Installation Qualification Protocol for Downflow Dispensing Booth
Document Control:
Document ID: IQ-DB-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed by: [Insert Reviewer Name]
Approval Date: [Insert Approval Date]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Downflow Dispensing Booth is installed according to the manufacturer’s specifications and meets the defined acceptance criteria for critical parameters affecting product quality.
Scope
This protocol applies to the Installation Qualification of the Downflow Dispensing Booth utilized in the Production/Dispensing area for weighing and dispensing operations under containment. This includes all associated utilities and systems required for its operation.
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 ensuring the equipment is maintained in accordance with manufacturer specifications.
Prerequisites
- Completion of equipment installation according to manufacturer specifications.
- Availability of all necessary documentation (user manuals, installation guides, etc.).
- Training of personnel on equipment operation and safety procedures.
Equipment Description
The Downflow Dispensing Booth is designed to provide a controlled environment for weighing and dispensing solid dosage forms while ensuring containment. It features HEPA filtration, adjustable air velocity settings, and alarm systems for differential pressure (DP) monitoring.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify air velocity at the booth’s work surface | Air velocity between 0.5 – 1.0 m/s | Calibration report |
| IQ-02 | Check HEPA filter integrity | Passes integrity test without leaks | Test results |
| IQ-03 | Test differential pressure alarms | Alarms activate within specified range | Alarm test log |
Detailed Test Cases
Test Case IQ-01: Air Velocity Verification
Procedure: Measure the air velocity at the work surface of the booth using an anemometer.
Acceptance Criteria: The measured air velocity should be within the range of 0.5 – 1.0 m/s.
Evidence: Document results in the validation report.
Test Case IQ-02: HEPA Filter Integrity Check
Procedure: Conduct a HEPA filter integrity test using a suitable aerosol challenge.
Acceptance Criteria: The filter must pass the integrity test without any detectable leaks.
Evidence: Include test results in the validation report.
Test Case IQ-03: Differential Pressure Alarm Test
Procedure: Simulate conditions to test the activation of the differential pressure alarms.
Acceptance Criteria: Alarms must activate within the specified pressure range.
Evidence: Log alarm test results in the validation report.
Deviations
Any deviations from the acceptance criteria or procedures must be documented, including an assessment of potential impact on product quality and proposed corrective actions.
Approvals
This protocol requires the following approvals:
- Validation Team Lead: ______________________ Date: ___________
- Quality Assurance Manager: ______________________ Date: ___________