Standard Operating Procedure for Filtration of Solutions
1) Purpose
The purpose of this SOP is to define the procedures for the filtration of solutions to ensure they are free of particulates and contaminants, and suitable for use in the manufacturing of injection products.
2) Scope
This SOP applies to all personnel involved in the filtration of solutions at [Company Name] used for the manufacturing of intramuscular, subcutaneous, and intravenous injection products.
3) Responsibilities
The responsibilities of this SOP include:
– Production Department: Performing the filtration of solutions.
– Quality Control (QC) Department: Testing and verifying the quality of filtered solutions.
– Quality Assurance (QA) Department: Reviewing and approving filtration procedures and records.
4) Procedure
4.1 Preparation for Filtration
4.1.1 Ensure the solution to be filtered has passed all preliminary quality control tests.
4.1.2 Verify the cleanliness and integrity of the filtration equipment and filter media.
4.2 Filtration Process
4.2.1 Assemble the filtration system according to the manufacturer’s instructions and standard operating procedures.
4.2.2 Perform a pre-use integrity test on the filter to ensure it is functioning correctly.
4.2.3 Filter the solution using the specified filter pore size and flow rate.
4.2.4 Monitor the filtration process to ensure consistent flow and absence of leaks.
4.3 Post-Filtration Testing
4.3.1 Take samples of the filtered solution for quality control testing.
4.3.2 Perform tests to verify that the solution meets specified quality criteria (e.g., sterility, absence of particulates).
4.3.3 Record test results and compare them with established acceptance criteria.
4.3.4 If the solution fails to meet quality criteria, investigate the cause and take corrective actions.
4.4 Filter Integrity Testing
4.4.1 Perform a post-use integrity test on the filter to confirm its integrity was maintained throughout the filtration process.
4.4.2 Document the results of the integrity test.
4.5 Documentation
4.5.1 Maintain records of all filtration steps, including filter lot numbers, integrity test results, and quality control test results.
4.5.2 Ensure all records are signed and dated by the responsible personnel.
5) Abbreviations, if any
– QC: Quality Control
– QA: Quality Assurance
6) Documents, if any
– Filtration Records
– Quality Control Test Records
– Filter Integrity Test Records
7) Reference, if any
– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
8) SOP Version
Version 1.0
