Standard Operating Procedure for Using Peristaltic Pump
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the peristaltic pump used in the manufacturing of otic dosage forms to ensure accurate and consistent pumping of liquid products.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the peristaltic pump in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the peristaltic pump as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the pumping process and verifying the accuracy of the pump.
Maintenance Personnel: Responsible for maintaining the peristaltic pump in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the peristaltic pump is on a stable, level surface.
4.1.1.2 Check that the pump is clean and free of any debris.
4.1.1.3 Verify that the pump is properly calibrated and functioning.
4.1.2 Loading the Pump
4.1.2.1 Prepare the liquid product to be pumped as per the batch record.
4.1.2.2 Load the tubing into the pump head according to the manufacturer’s instructions.
4.1.3 Pumping Process
4.1.3.1 Select the appropriate flow rate and speed settings as per the batch record.
4.1.3.2 Start the pump and monitor the pumping process.
4.1.3.3 Ensure that the liquid is being pumped accurately and consistently.
4.1.3.4 After the pumping cycle is complete, stop the pump.
4.1.4 Unloading the Pump
4.1.4.1 Carefully remove the tubing from the pump head.
4.1.4.2 Inspect the tubing and pump head for any signs of wear or damage.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the pump’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 peristaltic pump 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 pump and all parts regularly to prevent contamination.
4.3.1.2 Inspect the pump for any signs of wear or damage and replace parts as necessary.
4.3.2 Troubleshooting
4.3.2.1 If the pump 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
Pumping log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the peristaltic pump
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0