Document ID: IQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Installation Qualification Protocol for LAF Workstation in Ophthalmics
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the LAF Workstation operates in accordance with the specified requirements, ensuring an aseptic environment for the filling and assembly of sterile ophthalmic products.
Scope
This protocol applies to the Installation Qualification of the LAF Workstation used in the production area for sterile eye drops and eye ointments. It encompasses all aspects of the equipment’s installation and operational readiness.
Responsibilities
The following personnel are responsible for the execution of this IQ protocol:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Maintenance Team: Ensure equipment is properly installed and maintained.
Prerequisites
Ensure that the LAF Workstation is installed according to the manufacturer’s specifications and that all utilities are connected and operational.
Equipment Description
The LAF Workstation is designed to provide a Class A environment for the aseptic filling of ophthalmic products. It utilizes HEPA filtration to maintain air quality and ensure sterility during production processes.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify air velocity at the front of the workstation. | Air velocity must be between 0.45 to 0.75 m/s. | Calibration report and measurement logs. |
| IQ-02 | Conduct HEPA integrity smoke study. | No leaks detected; smoke should not escape. | Smoke study report. |
Detailed Test Cases
Test Case IQ-01: Air Velocity Verification
Measure the air velocity at the front of the LAF Workstation using an anemometer. Ensure readings fall within the specified range of 0.45 to 0.75 m/s.
Test Case IQ-02: HEPA Integrity Smoke Study
Perform a smoke study to verify HEPA filter integrity. Introduce smoke at the workstation and observe for any leaks. Results must show no smoke escaping the workstation.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team. A corrective action plan must be developed and executed.
Approvals
Prepared by: ____________________ (Validation Team)
Reviewed by: ____________________ (Quality Assurance)
Approved by: ____________________ (Department Head)