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.

• Method Suitability and Its Importance to the Test Method
• Sterility Test Failure: Possible Causes and Investigation
• Basics of Sterility Testing

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

• The Importance of Endotoxin Testing
• Endotoxin Essentials

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.

• Prevent Future Sterility Failures by Identifying Contaminating Microorganisms
• How Does Microbial ID Benefit Your Pharmacy?

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.

• The Essentials of USP <51>

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.

Microbial cleaning studies are essential to validating a facility’s cleaning SOP.  Pharmacies must demonstrate that cleaning agents, combined with instructions and procedures for their use, remove microbial contamination from surface areas where sterile drug products are compounded.

• Microbial Disinfectant Cleaning Challenge Studies