Microbiology Testing

A sterility test detects microbial contamination. A satisfactory result indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test.

An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.

This test is designed to increase the likelihood of detecting fungal microorganisms in sterile products.

This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.

An antimicrobial effectiveness test demonstrates the effectiveness of antimicrobial preservatives in preventing microbial proliferation in injections, topicals, oral products, single dose vials, and antacids packaged in multiple-dose containers.

These tests quantitate the total population of aerobic bacteria, yeast, and molds in raw materials, in-process samples, and finished products.

These tests verify the absence of objectionable microorganisms in drug products and raw materials.