Standard Operating Procedure for Using Sealing Machine
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the sealing machine used in the manufacturing of otic dosage forms to ensure secure and consistent sealing of containers.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the sealing machine in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the sealing machine as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the sealing process and verifying the integrity of the seals.
Maintenance Personnel: Responsible for maintaining the sealing machine in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the sealing 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 containers to be sealed as per the batch record.
4.1.2.2 Open the machine’s loading port and place the containers inside.
4.1.2.3 Close and secure the loading port.
4.1.3 Sealing Process
4.1.3.1 Select the appropriate sealing parameters (e.g., temperature, pressure, time) as per the batch record.
4.1.3.2 Start the machine and monitor the sealing process.
4.1.3.3 Ensure that each container is sealed securely and consistently.
4.1.3.4 After the sealing cycle is complete, stop the machine.
4.1.4 Unloading the Machine
4.1.4.1 Carefully remove the sealed containers from the machine.
4.1.4.2 Inspect the containers to ensure they are properly sealed and free from defects.
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 sealing 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
Sealing log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the sealing machine
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0
