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Fully Automated Dissolution Testing for USP methods 1 and 2

Sotax’s AT70 is used for completely Automated Dissolution for multiple unattended tests, including media preparation and delivery, automated dosage introduction, automated sampling, filtering and sample analysis by UV, HPLC, or UVFO, and vessel cleaning. The operator need only load the samples and collect the dissolution reports. The test can be done with paddles on tablets, capsules in sinkers and pellets in cartridges or with capsules/tablets in baskets with the addition on the BS60 basket station

AT70 SMART FOR USP 2 PADDLES TESTING

Fully Automated Dissolution Testing System for series of 10-15 dissolution tests using the paddle USP 2 method,
Fulfils all requirements EP, USP, FDA, FIP, GAMP, FDA 21 CFR part 11 guidelines
All functional steps (media preparation, supply, test execution with sampling and filter changes, cleaning) are carried out simultaneously
Fully controlled by the same WinSOTAX Dissolution Testing Software as 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 uses 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 available (IQ, OQ, PQ)

AT70 SMART FOR USP 2 PADDLES TESTING WITH OPTION BS60 FOR USP 1 BASKET TESTING

Here you can download and save your Automated Dissolution Testing brochure

Fully automated tablet dissolution system for a series of 10-15 dissolution tests using the paddle USP 2 method or up to 10 tests using the basket USP 1 method

Fulfils all requirements EP, USP, FDA, FIP, GAMP, FDA 21 CFR part11 guidelines

Fully controlled by the same WinSOTAX dissolution software as the 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 attaching and removing of all tests baskets
» A very short and extremely thorough cleaning cycle prevents carryover from test to test Customized On- and Off-line automation concepts
» Used baskets slide into a collection container filled with clean water
» Automatic lifting of the stirring unit with safety sensors when changing baskets
» 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)
» Operated by WinSOTAX Dissolution software for different HPLC types
» Monitoring of speed and temperature
» Automated tablet drop-in
» Basket and paddle start procedures
» Built-in syringes cleaning
» Complies to Pharmacopeias
» Designed as an alternative for long tests with a few sampling points or in case of adsorption problems on Teflon or in case of very low dosage of active (e.g. hormones)
» Report includes vessel temperature and rpm

FOR MORE INFORMATION PLEASE CONTACT carolmooney@jenesis.ie