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Fully Automated Dissolution Testing System
- fully automated dissolution testing system for series of 10-15 dissolution tests using the paddle usp 2 method, option bs60 for usp 1 tests
- fulfills all requirements ep, usp, fda, fip, gamp, fda 21 cfr part 11 guidelines
- fully controlled by the same winsotax dissolution testing software than semi-automated systems: easy for users' training and simplified method transfer
- all functional steps (media preparation, supply, test execution with sampling and filter changes, cleaning) are carried out simultaneously
- very high sample throughput due to simultaneous media dispensing for all test vessels
- a very short and extremely thorough cleaning cycle prevents carryover from test to test
- customized on- and off-line automation concepts
- fully automated pellet testing using sotax patented pellet devices
- fully automated capsules in sinkers' testing
- media change procedures allow additions or replacement of media (half change, full change)
- media replacement after off-line sampling
- system is using disposable syringes luer locked filters
- testing of a variety of dosage forms such as capsules, pellets and granulates is possible with sinkers and pellet devices
- complete validation and qualification documents (iq, oq, pq)