Standard Operating Procedure for Qualification of RABS (Restricted Access Barrier Systems)
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying Restricted Access Barrier Systems (RABS) used in pharmaceutical manufacturing areas, particularly for aseptic processing. This SOP ensures that the RABS are correctly installed, calibrated, and operate in compliance with the required specifications. The qualification process verifies that the RABS provide a sterile environment by maintaining the required airflow, pressure, and contamination control standards to protect the product during aseptic filling or other critical processes in pharmaceutical manufacturing.
2) Scope
This SOP applies to the qualification of RABS used in aseptic areas such as sterile filling lines, compounding rooms, and other controlled environments where pharmaceutical products are produced and handled. The qualification process includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This SOP is applicable to both new RABS and those that have undergone significant repairs, upgrades, or relocations. The qualification ensures that the RABS effectively maintain the desired sterile environment by controlling airflow, pressure, and preventing contamination.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the RABS is
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the RABS 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 RABS 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 RABS meets all performance criteria.
Maintenance Personnel: Ensures that the RABS 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 RABS:
1. Installation Qualification (IQ):
1.1 Review the RABS 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, ventilation, gas supply) 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, cleanliness, and space.
1.4 Confirm that all mechanical components are correctly installed, including the barrier system, airflow control mechanisms, HEPA filters, and operator glove ports.
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 RABS 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 airflow velocity, pressure differentials, and system alarms, are properly set and calibrated.
2.2 Conduct a dry run of the RABS to verify that it operates without issues. Monitor key parameters such as airflow patterns, pressure levels, and system response.
2.3 Test all control systems, ensuring that the airflow, pressure, and alarm systems work correctly.
2.4 Inspect the RABS to ensure that it maintains unidirectional airflow, maintains the required pressure differential between sterile and non-sterile zones, and prevents contamination.
2.5 Verify that the RABS can maintain the necessary sterile environment under typical operational conditions without deviation.
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 RABS under typical production conditions to monitor performance during routine use.
3.2 Verify that the RABS consistently provides the required sterile environment by monitoring airflow, pressure differentials, and contamination control.
3.3 Perform microbial testing to verify that the RABS effectively prevents microbial contamination in the sterile environment.
3.4 Measure airflow velocity, pressure, and microbial load at various points in the RABS to confirm that they meet the required standards.
3.5 Verify that the RABS system performs effectively under varying operational conditions, including changes in load, environmental fluctuations, or system malfunctions.
3.6 Document the results of the PQ, including microbial test results, airflow velocity, pressure differentials, 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 airflow, pressure, and microbial control.
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 RABS. This analysis should confirm that the system operates consistently within predefined parameters and meets the acceptance criteria for contamination control, airflow, and pressure.
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 RABS performance.
5. Requalification:
5.1 Requalify the RABS if significant changes are made to the equipment, such as replacing major components, relocating the system, or modifying the airflow or filtration system.
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
- Airflow and Pressure Logs
- Microbial 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: Airflow and Pressure Log
| Batch No. | Test Date | Airflow Velocity (m/s) | Pressure (Pa) | Microbial Load (CFU/m³) | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Airflow Velocity | Pressure | Microbial Load | Operator Name |
Template 3: Microbial Test Log
| Batch No. | Test Date | Microbial Load (CFU/m³) | Pass/Fail | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Microbial Load | Pass/Fail | Operator Name |
