SOP Guide for Pharma

Elixir Department: SOP for Level Sensor Usage in Storage Tanks – V 2.0

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Elixir Department: SOP for Level Sensor Usage in Storage Tanks – V 2.0

Standard Operating Procedure for Level Sensor Usage in Storage Tanks in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/144/2025
Supersedes SOP/ELX/144/2022
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 use, monitoring, and maintenance of level sensors in storage tanks for elixirs to ensure accurate volume tracking, prevent overfilling or underutilization, and maintain GMP compliance.

2. Scope

This SOP applies to all ultrasonic, radar, capacitance, and float-type level sensors installed in bulk storage tanks, intermediate holding tanks, and day tanks used in elixir manufacturing and storage operations.

3. Responsibilities

  • Production Operator:
    • Monitor level readings on the display panel or HMI.
    • Log readings at required intervals and report anomalies.
  • Engineering Department:
    • Install, calibrate, and maintain level sensors.
    • Ensure system integrity and replace faulty sensors as required.
  • QA Officer:
    • Review calibration logs and monitor deviations during audits or reviews.
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4. Accountability

The Production Head is accountable for ensuring this SOP is followed. The Engineering Head is responsible for ensuring level sensors are accurate, functional, and

compliant.

5. Procedure

5.1 Installation and Calibration

  1. Level sensors must be installed at designated ports with validated configurations for each tank.
  2. Calibrate the sensors with known volume references or using simulation tools at least once every 6 months or as per schedule.
  3. Ensure the calibration certificate is updated and the label “CALIBRATED” is affixed.

5.2 Pre-Operation Checks

  1. Check that the sensor display or integrated panel is powered and displaying correct values.
  2. Verify that the display shows zero when the tank is empty or matches the expected level when partially filled (based on prior record).
  3. Ensure signal cables are properly insulated and free from moisture or damage.

5.3 Monitoring During Use

  1. Monitor level readings in real-time on the control panel, SCADA screen, or HMI.
  2. Record readings at specified intervals (e.g., every 30 minutes or during transfer steps) in the Level Monitoring Log (Annexure-1).
  3. Use level sensors to trigger high/low level alarms during filling and emptying operations.
  4. Ensure no manual overrides of level signals are done unless approved by QA and Engineering.
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5.4 Handling Deviations

  1. If a sudden level drop or rise is observed without corresponding material movement, pause the operation and investigate.
  2. Possible causes: air bubble interference, sensor misalignment, or signal cable fault.
  3. Record deviation, notify Engineering and QA, and tag the sensor as “UNDER INVESTIGATION.”

5.5 Post-Use Procedure

  1. After batch completion or transfer, compare final level with recorded quantity for reconciliation.
  2. Clean non-submersible sensors only with lint-free cloth and 70% IPA. Do not immerse in cleaning solution.
  3. Disconnect portable sensors and store in designated clean area, if applicable.

5.6 Preventive Maintenance

  1. Engineering must inspect sensors monthly for accuracy, signal strength, and mechanical integrity.
  2. Update preventive maintenance log and replace any faulty sensor before the next use.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • HMI: Human Machine Interface
  • SCADA: Supervisory Control and Data Acquisition

7. Documents

  1. Level Monitoring Log (Annexure-1)
  2. Calibration Certificate
  3. Preventive Maintenance Log

8. References

  • 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
  • ICH Q9 – Quality Risk Management
  • WHO TRS 986 – Instrumentation 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: Level Monitoring Log

Date Tank ID Sensor ID Level (Litres) Time Operator Remarks
11/04/2025 ST-ELX-01 LS-003 720 10:45 Rajesh Kumar Stable Reading

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 deviation management and preventive maintenance steps Process Improvement QA Head
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