Operator: Responsible for setting up, operating, and cleaning the sealing machine.

Production Supervisor: Ensures adherence to procedure and proper documentation.

Quality Assurance: Performs line clearance and periodic checks.

4. Accountability

Department Head – Gel Manufacturing is accountable for ensuring compliance with this SOP.

5. Procedure

5.1 Pre-Operational Checks

1. Verify machine cleanliness and confirm cleaning status as per equipment label.
2. Check electrical connections and machine settings.
3. Ensure correct sealing jaws are installed based on tube type and size.
4. Confirm sealing temperature and dwell time settings per batch requirement.

5.2 Line Clearance

1. Inform QA to perform line clearance before starting operation.
2. Ensure removal of previous product, if any, and cleaning completion.
3. Document clearance in Line Clearance Record (Annexure-1).

5.3 Machine Setup

1. Switch ON the main power and preheat the sealing jaws to the required temperature.
2. Align filled tubes into holders or conveyor channels as applicable.
3. Set sealing cycle time and sealing pressure as per validation parameters.
4. Perform a dry run using empty tubes for alignment verification.

5.4 Operation

1. Feed gel-filled tubes into the sealer as per machine design (manual or automated).
2. Monitor seal quality—check for proper seal width, alignment, and no burn marks.
3. Record sealing parameters for each shift.
4. Randomly check samples every 30 minutes for seal strength.

5.5 Post-Operation

1. Shut down machine as per manufacturer’s instructions.
2. Allow jaws to cool before cleaning.
3. Clean the machine as per SOP/GM/055/2025.
4. Label equipment status accordingly.

6. Abbreviations

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

7. Documents

1. Batch Manufacturing Record (BMR)
2. Line Clearance Record – Annexure-1
3. Sealing Parameters Log – Annexure-2
4. Sealing Defect Observation Log – Annexure-3

8. References

• Manufacturer’s Equipment Manual
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

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: Line Clearance Record

Date	Batch No.	Machine ID	Previous Product Removed	Area Cleaned	QA Signature
			Yes / No	Yes / No

Annexure-2: Sealing Parameters Log

Date	Batch No.	Sealing Temp (°C)	Dwell Time (sec)	Pressure (bar)	Operator Signature

Annexure-3: Sealing Defect Observation Log

Date	Time	Defect Observed	Corrective Action Taken	QA Reviewed
		None / Burn mark / Misalignment

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Annexures added and updated sealing procedure	Review Update	QA Head