Automation of a 12 station Dissolution bath is different to common 6 vessel system. This system ADS1210 is composed of: a 12 vessel PTWS1210 dissolution bath, EPE auto sampling system, manual or automated Tablet Drop Magazine, tubing installation in PTFE (P), 16 channel Peristaltic Pump, UV/VIS Diode Array or other suitable Spectrophotometer and multi-cell changer (12 to 16 cells), the 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 12 samples simultaniously according to the USP/EP and most other Pharmacopoeia. The samples are pumped within a „closed loop“ for some time. For the measurement the pump is stopped and the cell changer moves from position 1 to 12.
The WinDiss32 software can be applied on-line to allow the control a PTWS1210 Dissolution Bath which may be equipped with the EPE auto sampling system, also of a peristaltic-, syringe-, or piston pump as well as a spectrophotometer (like the DAD SA500 which has 16 cell positions) with a multi-cuvette changer. In this case, position 13 is reserved for the blank and position 14 for the 100% dissolved active solution. Calculations are made based relative to the maximum absorbance from vessel 14 (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. The WinDiss32 software is 21CFR part 11 compliant and installed at a control PC system using Windows 00, XP or NTTM.
- System composed of PTWS 1210 dissolution bath, spectrophotometer and pump
- Closed loop operation
- Controlled by WinDiss32 software package