Document ID: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Cleanroom Facility Qualification
Objective: To establish and document the operational qualification of Grade A/B/C/D cleanrooms used for aseptic processing, ensuring compliance with regulatory standards.
Scope: This protocol applies to the operational qualification of cleanroom facilities used in the manufacturing of sterile injectables, specifically focusing on Grade A, B, C, and D environments.
Responsibilities:
- Validation Team: Responsible for executing the protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Engineering: Responsible for maintaining cleanroom conditions and equipment.
Prerequisites:
- Completion of Installation Qualification (IQ).
- All equipment must be calibrated and functioning as per specifications.
- Personnel must be trained in aseptic techniques and cleanroom protocols.
Equipment Description: The cleanroom facility consists of controlled environments classified into Grade A, B, C, and D, designed for the aseptic processing of injectable products. Key parameters include ISO class recovery, air change rate (ACH), differential pressure (DP), temperature, relative humidity (RH), and airflow visualization using smoke studies.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | ISO Class Recovery Test | ISO class recovery meets Annex 1 requirements | Test report |
| OQ-001-02 | Air Change Rate (ACH) Measurement | ACH within specified limits | Calibration certificate |
| OQ-001-03 | Differential Pressure (DP) Measurement | DP maintained at required levels | Monitoring logs |
| OQ-001-04 | Temperature and Humidity Monitoring | Temperature and RH within specified limits | Environmental logs |
| OQ-001-05 | Airflow Visualization with Smoke | Airflow patterns meet specifications | Video evidence |
Detailed Test Cases:
- Test ID: OQ-001-01 – Conduct ISO Class Recovery Test at specified locations within the cleanroom to confirm compliance with ISO standards.
- Test ID: OQ-001-02 – Measure air change rates using calibrated equipment, ensuring that the rate meets the specified criteria.
- Test ID: OQ-001-03 – Monitor differential pressure across cleanroom barriers to ensure that positive pressure is maintained.
- Test ID: OQ-001-04 – Record temperature and relative humidity at multiple points, ensuring they remain within defined ranges.
- Test ID: OQ-001-05 – Utilize smoke studies to visualize airflow patterns and ensure proper air circulation throughout the cleanroom.
Deviations: Any deviations from the protocol must be documented and justified. All deviations will be reviewed and approved by Quality Assurance.
Approvals:
- ____________________ Prepared By
- ____________________ Approved By