Antimicrobial/Preservative Effectiveness Testing Services

What is an antimicrobial or preservative effectiveness test?

Non-sterile products that contain multiple dosages, such as hand sanitizers, lotions, and cosmetics, may require antimicrobial effectiveness testing. The testing demonstrates the effectiveness of the preservative system in the product.

How is antimicrobial effectiveness testing performed?

Antimicrobial effectiveness testing is performed by inoculating the product with a known quantity of specified microorganisms, such as bacteria, yeasts, and molds.  The quantity of microorganisms found in the control sample is then compared to the sample over specified intervals over a 28-day period. The number of microorganisms that grow in a sample are counted and compared to establish limits to determine if the product meets the USP <51> standard for microbial contamination.

What is USP <51> testing standard?

USP <51> testing is a pharmacopoeia standard widely used in the industry to demonstrate the antimicrobial effectiveness of a product and determine the total number of viable microorganisms in non-sterile products, establishing limits for microbial contamination.

Why is antimicrobial effectiveness testing performed?

Antimicrobial effectiveness testing ensures non-sterile products are safe for use and consumption.

At STERIS, our testing is performed according to USP <51>

 

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