Copley Scientific has launched the Dissolution Tester DIS-EMC, a system that features enhanced mechanical calibration and is designed to meet rigorous calibration needs.
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 that has provided a platform for the development of a lid and stirring element.
This production method guarantees an internal diameter tolerance and blemish-free spherical radius of +/-0.13mm.
Friction-free bearings in the lid and a precision-ground shaft for the stirring element have enabled a 50 per cent 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 two.
Existing users of Copley DIS 6000 and DIS 8000 Dissolution Testers can exchange their standard Test Station for the EMC Test Station.
