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