Standard Operating Procedure for Use of Transfer Pumps in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/107/2025 |
| Supersedes | SOP/ELX/107/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To describe the procedure for the safe, effective, and GMP-compliant use of transfer pumps for transferring liquid materials during the manufacturing of elixirs.
2. Scope
This SOP is applicable to the operation, cleaning, and maintenance of portable and fixed transfer pumps used in the Elixir Department for transferring liquids from one container to another, including manufacturing vessels, storage tanks, and holding containers.
3. Responsibilities
- Production Operator:
- Set up, operate, and clean transfer pumps as per instructions.
- Document all operations in logbooks.
- Production Supervisor:
- Verify proper pump operation and authorize batch transfer.
- QA Officer:
- Verify cleanliness and approve pump before and after use if required.
4. Accountability
The Head of Production is accountable for ensuring that transfer pumps are operated, maintained, and cleaned according to GMP and safety standards.
5. Procedure
5.1
Pre-Operation Checks
- Check that the transfer pump is cleaned, dried, and labeled as “CLEANED.”
- Verify pump type, flow capacity, and compatibility with the material to be transferred.
- Ensure all hoses, clamps, and gaskets are intact and sanitized.
- Connect the pump inlet and outlet hoses to the respective source and destination tanks/vessels.
5.2 Operating Procedure
- Prime the pump if required as per its design (e.g., centrifugal pump, diaphragm pump).
- Start the pump and monitor for abnormal noise, vibration, or leakage.
- Adjust the flow rate using the control panel or manual valve to ensure smooth and splash-free transfer.
- Do not leave the pump running unattended during transfer.
- Monitor the volume transferred using level indicators or batch flow meters.
- Stop the pump once the transfer is complete and close all valves.
5.3 Post-Operation Activities
- Disconnect hoses and drain residual liquid from the pump system.
- Transfer the pump to the cleaning area for cleaning and sanitization as per the relevant SOP.
- Label the pump as “TO BE CLEANED” if cleaning is pending.
- Record operation details in the Transfer Pump Log (Annexure-1).
5.4 Cleaning and Storage
- Flush the pump with purified water followed by cleaning agent solution and final rinse with purified water.
- Dry the pump using compressed air or natural drying in a clean area.
- Label as “CLEANED” with date, time, and signature.
- Store the pump in a covered and designated area.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
7. Documents
- Transfer Pump Log (Annexure-1)
- Equipment Cleaning Log
- Batch Manufacturing Record (BMR)
8. References
- WHO TRS 986 – GMP for Pharmaceutical Manufacturing
- 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
- ISPE Baseline Guide Vol 5 – Commissioning and Qualification
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Transfer Pump Log
| Date | Batch No. | Material | Volume (L) | Pump ID | Operator | Verified By |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1044 | Flavored Base | 300 | TP-02 | Rajesh Kumar | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included cleaning and labeling steps for traceability | Process Control Enhancement | QA Head |