E. Disintegration Testing
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016
E-1
Beakers and Baskets Preparation
Before running a disintegration test, the basket assembly will
need to be prepared, the beaker media level will need to be
determined, the heater/circulator will need to be set, and the
media will need to be brought to the required temperature.
Filling the Beakers
USP <701> calls for a minimum submersion of the wire mesh
base of the basket assembly when the basket is at the highest
point of the stroke during a disintegration test. Because of slight
variations in beaker dimensions and inside surface geometry,
the amount of fluid required to fill a particular beaker to a specific
level in order to accommodate this requirement may vary. Use
the TOOLS MENU and the procedure below to help establish
the fluid level for a test.
1. Fill beakers with the required media to about the 900 mL
mark and insert beakers into the bath.
2. Snap basket assemblies onto the ends of the arms, as
described earlier.
3. If disks are a requirement for the test, include them in the
tubes for this procedure.
4. From the main menu select TOOLS.
5. Move the baskets to the upper limit of the stroke to ensure
that the wire mesh screen meets the minimum submersion
requirement.
6. Add or remove media as required to satisfy the wire mesh
screen’s minimum submersion requirement.
7. Using the TOOLS menu, move the baskets to the LOWER
position and confirm the beaker media does not overflow
the top of the glass tubes.