Document Number: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approved By: [Name]
Design Qualification Protocol for VHP Generator in Production Area
Meta Description: This document outlines the Design Qualification Protocol for the VHP Generator used in the decontamination of isolators and RABS in the production of Liposomes and Lipid Nanoparticles.
Tags: Equipment Validation, Design Qualification, VHP Generator, NDDS, Liposomes, LNP
Objective
The objective of this Design Qualification (DQ) Protocol is to validate the VHP Generator/Decontamination Unit to ensure it meets the requirements for decontaminating isolators and Restricted Access Barrier Systems (RABS) in the production of Liposomes and Lipid Nanoparticles.
Scope
This protocol applies to the VHP Generator located in the production area, specifically for the decontamination of isolators and RABS used in the manufacturing process of NDDS products.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for maintaining the equipment and ensuring it is operational during the validation process.
Prerequisites
- Installation Qualification (IQ) completion.
- Operational Qualification (OQ) completion.
- Training of personnel on the use of the VHP Generator.
Equipment Description
The VHP Generator/Decontamination Unit is designed to produce vaporized hydrogen peroxide (VHP) for the decontamination of isolators and RABS. Key features include:
- Automated control systems for precise concentration and dwell time.
- Real-time monitoring of aerosolized VHP concentration.
- Data logging capabilities for residuals and aeration records.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify concentration levels during decontamination. | Concentration must meet specifications as per URS Annex 11. | Concentration logs and reports. |
| DQ-02 | Document dwell time during decontamination. | Dwell time must be within the specified range. | Dwell time records. |
| DQ-03 | Check aeration and residuals after decontamination. | Residuals must be below acceptable limits. | Residuals test results. |
Detailed Test Cases
Test Case DQ-01
Objective: To verify the concentration levels during the decontamination process.
Procedure: Conduct a decontamination cycle and record concentration levels at specified intervals.
Expected Result: Concentration levels must remain within the specified limits as per URS Annex 11.
Test Case DQ-02
Objective: To document the dwell time during the decontamination process.
Procedure: Measure and record the dwell time during the decontamination cycle.
Expected Result: Dwell time must be within the specified range defined in the protocol.
Test Case DQ-03
Objective: To check aeration and residuals post-decontamination.
Procedure: Test for residuals after the decontamination cycle and document the results.
Expected Result: Residual levels must be below the acceptable limits as per safety guidelines.
Deviations
Any deviations from the established acceptance criteria must be documented and investigated. A root cause analysis should be conducted, and corrective actions must be implemented.
Approvals
This Design Qualification Protocol must be approved by the Quality Assurance and Engineering departments prior to execution.