Standard Operating Procedure for Membrane Filtration System
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Membrane Filtration System used in the pharmaceutical manufacturing of otic dosage forms to ensure effective filtration of liquids.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Membrane Filtration System in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Membrane Filtration System as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of filtration processes.
Maintenance Personnel: Responsible for maintaining the Membrane Filtration System in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Membrane Filtration System for cleanliness and integrity before use.
4.1.1.2 Ensure all inlet and outlet connections, membranes, and pressure gauges are clean and in good condition.
4.1.1.3 Verify that all safety devices and interlocks are functioning properly.
4.1.2 Preparation
4.1.2.1 Clean and sanitize the Membrane Filtration System and surrounding area.
4.1.2.2 Check and prepare all utilities (water, compressed air, etc.) required for
4.1.2.3 Ensure all process parameters (pressure, flow rate, temperature) are set according to filtration requirements.
4.2 Operation
4.2.1 Filtration Process
4.2.1.1 Start the Membrane Filtration System and ensure proper flow and pressure conditions.
4.2.1.2 Monitor filtration process parameters and adjust as necessary.
4.2.1.3 Replace membranes or clean filters as per standard operating procedures.
4.2.2 Quality Assurance
4.2.2.1 Perform integrity tests and quality checks on filtered product.
4.2.2.2 Record all critical parameters and observations during the filtration process.
4.2.2.3 Implement corrective actions for any deviations from specified parameters.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the filtration process and ensure all product is properly collected.
4.3.1.2 Clean and sanitize the Membrane Filtration System and associated equipment thoroughly.
4.3.1.3 Perform post-operation checks to ensure no residual product in the Membrane Filtration System.
4.3.2 Maintenance
4.3.2.1 Clean filtration membranes and check for any damage after each use.
4.3.2.2 Schedule regular maintenance for valves, pumps, and pressure gauges.
4.3.2.3 Document all maintenance activities and update maintenance records accordingly.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Batch records for each filtration batch
Maintenance records
Calibration records for pressure gauges and flow meters
7) Reference, if any
Manufacturer’s manual for the Membrane Filtration System
Pharmacopeial guidelines for pharmaceutical filtration processes
8) SOP Version
Version 1.0