New York, USA – July 27, 2022 – STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced multiple methods for Antimicrobial Preservative Effectiveness Testing following the USP General Chapter 51 on Antimicrobial Effectiveness Testing, as well as European Pharmacopoeia and other international standards. STEMart will provide clients with reliable and repeatable testing results to determine whether the products are free of microbial contaminants through the Antimicrobial Preservative Effectiveness test.
An antimicrobial or preservative is a chemical substance that kills microorganisms or inhibits the growth of microorganisms and is often added to non-sterile products to prevent microbiological contamination. Antimicrobial Preservative Effectiveness (APE) Testing, also known as Antimicrobial Effectiveness Testing (AET) or Preservative Efficacy Testing (PET), is a microbial challenge methodology used to evaluate the suitability of selected preservatives for product formulations. This test measures the effectiveness of antimicrobial preservatives in inhibiting the growth of microorganisms during the manufacturing process or throughout the product life cycle.
STEMart now offers multiple methods for Antimicrobial Preservative Effectiveness Testing to provide customers with reliable and repeatable testing results to determine whether new products are of qualified effectiveness. Meanwhile, customers can also submit data that is required by the appropriate regulatory agency.
This new test follows the USP General Chapter 51 on Antimicrobial Effectiveness Testing, as well as European Pharmacopoeia and other international standards. Both guidelines provide advice for conducting validation of the Recovery Method to determine the ability of routine testing procedures to identify challenging microorganisms in the presence of a product. If the product possesses antimicrobial properties, the medium used in the process has the potential to promote microbial growth.
In order to evaluate the antimicrobial effectiveness of a product, the product is inoculated with a prescribed quantity of specified microorganisms. The five most commonly used microorganisms for APE are Candida Albicans, Staphylococcus Aureus, Escherichia Coli, Pseudomonas aeruginosa, and Aspergillus brasiliensis. The effectiveness of the preservative is evaluated by comparing the initial level of microorganisms with the test material at various time intervals over a period of 28 days at a specified temperature, and the reduction of microorganisms is calculated logarithmically.
Antimicrobial effectiveness must be illustrated on all injections packaged in multiple-dose containers, multiple-dose topical and oral forms, and other dosage forms that contain antimicrobial preservatives. Hence, this test should be performed on all aqueous-based products including ophthalmic, otic, nasal, oral, irrigation, and dialysis fluids.
If you have additional questions about Antimicrobial Preservative Effectiveness Testing for medical devices or would like to know more about STEMart’s medical device development service, please visit https://www.ste-mart.com.
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.