area of gel manufacturing, including stainless steel vessels, jacketed vessels, and fixed or portable mixing units.

3. Responsibilities

• Production Operator: Responsible for cleaning and documenting the activity.
• Production Supervisor: To verify cleaning activities and sign off on the cleaning checklist.
• QA Officer: To verify cleanliness and release equipment for further use.

4. Accountability

Department Head and QA Head are accountable for ensuring compliance with the cleaning protocol and documentation practices.

5. Procedure

5.1 Preparation for Cleaning

1. Ensure the vessel is emptied completely after batch processing.
2. Disconnect power supply to any agitators or heating systems.
3. Wear appropriate PPE including gloves, apron, goggles, and safety shoes.

5.2 Cleaning Steps

1. Rinse the vessel with potable water to remove residual gel mass.
2. Prepare a 2% solution of a validated cleaning agent and circulate using internal spray balls or manual scrubbing with a nylon brush.
3. For stubborn residues, allow the cleaning agent to stand for 15 minutes before scrubbing again.
4. Rinse thoroughly with potable water to remove cleaning agent residue.
5. Follow up with two rinses using purified water.
6. Perform final rinse with Water for Injection (WFI) if the vessel is used in sterile gel manufacturing.
7. Visually inspect internal and external surfaces for cleanliness.
8. Dry the vessel using clean, lint-free cloth or allow to air-dry in controlled area.
9. Close the manhole and cover all ports with sterilized caps or aluminum foil.

5.3 Cleaning Frequency

• Batch-to-batch cleaning: When the same product is manufactured consecutively.
• Product-to-product cleaning: When a new formulation is processed.
• Weekly deep cleaning: Thorough cleaning even if equipment was not in use.

5.4 Cleaning Verification and Documentation

1. Perform swab testing for microbiological and chemical residue checks post-cleaning.
2. Record cleaning activity in the Gel Vessel Cleaning Log (Annexure-1).
3. Complete the Cleaning Checklist (Annexure-2) and attach any analytical reports.

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• QA: Quality Assurance
• WFI: Water for Injection

7. Documents

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

8. References

• GMP Guidelines
• Internal Validation Reports
• Cleaning Validation SOP

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: Gel Vessel Cleaning Log

Date	Vessel 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 Water Rinse
Cleaning Agent Application
Final WFI Rinse
Drying Completed

Annexure-3: Swab Test Report

Vessel ID	Date	Swab Location	Test Type	Result	Analyst	Approved By
		Inner Wall/Bottom Port	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	Added annexure formats, improved procedure detail	Periodic Review	QA Head