Document Control:
Protocol Number: OQ-STS-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Operational Qualification Protocol for Sterility Test Isolator/System
Objective: To validate the operational performance of the Sterility Test Isolator/System to ensure compliance with regulatory requirements and product specifications.
Scope: This protocol applies to the Sterility Test Isolator/System used in microbiology for sterility testing of NDDS products.
Responsibilities:
- Validation Team: Conducts the OQ testing and documentation.
- Quality Assurance: Reviews and approves the OQ protocol and results.
- Microbiology Department: Provides input on testing procedures and acceptance criteria.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of all necessary equipment and materials.
- Training of personnel on the operation of the Sterility Test Isolator/System.
Equipment Description:
The Sterility Test Isolator/System is designed for the sterile testing of NDDS products, ensuring a controlled environment to prevent contamination. Key features include:
- Leak integrity testing capabilities.
- Airflow monitoring for sterility assurance.
- VHP (Vaporized Hydrogen Peroxide) cycle for sterilization.
- Audit trail for cycle validation.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Perform leak integrity test. | No leaks detected. | Test report and log. |
| OQ-002 | Measure airflow rates. | Airflow within specified limits. | Flow meter readings. |
| OQ-003 | Conduct VHP cycle. | Successful cycle completion with audit trail. | Audit trail report. |
Detailed Test Cases:
- Test ID: OQ-001
- Procedure: Conduct a leak integrity test using the specified method.
- Acceptance Criteria: No leaks detected.
- Evidence: Documented results in test report.
- Test ID: OQ-002
- Procedure: Measure and record airflow rates at specified points.
- Acceptance Criteria: Airflow within specified limits.
- Evidence: Flow meter readings documented.
- Test ID: OQ-003
- Procedure: Execute the VHP cycle and verify the audit trail.
- Acceptance Criteria: Successful cycle completion with audit trail.
- Evidence: Audit trail report generated.
Deviations: Any deviations from the protocol must be documented and justified. This includes any out-of-specification results and corrective actions taken.
Approvals:
- Validation Team Lead: ___________________________ Date: __________
- Quality Assurance: ___________________________ Date: __________
- Microbiology Department Head: ___________________________ Date: __________
Data Integrity Checks: Ensure that all test results are recorded accurately and securely. Data must be backed up and verified against original entries to prevent loss or manipulation.