 | Regulatory agencies such as the FDA, EMEA and MCA require integrity testing of sterilizing- grade filters.For production operators, supervisors, and validation managers who need to perform on-site filter integrity tests, Millipore 's Integritest Exacta Integrity Instrument provides the highest level of confidence in the regulated biopharmaceutical industry. The Integritest Exacta is designed to comply with the FDA regulation 21 CFR Part 11. Users can conduct bubble point, diffusion, enhanced bubble point and HydroCorr (water-based test for hydrophobic filters)tests on disk, cartridge and TFF filters.
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