Design Qualification Protocol for LAF Workstation in Ophthalmics Production

Objective: To validate the design of the LAF Workstation to ensure it meets the requirements for aseptic processing of sterile ophthalmics.

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

Responsibilities:

• Validation Team: Prepare and execute the DQ protocol.
• Quality Assurance: Review and approve the DQ protocol.
• Production Team: Provide operational input and support during testing.

Prerequisites:

• Completion of User Requirement Specification (URS).
• Installation Qualification (IQ) must be completed and approved.

Equipment Description:

The LAF Workstation is a Grade A bench designed for aseptic filling and assembly processes. It provides a controlled environment to prevent contamination during the production of sterile ophthalmics.

Detailed Test Cases:

Test Case: Air Velocity Measurement

Objective: To verify that the air velocity in the LAF Workstation is within the specified range.

Procedure: Measure air velocity at various points in the workstation using an anemometer.

Acceptance Criteria: Air velocity must be within 0.45 to 0.60 m/s.

Evidence: Calibration report documenting the measurements.

Test Case: HEPA Integrity Smoke Study

Objective: To ensure the HEPA filters are functioning properly and there are no leaks.

Procedure: Introduce smoke into the workstation and observe airflow patterns.

Acceptance Criteria: No leakage or turbulence observed.

Evidence: Smoke study report detailing the observations.

Deviations: Any deviations from the acceptance criteria must be documented and evaluated for impact on product quality.

Approvals:

• Prepared by: ______________________
• Reviewed by: ______________________
• Approved by: ______________________