and containers used in the Gel Manufacturing Department after every batch transfer or as required.

3. Responsibilities

• Production Operator: Performs cleaning as per approved procedure.
• Production Supervisor: Ensures correct execution and documentation.
• QA Officer: Verifies and approves cleaning status before reuse.

4. Accountability

Production Head and Quality Assurance Head

5. Procedure

5.1 Pre-Cleaning Preparation

1. Ensure the vessel is empty and affixed with “To Be Cleaned” label.
2. Wear appropriate PPE including gloves, mask, goggles, and apron.
3. Check for residual product; scrape off if necessary using sterile spatula.

5.2 Cleaning Steps

1. Rinse the internal and external surfaces of the vessel with Purified Water (PW) to remove gross residue.
2. Prepare 2% v/v cleaning agent (e.g., non-ionic detergent) solution in warm water.
3. Scrub the inner and outer surfaces using a soft brush dedicated to vessel cleaning.
4. Rinse thoroughly with potable water followed by PW until no detergent residue remains (check pH of final rinse).
5. Perform final rinse using Water for Injection (WFI) if applicable for product type.
6. Invert the vessel on a draining stand and allow to dry in a designated clean area.

5.3 Post-Cleaning Verification

1. Visually inspect all internal surfaces under white light for cleanliness.
2. Record visual inspection results in the Cleaning Log.
3. Affix “Cleaned” status label with date, time, and operator initials.

5.4 Cleaning Frequency

• After each batch transfer or product changeover.
• Before vessel reuse if idle for more than 48 hours.
• After maintenance or repair activity.

6. Abbreviations

• PPE: Personal Protective Equipment
• PW: Purified Water
• WFI: Water for Injection
• QA: Quality Assurance

7. Documents

1. Cleaning Log of Transfer Vessels – Annexure-1
2. Visual Inspection Checklist – Annexure-2

8. References

• WHO TRS 986 – GMP for Pharmaceutical Products
• FDA 21 CFR Part 211.67 – Equipment Cleaning and Maintenance

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: Cleaning Log of Transfer Vessels

Date	Vessel ID	Cleaning Agent Used	Cleaned By	Inspected By	Status
					Cleaned/Rejected

Annexure-2: Visual Inspection Checklist

Check Point	Status (Yes/No)	Remarks
Residue-free surface
No discoloration or stains
No corrosion or pitting
Label applied

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
12/03/2022	1.0	Initial version	New SOP	QA Head
09/06/2025	2.0	Updated cleaning validation and rinse criteria	Annual GMP Review	QA Head