Standard Operating Procedure for Operation of Recirculation Loops in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/135/2025 |
| Supersedes | SOP/ELX/135/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To outline the standard procedure for the proper operation of recirculation loops used during elixir manufacturing to ensure uniform mixing, homogeneity, and temperature consistency of the bulk solution.
2. Scope
This SOP applies to all recirculation systems connected to mixing tanks, holding vessels, or transfer lines used in the Elixir Department for continuous or batch processing operations.
3. Responsibilities
- Production Operator:
- Setup and monitor the recirculation loop as per batch instructions.
- Ensure smooth operation without leakage or contamination.
- Engineering Department:
- Maintain pumps, valves, and flow meters associated with recirculation loops.
- QA Officer:
- Verify loop cleaning status, and review records for compliance.
4. Accountability
The Production Head is accountable for the implementation of this SOP, and the Engineering Head is responsible for equipment integrity and preventive maintenance.
5. Procedure
5.1 Pre-Operation Checks
- Ensure the
recirculation loop is labeled “CLEANED” and released by QA.
Check the integrity of pump seals, connections, valves, and flow meters.
Verify that the loop is connected to the correct tank as mentioned in the BMR.
5.2 Startup Procedure
- Open inlet and outlet valves of the recirculation line.
- Start the pump at a low flow rate to avoid air entrapment and gradually increase to operating capacity.
- Monitor the loop pressure and flow rate to match the validated parameters.
- Observe for vibration, noise, or leakage during operation.
5.3 During Operation
- Continue recirculation for the defined duration (e.g., 30–60 minutes) as per BMR.
- Check temperature and pH (if required) at inlet and outlet to ensure consistency.
- Take samples after stabilization (if specified) for homogeneity or microbiological testing.
- Record flow rate, duration, and temperature every 10–15 minutes.
5.4 Shutdown and Cleaning
- Switch off the pump and close all inlet/outlet valves.
- Drain the loop if required or initiate CIP cycle as per equipment configuration.
- Disassemble detachable parts (if manual cleaning required) and clean with validated cleaning solution.
- Dry and reassemble the loop or leave the system in CIP standby mode.
5.5 Safety and Precautions
- Ensure no air pockets remain in the system before starting recirculation.
- Do not operate pumps dry or at high RPMs without fluid.
- Use PPE while handling heated or flammable materials.
- Ensure flow direction and loop connection is confirmed by the supervisor before use.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- CIP: Clean-in-Place
7. Documents
- Recirculation Loop Log (Annexure-1)
- BMR for respective batch
- CIP Verification Sheet (if applicable)
8. References
- 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
- ICH Q9 – Quality Risk Management
- WHO TRS 1010 – GMP Equipment Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Recirculation Loop Log
| Date | Batch No. | Equipment ID | Start Time | End Time | Flow Rate (LPM) | Temperature (°C) | Operator | Remarks |
|---|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1063 | RC-01 | 09:00 | 09:40 | 12 | 32.5 | Rajesh Kumar | Uniform Mixing Achieved |
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 | Added troubleshooting and inline monitoring points | Process Optimization | QA Head |