SOP Guide for Pharma

Elixir Department: SOP for Operation of Level Control Valves – V 2.0

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Elixir Department: SOP for Operation of Level Control Valves – V 2.0

Standard Operating Procedure for Operation of Level Control Valves in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/148/2025
Supersedes SOP/ELX/148/2022
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 standardized procedure for the operation, adjustment, and monitoring of level control valves (LCVs) used in tanks and pipelines during elixir manufacturing processes to maintain optimal fluid levels and prevent overflow or dry run conditions.

2. Scope

This SOP applies to all pneumatic, electric, and mechanical level control valves installed in raw material tanks, holding vessels, blending tanks, and transfer lines in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Monitor valve operation and ensure fluid levels are within permissible range.
    • Log LCV operation data in the Level Valve Operation Logbook.
  • Engineering Department:
    • Install, calibrate, and maintain LCVs as per specifications.
    • Perform preventive maintenance and troubleshoot issues.
  • QA Officer:
    • Verify calibration records and review valve operation during batch review.
See also  Elixir Department: SOP for Dispensing Excipients for Oral Liquid Formulations - V 2.0

4. Accountability

The Production Head is accountable for proper valve usage during manufacturing. The Engineering Head is responsible for valve calibration and

functionality.

5. Procedure

5.1 Pre-Operation Checks

  1. Verify the valve label, calibration status, and functionality status tag.
  2. Ensure signal cable (in case of electric/pneumatic LCV) is properly connected to control system or HMI.
  3. Check for visible leaks, corrosion, or mechanical damage on the valve body or actuator.

5.2 Operating the Level Control Valve

  1. Set the desired minimum and maximum fluid level setpoints on the control panel or valve controller.
  2. Start the process (filling, transfer, blending) and monitor level feedback via SCADA or display panel.
  3. The LCV will automatically open or close based on real-time sensor input to maintain target levels.
  4. Manually override the valve operation only in case of sensor failure or during maintenance (with QA permission).
See also  Elixir Department: SOP for Visual Inspection Post Cleaning - V 2.0

5.3 Manual Operation Procedure (if required)

  1. Switch the valve to “Manual” mode using the selector on the control panel or valve actuator.
  2. Slowly operate the handwheel (mechanical) or jog switch (electrical) to adjust the valve opening.
  3. Continuously monitor the level during manual operation to prevent overfill or spillage.
  4. Return to “Auto” mode after completion of the operation and document the reason for manual intervention.

5.4 Monitoring and Logging

  1. Record operation start and end times, valve position changes, and level variations in the Valve Operation Logbook (Annexure-1).
  2. Log any abnormality or deviation observed and escalate to Engineering and QA.

5.5 Preventive Maintenance

  1. Clean valve surfaces monthly and lubricate moving parts where applicable.
  2. Inspect actuator seals, diaphragms, and sensors every quarter for wear and replace if necessary.
  3. Calibrate valve actuation response and feedback signal every 6 months using simulation tools.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • LCV: Level Control Valve
  • QA: Quality Assurance
  • HMI: Human Machine Interface
  • SCADA: Supervisory Control and Data Acquisition
See also  Elixir Department: SOP for Identification and Traceability of Manufacturing Tanks - V 2.0

7. Documents

  1. Level Valve Operation Logbook (Annexure-1)
  2. Calibration Certificate
  3. Maintenance Checklist

8. References

  • 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
  • WHO TRS 1010 – Instrumentation and Valve Control
  • 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: Level Valve Operation Logbook

Date Tank ID Valve ID Start Time End Time Setpoint Range (L) Operator Remarks
11/04/2025 TK-ELX-04 LCV-07 10:15 10:40 500–700 Rajesh Kumar Auto Functioning – No Deviations

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 manual override and SCADA linkage sections System Integration QA Head
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