Standard Operating Procedure for Filling Machines
1) Purpose
The purpose of this SOP is to provide guidelines for the operation and maintenance of filling machines used in the manufacturing of dental dosage forms to ensure accurate filling and compliance with regulatory standards.
2) Scope
This SOP applies to all filling machines used in the manufacturing process of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for operating and cleaning the filling machines. The Quality Assurance (QA) Department is responsible for verifying and documenting compliance with this SOP.
4) Procedure
4.1 Preparation
4.1.1 Verify that the filling machine is clean and in good working condition before use.
4.1.2 Ensure all containers and caps are prepared and ready for filling according to the batch record.
4.2 Setup and Calibration
4.2.1 Set up the filling machine as per the manufacturer’s instructions and batch record requirements.
4.2.2 Calibrate the filling machine to ensure accurate volume or weight measurements.
4.2.3 Verify calibration with standard weights or volumes as per the batch record.
4.3 Filling Operation
4.3.1 Start the filling machine and adjust the settings as per the batch record (e.g., fill volume, speed).
4.3.2 Place containers under the filling nozzles and initiate the filling process.
4.3.3 Monitor the filling process to ensure
4.3.4 Record start time, end time, and any deviations observed during filling in the batch record.
4.4 Cap Sealing
4.4.1 After filling, move containers to the cap sealing station according to batch record specifications.
4.4.2 Ensure caps are properly aligned and sealed onto containers using the cap sealing machine.
4.4.3 Inspect sealed containers for proper closure and integrity.
4.5 Cleaning
4.5.1 After use, turn off the filling machine and disconnect it from the power source.
4.5.2 Disassemble parts of the filling machine and clean all contact surfaces using approved cleaning agents.
4.5.3 Rinse thoroughly with purified water to remove any residual cleaning agents.
4.5.4 Inspect the filling machine for cleanliness and reassemble it after it is completely dry.
4.6 Maintenance
4.6.1 Perform regular preventive maintenance on the filling machine as per the manufacturer’s guidelines.
4.6.2 Record all maintenance activities in the equipment maintenance log.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
Batch Record
Equipment Maintenance Log
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0
