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Nondestructive test (filter remains usable after testing)
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Rapid, reliable, and repeatable
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Detects oversized pores or defects in membranes
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Correlates with filter pore size and retention rating
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Widely accepted in regulatory guidelines (FDA, EMA, WHO, ISO)
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Suitable for in-line or offline validation setups
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Filter Types: Hydrophilic and hydrophobic membranes (with pre-wetting for hydrophobic)
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Configurations: Single cartridge, capsule filters, disc filters
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Liquids for Wetting: Water, isopropanol-water mixture (for hydrophobic membranes)
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Test Equipment: Manual integrity testers, automated digital integrity testers
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Documentation: 21 CFR Part 11 compliant electronic records (for pharma validation)
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Typical Test Pressure Range: 200 mbar to 7 bar (depending on filter rating)
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Filter Pore Size Correlation:
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0.1 µm → ~3.5 bar
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0.2 µm → ~2.4 bar
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0.45 µm → ~1.0 bar
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0.65 µm → ~0.6 bar
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Gas Used: Compressed air or nitrogen
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Accuracy: ±2% of full scale (automated systems)
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Compliance: ASTM F316, PDA TR26, ISO 29463, EN 1822, GMP Annex 1
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Sterile filtration validation in pharma manufacturing
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Biotech fermentation media and buffer filtration
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Water-for-Injection (WFI) and purified water systems
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Final filtration in food & beverage (beer, wine, soft drinks)
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Microelectronics ultrapure water systems
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Medical device manufacturing sterility assurance
