Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations

This training course will provide scientific understanding and real-world practices for the management of bioburden and biofilm in pharmaceutical and biopharmaceutical production processes. Microbial control of pharmaceutical API and biopharmaceutical drug substance or API production processes is a significant quality and compliance problem today.

Major topics include the following:

• Mechanisms surrounding biofilm formation and the complex interactions that exist between planktonic and sessile modes of microbial contamination
• Principles and best practices in the design of facilities, utilities, and equipment to minimize bioburden with emphasis on biofilm control
• Proven practical approaches to preventing bioburden and biofilm using real word examples
• Typical control levels for various types and stages of biopharmaceutical production including critical utility systems
• Best current available technology and sampling practices for bioburden and biofilm detection, including trend analysis and decision principles within the quality management system

Consistent with PDA’s Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations, best practices for remediation of contaminated processes and equipment will be reviewed with case studies in remediation where possible. The case studies will provide lessons learned in effective quality investigations and regulatory interactions once problems occur. The training course will present practical approaches to the prevention, detection, and remediation of microbial contaminations that students can use in daily production and laboratory operations.

1. Discuss the principles and best practices of microbial control in pharmaceutical processes based on current best practices and regulatory expectations
2. Discuss the biology underlying bioburden development in pharmaceutical and biopharmaceutical drug substance production systems
3. Explain the mechanisms surrounding biofilm formation and the complex interactions between that exist between planktonic and sessile modes of microbial contamination
4. Present information on typical control levels/limits for various types and stages of biopharmaceutical production systems, including critical utility systems
5. Explain the principles and best practices in prevention, detection, and remediation of microbial contamination in pharmaceutical/biopharmaceutical drug substance or API production systems, including current regulatory guidance and expectations