Sartocheck 4 MultiUnit Accelerates Filter Integrity Tests
21 September 2006
"Time is money." This adage is particularly true in the biopharmaceutical industry, where extremely safe products have to be brought to market at an ever-faster pace. The components used in the processes equally have to be adapted to this accelerated pace.
For years, Sartorius has been the market and technology leader in filter integrity testing for the pharmaceutical and biotechnology industries. The product family under the Sartocheck trade name has been performing integrity testing for membrane filter systems, such as bubble point, diffusion or water intrusion tests, for just as long. Now, Sartorius has introduced the Sartocheck 4 MultiUnit on the market to enable users in fast-paced biopharmaceutical sectors to run parallel integrity tests.
The MultiUnit consists of the same mechanical and pneumatic components as Sartocheck 4 that are required to run a filter integrity test. The major advantage for users is that up to four MultiUnits can be connected to and controlled by one Sartocheck 4. The best part is that it does not matter how far apart the MultiUnits are from Sartocheck 4. The MultiUnits can thus be set up around the entire production area, and driven and monitored by one central Sartocheck 4. The Sartocheck 4 MultiUnit functions as an independent test unit powered by its own energy supply and with its own electronic and pneumatic components. This also means that the test results are reliably and securely saved to memory even in the event of a power failure or interruption in communications.
Basically, all results generated by the integrity tests carried out on the separate MultiUnits are transmitted back to the interfaced Sartocheck 4 via an RS-485 interface where the data are saved in the network or printed out. All aspects of data management are in strict compliance with CFR21 Part 11 guidelines.
Up to five different integrity tests can be run in parallel with the combination of four MultiUnits and one Sartocheck 4. This cuts down markedly the time spent on filter integrity testing at production facilities with a large number of filters to be tested.
Easy-to-Understand Menu Guidance – Perfect Data Security
Sartocheck 4 has long provided a compelling solution with its touchscreen user interface for easy operation and its network compatibility – not to mention the compliance of its data storage and management with CFR21 Part 11 regulations.
Sartocheck 4 performs all required test procedures fully automatically. Moreover, Sartocheck 4 archives all test results, i.e. passed or failed, in its results database. This gives the user comprehensive access to all data stored in Sartocheck 4 at all times.
Reaching Targets Faster and More Reliably
Sartocheck 4 and MultiUnit can also be equipped with an optional adapter for connecting a fan unit that retains any particles in the outlet air, thereby preventing any potential contamination in clean rooms. The Multiunit is supplied with a complete validation package that includes IQ and OQ records. Moreover, the Sartorius team offers PQ support as well. The Sartocheck 4 MultiUnit not only makes filter integration testing more reliably, but much faster as well.
