SOP Guide for Pharma

Elixir Department: SOP for Use of Jacketed Vessels – V 2.0

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Elixir Department: SOP for Use of Jacketed Vessels – V 2.0

Standard Operating Procedure for Use of Jacketed Vessels in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/065/2025
Supersedes SOP/ELX/065/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a procedure for the safe and effective operation of jacketed vessels used for heating or cooling during the manufacturing of elixir formulations.

2. Scope

This SOP applies to the preparation, operation, and cleaning of jacketed vessels used in the Elixir Department for maintaining temperature-sensitive processes.

3. Responsibilities

  • Production Operator:
    • Set up and monitor heating/cooling systems.
    • Document temperature readings and process conditions.
  • Production Supervisor:
    • Verify setup, functionality, and calibration of temperature gauges.
  • Engineering Department:
    • Perform preventive maintenance on jacket systems and validate temperature sensors.

4. Accountability

The Production Manager is accountable for ensuring that jacketed vessels are operated according to validated procedures and maintained in good working condition.

See also  Elixir Department: SOP for Dispensing of Preservatives for Elixirs - V 2.0

5. Procedure

5.1 Pre-Operation Checks

  1. Ensure the vessel is labeled “CLEANED” and has a valid cleaning tag.
  2. Inspect the jacket for any visible damage, leaks,
or wear.
  • Ensure inlet/outlet connections for heating/cooling fluid (e.g., steam or chilled water) are properly secured.
  • Verify the temperature gauge and sensor calibration tags.

    • 5.2 Heating Process

    1. Connect the steam line or electrical heating system and open the valve gradually.
    2. Set the desired jacket temperature based on BMR requirements (typically 50–60°C).
    3. Allow the system to reach steady-state temperature; monitor the batch temperature using the digital display or thermometer.
    4. Record temperature every 10 minutes during heating in the Jacketed Vessel Log (Annexure-1).

    5.3 Cooling Process

    1. Connect the chilled water or glycol system securely to the jacket.
    2. Start circulation and reduce the temperature gradually to the required set point (typically below 30°C).
    3. Ensure temperature does not drop below critical formulation limits.

    5.4 Monitoring During Operation

    1. Visually inspect for condensation, unusual noise, or steam/water leakage.
    2. Ensure batch temperature remains within the prescribed range.
    3. In case of deviation, inform supervisor and QA immediately.

    5.5 Post-Operation Activities

    1. Stop the steam or chilled water supply and disconnect lines.
    2. Allow the jacket and vessel to cool to room temperature.
    3. Clean the internal and external surfaces using approved cleaning agents.
    4. Label the vessel as “TO BE CLEANED” or “CLEANED” as per cleaning status.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • BMR: Batch Manufacturing Record
    • QA: Quality Assurance

    7. Documents

    1. Jacketed Vessel Log (Annexure-1)
    2. Temperature Monitoring Sheet (Annexure-2)
    3. Cleaning Record for Jacketed Vessels (Annexure-3)

    8. References

    • WHO TRS 986 Annex 2 – GMP for Pharmaceutical Production
    • 21 CFR Part 211.63 – Equipment Design and Maintenance

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Jacketed Vessel Log

    Date Batch No. Process Set Temp (°C) Duration (min) Operator Verified By
    11/04/2025 ELX-1011 Heating 55 45 Rajesh Kumar Sunita Reddy

    Annexure-2: Temperature Monitoring Sheet

    Time Jacket Temp (°C) Batch Temp (°C) Remarks
    10:00 AM 55 48 Stable
    10:10 AM 55 50 OK
    10:20 AM 55 53 OK

    Annexure-3: Cleaning Record for Jacketed Vessels

    Date Vessel ID Cleaned By Verified By Status
    11/04/2025 JV-07 Ajay Desai Manju Sharma Cleaned

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial SOP Issuance New SOP QA Head
    11/04/2025 2.0 Added Cooling Cycle and Monitoring Sheet Process Enhancement QA Head
    See also  Elixir Department: SOP for Storage of Raw Materials for Elixir Manufacturing - V 2.0
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