Document Control:
Document ID: DQ-LEV-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Design Qualification Protocol for Dust Extraction Unit
Meta Description: This Design Qualification Protocol outlines the validation process for the Dust Extraction Unit used in Solid Dosage Form production, ensuring compliance and safety in operator and product protection.
Tags: Equipment Validation, Dust Extraction, Design Qualification, Solid Dosage Form, Production, Containment
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Dust Extraction Unit (LEV) is designed and installed according to specifications that meet regulatory and operational requirements, providing protection for both operators and products.
Scope
This protocol applies to the Dust Extraction Unit utilized in the dispensing of solid dosage forms within the production and containment area. The DQ will cover the installation and operational aspects of the equipment.
Responsibilities
- Validation Team: Responsible for drafting and executing the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Engineering: Responsible for ensuring that the equipment is installed and operates according to specifications.
Prerequisites
- Completed User Requirement Specification (URS).
- Installation of the Dust Extraction Unit.
- Availability of relevant standard operating procedures (SOPs).
Equipment Description
The Dust Extraction Unit is designed for dust capture during the dispensing of solid dosage forms. It features a filtration system that ensures the integrity of the airflow and provides protection to operators and products by minimizing exposure to airborne particulates.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-LEV-01 | Verify airflow capture velocity | Minimum of 100 ft/min at the extraction point | Airflow measurement report |
| DQ-LEV-02 | Check filter integrity | No visible damage or leaks | Filter inspection report |
Detailed Test Cases
Test Case 1: Airflow Capture Velocity
Test ID: DQ-LEV-01
Procedure: Measure the airflow capture velocity at the extraction point using an anemometer.
Acceptance Criteria: Minimum of 100 ft/min.
Evidence: Documented airflow measurement report.
Test Case 2: Filter Integrity
Test ID: DQ-LEV-02
Procedure: Inspect the filter for any visible damage or leaks.
Acceptance Criteria: No visible damage or leaks.
Evidence: Documented filter inspection report.
Deviations
Any deviations from the acceptance criteria must be documented, investigated, and approved by the Quality Assurance department prior to proceeding with operational use.
Approvals
Prepared by: ____________________ Date: ___________
Reviewed by: ____________________ Date: ___________
Approved by: ____________________ Date: ___________