ASTM E3363-23

Standard Test Method for Quantitative Performance Evaluation of Antimicrobial Towelettes

SIGNIFICANCE AND USE
5.1 The plastic Petri plate (carrier) provides a closed system for enumeration and easy application of a pre-saturated or impregnated antimicrobial towelette by an analyst.  
5.2 Aliquoting of sterile 5 % non-heat-inactivated fetal bovine serum (five 10 µL spots) onto soiled carriers and inoculation of final test suspension onto treated carriers (five 10 µL spots) is conducted using a template and a positive displacement pipette, thereby ensuring a precise inoculum level and uniform distribution of soil and final test suspension.  
5.3 A single towelette is tested per 2-carrier set, eliminating the likelihood of cross contamination between carriers.  
5.4 The corkscrew-patterned circular motion of the product application (wipe outside to inside, wipe inside to outside using the wiping template; see Annex A3 – Annex A6) ensures uniform coverage and contact of disinfectant with the inoculated surface.  
5.5 The addition of neutralizer to the treated carriers at the end of the contact time results in neutralization of the test substance. This standard test method provides a procedure for performing neutralization verification to confirm that the microbicidal, microbistatic, or both types of activity of a test substance has been reduced by 50 % at the end of the contact time (see Annex A1 for neutralization verification procedure).  
5.6 The design of this standard test method minimizes any loss of viable organisms through carrier wash-off.  
5.7 It is optional to adjust (dilution in PBS) the inoculum to achieve desired control counts of 5.0 log10 CFU/carrier to 6.5 log10 CFU/carrier.  
5.8 Include, where applicable, comparisons of the test to other similar procedures such as Practices E1054 and E2362.
SCOPE
1.1 This test method quantitatively determines the effectiveness of various sizes of antimicrobial towelettes in treating hard, non-porous surfaces against Pseudomonas aeruginosa and Staphylococcus aureus.  
1.2 This test method may be used to evaluate towelettes for antimicrobial efficacy against additional microorganisms (with necessary modifications).  
1.2.1 This test method does not differentiate between chemical inactivation of the test microbe and mechanical removal of inoculum from a surface; rather, product efficacy is considered a combination of both attributes of a towelette-based formulation.  
1.3 This test method involves the use of hazardous materials, chemicals, and infectious microorganisms and therefore should be performed only by those trained in microbiological techniques in facilities designed and equipped for work with infectious agents at the appropriate biosafety level, a BSL-2 or higher laboratory; specifications provided in the “Biosafety for Biomedical and Microbiological Laboratories” (BMBL), 6th edition (BMBL).  
1.4 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP Standards—For example, 40 CFR, Part 160 of FIFRA) are required and to follow them when appropriate.  
1.5 Strict adherence to the protocol is necessary for the validity of the test results.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 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.

General Information

• Status: Published
• Publication Date: 31-Aug-2023
• ICS: 85.080.20 - Tissue paper
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

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: E3363 − 23
Standard Test Method for
Quantitative Performance Evaluation of Antimicrobial
1
Towelettes
This standard is issued under the fixed designation E3363; 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 1.8 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This test method quantitatively determines the effective-
ization established in the Decision on Principles for the
ness of various sizes of antimicrobial towelettes in treating
Development of International Standards, Guides and Recom-
hard, non-porous surfaces against Pseudomonas aeruginosa
mendations issued by the World Trade Organization Technical
and Staphylococcus aureus.
Barriers to Trade (TBT) Committee.
1.2 This test method may be used to evaluate towelettes for
antimicrobial efficacy against additional microorganisms (with 2. Referenced Documents
necessary modifications). 2
2.1 ASTM Standards:
1.2.1 This test method does not differentiate between chemi-
D5465 Practices for Determining Microbial Colony Counts
cal inactivation of the test microbe and mechanical removal of
from Waters Analyzed by Plating Methods
inoculum from a surface; rather, product efficacy is considered
E1054 Practices for Evaluation of Inactivators of Antimicro-
a combination of both attributes of a towelette-based formula-
bial Agents
tion.
E2362 Practice for Evaluation of Pre-saturated or Impreg-
1.3 This test method involves the use of hazardous
nated Towelettes for Hard Surface Disinfection
materials, chemicals, and infectious microorganisms and there- E2756 Terminology Relating to Antimicrobial and Antiviral
fore should be performed only by those trained in microbio-
Agents
3
logical techniques in facilities designed and equipped for work 2.2 AOAC Standards:
with infectious agents at the appropriate biosafety level, a
Official Method 955.15 Use-Dilution Method for Testing
BSL-2 or higher laboratory; specifications provided in the Disinfectants against Staphylococcus aureus. Revised
“Biosafety for Biomedical and Microbiological Laboratories”
2013
(BMBL), 6th edition (BMBL).
Official Method 964.02 Use-Dilution Method for Testing
Disinfectants against Pseudomonas aeruginosa. Revised
1.4 It is the responsibility of the investigator to determine
2013
whether Good Laboratory Practices (GLP Standards—For
4
2.3 Centers for Disease Control:
example, 40 CFR, Part 160 of FIFRA) are required and to
Biosafety in Microbiological and Biomedical Laborato-
follow them when appropriate.
ries 6th Edition, U.S. Department of Health and Human
1.5 Strict adherence to the protocol is necessary for the
Services, Public Health Service, Centers for Disease
validity of the test results.
Control and Prevention, National Institutes of Health,
1.6 The values stated in SI units are to be regarded as HHS Publication No. (CDC) 21- 1112, Revised June
standard. No other units of measurement are included in this
2020.
5
standard.
2.4 U.S. Government Regulations:
40 CFR Part 160 Federal Insecticide, Fungicide and Roden-
1.7 This standard does not purport to address all of the
ticide Act (FIFRA); Good Laboratory Practice Standards
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
mine the applicability of regulatory limitations prior to use.
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
1 3
This test method is under the jurisdiction of ASTM Committee E35 on For referenced AOAC standards, visit the AOAC website,
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct www.aoacofficialmethod.org/index.
4
responsibility of Subcommittee E35.15 on Antimicrobial Agents. Available from https://www.cdc.gov/labs/BMBL.html.
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Current edition approved Sept. 1, 2023. Published September 2023. DOI: Available from U.S. Government Publishing Office (GPO), 732 N. Capitol St.,
10.1520/E3363–23. NW, Washington, DC 20401, http://www.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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