New Antibiotic Potency Tests for Medical Devices

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STEMart, a provider of CRO services dedicated to integrated medical device and diagnostic clinical development, introduced new Antibiotic Potency Tests to assess the bioactivity or potency of various antibiotics for medical devices. The development of these new tests strictly follows the Antibiotics-Microbial Assays in USP General Chapter 81 to ensure the highest efficacy.

Microbial potency assays measure the biological activity or efficacy of antibiotics by growth repression on susceptible microorganisms at different concentrations. Meanwhile, all antibiotic products must be tested for potency before they are marketed. Both the EP and the USP require the use of microbiological assays on certain products. Compared with measuring the potency chemically, assessing antibiotic potency microbiologically can verify the ability of the antibiotic to destroy selected organisms and the concentrations at which the antibiotic can work effectively. In addition, microbiological potency testing can also measure the effectiveness of the antibiotic directly on living microorganisms.

Typically, the potency of an antibiotic product is determined by comparison with a standard or biological reference. The efficacy is expressed as the ratio of the dosage that inhibits the growth of susceptible microorganisms, relative to the standard substance dosage that reveals similar inhibition. In Pharmacopoeia, the two methods for performing microbial potency determinations are defined as the Diffusion (Cylindrical Plate) Method and the Turbidimetric Method.

The Diffusion (Cylinder-Plate) method is based on the diffusion of antibiotics in solid culture media. Metal cylinders or paper discs containing antibiotics are placed on agar medium with target microorganisms, which can be performed at multiple concentration levels to determine the minimum effective concentration. After incubation, the growth of the target organism is measured, which will be inhibited by an antibiotic.

The turbidimetric method is constructed based on the effectiveness of antibiotics in inhibiting the growth of target microorganisms. A series of known concentrations of antibiotics are added to the liquid medium containing the target microorganism. Subsequently, the mixture was incubated and the turbidity of the mixed solution was measured by spectrophotometric method. The turbidity of the solution positively correlates with microbial growth and, therefore, it is a measure of the effectiveness of the antibiotic.

STEMart now offers Antibiotic Potency Test to assess the bioactivity or potency of various antibiotics for medical devices. STEMart’s scientific and reliable testing with strict control can provide customers with full confidence in all testing results.

If you have additional questions about Antibiotic Potency Tests for medical devices or if you would like to know more about STEMart’s medical device development service, please visit our website.

About STEMart

STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer in order to enhance access to better health worldwide.

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STEMart is an industry-leading eCommerce platform, with an expanded global footprint, we now have a broad portfolio of more than 10,000 products. In the fields of science, technology, and engineering,... Read more