Operational Qualification Protocol for LAF Workstation in Ophthalmic Production

Objective

The objective of this protocol is to validate the operational performance of the LAF Workstation used in the production of sterile ophthalmic products, ensuring compliance with industry standards and regulatory requirements.

Scope

This protocol applies to the LAF Workstation located in the production area designated for the filling and assembly of sterile eye drops and eye ointments.

Responsibilities

The Quality Assurance team is responsible for the execution and approval of this protocol. The Production team is responsible for the operation and maintenance of the equipment.

Prerequisites

All personnel involved in the execution of this protocol must be trained in aseptic techniques and the operation of the LAF Workstation.

Equipment Description

The LAF Workstation is a Grade A bench designed to provide a sterile environment for the filling and assembly of ophthalmic products. It features HEPA filtration to ensure air quality and is equipped with airflow monitoring systems.

Test Plan

Detailed Test Cases

Test Case OQ-01: Air Velocity Measurement

Procedure: Use an anemometer to measure the air velocity at the work surface of the LAF Workstation. Record the measurements at multiple points.

Acceptance Criteria: The air velocity must be within the range of 0.45 m/s to 0.75 m/s.

Evidence: Document all readings in the measurement log.

Test Case OQ-02: HEPA Integrity Smoke Study

Procedure: Introduce smoke into the LAF Workstation and observe for any leakage around the HEPA filter.

Acceptance Criteria: No leakage should be detected during the smoke study.

Evidence: Record findings in the smoke study report.

Deviations

Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team for further investigation.

Approvals

Prepared By: ______________________

Date: ______________________

Approved By: ______________________

Date: ______________________