Sample Required - Please refer to USP <71> for correct batch size, or call us and ask for guidance
Turn Around - Results available 14 days after the start of the test, with a preliminary result at 7 days
SterilityUSP <797> <71>
Purpose - To validate that the method used during sterility testing will recover microbial contamination if present in routine samples.
Sample Required - 3x the required batch size* listed in USP
Turn Around - Results available in 5 days from the start of the test.
(Start could be delayed to be batched with other samples)
*Please refer to USP <71> for correct batch size, or call us and ask for guidance
Sterility Method Suitability/ValidationUSP <71>
Purpose - The Bacterial Endotoxins Test is a test to detect or quantify endotoxins from Gram-negative bacteria using amoebocyte lysate from the horseshoe crab per USP <85>.
Sample Required - Minimum 2ML in separate container
Turn Around - Results available in one week (or with Sterility Report)
EndotoxinUSP <797> <85>
Purpose - Check specifically for presence of fungal contamination. This test provides a more favorable media for molds and yeast.
Sample Required - No additional sample necessary if testing Sterility
Turn Around - 14 days (or with Sterility Report)
Purpose - This test assesses the effectiveness of the antimicrobial agents in a sample when challenged by specific microorganisms dictated per USP <51>. We request advanced notice of this test type to ensure no delays in the start of the test.
Sample Required - Minimum 55ML*
Turn Around - Results available within ~30 days from the start of the test
*For multi-test study, ≥50ML for each subsequent test