SOP Guide for Pharma

SOP for Qualification of Sterilizers (Autoclaves)

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SOP for Qualification of Sterilizers (Autoclaves)

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 during testing.
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.

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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.

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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.

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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

6) Documents

7) Reference

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
         
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