In Vitro Testing Strategies for Microbial Barrier Effectiveness

Published:

August 1, 2022

Category:

White Paper

MedTech Sponsors that intend to manufacture solid wound dressing products labeled to have barrier properties must conduct performance testing. While no standard currently exists for this type of testing, the U.S. Food and Drug Administration (FDA) does require the following In Vitro tests to be performed for wound dressing products: 1) loss of barrier function (microbial barrier effectiveness testing); and 2) microbial growth within the product (antimicrobial effectiveness testing).

In this White Paper, “In Vitro Testing Strategies for Microbial Barrier Effectiveness,” we provide recommended strategies and best practices regarding how to perform the aforementioned tests, including information on:

History of Wound Dressings
Characteristics of an Ideal Wound Dressing
Regulations, Significance and Procedure
Challenge Organism Preparation
Selection of Test Media
Test Article Preparation
Challenge Procedure
Interpretation of Results

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