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For general-use handwash studies, BioScience Laboratories follows the ASTM Standard, E1174, which includes a method for testing of general-use handwash products. This corresponds well to the method proposed by the Soap and Detergent Association (SDA) and Personal Care Products Council (PCPC).
CTFA/SDA has proposed a similar method for developing data to support label claims for general-use products, and BSLI does design studies based on this method, which, in turn, is patterned on the HCPHW method described in Section 2 and on ASTM Standard Method E 1174. Differences from the HCPHW method may include reduced period of product restriction; only five contamination/product application cycles, with samples after the first and fifth cycles; use of Escherichia coli as the contaminative species, rather than the more generally resistant Serratia marcescens; and suggested efficacy criteria of 1 Log10 after the first application and 1.5 Log10after the fifth application. Although many brands of antimicrobial general-use handwash products, often based on triclosan, triclocarban, or a quaternary ammoniated compound such as benzethonium chloride, are on the market, many in the FDA question whether products intended for general consumer use should contain antimicrobial agents at all, contending that soap, alone, is adequate.
Our start-to-finish solution for clinical trials begins with understanding our client’s end goals for the study and aiding them in the study design. Throughout the project we remain in on-going contact with our sponsors to ensure that the project is managed with the best interest of the client in mind.…
For over 25 years BioScience Laboratories has led the industry in Healthcare antimicrobial product testing. BSLI is a GLP, FDA and EPA audited and Contract Research Organization providing Phase I through IV clinical trials, as well as, in-vitro testing services. Put our extensive experience to work, we are eager to help.