Document Number: IQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Downflow Sampling Booth
Objective
The objective of this protocol is to establish the installation qualification (IQ) of the Downflow Sampling Booth to ensure it meets the specified requirements for raw material sampling under containment.
Scope
This protocol applies to the Downflow Sampling Booth used in the Production/Sampling area for raw material sampling, impacting product quality directly.
Responsibilities
- Validation Team: Prepare, execute, and document the IQ protocol.
- Quality Assurance: Review and approve the IQ protocol.
- Maintenance Team: Ensure the equipment is installed correctly and operationally ready.
Prerequisites
- Completion of equipment installation.
- All necessary utilities connected (electricity, air supply).
- Availability of required tools and materials for testing.
Equipment Description
The Downflow Sampling Booth is designed for raw material sampling under containment, ensuring that the sampling process does not compromise product quality. Key features include HEPA filtration, adjustable air velocity, and monitoring systems for differential pressure (DP) alarms.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify air velocity | Air velocity within specified range | Measurement logs |
| IQ-02 | Check HEPA integrity | HEPA filter integrity test passed | Test results |
| IQ-03 | Test DP alarms | DP alarms function correctly | Alarm test results |
Detailed Test Cases
Test Case IQ-01: Verify Air Velocity
Procedure: Measure the air velocity at the designated points using a calibrated anemometer. Ensure measurements are taken at various heights within the booth.
Acceptance Criteria: Air velocity must be within the range specified in the User Requirement Specification (URS).
Evidence: Document all measurements and compare them against the acceptance criteria.
Test Case IQ-02: Check HEPA Integrity
Procedure: Conduct a HEPA filter integrity test using a suitable method (e.g., aerosol challenge).
Acceptance Criteria: The filter must pass the integrity test without leaks.
Evidence: Provide test results and any relevant documentation.
Test Case IQ-03: Test DP Alarms
Procedure: Simulate conditions to test the functionality of the differential pressure alarms.
Acceptance Criteria: Alarms must activate as specified in the operational manual.
Evidence: Document the test results and alarm responses.
Deviations
Any deviations from this protocol must be documented and justified. A deviation report must be submitted for review and approval.
Approvals
Prepared By: ____________________ Date: ___________
Reviewed By: ____________________ Date: ___________
Approved By: ____________________ Date: ___________