Standard Operating Procedure for Validation of Cleaning Procedures for Capsule Fill Machines
| Department | Capsule Manufacturing |
|---|---|
| SOP No. | SOP/CM/161/2025 |
| Supersedes | SOP/CM/161/2022 |
| 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 validating the cleaning process of capsule fill machines. Ensuring that capsule fill machines are cleaned thoroughly and effectively between manufacturing batches is critical for preventing cross-contamination and ensuring product quality. This SOP ensures that cleaning procedures are consistent, reproducible, and compliant with GMP and regulatory standards.
2. Scope
This SOP applies to the cleaning validation of capsule fill machines used in the production of hard gelatin capsules. It covers all steps from pre-cleaning setup to post-cleaning testing and approval, including the use of cleaning agents, procedures, and the validation of cleaning efficacy.
3. Responsibilities
- Production Operators: Responsible for executing the cleaning procedure and ensuring that 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.
- Quality Assurance (QA) Team: Reviews and approves the cleaning validation plan and results, ensuring that the cleaning process complies with GMP and regulatory standards.
- Engineering Team: Ensures that cleaning equipment, including cleaning agents and washing systems, is properly calibrated and functioning during the validation process.
4. Accountability
The Capsule Manufacturing Supervisor is responsible for ensuring that the cleaning procedures for capsule fill machines 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 complies with GMP and regulatory standards.
5. Procedure
5.1 Preparation for Cleaning Validation
Before initiating the cleaning validation process, ensure the following preparations are made:
-
Review Validation Plan
- Review the cleaning validation plan, which includes the cleaning agents to be used, the equipment to be cleaned, cleaning parameters, and acceptance criteria. Ensure that the plan is approved by the QA department before starting the validation process.
-
Gather Materials and Equipment
- Ensure that all cleaning materials, including cleaning agents and tools, are available and meet the quality specifications for the validation process.
- Ensure that capsule fill machines and related equipment are ready for cleaning and validation.
-
Calibrate Equipment
- Ensure that all cleaning equipment 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 capsule fill machines:
-
Pre-Cleaning Setup
- Set up the cleaning system according to the SOP for cleaning capsule filling machines. Ensure that the cleaning agents, temperature, and time are properly set.
- Ensure that all parts of the machine that come in contact with the product are accessible for cleaning.
-
Start the Cleaning Process
- Start the cleaning process by applying the cleaning agents to the machine. Ensure that the process is carried out for the specified duration and under the required conditions.
- Record 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.
- Ensure that the rinsing process is performed thoroughly to prevent contamination.
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Sampling and Testing
- Take samples from cleaned equipment to test for residual contaminants, including cleaning agents, product residues, and microbial contamination.
- Perform tests such as swab tests and rinse water tests to check for cleanliness. 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. If any deviations or non-conformances are identified, investigate the cause and take corrective actions.
- If the equipment passes the validation criteria, approve the cleaning process for routine use. If the process does not meet the acceptance 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 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 of the cleaning process for traceability and regulatory compliance:
-
Cleaning Validation Log
- Document all cleaning parameters, including time, temperature, concentration of cleaning agents, and post-cleaning rinse details in the Cleaning Validation Log (Annexure 2).
-
Cleaning Validation Report
- Document the results of cleaning validation testing in the Cleaning Validation Report (Annexure 3).
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Validation Approval
- Ensure that the Cleaning Validation Report (Annexure 4) is signed and approved by the QA Manager and is stored 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 |
|---|---|---|---|---|
| Filling Machine 306 | 01/02/2025 | John Doe | Sealing and fill volume calibration | 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 during process validation | QA Head |
| 01/02/2025 | 2.0 | Updated cleaning validation parameters and added new equipment calibration details | Optimization of cleaning process and inclusion of new validation procedures | QA Head |