New Dissolution Tester has the Edge in Enhanced Mechanical Calibration

Copley Scientific has launched the Dissolution Tester DIS-EMC, a new system that features Enhanced Mechanical Calibration, and which is designed to meet the latest and most rigorous calibration needs in this field.

State-of-the-art manufacturing procedures bring new standards in controlling the tolerances and dimensions of the critical elements of the Test Station in which the dosage form resides. In line with current regulatory

guidance, this significantly reduces the potential of the dissolution tester to contribute to testing variability.

While accepted practice in the pharmaceutical industry has been to calibrate dissolution testers using a combination of mechanical checks and performance verification tablets, there is concern about the wide acceptance ranges and variability these generate. As a result the move is towards enhanced mechanical calibration as an alternative, or at least as a precursor, to chemical calibration.

Enhanced mechanical calibration requires strict control of the dimensions of, and the spatial relationships between, critical elements of the dissolution tester. Copley Scientific has identified these critical elements to be the dissolution vessel and lid, and the stirring element. Controlling these, while also maintaining stirring speed and media composition and temperature within tight limits, minimises any instrument contribution to test method variability. Using vacuum forming techniques, Copley Scientific has produced a vessel with superior dimensions and which has provided a platform for the development of a new lid and stirring element. This production method guarantees an internal diameter tolerance and blemish-free spherical radius of +/- 0.13 mm (compared with the traditional unit’s +/- 2 mm). Friction-free bearings in the lid and a precision-ground shaft for the stirring element have enabled a 50% reduction in tolerances relating to wobble, verticality and centring. The Dissolution Tester DIS-EMC betters the dimensional tolerances specified by the FDA by a factor of 2.