in tubes, jars, sachets, or other containers used in the Gel Manufacturing department.

3. Responsibilities

• Packaging Operators: Operate sealing machines and verify the integrity of each seal.
• Quality Assurance: Inspect sealed units during and after sealing process.
• Maintenance Engineer: Ensure periodic servicing and calibration of sealing machines.
• Packaging Supervisor: Ensure SOP compliance and documentation completeness.

4. Accountability

The Head – Manufacturing is accountable for implementing and monitoring the proper sealing operations to ensure contamination control of packaged gel products.

5. Procedure

5.1 Preparation

1. Verify the cleanliness of the sealing equipment and working area as per SOP for equipment cleaning.
2. Ensure the sealing machine is properly set up as per packaging component specifications (tube/jar type, material, cap style).
3. Check the sealing temperature, pressure, and dwell time settings.
4. Perform sealing on a few dummy samples and inspect for quality attributes such as uniformity, strength, and appearance.
5. Send dummy samples to QA for initial approval before batch processing.

5.2 Sealing Operation

1. Start sealing process only after line clearance and QA approval of trial samples.
2. Feed filled tubes/jars into the sealing machine carefully to avoid spillage or misalignment.
3. Ensure each unit is completely sealed with no product leakage, wrinkles, air pockets, or damage to packaging material.
4. Monitor sealing machine parameters at predefined intervals (e.g., every 30 minutes).
5. Remove any defective or incompletely sealed products from the line and record as rejected units.
6. Check seals periodically under magnification for fine cracks or breaches.

5.3 Contamination Prevention Measures

1. Maintain personal hygiene and gowning protocol while operating sealing stations.
2. Operate under Grade D environment with regular environmental monitoring (refer to environmental SOP).
3. Ensure packaging components (tubes, jars, seals) are pre-cleaned and kept in sanitized bins until use.
4. Avoid touching the sealing end with bare hands or unsterile tools.

5.4 Post-Sealing Activities

1. Segregate and label the sealed batch as “Sealed and Awaiting Inspection”.
2. Conduct random destructive testing on sealed units (Annexure-2).
3. Log sealing machine parameters, inspection results, and rejection counts in the Sealing Logbook (Annexure-1).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. Sealing Operation Logbook – Annexure-1
2. Seal Integrity Inspection Report – Annexure-2
3. Line Clearance Checklist
4. Batch Manufacturing Record (BMR)

8. References

• Schedule M – Packaging Section
• WHO TRS 986 – Guidelines on Packaging
• FDA 21 CFR Part 211.130 – Packaging and Labeling Control

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: Sealing Operation Logbook

Date	Batch No.	Start Time	End Time	Machine ID	Temp (°C)	Pressure (Bar)	Rejects	Operator

Annexure-2: Seal Integrity Inspection Report

Batch No.
Sample Size
Number of Acceptable Units
Number of Rejected Units
Observed Issues
QA Inspector Name
Date

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial Issue	New SOP implementation	QA Head
02/06/2025	2.0	Included seal integrity testing and updated preventive measures	Annual Review	QA Head