Standard Operating Procedure for Using Liquid Filling Machine
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the liquid filling machine used in the manufacturing of otic dosage forms to ensure accurate and consistent filling of liquid products.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the liquid filling machine in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the liquid filling machine as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the filling process and verifying the accuracy of the fill volumes.
Maintenance Personnel: Responsible for maintaining the liquid filling machine in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the liquid filling machine is on a stable, level surface.
4.1.1.2 Check that the machine is clean and free of any debris.
4.1.1.3 Verify that the machine is properly calibrated and functioning.
4.1.2 Loading the Machine
4.1.2.1 Prepare the liquid product to be filled as per the batch record.
4.1.2.2 Open the machine’s loading port
4.1.2.3 Close and secure the loading port.
4.1.3 Filling Process
4.1.3.1 Select the appropriate fill volume and speed settings as per the batch record.
4.1.3.2 Start the machine and monitor the filling process.
4.1.3.3 Ensure that each container is filled accurately to the specified volume.
4.1.3.4 After the filling cycle is complete, stop the machine.
4.1.4 Unloading the Machine
4.1.4.1 Carefully remove the filled containers from the machine.
4.1.4.2 Inspect the containers to ensure they are free from contamination and properly sealed.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the machine’s settings and indicators.
4.2.1.2 Record the results in the equipment log.
4.2.2 Monthly Calibration
4.2.2.1 Conduct a full calibration of the liquid filling machine monthly using standard test methods.
4.2.2.2 Document the calibration results and any adjustments made.
4.3 Maintenance
4.3.1 Routine Maintenance
4.3.1.1 Clean the machine and all parts regularly to prevent contamination.
4.3.1.2 Inspect the machine for any signs of wear or damage and replace parts as necessary.
4.3.2 Troubleshooting
4.3.2.1 If the machine displays error messages or fails to reach the required conditions, refer to the manufacturer’s manual for troubleshooting steps.
4.3.2.2 Contact maintenance personnel if the issue cannot be resolved.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Filling log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the liquid filling machine
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0