LAF Workstation / Grade A Bench – PQ Protocol

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Performance Qualification Protocol for LAF Workstation in Ophthalmics Production

Tags: Equipment Validation, Ophthalmics, Performance Qualification, Aseptic Processing

Objective

The objective of this protocol is to validate the performance of the LAF Workstation used in the aseptic filling and assembly of sterile ophthalmic products, ensuring compliance with regulatory requirements and ensuring product safety.

Scope

This protocol applies to the LAF Workstation utilized in the production area for the filling and assembly of sterile eye drops and eye ointments. It covers critical parameters affecting product quality.

Responsibilities

  • Validation Team: Responsible for executing the PQ protocol and documenting results.
  • Quality Assurance: Responsible for reviewing and approving the protocol and results.
  • Production Team: Responsible for operating the equipment during qualification activities.

Prerequisites

  • Completion of Installation Qualification (IQ) for LAF Workstation.
  • Training of personnel on the operation of the LAF Workstation.
  • Availability of necessary testing equipment and materials.

Equipment Description

The LAF Workstation is a Grade A bench designed for aseptic processing, providing a controlled environment for the filling and assembly of sterile ophthalmic products. It features HEPA filtration to maintain air quality and minimize contamination risk.

Test Plan

Test ID Procedure Acceptance Criteria Evidence
PQ-01 Measure air velocity at various points in the workstation. Air velocity must be within 0.45 to 0.75 m/s. Air velocity measurement report.
PQ-02 Conduct HEPA integrity smoke study. No leaks or contamination observed during the smoke study. Smoke study observation report.
See also  Air Classifier Mill – IQ Protocol

Detailed Test Cases

Test Case 1: Air Velocity Measurement

Procedure: Use an anemometer to measure air velocity at designated points in the LAF Workstation.

Acceptance Criteria: Air velocity must be within the range of 0.45 to 0.75 m/s at all points measured.

Evidence: Documented measurements recorded in the air velocity report.

Test Case 2: HEPA Integrity Smoke Study

Procedure: Introduce smoke into the workstation and observe for any leaks or areas of contamination.

Acceptance Criteria: No visible smoke leaks or contamination should be detected during the study.

Evidence: Smoke study observation report detailing findings.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions should be implemented as necessary.

Approvals

Prepared By: [Insert Name]

Approved By: [Insert Name]

Date of Approval: [Insert Date]

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