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Process Worldwide-PharmaTec 03-2004
Looking for the weak points
Filter integrity testing made easy

The Sartocheck 4 quickly and automatically tests the integrity of membrane filters. It is accurate, easy to use, and features new internal cleaning and drying techniques to reduce the risk of cross-contamination.

The new Sartocheck 4 represents the latest generation of filter integrity tester from Sartorius. Following on from the established Sartocheck 3, it makes the testing of production filters in the biotech and pharmaceutical industries even easier and more reliable. The filter integrity tester validates the integrity of membrane filter systems by running various tests: a bubble-point test, a diffusion test and a water intrusion test. The unit is easy to operate and has the high technical specification expected of an advanced instrument in the biopharmaceutical industry. The tester was developed in accordance with current GAMP guidelines. With its ability to assign individual user IDs, data management functions and audit trail that allows every action to be tracked, the instrument is in complete compliance with the regulations of 21 CFR Part 11. Clear menus and easy operation Users will find the self-explanatory and well-proven menu structure of the Sartocheck 3 repeated in the new Sartocheck 4. Test programs can be selected directly by pressing the relevant button on the display. The large, backlit, color touch screen shows clear high-contrast graphics as well as alphanumeric characters. It shows which test is currently in progress, and provides details of the filter’s test performance. All the tests are carried out fully automatically. Every test result, whether the test was passed or failed, is stored in a database. Users can access this stored data at any time and generate a hard copy using the built-in printer. Results can also be saved to a diskette via the internal disk drive. The database has room for 100 test programs and 100 test results; once its memory is 80% full, the Sartocheck 4 prompts the user to archive the data onto a diskette to prevent results from being overwritten or deleted.
Flexible solutions and new cleaning process For applications where the instrument must be sited remotely from the filter it is to check, such as when carrying out a water intrusion test on the vent filters of storage tanks, it is possible to use an external pressure sensor, which is available as an accessory. Optional external vent valves are also available for added convenience when performing water intrusion tests. Using an external vent valve avoids the risk of contamination that can occur when venting contaminated filters at the end of a test, for example. Sartocheck 4 features a new technique to ensure that the internal valve group and the reference tank are left thoroughly clean and dry after each test. All the steps needed for this procedure are shown on the display and described in easy-to-follow instructions. This significantly reduces the risk of cross-contamination.
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