Document Control Number: DQ-OPH-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for Sterile Grade Filter Housing
Meta Description: This document outlines the Design Qualification Protocol for the Sterile Grade Filter Housing used in the production of ophthalmic products, ensuring compliance with URS Annex1 standards.
Tags: Equipment Validation, Design Qualification, Ophthalmics, Filter Housing, Sterile Grade
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Sterile Grade Filter Housing is designed, installed, and operates according to the specified requirements for holding sterilizing-grade filters, thereby ensuring the integrity and safety of ophthalmic products.
Scope
This protocol applies to the Design Qualification of the Sterile Grade Filter Housing used in the production area for sterile eye drops and eye ointments. It covers the evaluation of the equipment’s critical parameters and compliance with regulatory standards.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for providing input on operational requirements and supporting the validation process.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) completed for the Filter Housing.
- Training of personnel on the operation of the Filter Housing.
Equipment Description
The Sterile Grade Filter Housing is designed to hold sterilizing-grade filters used in the production of sterile ophthalmic products. It is constructed from materials compliant with regulatory standards to ensure no contamination occurs during the filtration process. The critical parameter for this equipment is the pressure hold seal integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-TH-001 | Pressure Hold Test | Seal integrity maintained at specified pressure for 30 minutes | Test report and pressure log |
Detailed Test Cases
Test Case 1: Pressure Hold Test
Objective: To verify the integrity of the filter housing seal under pressure.
Procedure: Apply pressure to the filter housing and maintain for 30 minutes. Monitor for any pressure drop.
Acceptance Criteria: No pressure drop observed during the test period.
Evidence: Record pressure readings before and after the test, along with any observations.
Deviations
Any deviations from this protocol must be documented, including the reason for the deviation, impact assessment, and corrective actions taken.
Approvals
Prepared by: ____________________
Date: ____________________
Reviewed by: ____________________
Date: ____________________
Approved by: ____________________
Date: ____________________