where equipment temperature plays a critical role in processing, such as jacketed vessels, homogenizers, water baths, and filling lines.

3. Responsibilities

• Production Operator: Monitor and record equipment temperatures as per batch requirements.
• Production Chemist: Verify recorded temperature data and escalate deviations.
• QA Officer: Review logs and ensure SOP compliance during routine and in-process audits.
• Engineering Department: Maintain calibration of all temperature sensors and data loggers.

4. Accountability

The Head – Manufacturing is accountable for ensuring the implementation and compliance of this SOP within the department.

5. Procedure

5.1 Pre-Operation Check

1. Ensure all temperature sensors, gauges, thermocouples, or data loggers are calibrated.
2. Verify that the calibration stickers on equipment are within due date and clearly visible.
3. Ensure batch manufacturing record (BMR) specifies temperature ranges and critical control points for each equipment involved.

5.2 Monitoring Points and Intervals

The following are standard monitoring points during gel production:

• Jacketed Mixing Vessels: At startup, during heating, and before transferring.
• Homogenizers: Every 15 minutes during operation.
• Water Phase Heating: At start and every 10 minutes during heating.
• Oil Phase Heating (if applicable): At mixing and emulsification stages.
• Filling Machines: At start of filling and midpoint.

5.3 Acceptable Temperature Ranges

Equipment	Set Temp. (°C)	Acceptable Range (°C)	Monitoring Frequency
Jacketed Vessel	70	68–72	Every 15 min
Homogenizer	Room Temp	25–30	Every 15 min
Water Bath	60	58–62	Start and end
Oil Heater	85	83–87	Start and midpoint

5.4 Recording Procedure

1. Enter all temperature values into the Equipment Temperature Monitoring Log (Annexure-1).
2. Initial each entry and note time and equipment ID.
3. In case of deviation, inform Production Chemist immediately and note the action taken.

5.5 Handling Deviations

• In case of minor deviations (< ±2°C), allow auto-correction if within 5 minutes and document.
• For deviations exceeding acceptable range, halt the process, isolate the batch, and initiate deviation report as per QA SOP.

6. Abbreviations

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

7. Documents

1. Equipment Temperature Monitoring Log – Annexure-1
2. Deviation Report Form – Annexure-2

8. References

• WHO Technical Report Series No. 961
• ICH Q9 Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Equipment Temperature Monitoring Log

Date	Batch No.	Equipment ID	Time	Observed Temp. (°C)	Expected Range	Operator Initials	Remarks
			08:00
			08:15

Annexure-2: Deviation Report Form

Batch No.
Date
Equipment
Observed Temperature
Expected Temperature Range
Nature of Deviation
Corrective Action Taken
Reviewed By (QA)

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
03/06/2022	1.0	Initial SOP Release	New SOP	QA Head
02/06/2025	2.0	Real-time Logging Added	Process Monitoring Enhancement	QA Head