Document Control:
Document Number: DQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Reviewer Name]
Approved By: [Insert Approver Name]
Design Qualification Protocol for Air Shower in Solid Dosage Form Equipment Validation
Objective: To establish a Design Qualification (DQ) protocol for the Air Shower system used for personnel de-dusting prior to entry into the manufacturing area, ensuring compliance with regulatory standards and operational requirements.
Scope: This protocol applies to the Air Shower system located in the facility designated for solid dosage form (OSD) manufacturing. It covers the validation of the equipment’s critical parameters that impact product quality indirectly.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for providing technical support and equipment specifications.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation of Air Shower system in compliance with design specifications.
- Training of personnel on the operation of the Air Shower.
Equipment Description: The Air Shower is a personnel de-dusting system designed to remove particulate contamination from individuals before entering controlled areas. It operates by blowing high-velocity air to dislodge and remove dust particles from clothing and skin.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify air velocity during operation. | Air velocity must be within specified range of [insert range]. | Calibration report and measurement logs. |
| DQ-02 | Confirm cycle time of the air shower. | Cycle time must not exceed [insert time]. | Timing logs and observation records. |
| DQ-03 | Test interlocks functionality. | All interlocks must function correctly and prevent operation when doors are open. | Test results and operational logs. |
Detailed Test Cases:
- Test Case 1: Measure air velocity using an anemometer at designated points within the Air Shower. Document readings and compare against acceptance criteria.
- Test Case 2: Initiate the air shower cycle and record the time taken for completion. Ensure it does not exceed the specified acceptance criteria.
- Test Case 3: Test the functionality of interlocks by attempting to operate the system with doors open. Document whether the system prevents operation as expected.
Deviations: Any deviations from the acceptance criteria must be documented in the deviation log, including the nature of the deviation, impact assessment, and corrective actions taken.
Approvals:
- Validation Team Lead: ______________________ Date: ___________
- Quality Assurance Manager: ______________________ Date: ___________
- Engineering Manager: ______________________ Date: ___________