A typical automated dissolution system ADS70 is composed of: a PT-DT70 Dissolution Bath, flip back design, including 7 stirred vessels, tubing installation in PTFE (P) including in-situ sampling tubes with filter attached to each one, Peristaltic-, Syringe-, or Piston Pump, UV/VIS monochromator or Diode Array Spectrophotometer and multi-cell changer (6-8 cells), WinDiss32 software (fully 21CFR part 11 compliant) and a control PC system.
The perception of automation in dissolution testing differs greatly from user to user. The most labour intensive stage is taking samples at the specified time periods as found in the company SOP (Standard Operating Procedure). This involves the taking of 6 samples according to the USP/EP and most other Pharmacopoeia. Using a closed-loop automated dissolution test system a simultaneous stirrer start after dropping all tablets is possible, also there is no volume loss at all during the complete test run.
The WinDiss32 software can be applied on-line to allow the control of the PT-DT70 a peristaltic-, syringe-, or piston pump as well as a spectrophotometer (like the SA500 UV/VIS Diode Array or T70 UV/VIS Split-Beam and various other popular models) with a multi-cuvette changer. If 8 cell are available cell position 7 is reserved for the Blank or for the 100% dissolved active solution (Standard) while cell 8 can hold a reference standard solution. Calculations are made based relative to the maximum absorbance from an external 8th. (Standard) or a theoretical maximum absorbance for 100% dissolved active. Options also exist for concentration calculation based on a standard curve or a „mg/Abs. Unit“ profile which the user can enter.
- System composed of PT-DT70 dissolution bath, spectrophotometer and pump
- Closed loop operation
- Controlled by WinDiss32 software package