primary packaging of topical gel formulations in the Gel Manufacturing department.

3. Responsibilities

• Operators: Responsible for cleaning and documenting the activity.
• Line Supervisors: Ensure adherence to SOP and verify the effectiveness of cleaning.
• QA Personnel: Verify records and perform periodic audits for compliance.

4. Accountability

Department Head of Manufacturing and Head of QA shall ensure implementation and compliance with this SOP.

5. Procedure

5.1 Pre-Cleaning Activities

1. Ensure the tube sealing machine is switched off and the “To Be Cleaned” label is affixed.
2. Disconnect electrical and pneumatic connections before starting the cleaning activity.
3. Wear required PPE: gloves, mask, eye protection, and cleanroom gown.

5.2 Dismantling Parts

1. Dismantle removable parts such as sealing jaws, tube holders, and any contact surfaces.
2. Transport dismantled parts to the washing area in labeled SS trays.

5.3 Cleaning Removable Parts

1. Rinse with purified water to remove gel residue.
2. Wash with 2% v/v non-ionic detergent solution using nylon brushes.
3. Rinse thoroughly with purified water to remove detergent.
4. Final rinse with WFI if required.
5. Allow to dry in clean environment or with filtered air.

5.4 Cleaning Fixed Machine Body

1. Wipe machine body, rollers, sealing jaws (if not removed), and control panel with 70% IPA.
2. Use lint-free cloths and swabs to access hard-to-reach areas.

5.5 Post-Cleaning Inspection

1. Visually inspect all parts and surfaces for cleanliness.
2. Check for absence of residues, stains, and gel accumulation.

5.6 Reassembly and Labeling

1. Reassemble the machine using dry, clean components.
2. Affix “Cleaned” status label with date and operator signature.

5.7 Documentation and Verification

1. Fill the cleaning logbook (Annexure-1) and checklist (Annexure-2).
2. Supervisor to verify and QA to countersign upon random inspection.

5.8 Cleaning Frequency

• After every batch change and product switch.
• After extended idle period of 72 hours.
• Following any repair or maintenance activity.

6. Abbreviations

• IPA: Isopropyl Alcohol
• SS: Stainless Steel
• WFI: Water for Injection
• PPE: Personal Protective Equipment
• QA: Quality Assurance

7. Documents

1. Tube Sealing Machine Cleaning Log – Annexure-1
2. Cleaning Checklist – Annexure-2

8. References

• Manufacturer’s cleaning guidelines
• Internal GMP standards and validation protocols
• Cleaning validation master plan

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: Tube Sealing Machine Cleaning Log

Date	Machine ID	Product Name	Batch No.	Cleaned By	Verified By	Remarks

Annexure-2: Tube Sealing Machine Cleaning Checklist

Cleaning Step	Status (Yes/No)	Comments	Verified By
Residue removal
Detergent wash
Purified water rinse
IPA wipe down
Visual inspection
Label affixed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial SOP creation	New equipment addition	QA Head
02/06/2025	2.0	Enhanced checklist and annexures added	GMP compliance	QA Head