Healthcare Personnel Handwash

Healthcare Personnel Handwash

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. 

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Clinical Laboratory

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.  

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ASTM - E2784

Standard Test Method for Evaluation of the Effectiveness of Handwash Formulations Using the Paper Towel (Palmar) Method of Hand Contamination

This procedure has been designed to evaluate handwash products using a palmar surface only contamination method. This method is an alternative contamination procedure to that listed in Test Method…

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ASTM - E1327

Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions

The procedure should be used to test the degerming effectiveness of antimicrobial hand washing products used by health care personnel that are intended for frequent use, and that are intended to reduce the level of contamination…

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ASTM - E2276

Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the FIngerpads of Adults

This test method is designed to determine the activity of hygienic handwash and handrub agents against transient bacterial flora on hands and is not meant for use with surgical hand scrubs…

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ASTM - E2755

Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults

This test method is designed to determine the activity of leave-on hand sanitizers (also known as hand rubs, hygienic hand rubs, or hand antiseptics) against transient bacterial flora on the hands.

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ASTM - E1115

Standard Test Method for Evaluation of Surgical Hand Scrub Formulations

The procedure in this test method should be used to evaluate the activity of the test formulation in reducing the bacterial population of the hands immediately after a single use and to determine persistent activity (inhibition of growth) after…

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ASTM - E2613

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

This test method is designed to assess the ability of hygienic handwash and handrub agents to reduce levels of fungal contamination on hands. This test method is not meant for use with…

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ASTM - E2280

Standard Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) in Polymeric or Hydrophobic Materials

This test method is designed to evaluate (quantitatively) the antimicrobial effectiveness of agents incorporated or bound into or onto mainly flat (two dimensional) hydrophobic or polymeric surfaces.The method focuses primarily on assessing antibacterial…

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ASTM - E1174

Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations

The procedure may be used to test the effectiveness of antimicrobial handwashing agents. The test formulations may be designed for frequent use to reduce the transient bacterial flora on hands in water aided handwashing procedures.…

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Health Care Antiseptic

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.

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Commercial/Professional Products

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…

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