Standard Operating Procedure for Qualification of Sterilizers (Autoclaves)
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying sterilizers (autoclaves) used in pharmaceutical manufacturing for sterilizing equipment, containers, and materials. This SOP ensures that the sterilizers are correctly installed, calibrated, and operate according to the specifications, maintaining the required sterilization parameters such as temperature, pressure, and exposure time. The qualification process verifies that the sterilization process consistently meets regulatory and quality standards, ensuring product safety and efficacy.
2) Scope
This SOP applies to the qualification of sterilizers (autoclaves) used in pharmaceutical manufacturing processes, particularly for sterilizing equipment, containers, and materials that come into direct contact with drug products. The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This SOP is applicable to both new sterilizers and those that have undergone major repairs, upgrades, or relocations. The qualification ensures that the autoclave operates effectively and meets the necessary standards for the sterilization of pharmaceutical products and components.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the sterilizer is operated according to the qualification protocols and that critical parameters are monitored and recorded
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the sterilizer 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 sterilizer operates 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 sterilizer meets all performance criteria.
Maintenance Personnel: Ensures that the sterilizer is 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 sterilizers (autoclaves):
1. Installation Qualification (IQ):
1.1 Review equipment specifications and manufacturer manuals to ensure that the sterilizer meets the necessary requirements for installation.
1.2 Verify that all required utilities (e.g., electrical power, steam, water) are available and meet the specifications required for proper operation.
1.3 Ensure that the installation site meets the required environmental conditions such as temperature, humidity, cleanliness, and space.
1.4 Confirm that all mechanical components are correctly installed, including pressure and temperature sensors, steam delivery systems, and safety mechanisms.
1.5 Ensure that all electrical components, including controllers, display systems, and alarms, are correctly connected and functioning.
1.6 Perform a visual inspection to confirm that the equipment 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 temperature, pressure, and exposure time, are properly set and calibrated.
2.2 Conduct a dry run of the sterilizer to verify that it operates without issues. Monitor key parameters such as temperature, pressure, and cycle time.
2.3 Test all control systems, ensuring that the start/stop, heating, pressure, and sterilization cycle controls work correctly.
2.4 Inspect the sterilization process to ensure that the autoclave reaches the required sterilization temperature and pressure for the correct duration.
2.5 Verify that the system meets the specified temperature uniformity and pressure distribution throughout the sterilization chamber.
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 sterilization process using biological indicators (BIs) or other appropriate test materials to verify the effectiveness of the sterilization cycle.
3.2 Measure the temperature and pressure during the cycle to confirm that the sterilizer maintains the required sterilization conditions across the entire load.
3.3 Verify that the sterilization process kills any potential microbial contaminants, including conducting microbiological testing on test items before and after sterilization.
3.4 Ensure that the sterilizer operates within the required throughput, providing consistent sterilization for all loads.
3.5 Conduct tests to verify that the sterilization cycle meets the expected cycle time and that the load is evenly treated.
3.6 Document the results of the PQ, including microbial testing results, temperature and pressure data, 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 batch records, equipment logs, process parameters, and inspection results for temperature, pressure, and cycle time.
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 sterilization process. This analysis should confirm that the autoclave operates consistently within predefined parameters and meets the acceptance criteria for sterilization effectiveness.
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 sterilizer’s performance.
5. Requalification:
5.1 Requalify the sterilizer if significant changes are made to the equipment, such as replacing major components, relocating the machine, or modifying the sterilization system.
5.2 Periodically perform requalification to ensure that the equipment 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
- Sterilization Process Records
- Temperature and Pressure Logs
- Biological Indicator Test Results
- 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: Sterilization Process Log
| Batch No. | Test Date | Temperature (°C) | Pressure (psi) | Cycle Time (minutes) | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Temperature | Pressure | Time | Operator Name |
Template 3: Biological Indicator Test Log
| Batch No. | Test Date | Microbial Load (CFU/mL) | Pass/Fail | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Microbial Load | Pass/Fail | Operator Name |
