Automation of a 12 station Dissolution bath is different to common 6 vessel system. This system ADS-1210 is composed of: a 12 vessel PTWS-1210 dissolution bath, EPE-12 auto sampling system, manual tablet drop magazine, tubing installation in PTFE (P) including 3 mm stainless steel sampling tubes with attached filter tip, 16 channel Peristaltic, UV/VIS Diode Array or other Spectrophotometer and multi-cell changer (12-16 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 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 PTWS-1210 Dissolution Bath which may be equipped with the EPE-12 auto sampling system, also of a peristaltic-, syringe-, or piston pump as well as a spectrophotometer (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
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