Standard Operating Procedure for Tube Filling Machines
1) Purpose
The purpose of this SOP is to provide guidelines for the operation and maintenance of tube filling machines used in the manufacturing of dental dosage forms to ensure accurate and consistent filling of tubes and compliance with regulatory standards.
2) Scope
This SOP applies to all tube 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 tube 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 tube filling machine is clean and in good working condition before use.
4.1.2 Ensure all tubes and caps are prepared and ready for filling according to the batch record.
4.2 Setup and Calibration
4.2.1 Set up the tube filling machine as per the manufacturer’s instructions and batch record requirements.
4.2.2 Calibrate the tube filling machine to ensure accurate filling of tubes (volume or weight).
4.2.3 Verify calibration with standard weights or volumes as per the batch record.
4.3 Filling Operation
4.3.1 Start the tube filling machine and adjust the settings as per the batch record (e.g., fill volume, speed).
4.3.2 Load tubes into the filling station and initiate the filling process.
4.3.3 Monitor the filling process to ensure accurate and consistent filling of tubes.
4.3.4 Record start time, end time, and any deviations observed during filling in the batch record.
4.4 Sealing and Coding
4.4.1 After filling, move filled tubes to the sealing station according to batch record specifications.
4.4.2 Seal tubes with caps or closures as required, ensuring proper sealing integrity.
4.4.3 Code tubes with batch information and expiry dates using coding equipment.
4.5 Cleaning
4.5.1 After use, turn off the tube filling machine and disconnect it from the power source.
4.5.2 Disassemble parts of the tube 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 tube filling machine for cleanliness and reassemble it after it is completely dry.
4.6 Maintenance
4.6.1 Perform regular preventive maintenance on the tube 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
