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Antimicrobial Testing

Antimicrobial studies are used to evaluate the efficacy of an antimicrobial product feature or agent. WuXi AppTec Laboratory Testing Division Medical Device Platform’s comprehensive efficacy testing program provides relevant data that can speed formulation selection, verify product performance, and confirm the efficacy of antimicrobial agents when combined with devices.

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Program Features

Quickly evaluate activity and potency of antimicrobial product feature or agents.
Evaluate candidate materials and dose levels to determine impact on biofilm formation.
Evaluate the antimicrobial effectiveness of product candidates in a biologic system.
We also offer antimicrobial assays used to determine or confirm the effectiveness of treatments applied to commercial textiles and other industrial products.

Antimicrobial Efficacy

WuXi Medical Device Platform offers the following In Vitro assays to quantitatively or semi-quantitatively evaluate the antimicrobial activity of medical devices and their components, or other materials treated with antimicrobial agents. Many of methods listed here may be modified to include different or additional organisms, or accommodate a range of exposure times based on product application, claims and characteristics, the activity of the medical device and its components, or other materials treated with antimicrobial agents.
Determines the effectiveness of antimicrobial (preservative) substances for the following products: injections and other parenterals including emulsions, otic products, sterile nasal products and ophthalmic products made with aqueous bases or vehicles; topically used products made with aqueous bases or vehicles, nonsterile nasal products, and emulsions, including those applied to mucous membranes; oral products other than antacids that are made with aqueous bases or vehicles; and antacids made with an aqueous base.
Evaluates the method chosen to neutralize the antimicrobial properties of any product with inhibitory or microbiocidal activity.
Specifies the testing methods to quantitatively evaluate antimicrobial activity and antimicrobial efficacy of bacteria on the surface of antimicrobial products.
Demonstrates activity/potency of antimicrobials or antibiotics, based on measuring the zone of inhibition observed for specified microorganisms.
Quantitatively evaluates the effectiveness of a sample treated with a non-leaching antimicrobial by shaking in a known concentration of microorganisms for a distinct period of time.
Quantitatively evaluates the effectiveness of an antimicrobial agent incorporated into hydrophobic polymeric material.
Duplicate samples are inoculated with the selected challenge microorganisms. Changes in that inoculum population after neutralization are evaluated at time points selected based on intended use of the material or over a longer period of time to develop a kill model for the material.
This test method evaluates the ability of the test material to provide a barrier to microbial penetration.

Infection Model

WuXi Medical Device Platform offers the following In Vivo assays to semi-quantitatively evaluate the antimicrobial activity of medical devices and their components, or other materials with antimicrobial product features or that have been treated with antimicrobial agents. Many of the standard test methods listed here may be modified to include different or additional organisms, or accommodate different or additional exposure times based on product application, claims and characteristics, the activity of the medical device and its components, antimicrobial product features or other materials treated with antimicrobial agents. Antimicrobial Efficacy (AME) – In Vivo Studies
Each antimicrobial efficacy study is custom designed, using clinically relevant bacterial strains and several implant and infection-delivery methodologies to produce a consistent and non-lethal In Vivo device infection. Analyses of infection include semi-quantitative assessment of remaining viable bacteria from device and surrounding tissue, imaging, and identification of viable bacterial strain from the resulting infection.

Biofilm Studies

This method is designed to generate a biofilm under “medium fluid shear” conditions where the shear is caused by the continuous movement of a low nutrient medium over the test sample in a continuously stirred flow reactor.
This method is designed to generate a biofilm under “low fluid shear” conditions close to the air/ liquid interface under nutritive conditions caused by the flow of low nutrient medium, by gravity, over the surface of the sample.
This method is designed to generate a biofilm under “high shear” conditions where the shear is caused by the continuous flow of a low nutrient medium over the surface of the sample where the flow of nutrients is controlled in a continuously stirred flow reactor.

Industrial Product Antimicrobial Assays

Antimicrobial assays are used to determine or confirm the effectiveness of treatments applied to commercial textiles and other industrial products. Test methods for measuring antimicrobial activity include ASTM, AATCC and other standard or modified methods. Testing includes antibacterial and antifungal activity, with both qualitative and quantitative assays available.