solution preparation in the sterile manufacturing department.

3. Responsibilities

• Production Officer: Executes the cleaning operation as per defined protocol.
• Engineering Officer: Ensures water supply and maintenance of CIP systems.
• Quality Assurance (QA): Verifies cleanliness and signs off cleaning records.

4. Accountability

The Head of Production is accountable for ensuring proper cleaning and documentation of solution preparation vessels before and after each batch process.

5. Procedure

5.1 Pre-Cleaning Checks

1. Ensure vessel is disconnected from electrical supply and process lines.
2. Affix “Under Cleaning” status label on the equipment.
3. Ensure all used materials are removed from the vessel area.

5.2 Cleaning Steps

1. Manual Cleaning:
   • Rinse the vessel with purified water to remove gross residues.
   • Scrub internal surfaces using a nylon brush with 2% non-ionic detergent solution.
   • Pay special attention to impeller blades, baffles, and corners.
   • Rinse thoroughly with purified water until no foam remains.
2. Automated CIP (if applicable):
   • Initiate CIP cycle as per equipment SOP with preset water, detergent, and rinse cycles.
   • Ensure all drain valves are functioning properly.
3. Final Rinse:
   • Perform final rinse with Water for Injection (WFI).
   • Collect rinse water in clean sampling container for pH and TOC testing (if applicable).
4. Dry the vessel using clean lint-free wipes and compressed filtered air.

5.3 Post-Cleaning Inspection

1. Inspect vessel surfaces for cleanliness, absence of residues, and stains.
2. QA to perform visual inspection and approve the cleaning.
3. Log cleaning details in Cleaning Record (Annexure-1).

5.4 Frequency

• After each batch and product changeover.
• At least once every 7 days during idle time (if not used).

5.5 Special Considerations

• Use dedicated brushes and cleaning tools for each vessel size and type.
• Record any anomalies or deviations encountered during cleaning.

6. Abbreviations

• SOP: Standard Operating Procedure
• CIP: Clean-in-Place
• WFI: Water for Injection
• QA: Quality Assurance
• TOC: Total Organic Carbon

7. Documents

1. Cleaning Record – Annexure-1
2. Post-Cleaning Inspection Checklist – Annexure-2
3. pH and TOC Test Report – Annexure-3

8. References

• ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO TRS No. 961 Annex 6: GMP for Sterile Products
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Cleaning Record

Date	Vessel ID	Product	Cleaned By	Verified By
17/06/2025	SPV-001	Paracetamol Injection	Rajesh Kumar	Anita Sharma

Annexure-2: Post-Cleaning Inspection Checklist

Parameter	Checked	Remarks	QA Signature
Residue-free interior	Yes	Clean	Sunita Reddy
No stains or deposits	Yes	Accepted	Sunita Reddy

Annexure-3: pH and TOC Test Report

Sample Date	pH	TOC (ppb)	Tested By	Remarks
17/06/2025	6.8	180	Vinay Pawar	Within limits

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Updated cleaning frequency and added TOC test	Annual Review	QA Head