Standard Operating Procedure for Bottle Filling Machines
1) Purpose
The purpose of this SOP is to provide guidelines for the operation and maintenance of bottle filling machines used in the manufacturing of dental dosage forms to ensure accurate and consistent filling of bottles and compliance with regulatory standards.
2) Scope
This SOP applies to all bottle 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 bottle 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 bottle filling machine is clean and in good working condition before use.
4.1.2 Ensure all bottles and caps are prepared and ready for filling according to the batch record.
4.2 Setup and Calibration
4.2.1 Set up the bottle filling machine as per the manufacturer’s instructions and batch record requirements.
4.2.2 Calibrate the bottle filling machine to ensure accurate filling of bottles (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 bottle filling machine and adjust the settings as per the batch record (e.g., fill volume, speed).
4.3.2 Place bottles under the filling nozzles and initiate the filling process.
4.3.3 Monitor the filling process to ensure accurate and consistent filling of bottles.
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 filled bottles to the cap sealing station according to batch record specifications.
4.4.2 Ensure caps are properly aligned and sealed onto bottles using the cap sealing machine.
4.4.3 Inspect sealed bottles for proper closure and integrity.
4.5 Cleaning
4.5.1 After use, turn off the bottle filling machine and disconnect it from the power source.
4.5.2 Disassemble parts of the bottle 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 bottle filling machine for cleanliness and reassemble it after it is completely dry.
4.6 Maintenance
4.6.1 Perform regular preventive maintenance on the bottle 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
