Standard Operating Procedure for Validation of Dust Extraction Systems in Capsule Facilities
| Department | Capsule Manufacturing |
|---|---|
| SOP No. | SOP/CM/175/2025 |
| Supersedes | SOP/CM/175/2022 |
| 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 process for validating dust extraction systems used in capsule manufacturing facilities. Dust extraction systems are crucial for maintaining a clean and safe working environment by capturing and removing airborne particulates during the manufacturing process. This SOP ensures that the dust extraction system operates efficiently, meets GMP requirements, and complies with safety standards for capsule production.
2. Scope
This SOP applies to the validation of dust extraction systems used throughout the capsule manufacturing areas, including granulation, blending, encapsulation, and packaging areas. It covers the testing and documentation of system performance, ensuring the system meets the required standards for airflow, filtration efficiency, and dust removal.
3. Responsibilities
- Engineering Team: Responsible for the installation, maintenance, and troubleshooting of the dust extraction system, including calibration and performance testing during validation.
- Quality Control (QC) Team: Responsible for performing airflow, filtration, and dust concentration tests to validate the dust extraction system’s performance. They document all validation results and report deviations if any are found.
- Quality Assurance (QA) Team: Reviews and approves the validation documentation to ensure compliance with GMP and regulatory standards before the system is used for production.
- Production Team: Ensures that the dust extraction system operates properly during manufacturing runs and maintains the required environmental conditions for capsule production.
4. Accountability
The Engineering Supervisor is responsible for ensuring the installation and proper functioning of the dust extraction system. The QA Manager is responsible for reviewing and approving the validation results, ensuring compliance with regulatory requirements. The Production Supervisor ensures that the dust extraction system is integrated into regular production and operates correctly during manufacturing processes.
5. Procedure
5.1 Pre-Validation Setup
Before starting the validation process for the dust extraction system, ensure the following steps are completed:
-
Review Validation Plan
- Review the validation plan to ensure it includes all required tests, system specifications, and acceptance criteria. The plan must be approved by the QA department before initiating validation.
-
System Installation and Setup
- Ensure the dust extraction system is installed in the required production areas and that all components (e.g., ducts, filters, fans) are properly connected and functioning.
- Ensure that the system is capable of maintaining the required airflow and suction to effectively remove dust from the environment.
-
Calibrate Monitoring Instruments
- Calibrate airflow meters, dust concentration monitors, and other monitoring instruments used to measure system performance. 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 dust extraction system:
-
Verify Airflow Rates
- Measure the airflow rates at various points in the system using calibrated instruments to ensure that the system can maintain the required suction levels. Check that the airflow rate meets the specified range (e.g., 1000-2000 CFM).
-
Verify Filtration Efficiency
- Test the filtration efficiency of the system to ensure that it is effectively removing particulates from the air. Use particle counters or dust samplers to measure the concentration of airborne dust before and after filtration.
-
Test System Integrity
- Check for any leaks in the ducts, filters, and joints in the system that could compromise its efficiency. Use smoke tests or air flow visualization methods to detect leaks.
-
Verify Alarm Systems
- Test the alarm systems to ensure that they activate when airflow drops below acceptable levels or when the system detects a failure (e.g., filter blockage or fan malfunction).
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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 it meets all required specifications. Record the results in the PQ Log (Annexure 2).
5.3 Post-Qualification Activities
After successful completion of the PQ process, ensure the following activities are completed:
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System Integration into Production
- Integrate the validated dust extraction system into regular production operations and ensure that it operates properly during all production runs. Perform periodic checks to ensure continued performance.
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Operator Training
- Train operators on how to monitor and maintain the dust extraction system during production. Provide training on how to respond to alarms, take corrective actions, and perform routine system checks.
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Sign-Off and Approval
- Ensure that the PQ process is completed successfully and the system is signed off for use in production. The PQ Report should be reviewed and approved by the QA Manager and filed for record-keeping.
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 Dust Extraction Systems for Pharmaceutical Facilities
- 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 |
|---|---|---|---|---|
| Dust Extractor 202 | 01/02/2025 | John Doe | Calibration of airflow meter | 01/02/2026 |
Annexure 2: Performance Qualification Log
| Batch ID | PQ Date | Operator | Test Type | Results |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | Jane Smith | Airflow Test | Pass |
Annexure 3: Performance Qualification Report
| Batch ID | Test Date | Test Type | Results | Remarks |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | Dust Extraction System Test | Pass | System passed all airflow and filtration tests |
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 validation of dust extraction systems | QA Head |
| 01/02/2025 | 2.0 | Updated validation criteria and added new system checks | Inclusion of updated tests and requirements | QA Head |