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Semi Automated Dissolution Testing for USP methods 1,2, 5 and 6

To automate sampling or analysis a Semi-Automated Dissolution Tester is used. Samples can be taken simultaneously, filtered and collected in a fraction collector, withdrawn using a robotic arm or simultaneously sampled and analysed directly by UV or HPLC. It is also possible to collect a sample as well as analysing at the same time. Dissolution test can also be performed in situ by a fiber optic probe also called UVFO. The operator will fill the vessels with media, the tablets will be automatically dropped and the test will start and finish. Once the test has been completed, the operator will clean the system for the next test.

Based on the AT7 Smart dissolution bath various possibilities are offered according to your specific needs:

AT7 SMART OFF-LINE SYSTEM: AT7 WITH PUMP AND FRACTION COLLECTOR

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» Samples can be withdrawn from manifold probes or through the Hollow Shaft.
» With a piercing valve it is also possible to sample in closed vials without any evaporation
» A Peltier cooling effect can be also added to maintain sample at low temperature
» pH change or media replacement (constant volume work) with an additional valve
» Off-line systems can easily be upgraded to double off-line (2 baths for one fraction collector) due to the fraction collector design
» No possible cross contamination due to a possible cleaning phase between samples
» Off-line systems can be driven by firmware or software

On-line system: AT7 Smart with pump and UV Spectrophotometer

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» Controlled by 21 CFR part 11 compliant WinSOTAX dissolution software
» Direct sample on-line analysis for USP 1, 2, 5, 6 with different possible UV-Vis spectrophotometer types
» Samples can be withdrawn from manifold probes or through the Hollow Shaft
» Works in a closed loop without valve and without volume loss
» Filtering is done before reading with 25 mm internal or external luer-lock filters with the possibility (option FS7) to change them after each sampling point
» Standard monitoring, placebo subtraction, multi-wavelength and scan ability (depending on spectrophotometer brand)
» Cell changer from 7 to 16 positions allowing upgrade to double on-line systems (2 baths linked to one spectrophotometer)
» Variable pathlength 0.1 to 10 mm (up to 50 mm depending on the spectrophotometer brand)
» Virtual dilution allowing pathlength change during the test
» pH change during the test, manual or automatically with a valve

ON-LINE SYSTEM: AT7 SMART WITH PUMP, TRANSFER STATION AND HPLC

» Operated by WinSOTAX Dissolution software for different HPLC types
» Can be adapted to major brands of HPLC systems
» SOTAX CY7-50 piston pump for adsorption-free sampling
» Transfer station TS70 for simultaneous samples draw and storage in 5 rows of 7 closed flow-through cells (9 ml)
» Multifunction interface MF 70 for sample handling and standard monitoring via an 8/1 way valve into the HPLC injection loop
» Dilution option up to 1:20 with a choice of 3 different dilution media Sampling with manifold probes or Hollow Shaft

AT7 SMART WITH AUTOMATED SAMPLING DEVICE (ASD)

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» 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

AT7 SMART WITH FIBRE OPTIC

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» In-Situ Dissolution without pump nor filter
» Including the unique ARCHTM Probe low disturbance open architecture that minimizes any hydrodynamical effect
» Horizontal pathlength avoids bubble entrapment and excipient build up and allows small pathlengths e.g. 0.5 and 1 mm
» Easy Fiber Optic probe handling and removal due to an open AT7smart design
» Automatic centering and height adjustment
» Fast scanning intervals for flash release forms
» No multiplexer nor moving part for simultaneous measurements
» High sensitivity CCD detector
» No solarization, lower probe replacement cost

FOR MORE INFORMATION PLEASE CONTACT carolmooney@jenesis.ie