Standard Operating Procedure for Qualification of Air Compressors in Manufacturing Units
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying air compressors used in pharmaceutical manufacturing units. This SOP ensures that the air compressors are correctly installed, calibrated, and operate according to the required specifications. The qualification process verifies that the air compressors provide clean, dry, and reliable compressed air to support various manufacturing operations while maintaining product quality and ensuring compliance with regulatory standards.
2) Scope
This SOP applies to the qualification of air compressors used in pharmaceutical manufacturing units, including those that supply compressed air to systems for mixing, spraying, filling, and other critical processes. The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This SOP is applicable to both new air compressors and those that have undergone significant repairs, upgrades, or relocations. The qualification ensures that the air compressors perform reliably and consistently within specified parameters, providing safe and effective compressed air to support pharmaceutical production operations.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the air compressors are operated according to the qualification
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the air compressors are carried out in compliance with this SOP and meet all regulatory requirements. QA is responsible for reviewing and approving all qualification reports and documentation.
Production Supervisors: Oversee the qualification processes to ensure that operators follow the protocol and that the air compressors operate within the specified parameters.
Validation Team: Responsible for developing the qualification protocols, executing the IQ, OQ, and PQ runs, and analyzing the results to ensure the air compressors meet all performance criteria.
Maintenance Personnel: Ensures that the air compressors are properly installed, calibrated, and maintained, and that all mechanical and electrical systems are functioning correctly during the qualification process.
4) Procedure
The following steps should be followed for the IQ, OQ, and PQ of air compressors in manufacturing units:
1. Installation Qualification (IQ):
1.1 Review the air compressor specifications and manufacturer manuals to ensure that the equipment meets the necessary installation requirements.
1.2 Verify that all required utilities (e.g., electrical power, compressed air lines, cooling systems) are available and meet the specifications required for operation.
1.3 Ensure that the installation site meets the required environmental conditions such as temperature, humidity, and cleanliness.
1.4 Confirm that all mechanical components are correctly installed, including air filters, regulators, compressors, and air dryers.
1.5 Ensure that all electrical components, including controllers, alarms, sensors, and data loggers, are correctly connected and functioning.
1.6 Perform a visual inspection to confirm that the air compressors are installed according to the manufacturer’s instructions and that all components are intact.
1.7 Complete the IQ documentation, including checklists, equipment manuals, and relevant installation records, ensuring that all information is recorded and signed off by responsible personnel.
2. Operational Qualification (OQ):
2.1 Verify that all operational controls, such as pressure, airflow, and alarm systems, are properly set and calibrated.
2.2 Conduct a dry run of the air compressor to verify that it operates without issues. Monitor key parameters such as pressure, airflow, and temperature.
2.3 Test all control systems, ensuring that the pressure regulation, cooling systems, and alarms work correctly.
2.4 Inspect the air compressor to ensure that it maintains the required air pressure and airflow while preventing contamination of the compressed air.
2.5 Verify that the system can handle varying load conditions and operates within the acceptable range of pressure and airflow.
2.6 Document the results of the OQ, noting any deviations or issues encountered and corrective actions taken.
3. Performance Qualification (PQ):
3.1 Conduct the operation of the air compressor under typical production conditions to monitor performance during routine use.
3.2 Verify that the air compressor consistently provides the required air pressure, flow rate, and quality for the specific pharmaceutical manufacturing operations.
3.3 Measure and record the airflow and pressure at various points in the system to ensure uniformity and compliance with specifications.
3.4 Verify that the air compressor system performs effectively under varying operational conditions, such as changes in demand or temperature.
3.5 Ensure that the compressed air meets the required quality standards, including dryness, and is free of contaminants such as oil, particulates, and microbial contamination.
3.6 Document the results of the PQ, including airflow, pressure, quality test results, and any process deviations. Ensure that all records are signed and reviewed by responsible personnel.
4. Documentation and Reporting:
4.1 Record all data during the IQ, OQ, and PQ processes, including equipment logs, process parameters, and inspection results for pressure, airflow, and system performance.
4.2 Ensure that all forms, reports, and certificates are completed and signed by responsible personnel.
4.3 Perform statistical analysis on the collected data to assess the consistency and reliability of the air compressor system. This analysis should confirm that the system operates consistently within predefined parameters and meets the acceptance criteria for air quality and system performance.
4.4 Prepare a final qualification report, summarizing the results of the IQ, OQ, and PQ, including any deviations, corrective actions, and conclusions regarding the air compressor’s performance.
5. Requalification:
5.1 Requalify the air compressor if significant changes are made to the equipment, such as replacing major components, relocating the system, or modifying the air supply or filtration systems.
5.2 Periodically perform requalification to ensure that the system continues to perform as expected and remains in compliance with regulatory requirements.
5) Abbreviations
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- QA: Quality Assurance
- SOP: Standard Operating Procedure
6) Documents
- IQ/OQ/PQ Protocol
- Equipment Manufacturer Specifications
- Installation and Setup Reports
- Calibration Records
- Air Pressure and Flow Logs
- Air Quality Testing Logs
- Deviation and Corrective Action Reports
7) Reference
- FDA Guidance for Industry: Equipment Qualification
- International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ISO 9001: Quality Management Systems – Requirements
- USP Chapter 1151: Pharmaceutical Dosage Forms
8) SOP Version
Version 1.0 – Effective Date: DD/MM/YYYY
Annexure
Template 1: IQ/OQ/PQ Test Record
| Date | Time | Operator Initials | Test Type (IQ/OQ/PQ) | Test Results | Comments |
|---|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | IQ/OQ/PQ | Pass/Fail | Comments |
Template 2: Air Quality and Pressure Log
| Batch No. | Test Date | Pressure (Pa) | Airflow Velocity (m/s) | Air Quality Test Results | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Pressure | Airflow Velocity | Pass/Fail | Operator Name |
Template 3: Air Compressor Maintenance Log
| Batch No. | Test Date | Maintenance Activity | Operator Initials | Comments |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Maintenance Activity | Operator Name | Comments |