Standard Operating Procedure for Cleaning Validation of Gelatin Preparation Equipment
| Department | Capsule Manufacturing |
|---|---|
| SOP No. | SOP/CM/162/2025 |
| Supersedes | SOP/CM/162/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
The purpose of this SOP is to outline the procedures for cleaning validation of gelatin preparation equipment used in capsule manufacturing. Ensuring the cleanliness of gelatin preparation equipment is critical to prevent cross-contamination and ensure the quality and safety of the finished capsules. This SOP defines the cleaning validation process to ensure compliance with GMP and regulatory standards.
2. Scope
This SOP applies to the cleaning validation of gelatin preparation equipment, including gelatin dissolving tanks, mixing vessels, and other related systems. It covers the steps from pre-cleaning setup to post-cleaning testing and approval, including cleaning agents, procedures, and validation of cleaning effectiveness.
3. Responsibilities
- Production Operators: Responsible for executing the cleaning procedure, ensuring all equipment is cleaned according to the validated procedure.
- Quality Control (QC) Team: Performs sampling and testing of cleaned equipment to ensure compliance with cleanliness standards and verifies that the cleaning process is effective.
- Quality Assurance (QA) Team: Reviews and approves the cleaning validation plan and results, ensuring compliance with GMP and regulatory standards.
- Engineering Team: Ensures the calibration and proper functioning of cleaning equipment, including tanks and cleaning systems used during the validation process.
4. Accountability
The Capsule Manufacturing Supervisor is responsible for ensuring that the cleaning procedures for gelatin preparation equipment are validated according to this SOP. The QA Manager is responsible for reviewing and approving the cleaning validation results and ensuring that the cleaning process meets GMP and regulatory standards.
5. Procedure
5.1 Preparation for Cleaning Validation
Before starting the cleaning validation process, ensure the following preparations are completed:
-
Review Validation Plan
- Review the cleaning validation plan, including equipment to be cleaned, cleaning agents, cleaning parameters, and acceptance criteria. Ensure that the plan is approved by the QA department before initiating the validation process.
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Gather Materials and Equipment
- Ensure that all cleaning materials, such as cleaning agents, tools, and equipment, are available and meet the quality standards required for the validation process.
- Ensure that all gelatin preparation equipment, including mixing tanks and dissolution vessels, is available and ready for validation.
-
Calibrate Equipment
- Ensure that all cleaning equipment, such as washing systems and pumps, is calibrated and functioning correctly. Record calibration details in the Equipment Calibration Log (Annexure 1).
5.2 Cleaning Procedure Validation
Follow these steps to validate the cleaning process for gelatin preparation equipment:
-
Pre-Cleaning Setup
- Set up the cleaning system according to the SOP for cleaning gelatin preparation equipment. Ensure the cleaning agents, temperature, and time are appropriately set.
- Ensure that all parts of the gelatin preparation equipment, including tanks and mixing systems, are accessible for cleaning.
-
Start the Cleaning Process
- Begin the cleaning process by applying cleaning agents to the equipment. Ensure the process is carried out for the specified duration and under the required conditions.
- Document all relevant cleaning parameters, such as time, temperature, and concentration of cleaning agents, in the Cleaning Validation Log (Annexure 2).
-
Post-Cleaning Rinse
- After cleaning, perform a rinse with appropriate solutions to remove any residual cleaning agents from the equipment.
- Document the post-cleaning rinse process to ensure all surfaces are thoroughly cleaned and free from residual agents.
-
Sampling and Testing
- Collect samples from cleaned equipment to test for any residual contaminants, including cleaning agents, gelatin residues, and microbial contamination.
- Perform swab tests and rinse water tests to confirm cleanliness and compliance with established criteria. Document the results in the Cleaning Validation Report (Annexure 3).
-
Review Results
- Review the results of the testing to ensure that all equipment meets the established cleanliness standards. Investigate any deviations and take corrective actions if necessary.
- If the equipment passes the validation criteria, approve the cleaning process for routine use. If the cleaning process does not meet the criteria, revalidate the process and perform corrective actions.
5.3 Post-Validation Documentation
Ensure proper documentation of the cleaning validation process:
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Cleaning Validation Report
- Prepare the Cleaning Validation Report (Annexure 4) summarizing the cleaning activities, results, and any corrective actions taken during the validation process.
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Approval of Validation Results
- Review and approve the cleaning validation report to ensure that all data meets the validation criteria. The report should be signed and approved by the QA Manager.
5.4 Documentation
Ensure proper documentation for traceability and compliance:
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Cleaning Validation Log
- Document all cleaning parameters in the Cleaning Validation Log (Annexure 2), including cleaning time, temperature, cleaning agent concentration, and rinse details.
-
Cleaning Validation Report
- Document the results of all cleaning validation tests, including swab tests and rinse water tests, in the Cleaning Validation Report (Annexure 3).
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Final Cleaning Validation Report
- Ensure that the final Cleaning Validation Report (Annexure 4) is signed by the QA Manager and filed for future reference.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- API: Active Pharmaceutical Ingredient
- RPM: Revolutions Per Minute
7. Documents
- Annexure 1: Equipment Calibration Log
- Annexure 2: Cleaning Validation Log
- Annexure 3: Cleaning Validation Report
- Annexure 4: Final Cleaning Validation Report
8. References
- FDA Guidelines on Cleaning and Sanitization
- Good Manufacturing Practice (GMP) Guidelines
- USP <1072> – Cleaning Procedures
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 Calibration Log
| Equipment ID | Calibration Date | Operator | Calibration Details | Next Calibration Due |
|---|---|---|---|---|
| Gelatin Mixer 501 | 01/02/2025 | John Doe | Calibration of mixing speed and temperature | 01/02/2026 |
Annexure 2: Cleaning Validation Log
| Batch ID | Cleaning Date | Operator | Cleaning Parameters | Remarks |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | Jane Smith | Temperature: 50°C, Time: 30 minutes | No issues |
Annexure 3: Cleaning Validation Report
| Batch ID | Test Date | Test Type | Results | Remarks |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | Swab Test | Pass | No contamination detected |
Annexure 4: Final Cleaning Validation Report
| Batch ID | Validation Date | Operator | Validation Results | Action Taken |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | John Doe | Pass | Approved for production |
12. Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial version of SOP | Creation of SOP for cleaning validation of Gelatin Preparation Equipment | QA Head |
| 01/02/2025 | 2.0 | Updated cleaning validation parameters and added new testing procedures | Optimization of cleaning process and inclusion of updated testing methods | QA Head |