Standard Operating Procedure for Operation of Tablet Disintegration Tester

Purpose

The purpose of this SOP is to provide detailed guidelines for the proper operation of the tablet disintegration tester in pharmaceutical manufacturing. Disintegration testing is a critical quality control test that evaluates the time it takes for tablets to disintegrate into smaller particles in simulated gastrointestinal fluids. This SOP aims to ensure accurate and reliable disintegration test results, contributing to the assessment of tablet quality and compliance with regulatory standards.

Scope

This SOP applies to all personnel involved in operating the tablet disintegration tester within the pharmaceutical company.

Responsibilities

The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP.
The Production department is responsible for conducting the tablet disintegration testing.

Procedure

Preparation

Ensure that the tablet disintegration tester is clean, calibrated, and in proper working condition before starting the testing process.
Verify that all necessary accessories, such as disintegration baskets and sample cups, are available and in good condition.
Check that the tablet disintegration tester is connected to a stable power source and properly grounded.
Review the product’s batch record or quality control specifications to determine the required number of tablets for testing.

Disintegration Testing

Place the required number of tablets into the disintegration baskets or sample cups, as specified in the testing requirements.
Lower the disintegration baskets into the disintegration medium, which typically consists of simulated gastric fluid or other appropriate media.
Start the disintegration test and monitor the disintegration process for the specified time period.
After the test is completed, carefully remove the disintegration baskets from the medium and observe the extent of tablet disintegration.
Record the disintegration test results accurately in the appropriate records or data sheets.

Post-Testing

Review the disintegration test results and compare them with the predefined acceptance criteria specified in the product’s batch record or quality control specifications.
Document the disintegration test results, including the date, test parameters, and results obtained.
Take appropriate action for any tablets that do not meet the specified disintegration requirements, following the company’s standard operating procedures for out-of-specification results.
Notify the relevant departments if there are any quality issues or deviations found during the disintegration testing process.

Abbreviations

QA: Quality Assurance
SOP: Standard Operating Procedure

Documents

Tablet Disintegration Test Results Log

References

No specific references are applicable for this SOP.

SOP Version

This is version 1.0 of the SOP for Operation of Tablet Disintegration Tester.