Creams: SOP for CIP (Clean-in-Place) Systems in Cream Production – V 2.0

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Creams: SOP for CIP (Clean-in-Place) Systems in Cream Production – V 2.0

Standard Operating Procedure for CIP (Clean-in-Place) Systems in Cream Production

Department Creams
SOP No. SOP/CRM/094/2025
Supersedes SOP/CRM/094/2022
Page No. Page 1 of 6
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to establish the procedure for cleaning the cream production equipment using CIP (Clean-in-Place) systems. The objective is to ensure that all equipment is effectively cleaned without disassembly, maintaining product quality and preventing contamination.

2. Scope

This SOP applies to all production equipment used in the Creams Department that utilizes the CIP system, including mixers, filling machines, and pipelines. It covers the steps for cleaning, sanitizing, and verifying the cleanliness of the equipment.

3. Responsibilities

  • Production Team: Responsible for ensuring that all CIP systems are set up correctly before the cleaning process and verifying that the equipment is clean after the process is completed.
  • Maintenance Team: Responsible for inspecting the CIP system, ensuring it is functioning properly, and performing any necessary maintenance or repairs.
  • Quality Control (QC): Ensures that the CIP system is validated, the cleaning is effective, and there is no cross-contamination or residue in the equipment.

4. Accountability

The Head of Production is accountable for ensuring that the CIP system is properly implemented and maintained. The QA Manager is responsible for verifying that the cleaning process is completed according to this SOP and that the equipment is ready for production.

5. Procedure

5.1 Pre-CIP Checks

  1. Ensure that all equipment to be cleaned is properly isolated and disconnected from any product lines.
  2. Verify that the CIP system is functioning correctly, including pumps, valves, and hoses. Check for any leaks or damage in the system.
  3. Ensure that the cleaning agents, including detergents and sanitizers, are available and at the correct concentrations for cleaning.
  4. Consult the equipment’s cleaning specifications to determine the appropriate cleaning procedures, including temperatures, flow rates, and chemical requirements.
  5. Ensure that the equipment is properly disassembled, if needed, and that all accessible surfaces are free from any product residue before initiating the CIP process.
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5.2 Setting Up the CIP System

  1. Connect the CIP system to the production equipment, ensuring that the pipes and hoses are correctly attached to the cleaning points.
  2. Set the CIP system to the appropriate cycle, including pre-rinse, wash, post-rinse, and sanitization cycles, as required by the equipment’s cleaning specifications.
  3. Ensure that the temperature, pressure, and flow rates of the CIP system are set according to the manufacturer’s guidelines and equipment requirements.
  4. Check that the detergent and sanitizing agents are loaded into the system and that the correct amount of each is available for the cleaning process.

5.3 CIP Cleaning Process

  1. Initiate the CIP cleaning cycle, starting with a pre-rinse to remove any residual cream or product from the equipment.
  2. After the pre-rinse, introduce the detergent solution at the required temperature and flow rate. Ensure that all surfaces of the equipment are adequately cleaned.
  3. After the detergent cycle, rinse the equipment thoroughly with water to remove all detergent residues.
  4. Introduce the sanitizing solution into the system and ensure that it circulates through all parts of the equipment for the required time and temperature.
  5. After the sanitization cycle, perform a final rinse with clean water to ensure that no sanitizing agents remain in the equipment.
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5.4 Post-CIP Checks

  1. Inspect the equipment to ensure that it is visually clean and free from any product residues or detergent traces.
  2. Verify that the CIP system has run for the correct duration at the specified temperatures and flow rates as per the cleaning specifications.
  3. Check the cleaning solution tanks to ensure that the correct chemicals were used in the correct concentrations.
  4. If any residues are found, repeat the cleaning process or use additional cleaning agents as needed until the equipment is fully clean.

5.5 Verification of Cleanliness

  1. Once the CIP process is completed, the QC team must perform a visual inspection of the equipment to check for any remaining residues or contamination.
  2. Conduct a swab test or rinse water test on the cleaned surfaces to ensure that there are no traces of contamination or cleaning agents.
  3. If the swab or rinse water tests pass, document the results and approve the equipment for use in production.
  4. If the tests fail, repeat the cleaning process and re-test until the equipment passes the cleanliness verification.

5.6 Equipment Maintenance and Calibration

  1. After each CIP process, inspect the CIP system for any signs of wear, damage, or contamination. Ensure that all filters, nozzles, and hoses are properly cleaned and in good condition.
  2. Perform regular maintenance on the CIP system, including checking pumps, valves, and flow meters, to ensure they are functioning properly.
  3. Document any maintenance or repairs performed on the CIP system in the Equipment Maintenance Log (Annexure-1).

5.7 Documentation

  1. Record the details of each CIP cleaning cycle, including the date, cleaning cycle parameters (temperature, time, chemical concentration), and the results of the visual and swab tests, in the CIP Log (Annexure-2).
  2. Document any maintenance or repairs made to the CIP system in the Equipment Maintenance Log (Annexure-1).
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5.8 Final Approval

  1. The QA team must review the cleaning and verification records to ensure that the CIP system has been validated and the equipment is ready for the next production run.
  2. If any deviations are identified, corrective actions should be taken before the equipment is used for production.

6. Abbreviations

  • GMP: Good Manufacturing Practices
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Annexure-1: Equipment Maintenance Log
  2. Annexure-2: CIP Log

8. References

  • Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
  • International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • Manufacturer’s Guidelines for CIP Systems

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Maintenance Log

Equipment ID Maintenance Date Maintenance Type Operator Comments
CIP-001 21/01/2026 Inspection, lubrication John Doe Successfully completed maintenance

Annexure-2: CIP Log

CIP Cycle Date Equipment ID Cycle Type Temperature (°C) Time (minutes) Chemical Used Operator Results
21/01/2026 CIP-001 Wash, Sanitization 75 30 Detergent, Sanitizer Jane Smith Successful, no residues found

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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