Procedures for Conducting Disintegration Tests on Capsules

1) Purpose

The purpose of this SOP is to provide detailed guidelines for conducting disintegration tests to determine how quickly capsules disintegrate in a specified liquid medium.

2) Scope

This SOP applies to all disintegration tests conducted on capsules within the pharmaceutical manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing disintegration tests and documenting the results.

4) Procedure

1. Preparation for Disintegration Testing:
   1. Ensure that the disintegration testing apparatus is calibrated and clean.
   2. Prepare the liquid medium as specified in the test method.
   3. Label and prepare the capsules to be tested.
2. Performing the Disintegration Test:
   1. Place the capsules in the disintegration apparatus.
   2. Immerse the capsules in the liquid medium and start the apparatus.
   3. Record the time taken for each capsule to disintegrate completely in the disintegration test logbook.
3. Recording and Interpreting Results:
   1. Document the disintegration times for each capsule.
   2. Compare the results to the specified acceptance criteria.
   3. If any capsule fails to disintegrate within the acceptable time range, document the deviation and investigate the cause.
4. Handling Deviations:
   1. Identify and document any deviations from the specified acceptance criteria.
   2. Conduct a root cause analysis to determine the reason for the deviation.
   3. Implement corrective actions to address the deviation and prevent recurrence.
5. Documentation and Review:
   1. Record