Pace Analytical Life Sciences (PLS) operates a 40,000 square foot state of the art contract analytical laboratory that provides antimicrobial effectiveness testing for the pharmaceutical, biopharmaceutical and medical device industries. This test is also known as AET testing or preservative effectiveness testing.
This testing follows USP <51> at Pace Analytical Life Sciences. Many different types of products have the potential to support microbial growth. Contamination to the product can be introduced during the manufacturing process or more often during the products’ cycle of use with the patient. While some products may have intrinsic properties that will inhibit microbial growth it is more common for preservatives to be added by formulators to prevent any occurrence. Antimicrobial effectiveness testing is a valuable test for evaluating the effectiveness of the antimicrobial agents that are substances toxic to potential contaminating organisms. This test is a challenge test, or more specifically a preservative challenge test, that determines the preservative effectiveness of the sample product. During the test the sample product is challenged by at least five representative organisms at relatively high concentrations to accurately simulate contamination of the product. Additional organisms can be used to challenge the antimicrobial effectiveness of the formulation. The test takes place over a 28 day period during which samples are analyzed periodically to determine the antimicrobial effectiveness of the preservatives. Working with our clients we can provide direction in the choice of agents used as well as in the amounts needed to provide the product with antimicrobial effectiveness for its life cycle. Our lab is experienced with a wide range of product types for this testing including parenterals, orals and topicals.
Pace Analytical Life Sciences brings years of experience performing all types of analytical testing on many drug substances, drug products and medical devices. We bring the highest level of quality and attention to detail to our clients to assure that their antimicrobial effectiveness testing will be successfully executed.
We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.
Contact us to discuss your testing needs. 651-738-2728 Email Us