of all major and minor equipment, including mixing vessels, homogenizers, filling machines, pipelines, and transfer tools used in gel manufacturing.

3. Responsibilities

• Production Operator: To carry out equipment cleaning as per SOP and record activities.
• IPQA Officer: To verify cleaning and approve equipment for next batch use.
• Engineering: To support in maintenance of utilities and equipment parts, if needed.

4. Accountability

The Head – Manufacturing is accountable for compliance with this procedure and ensuring periodic training and monitoring of the cleaning process.

5. Procedure

5.1 Pre-Cleaning Activities

1. Ensure batch processing is completed and “To Be Cleaned” label is attached to the equipment.
2. Disconnect the power supply and clean any gel residue from external surfaces using a clean dry lint-free cloth.
3. Refer to the equipment cleaning logbook and review last cleaning record.

5.2 Cleaning Steps for Mixing Vessels and Homogenizers

1. Drain any remaining product from the vessel.
2. Rinse equipment with purified water to remove gross product residues.
3. Use 2% non-ionic detergent solution and manually scrub all internal contact surfaces using nylon brushes.
4. Rinse thoroughly with purified water until all detergent is removed (conductivity ≤1.3 µS/cm).
5. Perform final rinse with Water for Injection (WFI) if required for sterile applications.

5.3 Cleaning of Pipelines, Valves, and Fittings

1. Flush internal pipelines with purified water.
2. Circulate detergent solution through CIP system or manually clean removable parts.
3. Rinse with water until visually clear and free of foam.

5.4 Cleaning of Filling Equipment

1. Disassemble filling heads, nozzles, and hoppers as per equipment manual.
2. Soak in 2% detergent solution for 15–30 minutes, then scrub and rinse thoroughly.
3. Allow all parts to dry using compressed filtered air or clean dry cloth.

5.5 Post-Cleaning Activities

• Visually inspect cleaned equipment to ensure it is free from residue, streaks, or odor.
• Record the cleaning details in the Equipment Cleaning Log – Annexure-1.
• Affix a “Cleaned” status label with date and signature of the operator and verifier.

5.6 Swab Testing and Verification

1. Collect swab samples from contact surfaces as per QA protocol.
2. Submit samples to Quality Control for residue analysis.
3. Equipment may be released after approval from QA or upon meeting acceptance criteria.

6. Abbreviations

• cGMP: Current Good Manufacturing Practices
• QA: Quality Assurance
• CIP: Clean-In-Place
• WFI: Water for Injection

7. Documents

1. Equipment Cleaning Log – Annexure-1
2. Swab Sampling Record – Annexure-2
3. Cleaning Checklist – Annexure-3

8. References

• Schedule M – Good Manufacturing Practices
• WHO TRS No. 986 Annex 7: Cleaning Validation Guidelines
• Internal QA Policy Documents

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: Equipment Cleaning Log

Document to record date, time, product, equipment ID, and cleaning activities performed.

Annexure-2: Swab Sampling Record

Record of swab location, test result, and responsible QA personnel.

Annexure-3: Cleaning Checklist

Verification list of cleaning steps and equipment-specific components.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial version	Initial implementation	QA Head
02/06/2025	2.0	Updated swab sampling and CIP steps	GMP alignment	QA Head