Document Control Number: PQ-DC-BF-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Dust Collector / Bag Filter
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Dust Collector / Bag Filter operates consistently and effectively in controlling dust during the production and material transfer processes, ensuring compliance with the User Requirements Specification (URS).
Scope
This protocol applies to the Dust Collector / Bag Filter used in the production area for solid dosage forms, focusing on its performance in dust collection from product streams.
Responsibilities
- Validation Team: Responsible for executing the PQ and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Team: Responsible for providing access to the equipment and necessary support during testing.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary equipment and materials for testing.
- Training of personnel involved in the PQ process.
Equipment Description
The Dust Collector / Bag Filter is a system designed to remove particulate matter from the air in production areas. It utilizes a pulse cleaning mechanism to maintain optimal performance and efficiency in dust collection.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify DP pulse cleaning containment effectiveness. | Containment level within acceptable limits as per URS. | Test report and data logs. |
Detailed Test Cases
Test Case ID: PQ-01
- Objective: To assess the effectiveness of the DP pulse cleaning containment.
- Procedure: Activate the dust collector and monitor the containment levels during the pulse cleaning cycle.
- Acceptance Criteria: Containment levels must remain within the specified limits as defined in the URS.
- Expected Outcome: Successful containment with no exceedances.
Deviations
Any deviations from the acceptance criteria must be documented, including the nature of the deviation, potential impact, and corrective actions taken.
Approvals
Prepared by: ______________________
Title: ______________________
Date: ______________________
Reviewed by: ______________________
Title: ______________________
Date: ______________________
Approved by: ______________________
Title: ______________________
Date: ______________________