All components are assembled in one unit to provide a total solution to the analysis of solid dosage form dissolution profiles, while still maintaining full USP/EP specifications
Automation in dissolution testing is becoming an increasingly important topic.
Automation can mean different things to different people, but we now generally agree that the term 'fully automated system' means the use of a dissolution system with automatically timed sampling sequences of the test medium and the use of a suitable measuring instrument to calculate the concentration of released active material; normally this means a UV/vis spectrometer.
Most commercially available systems have a conventional layout of bath, pump, tubing and spectrometer.
Many such set ups are however, not qualified as a system especially when it comes to some component parts such as the pump.
The DTS 800 offers a welcomed departure from this set-up in that all components are assembled in one unit to provide a total solution to the analysis of solid dosage form dissolution profiles, while still maintaining full USP/EP specifications.
The positive aspects of this are quite clear.
The foot print of the system is greatly reduced.
The dissolution tester has many new and innovative features such as the Vibroban bath mountings which actually suppress vibration from other instrumentation in the lab.
Another innovation is the Monoshaft tool system which allows easy change of tool types (eg, from apparatus 1 to 2) with automatic head positioning to allow for the required tool displacement from the bottom of the vessel.
The bath components such as heater, pump and tubing are easily accessible from the front of the instrument for routine maintenance.
The screen on the front of the DTS 800 will give an automatic warning as and when the system OQ is due.
Samples are removed via a built-in EPE electronic sampling manifold which can be resident either full time in the sample medium or only for as long as the sample sequence requires, in order to fit in with current SOPs.
The sample tubing is greatly reduced in length between the sampling point and the pump.
This is also true for the pump to UV flow cell connection.
This means shorter pumping times for sampling sequences, easier sample line cleaning and less tubing to change when renewing sampling lines.
The on-board spectrometer is a Dad-type based on the market proven Tidas II design.
All measurements are carried out using a conventional eight cell changer but all radiation is taken to and from the cell changer via fibre guides to minimise moving parts and allow easy optimisation of cell positioning.
This spectrometer is able to collect and analyse whole spectra rather than just making single wavelength measurements.
This affords the user much more detailed analytical information.
Conformity with current regulations goes without saying; the Argus software system powers the instrumentation offering full 21 CFR part 11 compliance in all aspects of dissolution testing.
This includes audit trail, electronic signatures, stored data path definition and administrator/user group password protection.
This compact system provides a total solution to the analysis of dissolution profiles of solid dosage forms.
