in the Gel Manufacturing area.

3. Responsibilities

• Production Operator: Responsible for execution of the cleaning steps.
• Production Supervisor: To monitor and verify cleaning activities.
• Quality Assurance (QA): To perform cleanliness verification and release equipment for reuse.

4. Accountability

The Head of Production and Head of QA are accountable for ensuring cleaning effectiveness and compliance with this SOP.

5. Procedure

5.1 Pre-Cleaning Preparations

1. Turn off power supply to the homogenizer and affix “Under Cleaning” tag.
2. Ensure the machine is completely emptied of gel mass before initiating cleaning.
3. Don appropriate PPE including gloves, apron, face shield, and safety shoes.

5.2 Cleaning Process

1. Disassemble all detachable parts such as blades, stators, shafts, and screens as per equipment manual.
2. Rinse all parts with potable water to remove product residues.
3. Soak parts in a 2% validated detergent solution for 20–30 minutes to loosen adhering material.
4. Scrub surfaces with a nylon brush, ensuring corners, joints, and crevices are cleaned thoroughly.
5. Rinse each part with potable water followed by purified water until no foaming is observed.
6. Final rinse should be done with Water for Injection (WFI) if equipment is used in sterile production.
7. Allow the parts to air dry or use clean lint-free cloth to manually dry them.
8. Reassemble the parts after complete drying and ensure all fastenings are tightened appropriately.

5.3 Fixed Inline Homogenizers

1. Flush internal circuits using a CIP loop with a validated cleaning solution.
2. Allow circulation for 15 minutes followed by a thorough potable and purified water rinse.
3. Check the outlet for clarity and absence of residue.
4. Dry circuits using sterile compressed air if required.

5.4 Verification and Documentation

1. Visual inspection to confirm no residue or discoloration.
2. Perform swab test for microbial and chemical residue as per cleaning validation protocol.
3. Document cleaning activity in Homogenizer Cleaning Log (Annexure-1).
4. Complete the Cleaning Checklist (Annexure-2) and attach swab test report.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• CIP: Clean-In-Place
• WFI: Water for Injection

7. Documents

1. Homogenizer Cleaning Log – Annexure-1
2. Cleaning Checklist – Annexure-2
3. Swab Test Report – Annexure-3

8. References

• Manufacturer’s Equipment Manual
• Cleaning Validation Protocol
• GMP Guidelines

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: Homogenizer Cleaning Log

Date	Equipment ID	Product Name	Type of Cleaning	Performed By	Verified By	Remarks
			Batch/Product/Weekly

Annexure-2: Cleaning Checklist

Step	Status (Yes/No)	Comments	Checked By
Initial Rinse with Potable Water
Soaking in Cleaning Agent
Scrubbing and Brushing
Final WFI Rinse
Drying Completed

Annexure-3: Swab Test Report

Equipment ID	Date	Swab Location	Test Type	Result	Analyst	Approved By
		Rotor/Stator/Outlet	Microbial/Chemical

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	Updated with CIP-specific instructions and annexure formats	Periodic Review	QA Head