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BioScience Laboratories has been closely involved in the development and refinement of the methods used to evaluate healthcare personnel handwash products. Our understanding of the methods and how they must be conducted in order to accomplish the requirements of the FDA's Tentative Final Monograph (TFM), pp. 31448-31450 give our partners the advantage of unparalleled experience.
Formally, the studies involve 18 subjects per product tested, which, at a minimum, will be two- a test products and Hibiclens, a 4% CHG product required a s a reference for internal validity of studies performed for FDA approval. The general concept of the test is to determine how effectively handwash products or products designed for application without water can eliminate transient, contaminative, bacteria from the hands. For this test, the Gram-negative bacillus, Serratia marcescens, serves in the role of "transient, contaminative bacteria," and broth suspensions of it are applied to the hands of the subjects, after which they apply the test product. The qualification criteria specified by the FDA TFM for Healthcare Personnel Handwash products are 2 log10 reduction from baseline population within five minutes after the first product application, and a 3 log10 reduction from baseline population within five minutes after the tenth product application. Of note, also, is that Standard Method E1174, a similar, but not identical method for testing Healthcare Personnel Handwash products, is available from ASTM.
As with Surgical Scrub products, BSLI frequently designs relatively inexpensive, proof-of-concept studies of Healthcare Personnel Handwash products that use fewer subjects per product and relax certain other requirements mandated by the TFM Data from these studies are not intended for submission to the FDA, but to indicate whether products are worth funding for a full clinical study.
An elaboration often appended to Healthcare Personnel Handwash studies is an irritation assessment. In these studies, the skin of the hands is evaluated for dryness and erythema (redness) at the completion of the ten product applications for the antimicrobial testing.
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.
We have the knowledge base, equipment and experience to test your products for safety and efficacy to meet the global market. Serving such areas as food contact/non-food contact sanitizers and antimicrobial fabrics to name a few. We also offer a wide variety of safety testing in our in-vitro labs to…