Sterility

Sterility

Purpose - Check for microbial contamination. Complies with USP <797> and <71> if required number of vials are provided based upon batch size, and if Sterility Method Suitability has been completed.

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

Sterility

USP <797> <71>
$ 100

Sterility Method Suitability/Validation

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/Validation

USP <71>
$ 400

Endotoxin

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)

Endotoxin

USP <797> <85>
$ 110

Fungi

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)


Antimicrobial Effectiveness

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

Antimicrobial Effectiveness

USP <51>
$ 950