Calibration of Disintegration Test Apparatus – Detailed Explanation

The disintegration test apparatus is an essential quality control instrument used in the pharmaceutical industry to evaluate the time it takes for tablets or capsules to break down into smaller fragments under specific conditions. This ensures that the dosage form will properly disintegrate and release its active ingredient in the body.

Calibration of this apparatus is crucial to ensure that it functions accurately and delivers reliable and reproducible results in compliance with pharmacopeial standards such as USP, IP, BP, or EP.

1. Objective of Calibration

The primary objective of calibrating a disintegration test apparatus is to verify and ensure:

• The mechanical and temperature parameters are within acceptable limits.

• The test conditions simulate in-vivo conditions consistently.

• Regulatory compliance with pharmacopeial standards.

2. Components to be Calibrated

1. Temperature of the Water Bath

   • The bath should maintain 37.0 ± 2.0°C during operation.

   • A calibrated thermometer or digital temperature probe is used to measure and verify accuracy.

2. Stroke Frequency and Distance (Oscillation Movement)

   • The apparatus should move the basket assembly 30 times per minute ±1.

   • Stroke height should be 55 mm to 60 mm (depending on pharmacopeia).

   • Use a stopwatch and measurement scale or a motion sensor device for verification.

3. Timer Accuracy

   • The internal timer should be calibrated against a certified stopwatch.

   • Timer deviation should not exceed ±1%.

4. Basket Assembly and Mesh Integrity

   • Check that basket mesh complies with pharmacopeial standards (mesh size and structure).

   • Ensure no rust, breakage, or deformation.

5. Alignment and Movement

   • Ensure vertical and smooth movement of the basket assembly.

   • Check for misalignment, jerks, or uneven oscillation.

3. Calibration Procedure (Step-by-Step)

A. Temperature Calibration:

• Fill the water bath and allow it to reach a steady state.

• Use a calibrated thermometer to measure the temperature at 3 points (top, middle, and bottom of the beaker).

• Record values to ensure all readings fall within 37.0 ± 2.0°C.

B. Stroke Rate (Oscillation Speed):

• Start the apparatus and use a stopwatch to count strokes per minute.

• Count the number of up-down movements in 60 seconds.

• Should be 30 ± 1 strokes/min.

C. Stroke Height Verification:

• Use a scale or gauge to measure the vertical movement of the basket.

• It should fall within pharmacopeial limits (usually 55–60 mm).

D. Timer Calibration:

• Set the instrument timer for a defined period (e.g., 10 minutes).

• Use a calibrated stopwatch to verify it matches.

E. Physical Inspection:

• Inspect all baskets, discs, and tubes for cleanliness and damage.

• Ensure all parts are properly assembled and in good condition.

4. Calibration Frequency

• Daily/Before Use: Check water bath temperature and physical condition of parts.

• Monthly or Quarterly: Stroke count, height, and timer.

• Annually: Full calibration by certified personnel with traceable standards.

5. Documentation

Every calibration should be documented in a Calibration Log, including:

• Date and time

• Parameters tested

• Measured values

• Equipment used (with calibration status)

• Person performing the calibration

• Any corrective actions taken

6. Importance of Calibration

• Ensures accurate disintegration results.

• Maintains GMP compliance.

• Prevents product failures or recalls.

• Supports consistent drug performance and patient safety.

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