Elixir Department: SOP for Use of Jacketed Heating Tanks – V 2.0

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Elixir Department: SOP for Use of Jacketed Heating Tanks – V 2.0

Standard Operating Procedure for Use of Jacketed Heating Tanks in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/122/2025
Supersedes SOP/ELX/122/2022
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 standard procedure for the safe and efficient use of jacketed heating tanks during elixir manufacturing, including setup, operation, temperature control, monitoring, and shutdown processes.

2. Scope

This SOP applies to all operations involving jacketed heating tanks used for temperature-sensitive processes, such as heating solvents, preparing sugar syrups, and maintaining temperature-controlled mixing in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Ensure proper setup, operation, and monitoring of jacketed heating tanks.
  • Production Supervisor:
    • Verify operational parameters and log data as per BMR.
  • Engineering Department:
    • Maintain and calibrate heating systems, sensors, and safety controls.
  • QA Officer:
    • Approve readiness of equipment and monitor adherence to process parameters.

4. Accountability

The Head of Production is accountable for ensuring compliance with this SOP and that all jacketed heating tanks are operated as per validated procedures.

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5. Procedure

5.1 Pre-Operation Checks

  1. Verify that the jacketed tank is labeled as “CLEANED” and released by QA.
  2. Ensure that temperature sensors, control panels, and inlet/outlet connections are in good working condition.
  3. Check that the heating medium (usually steam or hot water) is available and the pressure is within operating limits.
  4. Ensure the pressure relief valve and emergency shutoff are functional.

5.2 Setup Procedure

  1. Connect inlet and outlet lines of the heating jacket to the utility system (steam, hot water, or oil).
  2. Confirm valve positions and purge air from the jacket line if required.
  3. Set the desired temperature range on the digital controller (as per BMR).
  4. Pre-warm the system for 5–10 minutes and stabilize the jacket temperature.

5.3 Operation Procedure

  1. Start the heating process and monitor jacket temperature and vessel product temperature continuously.
  2. Maintain the heating rate as specified in the manufacturing instruction sheet or BMR (e.g., gradual rise of 5°C every 5 minutes).
  3. Ensure that the product temperature does not exceed the target temperature.
  4. Record temperature readings at specified intervals (every 10–15 minutes).
  5. If overheating occurs, immediately shut off the heating medium and inform the supervisor.
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5.4 Post-Heating and Shutdown

  1. Once the heating process is complete, turn off the heating medium supply.
  2. Allow the system to cool down naturally or circulate cooling water if required.
  3. Disconnect utility lines and drain any condensate or residual fluid from the jacket.
  4. Label the tank as “TO BE CLEANED” after completion of batch processing.

5.5 Cleaning and Maintenance

  1. Follow standard cleaning SOPs for internal and external surfaces of the tank.
  2. Ensure that jacketed pipes and connectors are free from clogging or scale formation.
  3. Document any cleaning or maintenance activity in the Equipment Logbook.

5.6 Safety and Precautions

  1. Wear heat-resistant gloves and protective gear during heating operations.
  2. Do not open manhole or sampling valves while heating is active.
  3. Ensure all connections are properly secured to avoid leakage or burns.
  4. Monitor pressure gauges and alarms closely to prevent overpressure situations.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • BMR: Batch Manufacturing Record
  • cGMP: Current Good Manufacturing Practice

7. Documents

  1. Equipment Usage Log (Annexure-1)
  2. Preventive Maintenance Record
  3. BMR/Manufacturing Sheet

8. References

  • 21 CFR Part 211.63 – Equipment Design and Maintenance
  • WHO GMP – Heating System Guidelines
  • ICH Q8 – Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Usage Log

Date Equipment ID Batch No. Start Time End Time Set Temp (°C) Max Temp (°C) Operator
11/04/2025 JHT-201 ELX-1055 08:30 09:30 60 61.5 Rajesh Kumar

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 detailed pre-warmup and cooling steps Process Optimization QA Head
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