Gel Manufacturing unit for cleaning tanks, transfer lines, mixing vessels, and process piping.

3. Responsibilities

• Production Operator: Operates CIP systems as per SOP instructions.
• Maintenance Engineer: Ensures the system is calibrated and functional.
• Quality Assurance: Reviews cleaning records and validates cleaning operations.

4. Accountability

Department Head and QA Head are accountable for the implementation of this SOP.

5. Procedure

5.1 Pre-CIP Checks

1. Ensure the equipment to be cleaned is free from product remnants.
2. Verify that the CIP system is clean and no previous cleaning residue is present.
3. Ensure chemical tanks are filled with validated cleaning agents (e.g., caustic solution, acid rinse).
4. Verify that all valves and piping connections are in place.

5.2 Operation of CIP System

1. Power on the CIP system and select the appropriate cleaning cycle from the HMI panel.
2. Start the water rinse cycle to remove loose soil and residual product.
3. Follow with a hot caustic wash for 15–30 minutes, depending on residue type.
4. Rinse with purified water to remove caustic traces.
5. Perform an acid rinse (e.g., nitric acid solution) if scale or mineral deposits are expected.
6. Final rinse with Water for Injection (WFI) or purified water until conductivity meets specification.

5.3 Post-CIP Actions

1. Shut off the CIP system and disconnect any temporary piping or valves used.
2. Inspect cleaned equipment for water droplets, residue, or missed areas.
3. Dry equipment with filtered air or allow it to dry naturally depending on validation protocol.

5.4 Documentation and Verification

1. Record parameters like temperature, conductivity, flow rate, and duration in the CIP Logbook (Annexure-1).
2. Fill the CIP Execution Checklist (Annexure-2).
3. Supervisor to review and QA to verify and sign off the cleaning batch.

5.5 Cleaning Frequency

• After every production batch or product change.
• As per validated cleaning interval based on hold time study.

6. Abbreviations

• CIP: Clean-In-Place
• HMI: Human Machine Interface
• QA: Quality Assurance
• WFI: Water for Injection

7. Documents

1. CIP System Logbook – Annexure-1
2. CIP Execution Checklist – Annexure-2

8. References

• Validation Master Plan (VMP)
• GMP Guidelines by WHO and Schedule M
• Equipment Cleaning Validation Report

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: CIP System Logbook

Date	Equipment Cleaned	Chemical Used	Temp (°C)	Duration (min)	Conductivity (µS)	Operator	Verified By

Annexure-2: CIP Execution Checklist

Step	Performed (Y/N)	Remarks	Operator Signature	Verified By (QA)
Initial Water Rinse
Caustic Wash
Intermediate Rinse
Acid Rinse
Final Purified Water Rinse
Inspection and Drying

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial issue	New CIP System Implementation	QA Head
02/06/2025	2.0	Updated procedures and annexures	GMP Compliance	QA Head