Standard Operating Procedure for Use of Cooling Towers and Condensers in Recovery Process in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/060/2025 |
| Supersedes | SOP/API/060/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a controlled and standardized procedure for operating cooling towers and condensers used in solvent recovery during API manufacturing, ensuring safe, efficient, and GMP-compliant condensation of solvent vapors.
2. Scope
This SOP applies to all cooling tower and condenser operations supporting solvent recovery systems within the API manufacturing unit, including distillation columns, vacuum condensers, and storage chillers.
3. Responsibilities
- Operators: Start, monitor, and shut down cooling tower and condenser systems as per instructions.
- Engineering Department: Maintain the mechanical and electrical health of the cooling system.
- QA Department: Review operation logs and ensure adherence to validated parameters.
4. Accountability
The Engineering Head is accountable for the reliable performance of cooling and condensation systems. The Production Head is accountable for ensuring the systems are used as per validated recovery protocols.
5. Procedure
5.1 System Preparation
- Ensure cooling water is available in the recirculation tank and level is within limits.
- Check fan motor, pump, pipelines, and temperature gauges for proper condition.
- Clean condenser tubes if fouling is detected as per maintenance SOP.
- Ensure proper flow rate and temperature settings are available in the SCADA system or manual logbook.
5.2 Starting the Cooling System
- Start the circulation pump of the cooling tower.
- Start the condenser unit along with the distillation setup.
- Set target cooling water inlet and outlet temperatures (e.g., 28°C in, 35°C out).
- Record initial conditions in the “Cooling System Operation Log” (Annexure-1).
5.3 Monitoring During Operation
- Check and record:
- Water flow rate (LPM)
- Inlet and outlet temperatures
- Pressure drop across condenser
- Ensure condenser remains free from scaling and vapor bypass.
- In case of temperature rise above set point:
- Inspect fan, pump, and water tank levels
- Check for vapor leaks or fouling
5.4 Stopping the System
- After recovery, stop condenser and allow system to cool.
- Stop the cooling tower pump and fan.
- Clean the condenser and log activity in the “Equipment Cleaning Record”.
5.5 Preventive Maintenance
- Engineering team to perform:
- Descaling of condenser tubes every 3 months
- Lubrication of fan motor bearings monthly
- Cooling water quality checks monthly (Annexure-2)
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- SCADA: Supervisory Control and Data Acquisition
- LPM: Liters Per Minute
7. Documents
- Cooling System Operation Log (Annexure-1)
- Cooling Water Quality Report (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- US FDA 21 CFR Part 211 – Subpart D: Equipment
- Internal Maintenance SOP Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cooling System Operation Log
| Date | Batch No. | Inlet Temp (°C) | Outlet Temp (°C) | Flow Rate (LPM) | Operator |
|---|---|---|---|---|---|
| 13/04/2025 | REC-20250413 | 28 | 34 | 180 |
Annexure-2: Cooling Water Quality Report
| Date | pH | Hardness (ppm) | Conductivity (µS/cm) | Chlorides (ppm) | Remarks |
|---|---|---|---|---|---|
| 10/04/2025 | 7.2 | 120 | 140 | 15 | Acceptable |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | GMP Implementation | QA Head |
| 13/04/2025 | 2.0 | Updated with Flow Monitoring and Cleaning Details | Audit Suggestion | QA Head |