The development and existence of bioburden in pharmaceutical water systems is often misunderstood. Microorganisms are always present and have a keen ability to adapt to their environment. This is especially true in a Water-for-Injection (WFI) system, where microbial attachment and biofilm growth will occur regardless of flow rate, material of construction, turbulent flow and low nutrient conditions. While industry makes every effort to control and eliminate bioburden, traditional sanitization methods are not one-hundred-percent effective at accomplishing this objective. Additionally, because of the limitations and time to result delay of conventional plate counting, we may be at a disadvantage for assessing bioburden, causing us to use water at risk. This poster explores real-life examples of biofilm in pharmaceutical water systems, risk mitigation strategies, and how real-time microbial detection could be used as a tool for improved risk management and process control.
Tracy Radcliffe (Thu,) studied this question.