Pharma test

ADS610
Fully Automated Tablet Dissolution Testing

A typical automated dissolution system ADS610 is composed of: a 8 vessel dissolution bath type PTWS610, EPE auto sampling system, Tablet Drop Magazine with incorporated evaporation proof vessel cover design, ITMIndividual Temperature Monitoring System, PTFE tubing installation, Peristaltic or Piston Pump, a T70 UV/VIS split-beam spectrophotometer or any other suitable UV/VIS spectrophotometer such as the SA 500 Diode Array Spectrophotometer with a built-in Multi-Cell Changer (6, 8 or 16 cells), WinDiss32 (fully 21CFR part 11 & GAMP compliant) software 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 to 8 samples according to the USP/EP and most other Pharmacopoeia. A closed loop dissolution test system does not require staggered stirrer start as all samples are removed simultaneously. Media refilling is not required using a closed loop system as there is no media loss at all.

The WinDiss32 software can be applied on-line to allow the control a PTWS610 Dissolution Bath which is equipped with a Manual Tablet Drop Magazine, the EPE and ITM (option), also of a peristaltic-, piston-, or syringe pump as well as a UV/VIS spectrophotometer (single beam, double beam, diode array of various popular models) with a multi-cuvette changer. In the case of using an 8-cell changer, cell position 7 is reserved for the blank and cell position 8 for the 100% dissolved active solution. Calculations are made based relative to the maximum absorbance from vessel 8 (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 2000, XP or NT-4TM.

Using the state of the art Dissolution Software WinDiss32 the PTWS610 is connected to either a SA 500 Diode-Array, an Agilent 8453 or any other suitable UV/VIS Spectrophotometer. For more information please ask to get the demo software pack.

WinDiss32 includes different photometer, auto sampler and pump drivers. If you have preferred requirements please ask for information.