Standard Operating Procedure for Operation of Filtration Systems

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation of filtration systems in pharmaceutical manufacturing to achieve the desired product quality and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of filtration systems within the pharmaceutical manufacturing facility.

3. Responsibilities

• Production Operator: Responsible for carrying out the operation of filtration systems as per this SOP.
• Supervisor: Oversees the operation and ensures compliance with this SOP.

4. Procedure

4.1. Pre-Operation Checks

1. Inspect the filtration equipment for any visible damage, leaks, or defects. Report any issues to the supervisor.
2. Ensure that the equipment is clean and free from any residues or contaminants from previous operations.
3. Verify that all necessary utilities (e.g., electricity, compressed air) are available and functioning properly.

4.2. Setup

1. Assemble the filtration system components, including filter cartridges or membranes, as specified in the batch record or procedure.
2. Ensure that all connections are secure and properly sealed to prevent leaks.

4.3. Product Transfer

1. Transfer the product to be filtered into the appropriate vessel or tank.
2. Ensure that the product is well-mixed and ready for filtration.

4.4. Filtration Process

1. Start the filtration equipment according to the manufacturer’s instructions and the parameters specified in the batch record.
2. Monitor the filtration process closely to ensure that it proceeds as per the established parameters and criteria.
3. Record key parameters, such as flow rates, differential pressure, and time, as specified in the batch record.

4.5. Quality Checks

1. Collect samples of the filtrate at defined intervals for quality control and testing purposes.
2. Label and document the samples accurately, including the sampling time and location.
3. Conduct in-process quality checks to verify that the filtration process is meeting the desired criteria.

4.6. Post-Filtration Checks

1. Stop the filtration equipment when the process is completed or as directed by the supervisor.
2. Ensure that the product and filtration system are properly cleaned and sanitized after use.

4.7. Documentation

Properly document all aspects of the filtration system operation, including setup, parameters, quality checks, and cleaning procedures. Maintain records in a secure and accessible location for regulatory inspection.

5. Abbreviations

• GMP: Good Manufacturing Practices

6. Reference

[Insert any relevant references or standards applicable to the operation of filtration systems in the pharmaceutical industry]

7. SOP Version

This is version 1.0 of the “Operation of Filtration Systems SOP,” issued on [insert issuance date].