Microbiology

Sterility

Purpose - Check for microbial contamination. Complies with USP <797> and <71> if the required number of vials are provided based upon the 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 are available within 14 days, with preliminary result at 7 days.

Sterility Method Suitability

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 within 14 days.

_{*Please refer to USP <71> for correct batch size, or call us and ask for guidance.}

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 - 1 container (2 mL minimum)

Turn Around - Results available within 3 business days (or with Sterility Report)

Fungi

Purpose - Check specifically for presence of fungal contamination. This test provides a more favorable media for molds and yeast.

Sample Required - 1 container

Turn Around - Results available within 14 days (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 55 mL. 

Turn Around - Results available within 45 days (requires 35 day incubation).

Water Activity

Purpose - Test for the presence of water vapor which can support microbial growth and contribute to the hydrolytic breakdown of active ingredients. USP <1112>. 

Sample Required - Minimum 5 mL or 5 g.

Turn Around - Results available within 7 business days.

Visible Particulates

Purpose - Checks for the presence of visible particulates in sterile parenteral solutions by visualizing against a black and white background. This is particularly useful during stability studies of sterile products. USP <790>

Sample Required - Minimum of 10 containers.

Turn Around - Results available within 5 business days.

Microbial Enumeration of Nonsterile Products Method Validation

Purpose - Determines the total viable aerobic microbial count present per mL or per g of product. USP <61>

Sample Required - A minimum of 10 mL or 10 g.

Turn Around - Results available within 7 business days.

Test for Specified Microorganisms in Nonsterile Products Method Validation

Purpose - Checks for the presence of E. coli, Salmonella, Staphylcoccus, or Pseudomonas in a product. USP <62>

Sample Required - 10 mL of 10 g  (2x for validation)

Turn Around - Results available within 7 business days.

Microscopic Examination of Unknown Substance

Purpose - Under high magnification of up to 12,500x this service can be ordered to investigate unknown substances, such as microscopic particles to determine their identity and possible source.

Sample Required - Minimum 1 container.

Turn Around - Results available within 3 business days.