Elixir Department: SOP for Real-time Monitoring Sensors for Temperature – V 2.0

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Elixir Department: SOP for Real-time Monitoring Sensors for Temperature – V 2.0

Standard Operating Procedure for Real-time Monitoring Sensors for Temperature in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/143/2025
Supersedes SOP/ELX/143/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the procedure for the installation, calibration, operation, and monitoring of real-time temperature sensors used in elixir manufacturing to ensure accurate thermal control during production and storage processes.

2. Scope

This SOP applies to all digital and analog temperature sensors integrated into process tanks, transfer lines, mixing vessels, storage tanks, and environmental monitoring systems in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Monitor temperature readings and record observations in the BMR.
    • Alert Engineering if abnormal values or sensor faults are detected.
  • Engineering Department:
    • Calibrate and maintain sensors as per schedule.
    • Replace or repair faulty sensors and maintain calibration records.
  • QA Officer:
    • Verify calibration status and monitor deviations during batch record review.
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4. Accountability

The Production Head is accountable for proper use of temperature sensors. The Engineering Head is responsible for sensor performance, calibration, and data integrity.

5. Procedure

5.1 Sensor Installation and Calibration

  1. Ensure sensors are installed at validated locations with appropriate insulation and shielding.
  2. Use sensors with appropriate accuracy class (e.g., PT100 RTD, thermocouple type K, etc.).
  3. Calibrate all temperature sensors before installation using certified temperature baths or simulators.
  4. Maintain calibration frequency as per SOP/CAL schedule (e.g., quarterly or biannually).

5.2 Pre-Operation Checks

  1. Verify that the sensor is labeled “CALIBRATED.”
  2. Ensure no visible damage or moisture ingress in the sensor housing or cabling.
  3. Check that the display panel or PLC interface is communicating with the sensor.

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5.3 Monitoring During Operation

  1. Observe temperature in real-time via control panel or SCADA interface.
  2. Record values as per intervals defined in BMR (e.g., every 15–30 minutes).
  3. Ensure that process temperature remains within the acceptable range (e.g., 60–70°C for sugar syrup blending).
  4. If deviation is observed:
    • Pause heating/cooling if possible.
    • Record deviation and inform QA for impact assessment.

5.4 Post-Operation Procedures

  1. At the end of the process, log final temperature values.
  2. Disconnect sensor (if portable) and clean the probe using lint-free cloth and 70% IPA.
  3. Document any anomalies in the Sensor Monitoring Log (Annexure-1).

5.5 Preventive Maintenance and Safety

  1. Do not bend, twist, or stretch sensor leads excessively.
  2. Do not immerse non-submersible sensors in cleaning solutions.
  3. Inspect junctions and connectors for corrosion or loose fittings during monthly checks.
  4. Ensure backup sensors are available for critical processing tanks.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • SCADA: Supervisory Control and Data Acquisition
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7. Documents

  1. Sensor Monitoring Log (Annexure-1)
  2. Calibration Certificate
  3. BMR Temperature Sheet

8. References

  • ICH Q9 – Quality Risk Management
  • 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
  • WHO TRS 1010 – Instrument Calibration 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: Sensor Monitoring Log

Date Sensor ID Equipment Name Recorded Temp (°C) Setpoint (°C) Operator Remarks
11/04/2025 RTD-04 Sugar Syrup Tank 66.4 67.0 Sunita Reddy Within Range

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 Included SCADA monitoring and deviation handling Process Optimization QA Head
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