Document Control:
Protocol Number: OQ-DUST-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Operational Qualification Protocol for Dust Extraction Unit in Solid Dosage Form Production
Meta Description: This document outlines the Operational Qualification protocol for the Dust Extraction Unit used in the production of Solid Dosage Forms, ensuring compliance and safety standards.
Tags: Equipment Validation, Operational Qualification, Dust Extraction Unit, Solid Dosage Form
Objective
The objective of this protocol is to validate the operational performance of the Dust Extraction Unit (LEV) used for dispensing in the Solid Dosage Form production area, ensuring it meets specified acceptance criteria for operator and product protection.
Scope
This protocol applies to the Dust Extraction Unit utilized in the Production/Containment area for the handling of solid dosage forms. It encompasses all operational qualification activities necessary to demonstrate that the system functions as intended.
Responsibilities
- Validation Team: Responsible for executing the protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for providing access to the equipment and supporting the validation activities.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of necessary tools and instruments for testing.
- Access to relevant Standard Operating Procedures (SOPs).
Equipment Description
The Dust Extraction Unit is designed to capture airborne dust generated during the dispensing of solid dosage forms. It provides a critical function in maintaining a safe working environment for operators while ensuring product integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Measure airflow capture velocity at various points. | Capture velocity must be ≥ 100 ft/min. | Velocity measurement logs. |
| OQ-02 | Conduct filter integrity test. | No leaks detected; filter must maintain integrity. | Filter integrity test results. |
Detailed Test Cases
Test Case OQ-01: Airflow Capture Velocity
Procedure: Use an anemometer to measure the airflow velocity at designated points on the extraction unit. Record the values and compare against the acceptance criteria.
Expected Outcome: All measured velocities should be equal to or greater than 100 ft/min.
Test Case OQ-02: Filter Integrity
Procedure: Perform a filter integrity test using a suitable method (e.g., aerosol challenge). Document any leaks or failures.
Expected Outcome: The filter should show no signs of leakage, confirming its integrity.
Deviations
Any deviations from the protocol must be documented and justified. A formal deviation report should be submitted to Quality Assurance for review.
Approvals
Prepared by: _______________________ Date: ___________
Approved by: _______________________ Date: ___________