Filter Integrity Testing
Establish a Product-Specific Filter Integrity Test Specification
Filter integrity testing is a critical step in manufacturing sterile drug products.
Regulatory agencies and the Parenteral Drug Association (PDA) recommend pre-use and require post-use integrity testing to check for leaks or filter damage in the sterilizing-grade filters used to perform this process.
Minimum integrity test specifications for filters wetted with standard wetting fluids is available in our filters’ Certificate Of Quality: Water for hydrophilic filters and alcohol for hydrophobic filters.
For pre-use or post-use test with other fluid such as product, buffer or other flushing fluids, a specific integrity test specification shall be determined. Indeed, performing drug product based integrity testing minimizes delays in production and product release. This is because:
- The process fluid may have different properties than standard integrity testing fluids which can be alter the integrity test result
- If not thoroughly flushed, this can suppress the bubble point and result in false failures.
We perform the testing to establish the water-to-product integrity ratio, to determine the minimum acceptable integrity test value for filters wetted with process fluid. We can also determine the integrity specification for a filter wetted with product and rinsed out with your specific rinsing fluid.
Let us prove the integrity of the filters in your drug product manufacturing process.