Dissolution Tester Qualification – what does it mean?
Dissolution tester qualification is the process of checking the mechanical and physical elements of the dissolution tester to ensure they work correctly and can be controlled accurately. Dissolution tester qualification is often carried out once or twice a year to ensure the smooth, reliable running of the dissolution testers. This in turn ensures that the baths produce accurate results that are with USP/EP/JP compliance parameters across the laboratory.
Dissolution tester qualification involves many checks of the various parts of the machine, including shaft verticality, spinning speed and height settings, vessel dimensions and verticality, temperature checks, timer checks, vibration interference, vessel and shaft centring, basket and paddle wobble and many other parameters. All checks are carried out to set USP specifications and must fall within stipulated figures, if anything does not, or is found to be totally non-functioning, it must be repaired and checked again before the dissolution tester can be signed off as fit to use.
Dissolution tester qualification is an important part of your routine maintenance, and the engineers at Total Laboratory Services Ltd are experts in performing the dissolution qualification service on many makes and models. To find out more about our dissolution tester qualification service, please click here.