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Filter Integrity Testing

Integrity testing services for sterilizing-grade filters.

Filter integrity testing is a critical step in manufacturing of sterile drug products. With regulatory agencies and the Parenteral Drug Association (PDA) recommending pre-use and requiring post-use integrity testing, you can rely on our integrity testing to follow industry best practices — not only establishing a product-specific filter integrity test specification, but rigorously checking for leaks or filter damage in our sterilizing-grade filters.

Product-specific specification and testing

The Certificate of Quality for our filters includes minimum integrity test specifications for wetting with standard wetting fluids, such as water for hydrophilic filters or alcohol for hydrophobic filters. But determining a specific integrity test specification with other fluids such as product, buffer, or other flushing fluids can be to your advantage, minimizing delays in production and product release. This is because:

  • The process fluid may have different properties than standard integrity testing fluids, which can alter the integrity test result
  • Failure to thoroughly flush the process fluid can suppress the bubble point and result in false failures

Our testing can establish the water-to-product integrity ratio, and thus 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.

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Trust our Global Services Network

To learn more about our industry-leading validation services for biopharmaceutical manufacturers, look into these specialized capabilities performed at our laboratories worldwide.

  • Single-Use and Filter Validation Services
  • Bacterial Retention Testing
  • Chemical Compatibility Testing
  • Extractables and Leachables
  • Validation Services Consultancy
  • Validation Service Levels

Related Product Resources

Choosing the Right Validation Services
Drug Product-based Integrity Testing to Establish Product/Filter Test Specification Value
Bubble Test Method Using Aervent® 0.2 μm Hydrophobic Membrane with 60/40 IPA
Bubble Test Method Using Durapore® 0.45 μm Hydrophilic Membrane with 70/30 IPA
Bubble Point Ratio Determination for 60/40 and 70/30 IPA
Bubble Point Ratio Determination for Vesphene® llse (1:128)
Bubble Point Ratio Determination for LpH® se (1:256)

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Accelerate and simplify your path to market by using our BioReliance® Validation Services to select, test, and validate your filters, assemblies, and single-use systems for drug manufacturing and processing.
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Required by regulatory bodies worldwide, bacterial retention testing (BRT) is a critical step in filter validation. Our skilled validation specialists conduct BRT using each end-user’s worst-case biopharmaceutical processing conditions to ensure a best-case outcome.
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For local assistance and rapid response to your filtration validation needs, BioReliance® Validation Services offers a global network of highest-quality laboratories with in-country and in-region experts at strategic geographic centers.
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