Virucidal Efficacy on Surrogate Skin Surfaces (Ex-Vivo)

Test Purpose
The purpose of this test is to evaluate the effectiveness of topical skin products against a specific virus using an ex-vivo skin model. This virucidal test method is designed to be used as one stage in determining virucidal potential of liquid hand soaps, OTC topical or other skin products. This method utilizes a testing substrate that mimics the surface properties of human skin. The use of this skin model allows one to collect virucidal data following exposure of the product to virus contaminated skin tissue.

Test Summary
This test method is to be used to evaluate the effectiveness of topical skin products against designated viruses following a modification of test method ASTM E 1838 utilizing an ex-vivo skin model in lieu of human subjects. An aliquot of virus is inoculated onto the skin and allowed to dry. An aliquot of test substance is then inoculated onto the dried virus. Following exposure, the virus-test substance mixture is neutralized, serial dilutions are performed and each dilution is assayed for viral infectivity by an accepted assay method. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently.

Topical Antimicrobial tests include:

l  Microbial Time-Kill Tests

l  Minimum Inhibitory Concentration (MIC) Tests and

l  Minimum Bactericidal Concentration (MBC) Tests

l  AOAC Available Chlorine Equivalency Tests

l  Virucidal Suspension Tests

l  Virucidal Efficacy on Surrogate Skin Surfaces (Ex-Vivo)

l  Zone of Inhibition Tests