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