ASTM E2897-12

Standard Guide for Evaluation of the Effectiveness of Hand Hygiene Topical Antimicrobial Products using <i>ex vivo</i> 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 14-Nov-2012
• 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)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E2897 − 12
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 2. Referenced Documents
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1.1 This guide is designed to demonstrate the effectiveness 2.1 ASTM Standards:
ofhandhygienetopicalantimicrobialproductsusingpigskinas E1054Test Methods for Evaluation of Inactivators of Anti-
a surrogate model. microbial Agents
E1174Test Method for Evaluation of the Effectiveness of
1.2 Knowledge of microbiological techniques is required
Health Care Personnel Handwash Formulations
for these procedures.
E1874Test Method for Recovery of Microorganisms From
1.3 This standard guide can be used to evaluate topical
Skin using the Cup Scrub Technique
antimicrobial handwash or handrub formulations.
3. Terminology
1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3.1 Definitions:
standard.
3.1.1 antimicrobial ingredient, n—a substance added to a
1.5 This standard does not purport to address all of the formulation specifically for the inhibition or inactivation of
microorganisms.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3.1.2 neutralization, n—the process for inactivating or
priate safety and health practices and determine the applica-
quenchingtheactivityofamicrobicide,oftenachievedthrough
bility of regulatory limitations prior to use.
physical(forexample,filtrationordilution)orchemicalmeans.
3.1.3 resident microorganisms, n—microorganismsthatsur-
vive and multiply on the skin, forming a stable population.
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This guide is under the jurisdiction of ASTM Committee E35 on Pesticides,
3.1.4 transient microorganisms, n—microorganisms that
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents. contaminate the skin but do not form a stable population.
Current edition approved Nov. 15, 2012. Published November 2012. DOI:
3.1.5 test organism, n—an applied inoculum of an organism
10.1520/E2897-12.
2
that has characteristics which allow it to be readily identified.
Woolwine, J. D., and Gerberding, J. L., “Effect ofTesting Method onApparent
Activities of Antiviral Disinfectants and Antiseptics,” Antimicrobial Agents and
The test organism is used to simulate a transient topical
Chemotherapy, Vol 39, 1999, pp. 921–923.
3
Bush, L. W., Benson, L. M., and White, J. H., “Pigskin as a Test Substrate for
EvaluatingTopicalAntimicrobialActivity,” J. Clinical Microbiology,Vol 24, 1986,
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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
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E2897 − 12
microbial contaminant. It may also be referred to as a marker 6.9 Spectrophotometer—An instrument that can measure
organism, bacterial simulant, or bacterial contaminant. optical density at a wavelength of 620 nm.
3.1.6 test substance, n—a leave-on or wash-off product or
7. Reagents and Materials
formulation which incorporates antimicrobial ingredient(s).
7.1 Sterile Bacteriological Pipettes—10-mLcap
...