ASTM E1882-05
(Test Method)Standard Test Method for Evaluation of Antimicrobial Formulations by the Agar Patch Technique
Standard Test Method for Evaluation of Antimicrobial Formulations by the Agar Patch Technique
SIGNIFICANCE AND USE
This procedure can be used to evaluate formulations containing ingredients intended to inhibit growth of bacteria on intact skin and measures the difference, post-product-exposure, between numbers of bacterial colonies on active test formulation plates and numbers on control plates, expressed as percent inhibition.
This procedure may also be used to test for persistence of activity, as a function of time elapsed between application of active test formulation and application of active test plates.
Because no procedure for neutralization of the antimicrobial action of active ingredients can be included in the test, the agar patch method is limited to the extent that results expressed as percent inhibition do not differentiate between bacteriostatic and bacteriocidal effects and, hence, must not be portrayed as “reductions.”
SCOPE
1.1 This test method determines the antibacterial activity and persistence of test formulations, as measured by the inhibition of a test organism on an agar surface exposed to test sites on human skin treated with the formulations.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 It is the responsibility of the investigator to determine if Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) are required and to adhere to these practices, as appropriate.
1.4 In this test method, metric units are used for all applications except linear measure. In that case, inches are used and metric units follow in parentheses.
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. Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21 CFR, Ch. I, Parts 50 and 56 ).
General Information
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:E1882–05
Standard Test Method for
Evaluation of Antimicrobial Formulations by the Agar Patch
1
Technique
This standard is issued under the fixed designation E1882; 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.
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1. Scope
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2.2 Federal Standard
1.1 This test method determines the antibacterial activity
21 CFR, Ch. I, Parts 50 and 56 Protection of Human
and persistence of test formulations, as measured by the
Subjects
inhibition of a test organism on an agar surface exposed to test
sites on human skin treated with the formulations.
3. Terminology
1.2 A knowledge of microbiological techniques is required
3.1 active test formulation—a substance containing active
for these procedures.
ingredient(s).
1.3 It is the responsibility of the investigator to determine if
3.2 active ingredient—a substance performing a function
Good Laboratory Practice (GLP) and Good Clinical Practice
defined in the test method; in this test method, a substance
(GCP) are required and to adhere to these practices, as
added to a formulation specifically for the inhibition or
appropriate.
inactivation of microorganisms.
1.4 In this test method, metric units are used for all
3.3 active plate—inoculated agar plate that has been at-
applicationsexceptlinearmeasure.Inthatcase,inchesareused
tached to a skin site treated with an active formulation.
and metric units follow in parentheses.
3.4 antibacterial activity—killing of bacteria or supression
1.5 This standard does not purport to address all of the
of their growth or reproduction.
safety concerns, if any, associated with its use. It is the
3.5 control formulation—a formulation that does not con-
responsibility of the user of this standard to establish appro-
tain an active ingredient.
priate safety and health practices and determine the applica-
3.6 control plate—inoculated agar plate that has been at-
bility of regulatory limitations prior to use.Performanceofthis
tached to an untreated skin site, or one treated with a control
procedure requires the knowledge of regulations pertaining to
formulation.
the protection of human subjects (see 21 CFR, Ch. I, Parts 50
3.7 inhibition—prevention of bacterial population growth,
and 56 ).
either through lethality or through prevention of bacterial
2. Referenced Documents reproduction.
2
3.8 inoculum determination plate—an inoculated plate that
2.1 ASTM Standards:
has not been exposed to any skin test site.
E1874 Test Method for Evaluation of Antibacterial Washes
3.9 persistence—effectiveness of a test formulation in in-
by Cup Scrub Technique
hibiting bacteria, defined in terms of time elapsed between
application of test formulation and application of test plates.
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This test method is under the jurisdiction of ASTM Committee E35 on
3.10 resident microorganisms—microorganisms that live
Pesticides and is the direct responsibility of Subcommittee E35.15 onAntimicrobial
and multiply on skin, forming a permanent population.
Agents.
Current edition approved Nov. 1, 2005. Published November 2005. Originally
approved in 1997. Last previous edition approved in 2000 as E1882 – 00. DOI:
10.1520/E1882-05.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or Withdrawn. The last approved version of this historical standard is referenced
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM on www.astm.org.
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Standards volume information, refer to the standard’s Document Summary page on Available from Superintendent of Documents, U.S. Government Printing
the ASTM website. Office, Washington, D.C. 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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E1882–05
3.11 transient microorganisms—microorganisms from the 7. Reagents and Materials
environment that contaminate, but do not normally perma-
7.1 Bacteriological Pipettes, 10.0 and 2.2 or 1.1 mL capac-
nently colonize skin.
ity.
3.12 volar aspect of the forearms—the inside of the forearm
NOTE 1—Presterilized/disposable bacteriological pipettes are available
on the same plane as the palm of the hand.
from most laboratory supply houses.
7.2 Pipetter, with disposable tips capable of delivering 10
4. Summary of Test Method
µL.
4.1 This test method is conducted on subjects selected from
7.3 Plating Medium, soybean-casein digest agar, or equiva-
a group of volunteers who have refrained from using topical
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lent.
antimicrobials for at least one week and have minimal hair on
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7.4 Dilution Fluid, Butterfield’s phosphate buffer,or
the
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