ASTM E1153-03(2010)e1
(Test Method)Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces
Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces
SIGNIFICANCE AND USE
This test method shall be used to determine if a chemical has application as a non-food contact sanitizer or as a one-step cleaner/sanitizer.
SCOPE
1.1 This test method is used to evaluate the antimicrobial efficacy of sanitizers on precleaned inanimate, nonporous, non-food contact surfaces.
1.2 This test method may also be used to evaluate the antimicrobial efficacy of one-step cleaner/sanitizer formulations recommended for use on lightly soiled, inanimate, nonporous, non-food contact surfaces.
1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP) is required and to follow them where appropriate (see section 40 CFR, 160) or as revised.
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 may involve hazardous materials, chemicals and microorganisms and should be performed only by persons who have had formal microbiological training. 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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Designation: E1153 − 03(Reapproved 2010)
Standard Test Method for
Efficacy of Sanitizers Recommended for Inanimate Non-
Food Contact Surfaces
This standard is issued under the fixed designation E1153; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
´ NOTE—A warning note was moved into the text editorially in May 2010.
1. Scope 2.2 Federal Standard:
40CFR, Part 160, Good Laboratory Practice Standards
1.1 This test method is used to evaluate the antimicrobial
efficacy of sanitizers on precleaned inanimate, nonporous,
3. Significance and Use
non-food contact surfaces.
3.1 Thistestmethodshallbeusedtodetermineifachemical
1.2 This test method may also be used to evaluate the
has application as a non-food contact sanitizer or as a one-step
antimicrobial efficacy of one-step cleaner/sanitizer formula-
cleaner/sanitizer.
tions recommended for use on lightly soiled, inanimate,
nonporous, non-food contact surfaces.
4. Apparatus
1.3 It is the responsibility of the investigator to determine
4.1 Balance—Abalance with a platform to accommodate a
whether Good Laboratory Practices (GLP) is required and to
100-mL volumetric flask. This balance should be sensitive to
followthemwhereappropriate(seesection40CFR,160)oras
0.01 g.
revised.
4.2 Nonporous Test Surfaces, pre-cleaned.
1.4 The values stated in SI units are to be regarded as
4.2.1 Borosilicate Glass Squares, 25 by 25 by 2 mm slides,
standard. No other units of measurement are included in this
nonchipped.
standard.
4.2.2 Glazed Glass or Stainless Steel, of appropriate type,
1.5 This standard may involve hazardous materials, chemi-
approximately same size as in 4.2.1.
cals and microorganisms and should be performed only by
4.3 Glass Culture Tubes, recommended sizes: 18 to 20 by
persons who have had formal microbiological training.This
150 mm and 25 by 150 mm without lip.
standard does not purport to address all of the safety concerns,
4.4 Culture Tube Closures, appropriate sized nontoxic clo-
if any, associated with its use. It is the responsibility of the user
of this standard to establish appropriate safety and health sures.
practices and determine the applicability of regulatory limita-
4.5 Pipets or Dispensing Syringes, (or both), appropriately
tions prior to use.
calibrated and sterile.
4.6 Bacteriological Transfer Loop, 4 mm inside diameter
2. Referenced Documents
loop of platinum or platinum alloy wire or sterile, disposable
2.1 ASTM Standards:
plastic loops of approximate size.
D1193Specification for Reagent Water
4.7 Flasks or Containers:
E1054Test Methods for Evaluation of Inactivators of Anti-
4.7.1 Appropriate sizes with closures for preparation of
microbial Agents
culture medium and sterile distilled water.
4.7.2 Volumetric, 100 and 1000 mL, sterile.
4.8 Petri dishes, recommended sizes: 50 by 9 mm plastic,
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
and 100 by 15 mm, glass and plastic; sterile.
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
4.9 Jars, ointment jars, 2 oz (60 mL) with nontoxic lids,
Current edition approved April 1, 2010. Published May 2010. Originally
approved 1987. Last previous edition approved in 2003 as E1153–03. DOI:
sterile.
10.1520/E1153-03R10.
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 Available from the Superintendent of Documents, U.S. Government Printing
the ASTM website. Office, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E1153 − 03 (2010)
4.10 Graduated Cylinders, recommended sizes; 100 and 5.2.2.3 Place the desired amount of Solution 1 in a sterile
500 mL. 1-Lflaskandaddapproximately600mLsteriledistilledwater;
then add 4 mL of Solution 2 and dilute to exactly 1 L with
4.11 Flaming Apparatus—A bunsen burner or other appro-
sterile distilled water. Each millilitre of Solution 1 will give a
priate heat sterilizer.
water equivalent to 100 ppm of hardness calculated as calcium
4.12 Mixer—A “vortex” mixer is recommended.
carbonate (CaCO ) by the following equation:
4.13 Timer—A reliable stopwatch or laboratory timer ca-
TotalhardnessasppmCaCO (1)
pable of measuring elapsed time in seconds and minutes.
5@2.495 3ppmCa#1@4.115 3ppmMg#
4.14 pH Meter—A reliable pH meter to determine pH of
culture media.
5.2.3 The pH of synthetic hard water should be from 7.6 to
8.2.
4.15 Desiccator, recommended size: 200 mm inside diam-
5.2.4 The synthetic water to be used for the testing should
eter with approximately 125-mm chamber depth from inside
be analyzed chemically for hardness at the time of test.
plate to cover flange, glass.
Analysis may be performed by the method described in
4.16 Incubator,capableofmaintainingtemperatureof37 6
footnote 6(c) or by commercial available kit.
2°C.
5.2.5 Allwaterusedforpreparationoftestsolutionsshallbe
4.17 Sterilizer, steam sterilizer and hot air oven (180 6 2°C
sterile.
for 2 h).
5.3 Sanitizing Solutions—Freshly prepared solutions of
4.18 Colony Counter—Any one of several types may be
sanitizers shall be used in all tests.
used, for example Quebec.
5.4 Neutralizing Solutions—Solutions appropriate to inacti-
4.19 Membrane Filters, of 0.22 µm pore size.
vate sanitizing solutions shall be used in accordance with
Practices E1054.
4.20 Filter Assembly, autoclavable.
5.5 Culture Media:
4.21 Forceps.
(5(a))
5.5.1 Nutrient Broth.
(5(b))
5.5.2 Nutrient Agar.
5. Reagents and Materials
5.6 Soil,BovineSerum,asepticallyderivedandmaintained.
5.1 Purity of Reagents—Reagent grade chemicals shall be
used in all tests. Unless otherwise indicated, it is intended that
6. Preparation of Apparatus
all reagents shall conform to the specifications of the Commit-
tee onAnalytical Reagents of theAmerican Chemical Society, 6.1 Constant Humidity Chamber (Desiccator):
where such specifications are available. Other grades may be 6.1.1 At least one day prior to use, fill the lower portion of
used, provided it is first ascertained that the reagent is of a large size desiccator with about 500 mLof glycerin solution
sufficiently high purity to permit its use without lessening the having a refractive index of 1.4529 at 25°C (approximately
accuracy of the determination. 86.5% glycerin in distilled water will provide this refractive
index). This will provide a constant 40 to 41% relative
5.2 Water for Dilution of Product Under Test:
humidity at 37 6 2°C in which the inoculated nonporous
5.2.1 Water, sterile, deionized or distilled, equivalent to or
square surfaces will be dried prior to treatment with the
better than Type 3, see Specification D1193.
sanitizer.Replacetheporcelainfloorplateofthedesiccatorand
5.2.2 Association of Offıcial Analytical Chemists (AOAC)
5(c) store at 37 6 2°C to allow to come to equilibrium.
Synthetic Hard Water:
5.2.2.1 Solution 1—Dissolve 31.74 g magnesium chloride 6.2 Test Squares:
(MgCl ) (or equivalent of hydrates) and 73.99 g calcium 6.2.1 Test squares shall be dipped in 70 to 95% ethyl or
chloride (CaCl ) in boiled distilled water and dilute to 1 L. isopropyl alcohol, rinsed with distilled water, and air dried
Sterilize by autoclaving. before sterilization.
5.2.2.2 Solution 2—Dissolve 56.03 g sodium bicarbonate 6.2.2 Place test squares into a large, glass petri dish and
(NaHCO ) in boiled distilled water and dilute to 1 L. Sterilize sterilize in a hot air oven for2hat 180°C.
by membrane filtration. 6.2.3 After sterilization, place each square into separate 50
by 9 mm sterile plastic petri dishes using sterile technique.
7. Test Organisms
Reagent Chemicals, American Chemical Society Specifications, American
Chemical Society, Washington, DC. For suggestions on the testing of reagents not
7.1 Klebsiella (K.) pneumoniae American Type Culture
listed by the American Chemical Society, see Analar Standards for Laboratory
Collection(ATCC)4352and Staphylococcus (S.) aureusATCC
Chemicals, BDH Ltd., Poole, Dorset, U.K., and the United States Pharmacopeia
and National Formulary,U.S.PharmaceuticalConvention,Inc.(USPC),Rockville,
6538.
MD.
7.2 Maintenance of Test Organisms—Maintain stock cul-
“Official Methods of Analysis of the Association of Official Analytical
Chemists,”AssociationofOfficialAnalyticalChemists,Washington,DC,Chapter6:
turesof K. pneumoniaeand S. aureusonnutrientagar.Incubate
Disinfectants, 15th ed., 1990.
2 days at 37 6 2°C, then refrigerate at 5 to 7°C. Transfer
(a) Page 133, Section 955.11 A. (a).
cultureevery3days.Stockculturesusedforinoculationshould
(b) Page 133, Section 955.11 A. (c).
(c) Page 139–140, Section 960.09A. not be more than five passages removed from the ATCC
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E1153 − 03 (2010)
cultures (USP XXIII). Information on long term culture 10.1.4 Neutralizer Solution—Mix 62.5 mL of neutralizer
maintenance and storage is found in “Manual of Methods for stock (see 10.1.3), 6.25 mLof phosphate buffer stock solution
General Bacteriology” and “ATCC Catalogue of Bacteria and (see10.1.1),and381.25mLofdistilledwater.Dispense20mL
Bacteriophages”. portions into 25 by 150 mm culture tubes and sterilize for 20
min at 121°C.
8. Preparation of Inocula
10.2 Halogen Sanitizers—Neuralizer Solutions, Dissolve
8.1 K. pneumoniae and S. aureus—K. pneumoniae and S.
0.31 g of sodium thiosulfate and 0.30 mL of Triton X-100 in
aureus are grown in nutrient broth. From stock cultures, (no
500 mLof distilled water. Dispense 20 mLportions into 25 by
more than 30 days old), inoculate tubes containing 10 mL of
150 mm culture tubes and sterilize for 20 min at 121°C.
appropriate broth, and incubate for 24 h at 37 6 2°C. Using a
10.3 Other Sanitizing Agents—Use appropriate neutralizers
4 mm inside diameter transfer loop, transfer a loopfull of the
(see Practices E1054).
cultureintofreshbroth.Makethreeconsecutivedailytransfers
prior to use as an inoculum. The final transfer is incubated for
11. Procedures
48 h, and this culture is used for the test.
11.1 Inoculation of Test Squares:
8.2 Inocula for Testing Sanitizers for Use on Precleaned
11.1.1 Inoculate each sterile glass or other nonporous sur-
Surfaces—Thoroughly mix 48 h culture of test organism on
face (see 6.2.3) squares with exactly 0.02 mL of 48 h culture.
“vortex” mixer, then allow the culture to settle for 15 min
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