AET evaluates a product’s ability to reduce microbial populations over time when challenged with specific organisms. Testing can be performed on a range of products, including injections, parenterals, topicals, orals, antacids, and transdermals, and may include facility resident organisms. A neutralization study confirms that the selected diluent effectively neutralizes antimicrobial components. Formats include: - AET Individual Organism – USP <51>, CTFA M3/M4, EUPh 2.1.1, - ISO 11930:2012 - AET Mixed Organisms – CTFA M3/M4 - AET Product Neutralization – CTFA/USP Testing applies to product samples, water samples, and recovery tests when method manipulation is required. Method validation requires three product lots. Special considerations apply to samples that are opaque, highly colored, outside pH 6–8, contain polypropylene or cells, or are packaged in polypropylene. Low endotoxin vials are available for purchase for sample submission.
