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Why Your Products Need APE Testing?
An antimicrobial or preservative is defined as a chemical substance that will kill microorganisms or inhibit the growth of microorganisms, usually added to nonsterile products to protect them from microbiological contamination. If your product will be on the market, it is advised that it has been validated to be free from microbiological contaminants through Antimicrobial Preservative Effectiveness (APE) Testing.
Antimicrobial Preservative Effectiveness (APE) Testing , also know as Antimicrobial Effectiveness Testing (AET) or Preservative Efficacy Testing (PET) is a microbial challenge methodology performed to evaluate if the chosen preservative is appropriate for a product formulation. This test measures the effectiveness of antimicrobial preservatives to inhibit the growth of microorganisms during the manufacturing process or product use.
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. This test should be performed on all aqueous-based products including ophthalmic, otic, nasal, oral, irrigation, and dialysis fluids.
How To Perform APE Testing?
Both the EP 5.1.3 and the USP <51> give out guidance for conducting validation of the Recovery Method to determine the ability of the routine testing procedure to identify challenge microorganisms in the presence of a product. The potential of the media used in this process is accepted to promote microbial growth if the product appears antimicrobial properties.
To evaluate the antimicrobial effectiveness of a product, the product is inoculated with a prescribed quantity of specified microorganisms. The common five Antimicrobial Preservative Efficacy test organisms 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 to the test material at various time intervals over a period of 28 days at a specified temperature. The reduction of microorganisms is calculated logarithmically.
STEMart offers 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. Our scientific testing will provide you with reliable and replicate testing results to help you determine whether or not your product is effective in this area, and you can submit data that is required by the appropriate regulatory agency.
If you have any questions about Antimicrobial Preservative Effectiveness Tests or would like to find out more about our services, please feel free to contact us.