Live eLearning - PDA 716 Bio/Pharmaceutical Filtration Process Validation

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 qualification
• Regulatory requirements of filter validation
• Process validation of sterilizing grade filters

Topics to be addressed include:

• Filter manufacturers’ qualification steps
• Qualification documentation
• Regulatory needs and guidances
• Process validation activities, including viability testing, product bacteria challenge test, extractable/leachable testing, and other important tests

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

1. Make the right validation choices
2. Address regulator and regulatory requirements relevant to critical and non-critical filtration processes
3. Review key parameters for secure and reliable filtration processes
4. Justify your filtration activities