USP <51> Antimicrobial Effectiveness Testing

Preservative effectiveness in pharmaceutical manufacturing is one of the most important factors to test and monitor to help ensure product safety and efficacy. By testing products that use antimicrobial preservatives, facilities can provide an additional assurance that the preservatives are working as intended, preventing the growth of bacteria or fungi within products during manufacturing, storage, and transportation.

BA Sciences offers USP <51> antimicrobial effectiveness testing services. We have extensive experience in stringent testing standards, to provide the confidence and peace of mind that pharmaceutical, personal care, medical, and other product manufacturers need to maintain safe and efficient operations. We feature a full complement of testing equipment and facilities, providing the guidance and rigid adherence to USP <51> testing standards that set us apart as the standard of quality and service in the industry.

What Does USP <51> Testing Entail?

USP Chapter <51> testing standards apply to antimicrobial preservatives, most frequently found in pharmaceuticals, personal care products, and medical products, to name a few. These preservatives are designed to inhibit the survival and growth of potential product contaminants, which can threaten the safety of end users as well as product handlers. Even if product contaminants do not pose safety risks, they may reduce the effectiveness of products.

USP Chapter <51> microbial effectiveness testing is a key step in the manufacturing and fulfillment process. Product safety and quality are of paramount concern in the pharmaceutical field, and testing can help detect potential risks in products before they reach end users.

USP <51> testing — also called preservative effectiveness or preservative challenge testing — covers 5 different types of potential contaminants, 2 fungal and 3 bacterial. These microbes are:

  • Candida albicans (fungus/yeast)
  • Aspergillus brasiliensis (filamentous mold)
  • Escherichia coli (the bacteria commonly called E. coli)
  • Pseudomonas aeruginosa (a common bacteria that threatens these types of products)
  • Staphylococcus aureus (Staph bacteria)

In this type of testing, each contaminant is grown, harvested, and introduced into the testing samples in predetermined amounts and concentrations, following standardized testing methods. In general, 100-150 grams or ml of sample is required, which is then incubated at 22.5 degrees Celsius (+/- 2.5 degrees) for at least 28 days. Compendial articles are divided into four categories. The product category dictates both the time points the microbial population is assessed as well as the population reduction requirements at each respective time point.

The category type can be provided by the client, but BA Sciences can also help determine the product category in order to ensure testing is performed as appropriate. Samples are typically inspected at regular intervals depending on the category of the product, but 28 days is the required to make a reliable effectiveness determination for a given sample.

Following the inoculation period, samples and concentration levels are compared with testing standards, and a determination of product acceptability is delivered. This type of testing is a critical part of preventing the spread of some of the most common and dangerous microbes found in pharmaceutical products.

Working With BA Sciences

BA Sciences has been providing life science companies with reliable, high-quality analytical testing services for over 30 years. Each of our clients gets the benefit of a dedicated project manager who works with you to determine goals and requirements and the strategies and methods necessary to achieve them. We feature advanced technology, results-driven processes, the latest equipment, and a wide range of specialty services. As part of our core services, we strive to remain up to date with the most advanced and innovative methods to help our clients achieve greater outcomes. Our cGMP-compliant, FDA/DEA-registered, and ISO/IEC-17025:2005-certified laboratory is located just outside of Boston in Salem, N.H.

To learn more about everything we can do for your operations, contact one of our representatives today.

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