Verifies line clearance and cleaning status, and documents compliance with SOP.

4. Accountability

Head – Manufacturing is accountable for ensuring SOP adherence, operator training, and maintenance of documentation related to the operation and cleaning of the sealing machine.

5. Procedure

5.1 Pre-Startup Checks

1. Ensure the machine is clean, dry, and free from any previous product remnants.
2. Check that the sealing jaws are aligned, clean, and free from wear or residue.
3. Verify calibration of temperature and pressure gauges as per machine logbook.
4. Confirm electrical connections and ensure emergency stop functions are active.

5.2 Machine Operation

1. Switch ON the main power supply and set the appropriate sealing temperature (usually 120–150°C depending on tube type).
2. Allow the machine to reach the set temperature (observe via digital display or thermometer).
3. Load pre-filled tubes onto the machine one at a time into the sealing jaws.
4. Press the foot switch to initiate the sealing cycle.
5. Once sealing is complete, visually inspect each tube for defects like incomplete sealing, over-sealing, or burn marks.
6. Rejected tubes should be recorded and segregated for investigation.
7. Monitor every 30 minutes or 100 tubes for seal quality and document the results in the In-process Check Sheet – Annexure-1.

5.3 Shutdown Procedure

1. Switch off the heating element and allow it to cool to ambient temperature.
2. Switch off the main power supply.
3. Clean the area around the machine and dispose of rejected tubes in designated bins.

5.4 Cleaning Procedure

1. Ensure power is OFF and machine is cool before cleaning begins.
2. Use a clean lint-free cloth soaked in 70% IPA to wipe the sealing jaws and contact areas.
3. Clean external surfaces and foot pedal using a separate sanitized cloth.
4. Document cleaning activity in the Equipment Cleaning Log – Annexure-2.
5. If any foreign material or residue is not removed, repeat cleaning and report to maintenance if persistent.

5.5 Preventive Maintenance

1. Perform preventive maintenance monthly as per Maintenance SOP.
2. Replace sealing jaws if signs of wear or temperature malfunction occur.
3. Lubricate moving parts (except jaws) using food-grade lubricants.

6. Abbreviations

• IPA: Isopropyl Alcohol
• SOP: Standard Operating Procedure
• QA: Quality Assurance

7. Documents

1. Machine Logbook
2. In-process Check Sheet – Annexure-1
3. Equipment Cleaning Log – Annexure-2

8. References

• Operator Manual of Semi-Automatic Tube Sealing Machine
• Schedule M Guidelines – Primary Packaging

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: In-process Check Sheet

Time	No. of Tubes Sealed	Seal Integrity (Pass/Fail)	Remarks	Checked By

Annexure-2: Equipment Cleaning Log

Date	Time	Cleaning Performed By	Checked By (QA)	Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
10/03/2022	1.0	Initial issue	New equipment installed	QA Head
09/06/2025	2.0	Added preventive maintenance section and new annexures	Annual review	QA Head