Standard Operating Procedure for Use of Peristaltic Pumps in Formulation Processes
1) Purpose
This SOP describes the proper use and operation of peristaltic pumps in pharmaceutical formulation processes, including dispensing liquid ingredients and transferring formulations in a controlled manner.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of peristaltic pumps at [Company Name].
3) Responsibilities
- Operators: Responsible for setting up, operating, and cleaning the peristaltic pumps according to the process requirements.
- Quality Assurance (QA): Ensures that the flow rates and volumes meet product specifications.
- Maintenance Team: Responsible for the maintenance and calibration of the peristaltic pumps to ensure they operate within set parameters.
4) Procedure
4.1 Pre-Operation Setup
4.1.1 Equipment Inspection
- Inspect the peristaltic pump for cleanliness, and ensure it is free from damage. Check that the tubing is properly installed and that there are no cracks or leaks in the tubing system.
- Verify that the pump control panel and speed settings are functional. Document the inspection results in the equipment log.
4.1.2 Setting Up the Peristaltic Pump
- Install the correct tubing size based on the
flow rate required for the formulation process. Ensure that the tubing is securely attached to the pump head and the formulation containers.
Set the desired flow rate, volume, and pumping time according to the Batch Manufacturing Record (BMR). Record the setup parameters in the BMR.
4.2 Operation of the Peristaltic Pump
4.2.1 Pumping Procedure
- Start the peristaltic pump and monitor the flow rate and volume being transferred. Ensure that the flow is smooth and consistent, without any air bubbles or flow interruptions.
- Perform in-process checks to ensure the volume being dispensed matches the formulation specifications. Record the results in the BMR.
4.2.2 In-Process Adjustments
- If necessary, adjust the flow rate or volume to maintain consistency in the formulation process. Document any changes in the BMR.
4.3 Post-Operation Activities
4.3.1 Cleaning and Shutdown
- After completing the formulation process, turn off the peristaltic pump and disconnect the tubing. Disassemble any removable parts and clean them thoroughly using an approved cleaning agent.
- Rinse the tubing and pump components with sterile water and allow them to dry. Document the cleaning process in the cleaning log.
4.3.2 Final Documentation
- Ensure all pumping parameters, in-process checks, and cleaning activities are recorded in the Batch Manufacturing Record (BMR) and equipment log. Submit all documents to QA for approval.
4.4 Maintenance and Calibration
4.4.1 Routine Maintenance
- Inspect the peristaltic pump tubing, rollers, and motor weekly for wear and tear. Replace any worn-out components and document the maintenance activities in the maintenance log.
4.4.2 Annual Calibration
- Calibrate the flow rate control system annually to ensure accurate flow rates and volumes. Document the calibration results in the calibration log and submit for QA approval.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
6) Documents, if any
- Batch Manufacturing Record (BMR)
- Equipment Log
- Cleaning Log
- Maintenance Log
- Calibration Log
7) References, if any
- Manufacturer’s equipment manual
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Peristaltic Pump Operation Log Template
| Date | Batch No. | Flow Rate (mL/min) | Volume (mL) | Pumping Time (min) | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Flow Rate Measured | Volume Dispensed | Pumping Time | Operator Name | QA Name |