Installation Qualification Protocol for Dynamic HEPA Pass Box
Document Number: IQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Dynamic HEPA Pass Box is installed according to the manufacturer’s specifications and meets all operational requirements for material transfer with air purge in a controlled environment.
Scope
This protocol applies to the installation of the Dynamic HEPA Pass Box used in the Solid Dosage Form (OSD) area of the facility. It covers the verification of critical parameters that impact product quality indirectly.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with validation requirements. The Quality Assurance (QA) team will oversee the approval process.
Prerequisites
- Completion of equipment installation by qualified personnel.
- Availability of necessary documentation (URS, specifications, etc.).
- Training of personnel on the operation of the Pass Box.
Equipment Description
The Dynamic HEPA Pass Box is designed for the transfer of materials into and out of controlled environments while maintaining air quality through HEPA filtration. It is equipped with interlocks and alarms to ensure proper operation and integrity of the system.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation of HEPA filters and airflow. | HEPA filters installed per specifications; airflow rate within acceptable limits. | Installation report, airflow measurement data. |
| IQ-02 | Check interlocks and alarms functionality. | All interlocks and alarms function correctly according to specifications. | Test report of interlocks and alarms. |
Detailed Test Cases
Test Case 1: HEPA Filter Integrity
Procedure: Conduct a leak test on the HEPA filters to ensure integrity.
Acceptance Criteria: No leaks detected; HEPA filters maintain integrity.
Evidence: Leak test report.
Test Case 2: Airflow Measurement
Procedure: Measure airflow at designated points in the Pass Box using an anemometer.
Acceptance Criteria: Airflow within specified range (e.g., 100-120 ft/min).
Evidence: Airflow measurement log.
Test Case 3: Interlock Functionality
Procedure: Test all interlocks by attempting to operate the Pass Box with doors open.
Acceptance Criteria: System should not operate with doors open; alarms should activate.
Evidence: Functional test report.
Test Case 4: Alarm Response
Procedure: Trigger each alarm condition and verify response.
Acceptance Criteria: Alarms activate and are audible/visible as designed.
Evidence: Alarm test log.
Deviations
Any deviations from the acceptance criteria or procedures must be documented and addressed according to the deviation management process.
Approvals
Prepared By: ____________________________ Date: ____________
Approved By: ____________________________ Date: ____________