LimsPulse
Dosage-form testing

Disintegration Test Apparatus

Checks whether tablets or capsules break up within a stated time when moved up and down in a liquid at 37 °C. A quick, routine test for release and in-process control.

  • Pharmaceutical
  • Nutraceuticals and dietary supplements
  • Veterinary medicines
  • Contract testing labs
Illustration of Disintegration Test Apparatus
CALIBRATION

Disintegration tester calibration procedures

Stroke frequency & distance

Counts the number of up-and-down cycles per minute and measures the vertical travel of the basket-rack.

Open procedure

Temperature

Checks the immersion fluid temperature against a calibrated thermometer.

Open procedure
QUALIFICATION

Instrument qualification (DQ · IQ · OQ · PQ)

  1. 01

    DQ — Design qualification

    Confirms the model meets compendial basket-rack dimensions, stroke and frequency ranges, temperature control and the lab's need for one or more test stations.

  2. 02

    IQ — Installation qualification

    Records serial numbers, basket-racks, discs, beakers and their dimensional certificates, installation on a stable bench and documentation.

  3. 03

    OQ — Operational qualification

    Verifies stroke frequency, stroke distance, temperature control and the timer for each station.

  4. 04

    PQ — Performance qualification

    Demonstrates consistent performance in routine use, for example through periodic calibration and, where your SOP asks, testing of a well-characterised in-house product.

In LimsPulse · Calibration Management

Keep every Disintegration tester in control: usage logs, calibration and maintenance schedules, and automatic blocking of overdue instruments.

See how