Millipore has introduced the Integritest 4 instrument which is designed for fast and reliable integrity testing that meets regulatory integrity analysis requirements.
Millipore has introduced the Integritest 4 instrument which is designed for 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 HydroCorrSM (water-based test for hydrophobic filters) tests on disk and cartridge filters and tangential flow filtration (TFF) systems.
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 software algorithm that uses 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-pressurisation, and pressure hold tests.
A built-in printer generates test results, while a barcode reader input is available for accurate product identification.
Compatible with clean rooms, the integrity testing device is a robust and modular system enclosed in a water and splash-resistant case.
Instrument-grade inlet and outlet connections on the pneumatic manifold assembly minimise 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 customised validation protocol.
In addition, the modular architecture of the instrument allows it to be repaired and maintained on site by certified Millipore field technicians.
