Standard Operating Procedure for Using Sterilization Tunnel
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the sterilization tunnel used in the manufacturing of otic dosage forms to ensure effective sterilization of containers and closures.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the sterilization tunnel in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the sterilization tunnel as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the sterilization process and verifying results.
Maintenance Personnel: Responsible for maintaining the sterilization tunnel in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the sterilization tunnel is on a stable, level surface.
4.1.1.2 Check that the tunnel is clean and free of any debris.
4.1.1.3 Verify that the tunnel is properly calibrated and functioning.
4.1.2 Loading the Tunnel
4.1.2.1 Arrange the containers and closures to be sterilized on the conveyor belt, ensuring there is space between them for air circulation.
4.1.2.2 Start the conveyor belt and feed the items into the tunnel.
4.1.3 Sterilization Process
4.1.3.1 Select the appropriate temperature and time settings for the sterilization process.
4.1.3.2 Start the tunnel and monitor the process.
4.1.3.3 Allow the sterilization cycle to complete and ensure the tunnel reaches the required conditions for sterilization.
4.1.3.4 After the cycle is complete, allow the items to exit the tunnel and cool down.
4.1.4 Unloading the Tunnel
4.1.4.1 Carefully remove the sterilized items from the conveyor belt.
4.1.4.2 Inspect the items to ensure they are free from contamination and damage.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the tunnel’s temperature 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 sterilization tunnel 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 tunnel and all parts regularly to prevent contamination.
4.3.1.2 Inspect the tunnel for any signs of wear or damage and replace parts as necessary.
4.3.2 Troubleshooting
4.3.2.1 If the tunnel 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
Sterilization log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the sterilization tunnel
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0
