United States Pharmacopeia (USP) sterility testing for sterile dosage forms. Results in a Pass/Fail result, unlike USP for nonsterile dosage forms (tablets/liquids) with a TAMC/TYMC result. TrustPointe sterility testing is done using closed-system transfer in an ISO Class 5 Laminar Flow Hood to eliminate laboratory contamination of sterile samples during testing. The vials are never opened, and all of the sampling work is done in a hood designed to prevent microbial contamination. Lead time is 14 - 21 days for incubation and analysis. If the test fails, organism identification is available for an additional charge. USP recommends a number of vials to test based on batch size. All vials sent are composited and tested as one sample, so there is no additional charge for up to 20 vials: Less 100 vials: 10% or four vials, whichever is greater Between 100 and 500 vials: 10 vials Greater than 500 vials: 20 vials
