Millipore adds central management capability to its instruments to deliver the cost savings and the security targeted by the objectives behind 21 CFR Part 11
Conventional integrity test systems are very labour intensive and time consuming, requiring each task to be repeated manually on each instrument.
Millipore's new 3.0P upgrade software for its existing Integritest Exacta instruments optimises integrity testing by centralising management and consequently enabling the productivity gains intended by the industry to be reached. Millipore's automatic Integritest Exacta integrity instrument already used to provide the highest level of confidence for the regulated biopharmaceutical industry that need to perform on-site filter integrity testing.
Millipore has taken its product a step further and has designed a new centralised user management concept.
Validated test engine is identical in Exacta version 3.0 and 3.0P, however 3.0P version adds networking and central management for cost savings, as well as security. Contrary to conventional integrity testing systems, Integritest Exacta used with 3.0P software can be managed from a central location providing security by common network tools and configuration.
Tests results are instantly uploaded to a secure repository throughout the organisation, reducing paperwork errors and data loss.
Consequently, quality trends can also be analysed. The upgrade package includes the new software, on site assistance for installation of hardware and training in scope of implementation roles and tasks.
A planning guide containing comprehensive checklists and validation guidelines is also available.
Integritest Exacta is used to conduct bubble point, diffusion, enhanced bubble point and HydroCorr (water-based test for hydrophobic filters) tests on disk, cartridge and TFF filters.
Beyond the true 21 CFR Part 11 compliance, new Integritest Exacta 3.0P package provides highly efficient management through cost savings and security intended by the regulation, says Millipore.
