Standard Operating Procedure for Filling Machine Operation
1) Purpose
The purpose of this SOP is to outline the procedures for operating the filling machine to ensure accurate and sterile filling of injection products.
2) Scope
This SOP applies to all personnel involved in operating the filling machine at [Company Name] for the production of intramuscular, subcutaneous, and intravenous injection products.
3) Responsibilities
The responsibilities of this SOP include:
– Production Operators: Operating the filling machine according to the SOP.
– Maintenance Personnel: Ensuring the filling machine is in good working condition.
– Quality Assurance (QA) Department: Reviewing and approving filling machine operation procedures and records.
4) Procedure
4.1 Preparation for Filling
4.1.1 Ensure the filling machine and surrounding area are clean and disinfected.
4.1.2 Verify that the product to be filled has passed all preliminary quality control tests.
4.1.3 Ensure all materials (e.g., vials, stoppers) are sterilized and ready for use.
4.2 Filling Machine Setup
4.2.1 Set up the filling machine according to the manufacturer’s instructions.
4.2.2 Perform a pre-use check to ensure the machine is functioning correctly.
4.2.3 Calibrate the machine to ensure accurate fill volumes.
4.3 Filling Operation
4.3.1 Start the filling machine and monitor its operation.
4.3.2 Ensure vials are filled accurately and consistently.
4.3.3 Replace stoppers and caps as needed during the filling process.
4.3.4 Monitor for any issues (e.g., leaks, inconsistencies) and address them immediately.
4.4 Quality Control Checks
4.4.1 Take samples of filled vials for quality control testing.
4.4.2 Perform tests to verify that the fill volume and sterility meet specified criteria.
4.4.3 Record test results and compare them with established acceptance criteria.
4.4.4 If the product fails to meet quality criteria, investigate the cause and take corrective actions.
4.5 Shutdown and Cleanup
4.5.1 Once filling is complete, shut down the machine according to the manufacturer’s instructions.
4.5.2 Clean and disinfect the filling machine and surrounding area.
4.5.3 Perform a post-use check to ensure the machine is ready for the next operation.
4.6 Documentation
4.6.1 Maintain records of all filling machine operations, including setup, calibration, quality control checks, and maintenance activities.
4.6.2 Ensure all records are signed and dated by the responsible personnel.
5) Abbreviations, if any
– QA: Quality Assurance
6) Documents, if any
– Filling Machine Operation Records
– Quality Control Test Records
– Maintenance Logs
7) Reference, if any
– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
– Filling Machine Manufacturer’s Manual
8) SOP Version
Version 1.0