ASTM E2362-04

Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection

SIGNIFICANCE AND USE
This test method may be used to determine if a pre-saturated or impregnated towelette demonstrates antimicrobial effectiveness as a disinfectant on hard surfaces.
SCOPE
1.1 This practice is designed to evaluate the antimicrobial activity of pre-saturated or impregnated towelettes when used as a hard surface disinfectant.
1.2 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLPs) are required and to follow them when appropriate.
1.3 This practice should be performed only by those trained in microbiological techniques.
1.4 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 to determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Sep-2004
• ICS: 71.100.35 - Chemicals for industrial and domestic disinfection purposes
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Relations

• Replaced By: ASTM E2362-09 - Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection
• Effective Date: 01-Dec-2009
• Referred By: ASTM E2967-15 - Standard Test Method for Assessing the Ability of Pre-wetted Towelettes to Remove and Transfer Bacterial Contamination on Hard, Non-Porous Environmental Surfaces Using the Wiperator (Withdrawn 2024)
• Effective Date: 01-Oct-2004

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:E2362–04
Standard Practice for
Evaluation of Pre-saturated or Impregnated Towelettes for
Hard Surface Disinfection
This standard is issued under the fixed designation E2362; 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 3.5 neutralizer, n—a component used to render an active
agent incapable of destroying organisms by chemical or
1.1 This practice is designed to evaluate the antimicrobial
physical means.
activity of pre-saturated or impregnated towelettes when used
3.6 pre-saturated, adj—to be filled or impregnated with test
as a hard surface disinfectant.
substance prior to the time of its intended use.
1.2 It is the responsibility of the investigator to determine
3.7 towelette, n—A paper, cloth or non –woven blend
whether Good Laboratory Practices (GLP’s) are required and
material used as a transporter for a cleaning and/or disinfection
to follow them when appropriate.
agent.
1.3 This practice should be performed only by those trained
in microbiological techniques.
4. Summary of Practice
1.4 This standard does not purport to address all of the
4.1 A towelette impregnated or pre-saturated with a test
safety concerns, if any, associated with its use. It is the
substance is used to treat a carrier which has been inoculated
responsibility of the user of this standard to establish appro-
withatestorganismafteranaliquotofatestorganismhasbeen
priate safety and health practices and to determine the
inoculated, evenly distributed, and dried onto the carrier. The
applicability of regulatory limitations prior to use.
carrier is wiped using the pre-saturated or impregnated tow-
2. Referenced Documents elette simulating the application of the test substance and then
held for a pre-determined contact time. After the specified
2.1 ASTM Standards:
contact time, the test substance remaining on the carrier is
D1193 Specification for Reagent Water
neutralized and the carrier is subcultured to recover surviving
E1054 Test Methods for Evaluation of Inactivators of An-
testorganism.Theusedtowelette,afterthecontacttime,isalso
timicrobial Agents
cultured for surviving test organism.
2.2 Federal Standard
40 CFR, Part 160, Good Laboratory Practice Standards
5. Significance and Use
3. Terminology This test method may be used to determine if a pre-saturated
or impregnated towelette demonstrates antimicrobial effective-
3.1 carrier, n—a transportable surface onto which a test
ness as a disinfectant on hard surfaces.
organism will be inoculated and dried. The carrier will be
treated with the test substance and subcultured for survivors.
6. Apparatus
3.2 CFU, n—colony forming units
6.1 Incubator—any calibrated incubator that maintains a
3.3 disinfectant, n—a physical or chemical agent or process
temperature specific for propagation of organisms. (for ex-
that destroys pathogenic or potentially pathogenic microorgan-
ample, bacteria and mycobacteria at 35 6 2 °C and fungi at
isms in/on surfaces or objects.
25 6 2 °C).
3.4 impregnated, adj—saturated with test substance.
6.2 Sterilizer—any suitable steam sterilizer that produces
the conditions of sterilization is acceptable.
This practice is under the jurisdiction ofASTM Committee E35 on Pesticides
6.3 Test Towelettes—with instructions for use.
and Alternative Control Agents and is the direct responsibility of Subcommitee
E35.15 on Antimicrobial and Antiviral Agents. Current edition approved Oct. 1,
2004. Published October 2004. DOI: 10.1520/E2362-04.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or United States Environmental Protection Agency, Efficacy Data Requirements,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM “Pre-Saturated or Impregnated Towelettes for Hard Surface Disinfection” Standard
Standards volume information, refer to the standard’s Document Summary page on Operating Procedure for Testing of Towelette Disinfectants against Salmonella
the ASTM website. choleraesuis , Staphylococcus aureus, Pseudomonas aeruginosa, and Mycobacte-
Available from the Superintendent of Documents, U.S. Government Printing rium bovis (BCG), EPA/OPP Microbiology Laboratory, Ft. Meade, MD. SOP#
Office, Washington D.C. 20402 MB09-01, Revised 11/08/00.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2362–04
6.4 Timer (Stop-clock)—a calibrated timer that displays min 7.5.2 Middlebrook 7H11 Agar—Mycobacteria.
and s. 7.5.3 Sabouraud Dextrose Agar—Fungi.
6.5 Spectrophotometer—calibrated to 650 nm. 7.6 Other subculture agars, broths and neutralizers may be
6.6 Mixer—a vortex mixer is recommended. used where appropriate.
6.7 pH meter—acalibratedpHmetertodeterminethepHof
7.7 Soil—Blood Serum, such as heat inactivated fetal bo-
media. vine serum or other appropriate alternative soil.
6.8 Nonporous Test Carriers—borosilicate glass slides, 25
7.8 Dilution Fluid—sterile phosphate buffered water
3 75 3 2 mm slides, pre-cleaned (or other hard surfaces and (PBDW), sterile saline or Butterfield’s Buffer.
sizes as appropriate).
7.9 Carrier Preparation Solutions—70-95 % isopropyl al-
6.9 Glass Culture Tubes—20 3 150 or 25 3 150 mm cohol, deionized or distilled water.
without lip or equivalent.
6.10 Culture Tube Closures—appropriate size nontoxic clo-
8. Test Organisms
sures.
8.1 Bacteria Test Organisms:
6.11 Petri Dishes—100 3 15 mm, glass and plastic, sterile.
8.1.1 Staphylococcus aureus (ATCC 6538), Salmonella
6.12 Balance—a calibrated balance sensitive to 0.1 g.
choleraesuis (ATCC 10708), and Pseudomonas aeruginosa
6.13 Micropipettor—calibrated for dispensing 10 µL.
(ATCC 15442).
6.14 Forceps—sterilizable forceps.
8.1.2 Other bacterial organisms may be tested using appro-
6.15 Sterilizer Apparatus—a bunsen burner or other appro-
priate culture and subculture procedures.
priate heat sterilizer.
8.2 Mycobacteria Test Organisms:
6.16 Bacteriological Culture Loop — 4 mm inside diameter
8.2.1 Mycobacterium chelonae (ATCC 35752).
loop of platinum or platinum alloy wire or sterile disposable
8.2.2 Mycobacterium bovis (ATCC 35743)
plastic loops of appropriate size.
8.2.3 Other mycobacteria strains may be tested using appro-
6.17 Colony Counter—any one of several types may be
priate culture and subculture procedures.
used, for example Quebec.
8.3 Fungi Test Organisms:
6.18 Gloves—sterile gloves not possessing antimicrobial
8.3.1 Trichophyton mentagrophytes (ATCC 9533)
properties.
8.3.2 Other fungi strains may be tested using appropriate
6.19 Pipette—sterile volumetric pipettes.
culture and subculture procedures.
6.20 Glass Jars—100 mL or other appropriate vessel.
6.21 Filter Paper—9 cm (Whatman No. 2, or equivalent)
9. Preparation of Organism
sterilized prior to use.
9.1 Bacteria—Maintain stock cultures of S. aureus and S.
6.22 Thermometer—calibrated thermometer.
choleraesuis on Nutrient Agar slants. Maintain stock cultures
6.23 Glass Beads—3 –5 mm sterile beads.
of P. aeruginosa on Cystine Trypticase Agar slants. Incubate
6.24 Gauze—sterile cotton gauze.
freshly subcultured stock cultures for 48 64hat35 6 2 °C,
6.25 Hemacytometer—calibrated hemacytometer.
then refrigerate cultures at 2-8 °C for up to 30 days. Stock
6.26 Glass Wool—sterile grease free glass wool.
cultures used for inoculation of broth cultures should not
6.27 Hot air oven—ability to maintain 180°C.
undergo more than 5 passages from the first subculture from
6.28 Tissue grinder—sterile disposable or sterilizable glass.
the ATCC stock.
6.29 Orbital Shaker—calibrated shaker.
9.1.1 Bacteria Inoculum Preparation—From stock cultures,
7. Reagents
inoculate tubes containing 10 mL of the appropriate fresh
culture broth and incubate for 24 64hat35 6 2 °C. Using a
7.1 Culture Media—Bacteria
7.1.1 Nutrient Broth—Pseudomonas aeruginosa, 4 mm inside diameter transfer loop, transfer one loopful of the
culture into fresh culture broth. Make at least 3 but less than 15
7.1.2 Cystine Trypticase Agar—Pseudomonas aeruginosa,
7.1.3 Synthetic Broth—Salmonella choleraesuis and Sta- consecutive daily transfers prior to use as inoculum for testing.
Incubate the final transfer for 48 6 4 h, and use these cultures
phylococcus aureus.
7.1.4 Nutrient Agar. in the test. Aseptically remove the pellicle from the P. aerugi-
7.1.5 Fluid Thioglycollate Broth. nosa culture before use in the test.
7.2 Culture Media—Mycobacteria 9.2 Mycobacteria—Maintain a stock culture of Mycobacte-
7.2.1 Middlebrook 7H11 or 7H9 Agar Slants. rium organisms on Middlebrook 7H11 or 7H9 agar slants by
7.2.2 Modified Proskauer-Beck Broth. monthly transfer and incubation for 15-30 days at 35 62°C
7.3 Culture Media—Fungi followed by storage at 2-8 °C.
7.3.1 Sabouraud Dextrose Agar plates. 9.2.1 Mycobacteria Inoculum Preparation—From stock
7.3.2 Sabouraud Dextrose Agar slants. culture, inoculate Modified Proskauer-Beck (MPB) Broth
7.4 Neutralizing Subculture Media—A neutralizing growth tubes and incubate 10-25 days at 35 6 2 °C. Add 1.0 mL of
medium capable of supporting the growth of the test organism 0.1 % Tween 80 in saline to this 10-25-day culture, transfer to
following exposure to the test material in accordance with a sterile tissue grinder and grind thoroughly. Finally transfer
E1054. the appropriate volume of suspension from the grinder to a
7.5 Subculture Agar vessel appropriate for spectrophotometric determination. Cali-
7.5.1 Tryptic Soy Agar—Bacteria. brate a spectrophotometer to 650 nm using a MPB blank as the
E2362–04
100 % transmittance point. Measure transmittance of the cul- sterile pipette tip or 4.0 mm id loop used for inoculation and
ture suspension. Adjust culture suspension with MPB to a recover with the Petri dish lid.
target of 15-20 % transmittance to achieve a $ 1.0 3 10
10.3 Carrier Drying:
CFU/carrier concentration.
10.3.1 Place all Petri dishes containing inoculated carriers
9.3 Fungi—Maintain a stock culture of Trichophyton men-
into an incubator equilibrated at 3562°C until dry, but no
tagrophytes on Sabouraud Dextrose agar slants by transferring
longer than 40 min.
at less than or equal to 3 month intervals and incubate 10 days
10.4 Carrier Treatment/Application of Product:
at 2562°C, followed by storage at 2-8°C.
10.4.1 Wipe the inoculated test area according to label
9.3.1 Conidial Suspension Preparation—From stock cul-
instructions or the procedure under test. The wiping procedure
ture, inoculate Sabouraud DextroseAgar plates
...