Standard Operating Procedure for Validation of Dehumidifiers in Capsule Manufacturing Areas
| Department | Capsule Manufacturing |
|---|---|
| SOP No. | SOP/CM/174/2025 |
| Supersedes | SOP/CM/174/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
The purpose of this SOP is to provide a standardized procedure for validating dehumidifiers used in capsule manufacturing areas. Dehumidifiers are essential for controlling the humidity levels in the production environment, which directly affects the quality and stability of capsules. This SOP ensures that the dehumidifiers operate efficiently and maintain the required environmental conditions to comply with GMP and regulatory standards.
2. Scope
This SOP applies to the validation of dehumidifiers in capsule manufacturing areas, including the areas where capsule shells are prepared and dried. It includes the process of testing the system’s capacity to control humidity, its operational efficiency, and its ability to maintain a stable environment throughout production.
3. Responsibilities
- Engineering Team: Responsible for the installation, calibration, and maintenance of the dehumidifiers. They will perform initial functional tests and ensure proper operation during validation.
- Quality Control (QC) Team: Responsible for performing environmental testing to verify that the dehumidifier meets the required humidity control specifications and documenting the results of validation tests.
- Quality Assurance (QA) Team: Reviews and approves the validation results and ensures that the dehumidifier meets GMP and regulatory standards before it is used in production.
- Production Team: Ensures that the dehumidifiers are functioning correctly during production and that the environmental conditions are maintained at the appropriate levels for capsule production.
4. Accountability
The Engineering Supervisor is responsible for ensuring the proper installation and calibration of dehumidifiers. The QA Manager is responsible for reviewing and approving the validation results to ensure compliance with GMP and regulatory requirements. The Production Supervisor ensures the dehumidifiers are functioning correctly during production runs.
5. Procedure
5.1 Pre-Validation Setup
Before starting the dehumidifier validation process, ensure the following steps are completed:
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Review Validation Plan
- Review the dehumidifier validation plan to ensure it includes all necessary tests, system specifications, and acceptance criteria. The plan must be approved by the QA department before initiating validation.
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System Installation and Setup
- Ensure that the dehumidifiers are correctly installed and connected to the appropriate areas in the capsule manufacturing environment. Confirm that all required utilities (electricity, drainage) are properly set up.
- Ensure the system is capable of achieving the required humidity levels as per the production specifications (e.g., 35-45% RH for capsule shell production).
-
Calibration of Monitoring Instruments
- Calibrate humidity sensors and other monitoring instruments to ensure accurate readings of environmental conditions. Record calibration details in the Equipment Calibration Log (Annexure 1).
5.2 Performance Qualification (PQ) Testing
Follow these steps to perform the performance qualification of the dehumidifier system:
-
Verify Humidity Control
- Measure the relative humidity at various locations in the production areas using calibrated hygrometers. Ensure that the system can maintain the required humidity level (e.g., 35-45% RH) consistently.
-
Test System Response to Load Changes
- Simulate load changes in the production environment (e.g., opening doors, changes in personnel) and verify that the dehumidifier responds appropriately by maintaining stable humidity levels.
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Test Operational Efficiency
- Verify that the dehumidifiers can handle the required volume of air and maintain desired humidity levels without exceeding energy consumption limits. Check that the system operates within the acceptable range for both temperature and humidity.
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Verify Alarm Systems
- Test the alarm systems to ensure they activate when the system deviates from the acceptable operating conditions (e.g., if the humidity falls below or rises above the specified range).
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Document PQ Results
- Document the results of all performance qualification tests. If any deviations are found, investigate the causes and take corrective actions. Re-test the system until all performance criteria are met. Record the results in the PQ Log (Annexure 2).
5.3 Post-Qualification Activities
Once the PQ tests are completed, the following steps should be completed:
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System Integration into Production
- Once the dehumidifier passes all PQ tests, integrate it into regular production operations. Ensure that the system maintains optimal humidity levels throughout the production runs.
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Operator Training
- Train operators on how to monitor the system’s performance during production, how to troubleshoot common issues, and how to handle alarms and deviations from set points.
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Sign-Off and Approval
- Ensure that the PQ process is completed successfully, and the dehumidifier system is signed off for use in production. The PQ Report should be reviewed, approved, and filed for future reference.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- PQ: Performance Qualification
- QA: Quality Assurance
- QC: Quality Control
- PPE: Personal Protective Equipment
7. Documents
- Annexure 1: Equipment Calibration Log
- Annexure 2: Performance Qualification Log
- Annexure 3: Performance Qualification Report
8. References
- FDA Guidelines on Environmental Control Systems
- Good Manufacturing Practice (GMP) Guidelines
- USP <797> – Pharmaceutical Compounding – Sterile Preparations
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 |
|---|---|---|---|---|
| Dehumidifier 107 | 01/02/2025 | John Doe | Calibration of humidity sensors | 01/02/2026 |
Annexure 2: Performance Qualification Log
| Batch ID | PQ Date | Operator | Test Type | Results |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | Jane Smith | Humidity Control Test | Pass |
Annexure 3: Performance Qualification Report
| Batch ID | Test Date | Test Type | Results | Remarks |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | Dehumidifier System Test | Pass | Dehumidifier passed all tests for temperature and humidity control |
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 dehumidifier validation in capsule manufacturing | QA Head |
| 01/02/2025 | 2.0 | Updated system checks and added new criteria for performance qualification | Improvement of validation tests and inclusion of new checks | QA Head |