Filter Integrity Testing
Drug Product-Based to Reduce Delays
Filter integrity testing is a critical step in validating the filters used 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.
Filter Integrity Pre-Use
For pre-use, we provide minimum integrity test specifications for filters wetted with standard wetting fluids:
- Water for hydrophilic filters
- Alcohol for hydrophobic filters
Filter Integrity Post-Use
For post-use, the filter is wet with the process fluid (drug product) it filtered. Performing drug product-based integrity testing minimizes delays in production and product release. This is because:
- The process fluid often changes the properties of the membrane
- If not thoroughly flushed, this can suppress the bubble point and result in false failures
Merck performs the testing to establish the water-to-product integrity ratio, to determine the minimum acceptable integrity test value for filters wetted with process fluid.
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