Millipore introduces new filter integrity instrument
that allows biopharmaceutical production to conduct on-site bubble
point, diffusion and HydroCorrSM tests on disk, cartridge and
tangential flow filtration (TFF) filters.
The introduction of this instrument is Millpore's response to regulatory agencies' requirements that integrity testing must be included in sterilizing grade filters. Millipore's Integritest 4 features a graphical user interface with touch-screen menus and toolbars that can be customised based on operational roles.
This system employs a software algorithm that utilises data points from the accurate portion of a pressure-flow curve while avoiding dependencies on the volatile portions. The accuracy of this algorithm is key to proving that the filter is integral.
The instrument also brings new test options for accelerated mode, asymmetric bubble point, multi-layer pre-pressurisation, and pressure hold tests. Results are provided via the built-in printer, and a barcode reader input is available for accurate product identification.
The device is enclosed in a water and splash resistant case with a built-in efficiency filter preventing dust produced by the instrument. Instrument-grade inlet and outlet connections on the pneumatic manifold assembly minimise leads and provide more precise results.
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.
Details of the Integritest 4 along with ordering information can be found on Millipore's website.
