Installation Qualification Protocol for Air Shower Equipment
Document Number: IQ-ASH-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approved By: [Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Air Shower equipment is installed correctly and operates as intended within the Solid Dosage Form (OSD) facility, ensuring personnel de-dusting before entry.
Scope
This protocol applies to the Air Shower system used for personnel de-dusting in the OSD area of the facility. It covers the validation of equipment critical parameters and compliance with the User Requirements Specification (URS).
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Maintenance Team: Responsible for any required maintenance and support during the validation process.
Prerequisites
- Completion of equipment installation.
- Availability of necessary tools and safety equipment.
- Training of personnel involved in the validation process.
Equipment Description
The Air Shower is a personnel de-dusting system designed to remove particulate contamination from personnel before entering critical areas. The system operates by directing high-velocity air through nozzles to blow off dust and contaminants.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| IQ-ASH-01 | Verify air velocity during operation. | Air velocity within specified range as per URS. | Calibration records and measurement logs. |
| IQ-ASH-02 | Check cycle time for air shower operation. | Cycle time meets URS specifications. | Timing records. |
| IQ-ASH-03 | Test interlocks for functionality. | All interlocks function correctly. | Test results and logs. |
Detailed Test Cases
Test Case 1: Air Velocity Measurement
Objective: To verify that the air velocity meets the specifications outlined in the URS.
Procedure: Measure air velocity at designated points using an anemometer.
Acceptance Criteria: Air velocity must be within the range specified in the URS.
Evidence: Documented measurement results with timestamps.
Test Case 2: Cycle Time Verification
Objective: To ensure the air shower operates within the specified cycle time.
Procedure: Record the time taken for one complete air shower cycle.
Acceptance Criteria: Cycle time must meet the specifications in the URS.
Evidence: Timing logs with documented results.
Test Case 3: Interlock Functionality Test
Objective: To confirm that all safety interlocks are functioning correctly.
Procedure: Test each interlock by simulating conditions to ensure they engage and disengage as expected.
Acceptance Criteria: All interlocks must function properly without failure.
Evidence: Test results and logs demonstrating interlock performance.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the validation outcome. An investigation must be conducted to determine the cause and corrective actions must be implemented.
Approvals
__________________________ Validation Team Lead
Date: ___________
__________________________ Quality Assurance
Date: ___________