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

3. Responsibilities

• Operators: To clean the machine as per procedure and record cleaning activity.
• Line Supervisor: To verify cleaning and ensure completeness of documentation.
• QA Personnel: To approve cleaning and perform random checks for compliance.

4. Accountability

The Head of Production and Head of Quality Assurance shall be accountable for the implementation and enforcement of this SOP.

5. Procedure

5.1 Preparation Before Cleaning

1. Ensure that the filling operation has been completed and the machine is switched off.
2. Affix a “To Be Cleaned” label on the equipment.
3. Wear appropriate PPE such as gloves, face mask, goggles, and apron.
4. Disconnect the machine from power and compressed air supply.

5.2 Dismantling of Parts

1. Dismantle all contact parts like filling nozzles, hoses, pump assembly, gel feed tank, etc.
2. Place all dismantled parts in labeled stainless steel trays for cleaning.
3. Transport the parts to the designated equipment washing area.

5.3 Cleaning of Machine Parts

1. Rinse all parts with purified water to remove residual gel.
2. Wash parts using 2% v/v non-ionic detergent solution. Scrub gently with nylon brushes.
3. Rinse thoroughly with purified water to remove detergent residues.
4. Perform a final rinse with Water for Injection (WFI), if applicable.
5. Visually inspect parts for cleanliness. No traces of gel should remain.

5.4 Cleaning of Machine Body and Non-Contact Surfaces

1. Wipe the outer surfaces of the machine with a lint-free cloth dampened with 70% IPA.
2. Clean the control panel and display screen carefully using a dry lint-free cloth.
3. Pay special attention to corners, joints, and inaccessible areas using suitable tools.

5.5 Drying and Reassembly

1. Allow the parts to dry in a controlled area or dry using clean compressed air.
2. Reassemble the machine as per the equipment SOP once fully dry.
3. Apply a “Cleaned” status label with date, time, and signature of operator and verifier.

5.6 Cleaning Verification

1. Conduct a swab test (refer to Annexure-3) for critical parts before reuse.
2. Ensure the cleaning checklist and logbook are properly filled and verified.

5.7 Cleaning Frequency

• After every batch change or product change.
• If the machine is idle for more than 72 hours.
• After preventive maintenance.

6. Abbreviations

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

7. Documents

1. Filling Machine Cleaning Log – Annexure-1
2. Filling Machine Cleaning Checklist – Annexure-2
3. Swab Test Report Format – Annexure-3

8. References

• Manufacturer’s Equipment Manual
• GMP Guidelines for Cleaning Validation
• Internal Quality Management Procedures

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: Filling Machine Cleaning Log

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

Annexure-2: Filling Machine Cleaning Checklist

Step	Status (Yes/No)	Comments	Checked By
Gel residue removed
Detergent wash performed
Purified water rinse done
IPA wipe down completed
Cleaning log updated

Annexure-3: Swab Test Report Format

Swab Location	Surface Area (cm²)	Swab Taken By	Test Performed	Result	Remarks
Filling Nozzle	25		TOC
Pump Assembly	25		Residue

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial issue	New SOP	QA Head
02/06/2025	2.0	Checklist and swab report format added	GMP alignment	QA Head