Millipore Corp.

Millipore's new Integritest 4 instrument provides fast and reliable integrity testing that meets regulatory integrity analysis requirements. This tool allows biopharmaceutical production operators, supervisors and validation managers to conduct on-site bubble point, diffusion, enhanced bubble point and HydroCorr (water-based test for hydrophobic filters) tests on disk, cartridge and tangential flow filtration (TFF) filters with the highest level of confidence.

Easy-to-use, the Integritest 4 features an intuitive graphical user interface with touch-screen menus and toolbars that can be customized based on operational roles. To provide accuracy and reproducibility, this system employs a unique software algorithm that utilizes data points from the accurate portion of a pressure-flow curve while avoiding dependencies on the volatile portions. The Integritest 4 also brings new test options for accelerated mode, asymmetric bubble point, multi-layer pre-pressurization, and pressure hold tests. Test results are provided via the built-in printer, and a barcode reader input is available for accurate product identification.

Clean room-compatible, Millipore’s integrity testing device is a robust and modular system enclosed in a water and splash resistant case. A built-in high efficiency filter prevents dust produced by the instrument. Instrument-grade inlet and outlet connections on the pneumatic manifold assembly minimize leads and provide more precise results. The exterior surfaces can be wiped clean with alcohol, bleach and dilute sodium hydroxide.

Developed and validated according to the GAMP 4 Guide for Validation of Automated Systems, the Integritest 4 instrument can be qualified on-site using a customized validation protocol. In addition, the modular architecture of this new instrument allows for on-site maintenance and repair by certified Millipore Field Technicians.

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