ASTM E2897-22

Standard Guide for Evaluation of the Effectiveness of Hand Hygiene Topical Antimicrobial Products using <emph type="bdit">ex vivo</emph> Porcine Skin

SIGNIFICANCE AND USE
5.1 The guide may be used to demonstrate the effectiveness of topical antimicrobial products using pigskin as a surrogate for human skin and the cup scrub technique for sampling.  
5.2 The techniques described can be used to simulate Test Method E1174 and will use the pigskin substrate to overcome limitations posed by exposure of human subjects to potentially pathogenic microorganisms, while offering the benefit of applicability to a wide variety of hand-washing conditions that cannot be simulated in test tubes.  
5.3 Use of the pigskin surrogate offers less expensive and higher throughput screening.
SCOPE
1.1 This guide is designed to demonstrate the effectiveness of hand hygiene topical antimicrobial products using pigskin as a surrogate model.  
1.2 Knowledge of microbiological techniques is required for these procedures.  
1.3 This standard guide can be used to evaluate topical antimicrobial handwash or handrub formulations.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 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-Mar-2022
• ICS: 07.100.99 - Other standards related to microbiology
• 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

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: E2897 − 22
Standard Guide for
Evaluation of the Effectiveness of Hand Hygiene Topical
1
Antimicrobial Products using ex vivo Porcine Skin
This standard is issued under the fixed designation E2897; 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.
INTRODUCTION
Use of ex vivo animal skin models such as pigskin has widely been used as surrogate for human
skin. Pigskin model is a safe, inexpensive, accurate, and reliable platform of testing antiseptic
2,3,4
efficacy. The test guide described here utilizes sterilized pigskin to evaluate the effectiveness of
hand hygiene topical antimicrobial products. The pigskin substrate is used to overcome limitations
posed by exposure of human subjects to potentially pathogenic microorganisms, while offering the
benefit of applicability to a wide variety of hand-washing conditions that cannot be simulated in test
tubes.The microbial reduction is the difference in log value obtained from artificially contaminated
10
pigskins after use of test formulation to the log value obtained from contaminated pigskins not
10
exposed to the test formulation.
1. Scope 1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This guide is designed to demonstrate the effectiveness
ization established in the Decision on Principles for the
ofhandhygienetopicalantimicrobialproductsusingpigskinas
Development of International Standards, Guides and Recom-
a surrogate model.
mendations issued by the World Trade Organization Technical
1.2 Knowledge of microbiological techniques is required
Barriers to Trade (TBT) Committee.
for these procedures.
2. Referenced Documents
1.3 This standard guide can be used to evaluate topical
5
2.1 ASTM Standards:
antimicrobial handwash or handrub formulations.
E1054PracticesforEvaluationofInactivatorsofAntimicro-
1.4 The values stated in SI units are to be regarded as
bial Agents
standard. No other units of measurement are included in this
E1174Test Method for Evaluation of the Effectiveness of
standard.
Healthcare Personnel Handwash Formulations
1.5 This standard does not purport to address all of the
E1874Test Method for Recovery of Microorganisms From
safety concerns, if any, associated with its use. It is the
Skin using the Cup Scrub Technique
responsibility of the user of this standard to establish appro-
3. Terminology
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3.1 Definitions:
3.1.1 antimicrobial ingredient, n—a substance added to a
1
formulation specifically for the inhibition or inactivation of
This guide is under the jurisdiction of ASTM Committee E35 on Pesticides,
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
microorganisms.
Subcommittee E35.15 on Antimicrobial Agents.
3.1.2 neutralization, n—the process for inactivating or
Current edition approved April 1, 2022. Published May 2022. Originally
approvedin2012.Lastpreviouseditionapprovedin2017asE2897–12(2017).DOI:
quenchingtheactivityofamicrobicide,oftenachievedthrough
10.1520/E2897-22.
physical(forexample,filtrationordilution)orchemicalmeans.
2
Woolwine, J. D., and Gerberding, J. L., “Effect ofTesting Method onApparent
Activities of Antiviral Disinfectants and Antiseptics,” Antimicrobial Agents and 3.1.3 resident microorganisms, n—microorganismsthatsur-
Chemotherapy, Vol 39, 1999, pp. 921–923.
vive and multiply on the skin, forming a stable population.
3
Bush, L. W., Benson, L. M., and White, J. H., “Pigskin as a Test Substrate for
EvaluatingTopicalAntimicrobialActivity,” J. Clinical Microbiology,Vol 24, 1986,
5
pp. 343–348. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
McDonnel, G., Haines, K., Klein, D., Rippon, M., Walmsley, R., and Pretzer, contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
D., “Clinical Correlation of a SkinAntisepsis Model,” J. Microbiological Methods, Standards volume information, refer to the standard’s Document Summary page on
Vol 35, 1999, pp. 31–35. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2897 − 22
3.1.4 transient microorganisms, n—microorganisms that 6.7 Water Temperature Regulator and Temperature
contaminate the skin but do not
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2897 − 12 (Reapproved 2017) E2897 − 22
Standard Guide for
Evaluation of the Effectiveness of Hand Hygiene Topical
1
Antimicrobial Products using ex vivo Porcine Skin
This standard is issued under the fixed designation E2897; 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.
INTRODUCTION
Use of ex vivo animal skin models such as pigskin has widely been used as surrogate for human
skin. Pigskin model is a safe, inexpensive, accurate, and reliable platform of testing antiseptic
2,3,4
efficacy. The test guide described here utilizes sterilized pigskin to evaluate the effectiveness of
hand hygiene topical antimicrobial products. The pigskin substrate is used to overcome limitations
posed by exposure of human subjects to potentially pathogenic microorganisms, while offering the
benefit of applicability to a wide variety of hand-washing conditions that cannot be simulated in test
tubes. The microbial reduction is the difference in log value obtained from artificially contaminated
10
pigskins after use of test formulation to the log value obtained from contaminated pigskins not
10
exposed to the test formulation.
1. Scope
1.1 This guide is designed to demonstrate the effectiveness of hand hygiene topical antimicrobial products using pigskin as a
surrogate model.
1.2 Knowledge of microbiological techniques is required for these procedures.
1.3 This standard guide can be used to evaluate topical antimicrobial handwash or handrub formulations.
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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.6 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.
1
This guide is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 1, 2017April 1, 2022. Published April 2017May 2022. Originally approved in 2012. Last previous edition approved in 20122017 as
E2897E2897–12(2017).–12. DOI: 10.1520/E2897-12R17.10.1520/E2897-22.
2
Woolwine, J. D., and Gerberding, J. L., “Effect of Testing Method on Apparent Activities of Antiviral Disinfectants and Antiseptics,” Antimicrobial Agents and
Chemotherapy, Vol 39, 1999, pp. 921–923.
3
Bush, L. W., Benson, L. M., and White, J. H., “Pigskin as a Test Substrate for Evaluating Topical Antimicrobial Activity,” J. Clinical Microbiology, Vol 24, 1986, pp.
343–348.
4
McDonnel, G., Haines, K., Klein, D., Rippon, M., Walmsley, R., and Pretzer, D., “Clinical Correlation of a Skin Antisepsis Model,” J. Microbiological Methods, Vol
35, 1999, pp. 31–35.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2897 − 22
2. Referenced Documents
5
2.1 ASTM Standards:
E1054 Practices for Evaluation of Inactivators of Antimicrobial Agents
E1174 Test Method for Evaluation of the Effectiveness of Healthcare Personnel Handwash Formulations
E1874 Test Method for Recovery of Microorganisms From Skin using the Cup Scrub Technique
3. Terminology
3.1 Definitions:
3.1.1 antimicrobial ingredient, n—a substance added to a formulation specifically for the inhibition or inactivation of
microorganisms.
3.1.2 neutralization, n—the process for inactivating or quenching the activity of a microbicide, often achieved through physical
(for example, filtration or dilution) or chemical means.
3.1.3 resident microorganisms, n—microorganisms that survive and multiply on the skin, forming a stable population.
3.1.4 transient microorganisms, n—microorganisms that contaminate the skin but do not form a stable population.
3.1.
...