E. Disintegration Testing
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016
E-3
Setting the Heater/Circulator
1. Turn on the heater/circulator using the power switch
located on the back right side of the unit.
2. Press the Stop button if the heater is running.
3. Press the Menu button until the temperature function and
the word “Set” appears on the screen.
4. Use the plus (+) and minus (-) buttons to set the target
bath temperature.
5. Press the Menu button until the timer function and the word
“Set” appear on the screen.
6. Use the plus (+) and minus (-) buttons to set the timer.
7. Press the Run button to start the heater/circulator.
Verify Media Temperature
Allow water in bath to come up to temperature (approximately
15 minutes when starting from room temperature). Placing
baskets into warmed media will lower the temperature slightly.
Set temperature to 38 °C to compensate for this effect. Check
temperature of media inside the beaker using an external
calibrated thermometer. Adjust heater setting as needed to
bring media to correct temperature for the test.
Place Dosages in Basket
After all other test preparations are complete, and just before
starting the test, ensure the basket assemblies, mesh screens
and glass tubes are completely dry before placing dosage
forms into the tubes. If required by the test method or SOP,
place disks on top of dosages.