Methods | Biofilm



Biofilm

Biofilm Testing Capabilities:

BioScience Laboratories, Inc. (BSLI) offers newly expanded services to provide substantiation for anti-biofilm claims and anti-biofilm testing. Each study design can be customized to evaluate a variety of antimicrobial product types, including liquid disinfectants, surface coatings, antimicrobial surface technologies, wound dressings, wound irrigation solutions, catheters, or other devices. BSLI uses current ASTM Methods for evaluating anti-biofilm products, where each method can be modified to support testing for sponsors seeking specific indications/claims for their anti-biofilm technologies.

EPA Regulatory Requirements:

The US EPA has recently provided a Draft Guidance in 2016 for sponsors pursuing assessment of efficacy of antimicrobial products intended to control biofilms on hard, non-porous surfaces, requiring a minimum 6 log reduction in viable bacteria.

BSLI performs testing using the new proposed methods, which are US EPA Standard Operating Procedures based on ASTM E2562-12 and ASTM E2871-13. According to the Draft Guidance, the Agency will evaluate claims against additional bacteria or modified methods to support claims for a product on a case-by-case basis.

FDA Regulatory Requirements:

There is no FDA recognized assay to evaluate appropriate amount of biofilm or what constitutes a clinically meaningful reduction in biofilm. Nevertheless, BSLI has experience in navigating this regulatory environment and seeks to provide data for clients pursuing anti-biofilm indications or claims such as:

  • “controlling biofilm” or “minimize microbial colonization”
  • “prevent biofilm formation”
  • “biofilm removal”
  • “reduction of biofilm” or “kills biofilm”
  • “inhibit bacterial colonization”
  • “affects the growth of biofilm formation”

These FDA-proposed indications/claims have not all been approved for current technologies and the FDA strongly advocates performance testing protocols for studies used to support indications for devices with added antimicrobial agents be submitted via the presubmission process to receive preliminary feedback.

BSLI is available to help develop and execute testing for medical devices, wound dressings, and other FDA regulated products for pioneer companies that want to lead the industry in the regulatory arena for anti-biofilm products.

ASTM E2562-12

CDC Biofilm Reactor Protocol

BioScience Labs provides services for evaluation of product efficacy in the prevention and/or removal of biofilms using in-vitro techniques.  This method is representative of environments where the resulting biofilm exists under…

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ASTM E2871-13

Single Tube Method

BioScience Labs provides services for evaluation of product efficacy in the prevention and/or removal of biofilms using in-vitro techniques. This method is typically used in conjunction with biofilm grown in the CDC Biofilm…

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ASTM E2799-12

MBEC Reactor Protocol

BioScience Labs provides services for evaluation of product efficacy in the prevention and/or removal of biofilms using in-vitro techniques.  This method serves as a high throughput screening (HTS) assay to evaluate biofilm grown…

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ASTM E2647-08

Drip Flow Reactor Protocol

BioScience Labs provides services for evaluation of product efficacy in the prevention and/or removal of biofilms using in-vitro techniques. This method represents a low fluid shear environment with an air-liquid interface, resulting…

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Colony Biofilm Method

Biofilms in a Zero-Shear Environment

BioScience Labs provides services for evaluation of product efficacy in the prevention and/or removal of biofilms using in-vitro techniques.  This methodology evaluates colony biofilms grown in a zero-shear environment and…

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Biofilm Tissue Irritation

Biofilm Testing in Conjunction with Tissue Models

BioScience Labs provides services for evaluation of product efficacy in the prevention and/or removal of biofilms using in-vitro techniques. Our technicians have experience in the evaluation of irritation or potential…

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