Dissolution Tester Qualification
Total Laboratory Services Ltd have over 20 years experience carrying out dissolution tester qualification and installations. We provide the full Operational Qualification package, fully adhering to USP guidelines when qualifying your dissolution bath.
Our engineer will attend your laboratory and complete a full dissolution tester qualification, checking paddle height, basket height, speed, shaft wobble, shaft verticality, vessel dimensions, vessel centring, vessel verticality, heating temperature, media temperature and the test timer along with a vibration check and system level-up. Every condition we check is tested against the USP mechanical qualification tolerances, and any deviations are corrected on-site wherever possible.
Once completed, we supply you with our dissolution tester qualification documentation, along with any associated printouts to confirm a successful qualification has taken place, certifying your dissolution bath is within USP specifications.
We recommend either 6 monthly or annual dissolution tester qualification visits for every dissolution bath you have, and we can combine multiple baths into single visits to make things easier for you.
All of our equipment is certified and calibrated to the highest standards, and our engineers are fully trained by ERWEKA and experienced with USP compliance guidelines. We can perform a dissolution tester qualification on most baths across a broad range of manufacturers.
Alongside a dissolution tester qualification, we can also provide a preventative maintenance check of your dissolution bath. This is where we check for general wear and tare of the equipment, including the drive belt, basket mesh, cracked vessels, internal wiring connections and the lifter column.
Please contact us today for a price for any dissolution tester qualification requirements that you may have. We’re always happy to help.