Sartocheck 4 tests the integrity of membrane filter systems by running various test methods, such as the bubble point test, diffusion test, and water intrusion test. The unit is easy to operate and combines all of the high technical requirements placed on an advanced testing instrument in the biopharmaceutical industry.
Sartocheck 4 was developed in accordance with current GAMP guidelines. With its individual user ID assignment capability, data management functions and audit trail to allow tracking of all actions, it is in complete compliance with the regulations of 21 CFR Part 11. The ergonomically designed Sartocheck 4 unit archives all test results – whether a test has been passed or failed – in the results database. The user can access all data stored in Sartocheck 4 at any time and generate a printout using the built-in printer. Results can also be saved externally to a diskette via the internal disk drive. The unit manages the data of up to 100 test programs and 100 test results in its integrated database. If more than 80 results have been saved in the database, the user will be prompted to archive the results database on a diskette to prevent results from being overwritten or deleted.