ASTM E1589-05(2010)
(Test Method)Standard Test Method for Evaluation of First Aid Antiseptic Drug Products
Standard Test Method for Evaluation of First Aid Antiseptic Drug Products
SIGNIFICANCE AND USE
The procedures in this test method should be used for in vivo evaluation the antimicrobial activity of drug products applied topically to the skin that are intended to help prevent infection in minor cuts, scrapes and burns.
This test method is applicable for testing liquids, ointments, powders, films, or dressing containing or impregnated with an antimicrobial for their effect to reduce an enhanced skin microflora or their effects to suppress the growth of the skin flora, or both.
SCOPE
1.1 The tests described in this test method are designed to evaluate antimicrobial agents in formulations intended for use as first aid antiseptic products for their ability to reduce or suppress the growth, or both, of the skin microflora.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. (See CFR Parts 50 and 56.)
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.
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Standards Content (Sample)
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Designation: E1589 − 05(Reapproved 2010)
Standard Test Method for
Evaluation of First Aid Antiseptic Drug Products
This standard is issued under the fixed designation E1589; 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 3.2 neutralization, n—a process which results in quenching
or inactivating inactivation of the antimicrobial activity of a
1.1 The tests described in this test method are designed to
formulation. This may be achieved with dilution of the
evaluate antimicrobial agents in formulations intended for use
formulation, or with the use of chemical agents, called neu-
as first aid antiseptic products for their ability to reduce or
tralizers.
suppress the growth, or both, of the skin microflora.
3.3 neutralizer, n—a procedure or chemical agent used to
1.2 A knowledge of microbiological techniques is required
inactivate,neutralize,orquenchthemicrobiocidalpropertiesof
for these procedures.
an antimicrobial agent.
1.3 Performance of this procedure requires the knowledge
3.4 resident microorganisms , n—microorganisms that live
of regulations pertaining to the protection of human subjects.
and multiply on skin, forming a permanent population.
(See CFR Parts 50 and 56.)
3.5 sampling fluid, n—a recovery fluid that may or may not
1.4 The values stated in SI units are to be regarded as
contain a neutralizer to inactivate the active ingredients in test
standard. No other units of measurement are included in this
and internal reference formulations.
standard.
3.6 test formulation , n—a formulation containing an active
1.5 This standard does not purport to address all of the
ingredient(s).
safety concerns, if any, associated with its use. It is the
3.7 transient microorganisms, n—microorganisms that con-
responsibility of the user of this standard to establish appro-
taminate but do not normally permanently colonize the skin.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4. Summary of Test Methods
2. Referenced Documents
4.1 These test methods describe standard in vivo techniques
to determine the following:
2.1 ASTM Standards:
4.1.1 Effect of the Test Formulation to Reduce an Artificially
D1193 Specification for Reagent Water
Enhanced Skin Microbial Flora—The forearms of subjects are
E1054 Test Methods for Evaluation of Inactivators of Anti-
occluded for 48 h prior to application of the test formulation to
microbial Agents
3 increase the microbial population on the skin of the volar
2.2 Federal Standards:
forearm surface. At treatment the occlusion material is re-
CFR Parts 50 and 56
moved and the skin is allowed to dry, the test formulation is
then applied to selected sites. At a pre-determined time(s)
3. Terminology
following application, the sites are microbiologically sampled
3.1 active ingredient, n—a substance performing a function
and the samples plated for total aerobic bacteria count. The
defined by this method.
counts obtained from the treated sites are compared to counts
obtained from untreated occluded sites.
4.1.2 Effect of the Test Formulation to Suppress the Growth
This test method is under the jurisdiction of ASTM Committee E35 on
of Normal Skin Flora When Applied As a Dressing—The
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
dressingsareappliedtotheforearmfor24h.Thedensityofthe
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
resident microorganisms that develop under the dressings are
Current edition approved April 1, 2010. Published May 2010. Originally
approved in 1994. Last previous edition approved in 2005 as E1589 – 05. DOI:
comparedtothepopulationthatdevelopsonasimilaruntreated
10.1520/E1589-05R10.
occluded site. Following 24 h of occlusion, the sites are
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
microbiologically sampled and the samples plated for total
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 aerobic bacteria count.
the ASTM website.
4.2 Theprincipalofthetestisthatthemicrofloraofforearm
Available from U.S. Government Printing Office, Superintendent of
Documents, Washington DC, 20402. skin is sparse. The impermeable dressing will increase surface
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1589 − 05 (2010)
moisture by preventing diffusional water loss and thus expand 7.9 Plating Medium—Soybean-casein digest agar medium
transient resident skin microorganisms population. A signifi- or commercial equivalent.
cant antimicrobial effect by the test agent will be reflected by
7.10 Personal Hygiene Kit—contents may include various
significantly lower population recovered from the nontreated
non-antimicrobial formulations such as shampoo, hand soap,
site.
non-aerosol deodorant, and gloves at the discretion of the
investigator.
5. Significance and Use
7.11 Adhesive Tape—surgical or other appropriate adhesive
5.1 The procedures in this test method should be used for in
tape.
vivo evaluation the antimicrobial activity of drug products
applied topically to the skin that are intended to help prevent
8. Procedure
infection in minor cuts, scrapes and burns.
8.1 Reduction of Microbial Flora by Products That Are Not
5.1.1 This test method is applicable for testing liquids,
Applied Under Dressings.
ointments, powders, films, or dressing containing or impreg-
8.1.1 Number of Subjects—Sample size calculations should
nated with an antimicrobial for their effect to reduce an
be done to determine the number of subjects necessary to find
enhancedskinmicrofloraortheireffectstosuppressthegrowth
statistically significant differences (reductions) from baseline.
of the skin flora, or both.
The number of subjects required depends on the statistical
6. Apparatus
confidence required for the expected results, the variability
encountered in the data collection (for example, variability in
6.1 Colony Counter—Any of several types may be used, for
example, Quebec colony counter. reductions from baseline), and the expected efficacy of the test
product (for example, its expected reduction from baseline).
6.2 Incubator—Any incubator capable of maintaining a
The minimum number of subjects (n) required for each test
temperature of 35 6 2°C.
formulation can be estimated from the following equation:
6.3 Sterilizer—Any suitable steam sterilizer capable of pro-
Z 1Z
~ !
α/2 β
ducing the conditions or sterilization.
n.S (1)
S D
D
6.4 Timer (Stop-Clock)—One that can be read for hours and
S = estimate of variance (of reductions from baseline
minutes.
based on in-house data pool)
7. Reagents and Materials
(Z = cumulative probability of the standard normal
α/2
distribution, = 1.96 for α=0.05,
7.1 Bacteriological Pipette—5.0 and 2.2 mL or 1.1 mL
Z = power of the test = 0.842 for β = 0.80,
capacity.
β
D = expected efficacy (expected reduction from
NOTE 1—Presterilized/disposable bacteriological pipettes are available
baseline).
from most laboratory supply houses.
NOTE 3—Experience has shown that a range from 12–18 subjects
7.2 Water Dilution Bottles—Any sterilizable container hav- provides acceptable data.
ing a 150 to 200 mL capacity and tight closure.
8.1.2 Subject Inclusion Criteria:
7.3 Scrubbing Cups—Sterile cylinders, (Recommended 8.1.2.1 Individuals between the ages of 18 and 65 years
being preferably both male and female,
height approximately 2.5 cm, inside diameter 2–3 cm.
8.1.2.2 Hands and forearms free of dermatoses, lesions,
7.4 Rubber Policeman—Can be fashioned in the laboratory
open wounds hangnails, or other skin disorders, and
or purchased from most laboratory supply houses.
8.1.2.3 Are in general good health as evidenced by
...
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