Standard Operating Procedure for Preparing Equipment for CIP and SIP Processes
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/117/2025 |
| Supersedes | SOP/CRM/117/2022 |
| Page No. | Page 1 of 5 |
| 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 preparing equipment for Clean-in-Place (CIP) and Steam-in-Place (SIP) processes in the cream manufacturing process. Proper preparation of equipment ensures the effectiveness of the cleaning and sterilization processes, maintaining GMP compliance and product quality.
2. Scope
This SOP applies to all cream manufacturing equipment that requires CIP and SIP processes, including homogenizers, mixers, tanks, and pipes. It covers the preparation of equipment for cleaning and sterilization to prevent contamination and ensure that the equipment is free from residues and microorganisms.
3. Responsibilities
- Production Team: Responsible for ensuring that equipment is properly prepared for CIP and SIP processes before production and after cleaning.
- Maintenance Team: Responsible for ensuring that equipment is operational and in good condition for CIP and SIP procedures and for performing necessary repairs or adjustments.
- Quality Control (QC): Verifies that the equipment is correctly prepared and cleaned, ensuring that it meets GMP standards and does not affect product quality.
4. Accountability
The Production Supervisor is accountable for ensuring that all equipment is properly prepared for CIP and SIP processes before production runs. The Maintenance Supervisor is responsible for ensuring that the equipment is operational and in good working order before and after the cleaning processes.
5. Procedure
5.1 Preparing Equipment for CIP
- Ensure that the equipment is powered off, and all electrical connections are disconnected. Lockout/tagout procedures must be followed to prevent accidental startup during cleaning.
- Remove any product residues from the equipment. Manually clean any visible residue or debris that may obstruct the CIP process.
- Disassemble parts of the equipment that may be difficult to clean using the CIP system, such as valves, nozzles, or other components that require manual cleaning. Clean these parts separately according to the manual cleaning SOP.
- Ensure that the CIP spray balls, nozzles, and pipes are properly positioned and aligned for effective cleaning. Verify that there are no blockages in the CIP system.
- Fill the CIP tanks with the appropriate cleaning solution as per the SOP for cleaning agents. Ensure the correct concentration and temperature of the cleaning solution before beginning the CIP cycle.
- Check the pressure settings for the CIP system and ensure that the spray system is functioning correctly. Verify that the equipment can be completely covered by the cleaning solution and that all surfaces will be adequately cleaned.
5.2 Preparing Equipment for SIP
- Before initiating the SIP process, ensure that all equipment is clean and free from any cleaning agent residues or debris. Verify that the CIP process has been successfully completed, and there are no residues remaining from the cleaning solutions.
- Inspect all temperature sensors and pressure relief valves to ensure they are working properly. These components are critical to controlling the steam temperature and preventing overpressure during sterilization.
- Check the steam source to ensure that it is properly pressurized and the steam generator is operating within the required specifications.
- Verify that the steam distribution system, including all pipes and connections, is free of leaks. Ensure that the system is capable of providing adequate steam flow to the equipment to reach the desired temperature.
- Ensure that the equipment is isolated from the production line and that all openings are sealed to prevent contamination after sterilization.
- Start the SIP cycle by introducing steam into the equipment. Monitor the equipment to ensure that the temperature reaches the required level for sterilization, typically 121°C, and is maintained for the specified duration (e.g., 15-20 minutes).
5.3 Monitoring and Verification
- Monitor the temperature and pressure throughout the CIP and SIP processes to ensure that the equipment is operating within the desired parameters. Use calibrated instruments to verify that the temperatures reach and maintain the required levels.
- Record the temperature, pressure, and duration of the CIP and SIP cycles in the Cleaning and Sterilization Log (Annexure-1). Ensure that all readings are within the specified limits.
- If deviations are observed during the CIP or SIP processes, stop the process immediately, investigate the cause, and take corrective actions. Document the deviation in the Deviation Log (Annexure-2) and notify the Quality Control team.
5.4 Post-Cleaning and Post-Sterilization Checks
- After the CIP and SIP processes are completed, visually inspect the equipment for any remaining residues or contamination. If residues are found, repeat the cleaning or sterilization cycle as necessary.
- Verify that all equipment parts are reassembled correctly after cleaning and sterilization. Ensure that all connections are tight and that no parts are missing.
- Perform a function check on the equipment to ensure it is ready for production. Test any automated features, such as pumps, valves, and controllers, to ensure they are functioning correctly.
- Record the final temperature and pressure readings after the SIP cycle is complete in the Temperature and Pressure Log (Annexure-3). Ensure that these values are within the specified limits.
5.5 Documentation and Record-Keeping
- Maintain accurate records of all CIP and SIP activities, including temperatures, pressures, cleaning solutions used, and any deviations or corrective actions taken. These records should be documented in the Cleaning and Sterilization Log (Annexure-1) and other relevant logs.
- Ensure that all records are reviewed by the Quality Control team for compliance with GMP standards.
- Retain all documentation for a minimum of two years or as required by regulatory guidelines.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- CIP: Clean-in-Place
- SIP: Steam-in-Place
7. Documents
- Annexure-1: Cleaning and Sterilization Log
- Annexure-2: Deviation Log
- Annexure-3: Temperature and Pressure 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 Manual for CIP and SIP Equipment
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning and Sterilization Log
| Batch Number | CIP Start Time | CIP End Time | SIP Start Time | SIP End Time | Operator |
|---|---|---|---|---|---|
| 12345 | 10:00 AM | 10:30 AM | 10:40 AM | 11:00 AM | John Doe |
Annexure-2: Deviation Log
| Deviation Date | Batch Number | Deviation Description | Corrective Action Taken | Operator |
|---|---|---|---|---|
| 21/01/2026 | 12345 | Low steam pressure | Replaced faulty steam valve | Jane Smith |
Annexure-3: Temperature and Pressure Log
| Time | Temperature (°C) | Pressure (Bar) | Operator |
|---|---|---|---|
| 10:00 AM | 121°C | 2.0 | John Doe |
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 |