Standard Operating Procedure for Using Magnetic Stirrer
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the magnetic stirrer used in the manufacturing of otic dosage forms to ensure uniform mixing of liquid products.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the magnetic stirrer in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the magnetic stirrer as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the stirring process and verifying the uniformity of the mixture.
Maintenance Personnel: Responsible for maintaining the magnetic stirrer in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the magnetic stirrer is on a stable, level surface.
4.1.1.2 Check that the stirrer is clean and free of any debris.
4.1.1.3 Verify that the stirrer is properly calibrated and functioning.
4.1.2 Loading the Stirrer
4.1.2.1 Prepare the liquid product to be mixed as per the batch record.
4.1.2.2 Place a clean magnetic stir bar into the container with the liquid product.
4.1.3 Stirring Process
4.1.3.1 Select the appropriate stirring speed and duration as per the batch record.
4.1.3.2 Start the stirrer and monitor the mixing process.
4.1.3.3 Ensure that the liquid is being mixed uniformly and consistently.
4.1.3.4 After the stirring cycle is complete, stop the stirrer.
4.1.4 Unloading the Stirrer
4.1.4.1 Carefully remove the container from the stirrer platform.
4.1.4.2 Remove the magnetic stir bar from the container and clean it thoroughly.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the stirrer’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 magnetic stirrer 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 stirrer and all parts regularly to prevent contamination.
4.3.1.2 Inspect the stirrer for any signs of wear or damage and replace parts as necessary.
4.3.2 Troubleshooting
4.3.2.1 If the stirrer 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
Stirring log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the magnetic stirrer
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0