Standard Operating Procedure for Using Pressure Gauges During Filtration in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/136/2025 |
| Supersedes | SOP/ELX/136/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standard procedure for monitoring, interpreting, and recording pressure readings using pressure gauges during filtration processes in elixir manufacturing. Accurate pressure monitoring helps in identifying filter integrity, clogging, and ensuring consistent product quality.
2. Scope
This SOP is applicable to all pressure gauges installed on filter housings, transfer lines, and tanks used for the filtration of elixirs including sugar-based, alcohol-based, and aqueous formulations in the Elixir Department.
3. Responsibilities
- Production Operator:
- Read and record pressure gauge values during filtration.
- Inform supervisor in case of abnormal pressure rise or drop.
- Production Supervisor:
- Verify records and ensure preventive actions are taken when deviations occur.
- Engineering Department:
- Calibrate pressure gauges and maintain mechanical integrity.
- QA Officer:
- Ensure pressure logs are complete and review for batch release.
4. Accountability
The Production Head is accountable for implementation, and the Engineering Head is accountable for the calibration
and maintenance of pressure monitoring instruments.
5. Procedure
5.1 Pre-Operation Checks
- Ensure the pressure gauge is labeled “CALIBRATED” and is within due date.
- Verify proper installation of the gauge on the filter inlet and outlet ports.
- Check that no visible cracks, leaks, or mechanical damage are present on the dial or connection.
5.2 Monitoring During Filtration
- Start the filtration process and record the initial inlet and outlet pressure.
- Monitor the pressure every 15 minutes or as specified in the BMR.
- Maintain differential pressure within validated limits (e.g., 0.5–1.5 bar).
- Watch for:
- Sudden pressure rise — may indicate clogging or blockage
- Sudden pressure drop — may indicate leakage or rupture
- Immediately pause filtration and inform the supervisor if deviations are observed.
5.3 Post-Filtration Checks
- Record final pressure readings.
- Ensure that pressure returns to ambient once the system is shut down.
- Document any anomalies or pressure-related incidents in the deviation log.
5.4 Preventive Maintenance
- Engineering team must:
- Calibrate pressure gauges every 6 months or as per calibration schedule.
- Replace damaged, inaccurate, or rusted gauges.
5.5 Safety and Precautions
- Do not operate gauges beyond their maximum pressure rating.
- Never tap, hammer, or apply mechanical force on gauge bodies.
- Use protective barriers for high-pressure filtration setups.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- PSI: Pounds per Square Inch
7. Documents
- Pressure Gauge Monitoring Log (Annexure-1)
- BMR Filtration Sheet
- Calibration Certificate
8. References
- 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
- WHO GMP Guidelines – Equipment Monitoring
- ICH Q9 – Quality Risk Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Pressure Gauge Monitoring Log
| Date | Batch No. | Filter ID | Inlet Pressure (bar) | Outlet Pressure (bar) | Differential Pressure (bar) | Operator | Remarks |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1064 | F-05 | 1.5 | 0.7 | 0.8 | Sunita Reddy | Within Limit |
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 monitoring frequency and safety protocols | Process Control Update | QA Head |