volunteers are to be provided with a kit of non-
suitable diluent, adjusted to pH 7.2 6 0.1 with effective
antimicrobial personal care products for exclusive use during
neutralizer if required.Adjust pH with 0.1 N HCl or 0.1 N Na
the test and protective gloves to be worn when contact with
OH (See Test Methods E10
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