For a manual sampling Dissolution Bath, also called Dissolution Tester, the operator will stagger the sample introduction and withdraw a sample using a cannula from the vessel at defined time points. The sample will then be filtered and analyzed independently. 

 

 

To automate sampling or analysis, a Semi-Automated Dissolution Testing System, also called 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 Samples can be taken simultaneously, filtered and collected in a fraction collector, withdrawn using a robotic arm or simultaneously sampled and analyzed directly by UV or LC. It is also possible to collect a sample as well as analyzing at the same time. 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.

 

For a completely automated Dissolution process for multiple unattended tests, including media preparation and delivery, automated dosage introduction, automated sampling, filtering and sample analysis by UV or HPLC, and vessel cleaning, then a Fully Automated Dissolution Testing System, also called fully Automated Dissolution Tester, can be used. The operator would 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 in baskets. 

The validation of these 3 types of systems according to the regulations can be done by SOTAX specially trained service engineers.

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