Calibration of Disintegration Test Apparatus in Pharmaceuticals

1. Introduction

The Disintegration Test Apparatus is used to determine the time required for tablets or capsules to disintegrate into particles small enough to pass through a defined mesh under prescribed conditions. Calibration ensures the apparatus functions within pharmacopoeial requirements, ensuring consistent and reliable results.

2. Objective

• To verify that the disintegration test apparatus meets USP, EP, IP specifications.

• To ensure the basket-rack assembly moves at the specified frequency and distance.

• To confirm the temperature of the immersion fluid remains within specified limits.

3. Principle

Calibration checks critical parameters such as:

• Temperature Accuracy: The water bath should maintain 37 ± 2 °C.

• Strokes per Minute: Basket rack assembly should move 29–32 cycles per minute.

• Stroke Length: Vertical movement should be 55 ± 2 mm.

• Timer Accuracy: The timer should measure accurately in seconds/minutes.

4. Equipment Required

• Calibrated thermometer (±0.1 °C accuracy)

• Stopwatch or calibrated timer

• Ruler or vernier caliper (for stroke length)

• Tachometer or stopwatch (for cycle counting)

• Standard reference tablets (if performing performance verification)

5. Calibration Procedure

A. Temperature Check

1. Fill the water bath with distilled water to the required level.

2. Set the thermostat to 37.0 °C.

3. Allow stabilization for at least 15 minutes.

4. Measure the temperature in each vessel using a calibrated thermometer.

5. Acceptance Criteria: 37 ± 2 °C.

B. Stroke Frequency Check

1. Start the apparatus.

2. Count the number of complete cycles per minute using a stopwatch.

3. Acceptance Criteria: 29–32 cycles/min.

C. Stroke Length Check

1. Measure the vertical distance traveled by the basket rack using a ruler or caliper.

2. Acceptance Criteria: 55 ± 2 mm.

D. Timer Accuracy

1. Set the built-in timer to 1, 5, and 15 minutes.

2. Compare with a calibrated stopwatch.

3. Acceptance Criteria: ±1 second/minute.

6. Frequency of Calibration

• Before first use

• Monthly or as per SOP

• After repairs or relocation

7. Documentation

Calibration records should include:

• Apparatus ID and location

• Date of calibration

• Parameters checked (temperature, stroke length, strokes/min, timer)

• Observations and results

• Analyst and reviewer signatures

8. Regulatory References

• USP <701> Disintegration

• IP General Chapter on Disintegration Test

• EP 2.9.1 Disintegration of Tablets and Capsules

• WHO GMP Guidelines