Document Control
Document ID: OQ-FBP-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Operational Qualification Protocol for Fluid Bed Processor in Granulation
Objective: To validate the operational performance of the Fluid Bed Processor (FBP) used for top spray granulation in the production of solid dosage forms.
Scope: This protocol applies to the Fluid Bed Processor utilized in the production area for granulation processes impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for protocol execution and data analysis.
- Quality Assurance: Responsible for protocol approval and compliance verification.
- Production Team: Responsible for providing necessary equipment access and operational support.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on Fluid Bed Processor operation.
- Availability of necessary materials and resources for testing.
Equipment Description:
The Fluid Bed Processor (FBP) is designed for top spray granulation, featuring a controlled environment for optimal granule formation. Key critical parameters include inlet/outlet temperature, airflow, spray rate, and PLC control.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-FBP-01 | Measure inlet temperature during operation. | Inlet temperature within specified range (e.g., 60-70°C). | Temperature logs. |
| OQ-FBP-02 | Measure outlet temperature during operation. | Outlet temperature within specified range (e.g., 50-60°C). | Temperature logs. |
| OQ-FBP-03 | Verify airflow rate during operation. | Airflow rate within specified range (e.g., 50-100 m³/h). | Airflow measurement logs. |
| OQ-FBP-04 | Measure spray rate during operation. | Spray rate within specified range (e.g., 1-5 L/h). | Spray rate logs. |
| OQ-FBP-05 | Verify PLC functionality and control. | PLC operates within expected parameters without errors. | PLC logs and error reports. |
Detailed Test Cases
Test Case OQ-FBP-01: Inlet Temperature Measurement
- Procedure: Record inlet temperature at startup and during operation.
- Acceptance Criteria: Temperature must remain within the range of 60-70°C.
- Evidence: Documented temperature logs for all runs.
Test Case OQ-FBP-02: Outlet Temperature Measurement
- Procedure: Record outlet temperature at startup and during operation.
- Acceptance Criteria: Temperature must remain within the range of 50-60°C.
- Evidence: Documented temperature logs for all runs.
Test Case OQ-FBP-03: Airflow Rate Verification
- Procedure: Measure airflow rate during operation.
- Acceptance Criteria: Airflow must remain within the range of 50-100 m³/h.
- Evidence: Documented airflow measurement logs.
Test Case OQ-FBP-04: Spray Rate Measurement
- Procedure: Measure spray rate during operation.
- Acceptance Criteria: Spray rate must remain within the range of 1-5 L/h.
- Evidence: Documented spray rate logs.
Test Case OQ-FBP-05: PLC Functionality Verification
- Procedure: Monitor PLC operation during testing.
- Acceptance Criteria: No PLC errors during operation.
- Evidence: PLC logs and error reports.
Deviations
Any deviations from the acceptance criteria must be documented, including the nature of the deviation, the impact on product quality, and corrective actions taken.
Approvals
Approved By: [Name]
Date of Approval: [Date]