Request Information

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.

  • Let BioReliance® Validation Services prove the integrity of filters in your drug product manufacturing process.

View Our Webinars