Addressing Biofilm and Other Non-Routine Microbial Events

Regulatory agencies and senior management are placing more emphasis on how individuals and organizations respond to non-routine microbial events including single and multi-species biofilm contamination. The preference is to apply a scientific, risk-based approach to address non-routine microbial events.

This training course will provide an overview of contamination control best practices. It will demonstrate the setup and operation of the ASTM and EPA approved high shear CDC biofilm reactor and single tube test methods. The case studies on addressing non-routine microbial events are derived from visiting hundreds of sites around the world to investigate non-routine events. The review of the case studies will provide confidence in asking the right questions, assessing severity, understanding the critical parameters and quality attributes, investigating different options, and ultimately applying a corrective action or preventive maintenance approach to address the root cause. Understanding the root cause through constructive brainstorming and investigation will reduce unscheduled corrective action activities and reduced manufacturing delays and impact to product.

1. Evaluate contamination control best practices
2. Compare and contrast the different risk-based tools
3. Apply various risk-based approaches to real-world case studies to address non-routine events
4. Evaluate and discuss laboratory test results using the methods on single species biofilms under various conditions
5. Describe the different steps in a risk-based flow diagram