Standard Practice for Determining the Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

Importancia y uso:

5.1 This in vivo procedure is designed to test the ability of hygienic handwash or handrub agents to eliminate fungal contamination from experimentally-contaminated hands. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of an input control (two), control for culturable cells of the test fungus remaining after the inoculum has dried (two), fungal cells eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the fungus-eliminating efficiency of the formulation under test. No more than 100 µL of the test fungal suspension is required to complete one test.

5.2 Whereas this practice is designed to work with fungi, similar ASTM standards exist for testing against viruses (Test Method E1838) and vegetative bacteria (Test Method E2276).

5.3 The levels of culturable microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (5). A step for the drying of fingerpads after exposure to the control or test solution, therefore, has not been included to avoid fungal removal by the drying process itself.

5.4 This practice is not designed to test surgical hand scrubs or preoperative skin preps.

5.5 The level of contamination with culturable fungi on each fingerpad after the drying of the inoculum should be at least 10⁴ CFU so that it would permit the detection of up to a 4-log₁₀ reduction in the viability titer of the test organism by a test formulation under the conditions of this test. This in itself does not represent the product performance criterion, which may vary depending on the jurisdiction and the nature of the formulation being evaluated.

Subcomité:

E35.15

Referida por:

E2276-10R19, E1838-17

Volúmen:

11.08

Número ICS:

71.100.70 (Cosmetics. Toiletries)

Palabras clave:

antisepsis; Aspergillus brasiliensis; Candida albicans; conidia; eluent; fingerpads; fungus-eliminating activity; hygienic handrubs; hygienic handwashing; infection control; in vivo testing; soil load; standard hard water; subjects;