Standard Operating Procedure for Sterile Filtration

1) Purpose

The purpose of this SOP is to provide guidelines for the sterile filtration process used in the production of ocular dosage forms, ensuring the removal of microorganisms and particulates from the product solutions.

2) Scope

This SOP applies to all sterile filtration processes involved in the production of ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include performing the sterile filtration process, monitoring the filtration system, and maintaining the equipment. Production staff are responsible for following this procedure, and the maintenance team is responsible for regular checks and servicing.

4) Procedure

4.1 Preparation

1. Ensure all components of the filtration system are clean and sterilized.
2. Assemble the filtration system in a sterile environment, using sterile gloves and tools.
3. Prepare the product solution to be filtered, ensuring it is within the required specifications.

4.2 Filtration Process

1. Connect the sterile filter to the filtration system, ensuring all connections are secure and leak-proof.
2. Prime the filter with a small volume of the product solution to remove any air bubbles.
3. Begin the filtration process, maintaining a steady flow rate as specified in the product batch record.
4. Monitor the pressure differential across the filter throughout the process to ensure it remains within acceptable limits.
5. Collect the filtrate in a sterile container, ensuring the container is properly labeled with the batch number and date.

4.3 Post-Filtration

1. Inspect the filter for integrity by performing a filter integrity test (e.g., bubble point test) as per the manufacturer’s guidelines.
2. Document the results of the filter integrity test in the batch record.
3. Dispose of the used filter and any waste materials according to the facility’s waste disposal procedures.
4. Clean and sanitize the filtration system components as per the standard cleaning procedures.

4.4 Maintenance

1. Perform regular maintenance of the filtration system as per the manufacturer’s recommendations.
2. Check and replace any worn or damaged parts to ensure the system’s reliability.
3. Document all maintenance activities in the maintenance logbook.

5) Abbreviations, if any

None

6) Documents, if any

1. Batch record
2. Maintenance logbook
3. Filter integrity test results

7) Reference, if any

GMP Guidelines for sterile filtration processes in pharmaceutical manufacturing.

8) SOP Version

Version 1.0