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BioScience Labs (BSLI) offers services to companies that want to substantiate anti-biofilm claims for their products. BSLI is at the anti-biofilm fore-front of the regulatory process and we can assist you in test design and execution. We are able to support anti-biofilm efficacy claims, such as biofilm: kill, removal, prevention and barrier.
The EPA is the furthest along concerning regulatory guidance. The EPA provided 5 ASTM approved methods for growth and sampling of biofilms. There is currently a SOP/preliminary guidance for evaluation of liquid disinfectants.
The US FDA does not have specific guidance for companies to make anti-biofilm claims. BioScience Labs is available to help develop and execute testing for medical devices and other FDA regulated products for companies that want lead the industry into the regulatory arena for anti-biofilm products. The current FDA guidance advocates for pre-submission of protocols.
Using ASTM Methods, customized experiments, and regulatory insight, Bioscience Laboratories, Inc. can help you develop the data you need to get ahead of your competition and support your anti-biofilm product claims.