Document Number: DQ-FBP-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Fluid Bed Processor in Granulation
Objective: This document outlines the Design Qualification (DQ) protocol for 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 Granulation area of the production facility. It ensures that the equipment meets the defined requirements and performance criteria.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documentation.
- Quality Assurance: Responsible for reviewing and approving the DQ documentation.
- Production Team: Responsible for providing operational input and feedback on the equipment.
Prerequisites:
- Completion of User Requirement Specification (URS)
- Installation Qualification (IQ) completion
- Training of personnel on FBP operation
Equipment Description:
The Fluid Bed Processor is designed for top spray granulation. It operates by utilizing a controlled airflow to facilitate the granulation process, ensuring uniformity and consistency in product quality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-FBP-01 | Verify inlet and outlet temperatures during operation. | Inlet temp: 20-25°C; Outlet temp: 30-35°C | Temperature logs |
| DQ-FBP-02 | Measure airflow rates at various settings. | Airflow: 100-500 m³/h | Airflow meter readings |
| DQ-FBP-03 | Validate spray rate consistency. | Spray rate: 2-10 L/h | Spray rate logs |
| DQ-FBP-04 | Check PLC functionality and settings. | PLC settings match operational requirements | PLC configuration report |
Detailed Test Cases:
- Test Case ID: DQ-FBP-01
Description: Monitor and record the inlet and outlet temperatures during operation.
Steps:- Start the FBP.
- Record the inlet and outlet temperatures at 5-minute intervals for 30 minutes.
- Test Case ID: DQ-FBP-02
Description: Measure and document airflow rates at specified settings.
Steps:- Set airflow to the desired level.
- Record airflow readings using an airflow meter.
- Test Case ID: DQ-FBP-03
Description: Validate the spray rate during operation.
Steps:- Set the spray rate to the desired level.
- Measure the output over a specified time.
- Test Case ID: DQ-FBP-04
Description: Verify PLC settings and functionality.
Steps:- Access the PLC interface.
- Compare settings to the operational requirements.
Deviations: Any deviations from the acceptance criteria must be documented and evaluated for impact on product quality. Corrective actions should be taken as necessary.
Approvals:
- Prepared By: _____________________
- Reviewed By: _____________________
- Approved By: _____________________
Data Integrity Checks:
- Ensure all data entries are logged in real-time to prevent data loss.
- Implement audit trails for all parameter settings and adjustments.
- Regularly back up data to secure locations.