ASTM WK36911

    New Guide for Measuring the Inactivation of Persistent Activity of a Topical Antimicrobial Products Using Ex Vivo Porcine Skin

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    Developed by Subcommittee: E35.15 | Committee E35 | Contact Staff Manager



    WK36911

    1. Scope

    1.1 This guide is designed to demonstrate the compatibility of topical antimicrobial products and the ability to maintain persistent activity exhibited by products used in health care setting. This method uses pigskin as surrogate model. 1.2 Knowledge of microbiological techniques is required for these procedures. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This guide can be used to evaluate topical antimicrobial handwash or handrub formulations. 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.

    The guide may be used to demonstrate the compatibility of hand hygiene topical antimicrobial products using pigskin as surrogate for human skin and cup scrub sampling technique. The reference formulation should contain ingredients known to have residual activity, while the test formulations may or may not contain antimicrobial agent. The guide would permit testing of pathogens that otherwise would most be used on human subjects while permitting testing of conditions that cannot be simulated in a testtube. This guide is conducted on pigskin substrates that have been shaved to remove the hair and sterilized using gamma radiation before the initiation of the test. Persistent activity is achieved by multiple applications of reference formulation to establish chemical deposition/reservoir. Activity of a test material is measured by comparing the number of test microorganisms recovered from artificially contaminated pigskins after use of a reference formulation known to have persistent activity due to chemical reservoir to the number of test microorganisms recovered from contaminated pigskins exposed to the reference formulation followed by exposure to a test formulation that may or may not contain an active ingredient. The investigator should also be aware that there may be health risks associated with the use of this organism and appropriate precautions should be undertaken.


    Keywords

    antibacterial wash; pigskin; inactivation; persistent activity; chemical deposition

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:
    03-19-2012

    Technical Contact:
    Peter Karanja

    Item:
    006

    Ballot:
    E35.15 (12-03)

    Status:
    Negative Votes Need Resolution