Standard Operating Procedure for Filter Integrity Testing

1) Purpose

The purpose of this SOP is to outline the procedure for performing filter integrity testing to ensure that the sterile filters used in the production of ocular dosage forms are functioning correctly and effectively retaining microorganisms.

2) Scope

This SOP applies to all sterile filters used in the production of ocular dosage forms within the pharmaceutical manufacturing facility, ensuring the integrity of the filters before and after use.

3) Responsibilities

The responsibilities include performing the filter integrity tests, documenting the results, and maintaining the testing equipment. Production staff are responsible for following this procedure, and the maintenance team is responsible for regular checks and calibration of the testing equipment.

4) Procedure

4.1 Pre-Use Integrity Testing

1. Assemble the filter system and ensure it is properly connected to the integrity testing equipment.
2. Prime the filter with sterile water or an appropriate test fluid as specified by the filter manufacturer.
3. Perform the integrity test (e.g., bubble point test, diffusion test, or pressure hold test) according to the filter manufacturer’s instructions.
4. Record the test results, ensuring they meet the acceptance criteria specified by the filter manufacturer.
5. If the filter fails the integrity test, replace it with a new filter and repeat the testing procedure.

4.2 Post-Use Integrity Testing

1. After the filtration process, perform the integrity test on the used filter to ensure it remained intact throughout the process.
2. Use the same testing method as the pre-use integrity test (e.g., bubble point test, diffusion test, or pressure hold test).
3. Record the test results, ensuring they meet the acceptance criteria specified by the filter manufacturer.
4. If the filter fails the post-use integrity test, investigate the cause and assess the impact on the product batch. Follow the facility’s deviation handling procedures.

4.3 Maintenance and Calibration

1. Perform regular maintenance on the filter integrity testing equipment as per the manufacturer’s recommendations.
2. Calibrate the integrity testing equipment periodically to ensure accurate results.
3. Document all maintenance and calibration activities in the equipment logbook.

5) Abbreviations, if any

None

6) Documents, if any

1. Integrity test records
2. Equipment logbook
3. Calibration certificates

7) Reference, if any

GMP Guidelines for filter integrity testing in pharmaceutical manufacturing.

8) SOP Version

Version 1.0