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
USP <71> <797>$160 for 2-5 containers
$175 for 6-10 containers
$205 for 11+ containers
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.
Sterility Method Suitability
USP <71>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)
Endotoxin
USP <85> <797>$480 Validation (ENDV)
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)
Fungi
Mold / Yeast
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).
Antimicrobial Effectiveness
USP <51>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.
Water Activity
USP <795> <922>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.
VISIBLE PARTICULATES
USP <790>per 10 containers
Additional +$10 per container
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.
MICROBIAL ENUMERATION OF NONSTERILE PRODUCTS METHOD VALIDATION
USP <61>$500 Validation (MEV)
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.
TEST FOR SPECIFIED MICROORGANISMS IN NONSTERILE PRODUCTS METHOD VALIDATION
USP <62>$230 Validation (SMV), per microbe
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.