Design Qualification Protocol for Fluid Bed Coater in Solid Dosage Form
Document Number: DQ-FBC-001
Version: 1.0
Date: 2023-10-05
Prepared by: [Your Name]
Reviewed by: [Reviewer Name]
Approved by: [Approver Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Fluid Bed Coater (Wurster/Bottom Spray) is appropriately designed to meet the specified requirements for pellet coating in solid dosage form production.
Scope
This protocol covers the validation of the Fluid Bed Coater used in the production area for coating pellets, including the assessment of critical parameters and compliance with applicable regulatory standards.
Responsibilities
The Validation Team is responsible for executing this protocol, while the Quality Assurance (QA) team will oversee compliance and documentation.
Prerequisites
- Completion of User Requirement Specification (URS)
- Installation Qualification (IQ) completed
- Operational Qualification (OQ) completed
Equipment Description
The Fluid Bed Coater (Wurster/Bottom Spray) is designed for the coating of pellets with a variety of coating solutions. It operates using a bottom spray method, ensuring uniform coating and optimal product quality.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-FBC-01 | Verify airflow temperature | Within specified range as per URS Annex11 | Calibration records |
| DQ-FBC-02 | Check spray rate | Consistent with URS Annex11 | Spray rate logs |
| DQ-FBC-03 | Monitor filter differential pressure (DP) | DP within acceptable limits as per URS Annex11 | DP monitoring records |
| DQ-FBC-04 | Verify PLC functionality | PLC operates without errors | PLC test results |
Detailed Test Cases
Test Case 1: Verify Airflow Temperature
Procedure: Measure the airflow temperature using calibrated thermocouples.
Acceptance Criteria: Airflow temperature must be within the specified range as defined in URS Annex11.
Evidence: Calibration records and temperature logs must be maintained.
Test Case 2: Check Spray Rate
Procedure: Measure the spray rate during operation using flow meters.
Acceptance Criteria: Spray rate must be consistent with the parameters outlined in URS Annex11.
Evidence: Spray rate logs must be documented.
Test Case 3: Monitor Filter Differential Pressure (DP)
Procedure: Monitor the differential pressure across the filter during operation.
Acceptance Criteria: DP must remain within acceptable limits as per URS Annex11.
Evidence: DP monitoring records must be collected and reviewed.
Test Case 4: Verify PLC Functionality
Procedure: Conduct functionality tests on the PLC to ensure proper operation.
Acceptance Criteria: PLC must operate without errors and provide accurate readings.
Evidence: PLC test results must be documented.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan must be developed and approved before proceeding.
Approvals
All sections of this protocol must be reviewed and approved by designated personnel before execution.