Standard Operating Procedure for Qualification of Boilers for Steam Generation
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying boilers used for steam generation in pharmaceutical manufacturing. This SOP ensures that the boilers are correctly installed, calibrated, and operate in compliance with the required specifications. The qualification process verifies that the boilers produce clean, dry steam at the required pressure and temperature to meet the needs of pharmaceutical manufacturing processes, while ensuring compliance with regulatory and safety standards.
2) Scope
This SOP applies to the qualification of boilers used in pharmaceutical manufacturing for the production of clean, dry steam. The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This SOP is applicable to both new boilers and those that have undergone significant repairs, upgrades, or relocations. The qualification ensures that the boilers produce steam that meets the required quality and operational parameters and operates safely and reliably.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the boiler operates according to the qualification protocols, and that critical parameters such as pressure, temperature, and steam quality are monitored and recorded
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the boilers 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 boilers 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 boilers meet all performance criteria.
Maintenance Personnel: Ensures that the boilers are properly installed, maintained, and calibrated, 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 boilers for steam generation:
1. Installation Qualification (IQ):
1.1 Review the boiler specifications and manufacturer manuals to ensure that the equipment meets the necessary installation requirements.
1.2 Verify that all required utilities (e.g., water supply, electrical power, steam lines) 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 space.
1.4 Confirm that all mechanical components are correctly installed, including boilers, burners, heat exchangers, pressure vessels, and safety valves.
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 boiler is 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, temperature, steam flow, and system alarms, are properly set and calibrated.
2.2 Conduct a dry run of the boiler to verify that it operates without issues. Monitor key parameters such as steam pressure, temperature, and water level.
2.3 Test all control systems, ensuring that the burner system, pressure regulation, and steam generation systems work correctly.
2.4 Inspect the boiler to ensure that it maintains the required steam temperature, pressure, and quality during operation.
2.5 Verify that the system can handle varying load conditions and operate within the acceptable range of pressure and temperature.
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 boiler under typical production conditions to monitor performance during routine use.
3.2 Verify that the boiler consistently produces the required quality of steam, including appropriate pressure, temperature, and dryness.
3.3 Measure the steam quality and ensure that it meets the required specifications for pharmaceutical manufacturing processes, including the absence of contaminants such as oil or other impurities.
3.4 Ensure that the boiler maintains the required steam generation capacity over extended periods under typical operational conditions.
3.5 Verify that the system operates effectively under varying operational conditions, such as fluctuations in load or changes in steam demand.
3.6 Document the results of the PQ, including steam quality test results, pressure, temperature measurements, 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 system logs, pressure and temperature measurements, steam quality test results, and inspection reports.
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 boiler system. This analysis should confirm that the system operates consistently within predefined parameters and meets the acceptance criteria for steam quality, pressure, and temperature.
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 boiler’s performance.
5. Requalification:
5.1 Requalify the boiler if significant changes are made to the equipment, such as replacing major components, relocating the system, or modifying the steam generation process.
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
- Boiler Manufacturer Specifications
- Installation and Setup Reports
- Calibration Records
- Steam Quality Logs (Pressure, Temperature, Dryness)
- 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 1231: Steam for Pharmaceutical Purposes
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: Steam Quality Log
| Batch No. | Test Date | Pressure (bar) | Temperature (°C) | Dryness (%) | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Pressure | Temperature | Dryness | Operator Name |
Template 3: Deviation and Corrective Action Log
| Batch No. | Test Date | Deviation Description | Corrective Action Taken | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Deviation | Corrective Action | Operator Name |
