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Microbiology, Pharmaceuticals

Do You Need Preservative Efficacy Data?

If you have a product that will be on the market, it is advised that you have proof that it is free from microbiological contaminants.  Antimicrobial preservatives are substances added to nonsterile dosage forms of drugs or products to protect them from microbiological contamination.  Microbes can be introduced inadvertently during manufacturing, or during the continual use of a product.  We can help you determine whether or not your product is effective in this area so that you can submit data that is required by the appropriate regulatory agency.

The antimicrobial effectiveness test (AET), also known as the preservative efficacy test, is performed to determine if the chosen preservative is appropriate for a product formulation.  It is also carried out as part of a stability study, to ascertain whether a preservative system is still effective up to the expiration date or a product. Testing is performed according to compendial requirements in USP <51> and EP 5.1.3.

Time Kill Analysis measures the change in a population of microorganisms within a specified sampling time when after exposure to antimicrobial test materials in vitro.  The test is carried out to evaluate an antimicrobial test material or disinfectant and assesses the in vitro reduction of a microbial population of test organisms after exposure to a test material.

Pacific BioLabs provides many types of microbiology testing services, including antimicrobial effectiveness testing and time kills tests.

Pacific BioLabs