Document Number: PQ-LEV-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Dust Extraction Unit in Solid Dosage Form Equipment
Meta Description: Comprehensive Performance Qualification protocol for the Dust Extraction Unit used in Solid Dosage Form manufacturing, ensuring compliance and operator safety.
Tags: Equipment Validation, Performance Qualification, Dust Extraction Unit, Solid Dosage Form, OSD, Pharmaceutical Validation
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Dust Extraction Unit (LEV for dispensing) operates according to the defined specifications, ensuring effective dust capture for operator and product protection.
Scope
This protocol applies to the Dust Extraction Unit utilized in the Production/Containment area for Solid Dosage Form manufacturing. It encompasses the evaluation of airflow capture velocity and filter integrity.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Management: Ensures equipment is available and operational for testing.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary tools and equipment for testing.
- Training of personnel on the operation of the Dust Extraction Unit.
Equipment Description
The Dust Extraction Unit is designed to capture airborne particulates generated during the dispensing of solid dosage forms. It operates by creating a negative pressure environment to ensure that dust is effectively contained and filtered, thus protecting operators and the product.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-LEV-001 | Measure airflow capture velocity at the extraction point. | Capture velocity ≥ 100 ft/min. | Calibration report and measurement logs. |
| PQ-LEV-002 | Inspect filter integrity post-operation. | No visible damage or blockage. | Visual inspection report. |
Detailed Test Cases
Test Case 1: Airflow Capture Velocity
Objective: To ensure that the Dust Extraction Unit maintains an adequate airflow capture velocity.
Procedure: Using an anemometer, measure the airflow velocity at the extraction point while the unit is operational.
Expected Result: The capture velocity must be equal to or greater than 100 ft/min.
Test Case 2: Filter Integrity Inspection
Objective: To verify that the filter of the Dust Extraction Unit is intact and functioning properly.
Procedure: After a defined operational period, visually inspect the filter for any signs of damage or blockage.
Expected Result: The filter should show no visible damage or blockage.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be conducted, and corrective actions implemented as necessary.
Approvals
_____________________ Validation Team Lead Date: ____________
_____________________ Quality Assurance Manager Date: ____________
_____________________ Production Manager Date: ____________