SOP Guide for Pharma

Elixir Department: SOP for Pressure Relief Valve Operation – V 2.0

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Elixir Department: SOP for Pressure Relief Valve Operation – V 2.0

Standard Operating Procedure for Pressure Relief Valve Operation in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/154/2025
Supersedes SOP/ELX/154/2022
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 procedure for the correct operation, inspection, and maintenance of pressure relief valves (PRVs) installed in the elixir manufacturing area to protect equipment and personnel from overpressure scenarios.

2. Scope

This SOP applies to all pressure relief valves installed on mixing tanks, transfer lines, holding vessels, and CIP/SIP systems in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Monitor PRV indicators during operation and report anomalies.
    • Record any activation or maintenance activity in the PRV Logbook.
  • Engineering Department:
    • Perform installation, testing, calibration, and maintenance of PRVs.
    • Ensure PRVs are tagged, functional, and within calibration validity.
  • QA Officer:
    • Review PRV status during batch review and audit readiness inspections.
See also  Elixir Department: SOP for Use of Barcode Systems During Dispensing - V 2.0

4. Accountability

The Engineering Head is accountable for PRV safety and calibration. The Production Head is responsible for operator awareness and incident reporting.

5. Procedure

5.1 Description of PRVs

Pressure Relief Valves are spring-loaded or pilot-operated safety devices that automatically open to relieve internal pressure when it exceeds a predefined setpoint. These valves prevent pressure buildup that could damage equipment or compromise batch integrity.

5.2 Pre-Operation Checks

  1. Visually inspect the PRV for physical damage, leaks, or dust accumulation.
  2. Verify that the calibration tag is present and valid (calibrated within the last 6 months).
  3. Ensure the valve outlet is not obstructed and is directed to a safe discharge area.
  4. Confirm that the set pressure matches the design specification for the equipment.

5.3 During Operation

  1. Monitor pressure gauges on associated equipment regularly.
  2. If the PRV activates:
    • Stop the ongoing process immediately.
    • Record the incident in the PRV Logbook (Annexure-1).
    • Inform Engineering and QA without delay.
  3. Do not attempt to reset the PRV manually unless trained and authorized.
See also  Elixir Department: SOP for Compatibility Testing with Containers - V 2.0

5.4 Post-Activation Inspection

  1. Engineering must inspect the PRV and associated pressure line for integrity.
  2. Clean or replace the PRV if it was fouled or stuck during activation.
  3. Conduct functionality test using nitrogen or water under pressure simulation.
  4. Record findings and actions taken in the Maintenance Logbook (Annexure-2).

5.5 Preventive Maintenance

  1. Every 6 months, remove and calibrate each PRV at the approved calibration lab.
  2. Replace the PRV if it fails to reseat or leaks during bench test.
  3. Update calibration certificate and tag after successful verification.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • PRV: Pressure Relief Valve
  • QA: Quality Assurance
  • CIP: Clean-In-Place
  • SIP: Steam-In-Place

7. Documents

  1. PRV Activation and Inspection Logbook (Annexure-1)
  2. Maintenance and Calibration Log (Annexure-2)
  3. Calibration Certificate (external or internal)

See also  Elixir Department: SOP for Addition of Volatile Solvents Under Fume Hood - V 2.0

8. References

  • 21 CFR Part 211 – Equipment Safety and Maintenance
  • WHO TRS 1010 – Utility and Engineering Controls in Pharma
  • GAMP 5 – Engineering Practice for Pressure Safety Devices

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: PRV Activation and Inspection Logbook

Date PRV ID Equipment Activation Pressure Operator Remarks
11/04/2025 PRV-ELX-09 MXR-03 2.2 bar Sunita Reddy Activated during heating; Engineering notified

Annexure-2: Maintenance and Calibration Log

Date PRV ID Calibrated Pressure Status Technician Remarks
10/04/2025 PRV-ELX-09 2.0 bar PASS Ramesh Nair Calibrated and reseated

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 CIP/SIP valve references Process Expansion QA Head
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