Filtration Processes in the Pharmaceutical and Biopharmaceutical Industry

Filtration processes are manifold and often critical within biopharmaceutical processes. Knowing different filter types, use and criticalities will help to make appropriate choices of which filter should be used where, what is required to size a filter system appropriately, what to look out for and, if needed, how to troubleshoot filtration problems. Moreover, filter integrity testing is as much a key success factor of sterilizing grade filtration as the filter itself. Again, the right choice of test, when to test and what to do when a test fails are critical knowledge points within the filtration processes.

This interactive training course addresses the following topics:

• Design, construction and manufacturing of pre-, depth and membrane filters
• Contaminant retention mechanisms for liquid and gas filtration including sieve retention and adsorptive sequestration
• Pre-/Post-use integrity testing using diffusional airflow, bubble point, pressure-hold and water intrusion test
• Process validation requirements for membrane filters, including microorganism challenges, extractables and other testing parameters
• Troubleshooting integrity test and filtration process design issues
• Filter material, size and combination choices

Please note that this training course has hands-on lab activities.

1. Apply knowledge of filter properties to select the appropriate filter for a specific process
2. Design and select different integrity test methods
3. Differentiate and optimize pre-filter and final filter arrangements
4. Identify filterability and scalability requirements for filtration optimization
5. Describe validation and process performance qualification requirements
6. Resolve integrity test failures and troubleshoot filtration process issues