The Contamination Triangle: A New Model for Assessing the Risk of Biological Process Contamination and Performing Investigations

by Bill Ogden
Volume 15, Issue 1 (Spring 2016)

Microbial contamination is of great concern in pharmaceutical and biotech manufacturing. Many organizations struggle with determining the root cause of contamination when it occurs, and identifying effective safeguards to prevent future contaminations. This article will introduce a new model for understanding microbial contamination in biopharmaceutical and sterile products and processes. The “Contamination Triangle” identifies the three factors necessary for microbial ingress into a sterile (or pure) system. The use of this model will provide guidance for contamination investigations, clarify the explanation of the contributing root causes in Non-Conformances, and assist in identifying risks and risk mitigation measures as part of a Failure Modes and Effects Analysis (FMEA) or other risk assessment method...

Ogden B. The contamination triangle: a new model for assessing the risk of biological process contamination and performing investigations. BioProcess J, 2016; 15(1): 49–53.

Posted online April 7, 2016.