Standard Operating Procedure for Heating Using Steam Jacketed Systems in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/109/2025
Supersedes	SOP/ELX/109/2022
Page No.	Page 1 of 8
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To outline the procedure for the safe and effective use of steam jacketed systems for heating liquid formulations during elixir manufacturing processes, ensuring uniform temperature control and product integrity.

2. Scope

This SOP applies to all operations involving heating of product batches in jacketed vessels using steam in the Elixir Department.

3. Responsibilities

• Production Operator:
  • Set up and operate the steam jacketed system as per instructions.
  • Monitor temperatures and document heating parameters.
• Production Supervisor:
  • Verify proper system setup, authorize heating, and review records.
• Engineering Technician:
  • Ensure that the steam lines, traps, and pressure gauges are functional and maintained.
• QA Officer:
  • Verify the heating process compliance during in-process checks.

4. Accountability

The Head of Production is accountable for ensuring the heating process is performed under controlled conditions and documented in accordance with GMP standards.

5. Procedure

5.1 Pre-Operation Checks

1. Ensure the mixing vessel and steam jacket are cleaned and labeled “CLEANED.”
2. Verify that steam supply is available and the pressure is within the range of 3–5 bar (unless otherwise specified).
3. Ensure all pressure relief valves, gauges, and condensate traps are functioning correctly.
4. Check calibration status of temperature probes or sensors installed in the vessel.

5.2 Heating Operation

1. Start gentle stirring of the product before initiating heating.
2. Gradually open the steam inlet valve to allow steam into the jacket.
3. Monitor the product temperature using the digital or analog sensor.
4. Maintain temperature as per the batch manufacturing record (e.g., 60–70°C).
5. Do not allow product to overheat beyond the specified temperature to avoid degradation.

5.3 Temperature Holding and Monitoring

1. Hold the product at the target temperature for the required time (e.g., 30 minutes).
2. Record the temperature at every 5-minute interval during heating and holding phase.
3. Continue stirring to ensure uniform heat distribution.

5.4 Post-Heating Activities

1. Close the steam inlet valve once the heating process is completed.
2. Open the condensate drain to remove trapped steam.
3. Allow the product to cool as per batch instructions or initiate the next process step.

5.5 Documentation

1. Enter all temperature readings, time, and remarks in the Heating Log (Annexure-1).
2. Attach a copy of the log to the respective BMR.
3. Ensure that any deviation in temperature is reported and investigated as per deviation management SOP.

6. Abbreviations

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

7. Documents

1. Heating Log (Annexure-1)
2. Batch Manufacturing Record (BMR)

8. References

• 21 CFR Part 211.113 – Control of Heating Conditions
• WHO TRS 1010 – GMP Guidelines
• ISPE Baseline Guide – Utilities and Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Heating Log

Date	Batch No.	Tank No.	Start Temp (°C)	Max Temp (°C)	Hold Time (min)	Operator	Supervisor
11/04/2025	ELX-1046	TK-03	28	65	30	Rajesh Kumar	Sunita Reddy

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 holding phase documentation and cooling instructions	Process Optimization	QA Head