Live eLearning - PDA 717 Bio/Pharmaceutical Filter Integrity Testing

Filtration is used to separate unwanted contaminants both viable and non-viable from fluid streams. Filtration becomes the prevalent sterilization method due to the increase in bioprocess applications. The filter can be a protective unit to prolong the life of other equipment, to reduce the bioburdens or the highly critical last barrier before the vial. The criticality of the performance of the filtration steps shall not be underestimated but require in-depth knowledge to run the filtration processes in a robust and optimal manner. This training course will focus on:

• Filter integrity testing
• Regulatory requirements of filter integrity testing, including PUPSIT and the PDA initiatives
• Trouble shooting of integrity tests

Topics to be addressed include:

• Non-destructive integrity test correlation to the bacteria challenge test
• Description and functions of the different integrity tests
• Regulatory needs and guidances, including an update on PUPSIT and the PDA initiative
• Points to consider in integrity testing and trouble shooting

The training course format will be lecture with a question and answer session after the presentation.

1. Make the right integrity test choices
2. Address regulator and regulatory requirements relevant to when to test and how
3. Understand what influences integrity tests and what to do when a filter fails