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.

5. Procedure

5.1 Pre-Operation Checks

Ensure the vessel is labeled “CLEANED” and has a valid cleaning tag.
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

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

5.3 Cooling Process

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

5.4 Monitoring During Operation

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

5.5 Post-Operation Activities

Stop the steam or chilled water supply and disconnect lines.
Allow the jacket and vessel to cool to room temperature.
Clean the internal and external surfaces using approved cleaning agents.
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

Jacketed Vessel Log (Annexure-1)
Temperature Monitoring Sheet (Annexure-2)
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