Document ID: DQ-EC-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Encapsulation Coater (Wurster/Bottom Spray)
Objective: To establish a Design Qualification (DQ) protocol for the Encapsulation Coater used in the coating of microspheres and microcapsules for controlled release applications.
Scope: This protocol applies to the validation of the Encapsulation Coater in the R&D/Production area, focusing on its use for coating particles.
Responsibilities:
- Validation Team: Ensure compliance with the protocol and documentation.
- Quality Assurance: Review and approve the DQ protocol.
- Operations: Execute the procedures outlined in the DQ protocol.
Prerequisites:
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) of the equipment.
- Training of personnel on equipment operation.
Equipment Description:
The Encapsulation Coater (Wurster/Bottom Spray) is designed for the coating of particles, facilitating controlled release formulations. Key features include adjustable spray rate, temperature control, and airflow management.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-EC-001-01 | Verify spray rate settings. | Spray rate within specified range. | Calibration records. |
| DQ-EC-001-02 | Measure temperature during operation. | Temperature within defined limits. | Temperature logs. |
| DQ-EC-001-03 | Assess airflow uniformity. | Airflow meets uniformity specifications. | Airflow measurement report. |
| DQ-EC-001-04 | Review audit trail functionality. | Audit trail captures all critical actions. | Audit trail report. |
Detailed Test Cases:
- Test Case ID: DQ-EC-001-01
Objective: Verify the spray rate settings of the encapsulation coater.
Procedure: Set the spray rate and measure output using calibrated equipment.
Acceptance Criteria: Spray rate must be within the specified range as per URS.
Expected Outcome: Successful verification of spray rate settings. - Test Case ID: DQ-EC-001-02
Objective: Measure temperature during operation.
Procedure: Monitor temperature readings throughout the operation.
Acceptance Criteria: Temperature readings must remain within defined limits.
Expected Outcome: Successful temperature monitoring. - Test Case ID: DQ-EC-001-03
Objective: Assess airflow uniformity.
Procedure: Conduct airflow measurements at various points.
Acceptance Criteria: Airflow must meet uniformity specifications.
Expected Outcome: Successful assessment of airflow. - Test Case ID: DQ-EC-001-04
Objective: Review audit trail functionality.
Procedure: Check audit trail logs for completeness and accuracy.
Acceptance Criteria: Audit trail must capture all critical actions.
Expected Outcome: Successful review of audit trail.
Deviations: Any deviations from this protocol must be documented and approved by the Quality Assurance department.
Approvals:
- Validation Team Lead: ____________________ Date: __________
- Quality Assurance: ____________________ Date: __________
- Operations Manager: ____________________ Date: __________
Data Integrity Checks:
- Ensure all data logged during testing is backed up and secured.
- Conduct routine checks to verify data accuracy and completeness.
- Implement access controls to maintain data integrity.