Document Control
Document Number: OQ-DC-BF-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approved By: [Name]
Operational Qualification Protocol for Dust Collector / Bag Filter System
Objective: To validate the operational performance of the Dust Collector / Bag Filter system in the production area for effective dust collection from product streams.
Scope: This protocol applies to the Dust Collector / Bag Filter system used in the Solid Dosage Form production area, impacting product quality directly.
Responsibilities:
- Validation Team: Preparation and execution of the OQ protocol.
- Quality Assurance: Review and approval of the protocol and results.
- Production: Provide access to the equipment and assist in the execution of tests.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Equipment operational and maintenance manuals available.
- Personnel trained on the operation of the Dust Collector / Bag Filter.
Equipment Description:
The Dust Collector / Bag Filter system is designed for the collection of dust generated during the production of solid dosage forms. It utilizes a pulse cleaning mechanism to maintain optimal performance and minimize contamination risks.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-DC-001 | Verify DP pulse cleaning containment functionality. | Containment levels must not exceed URS specifications. | Test report showing containment levels. |
| OQ-DC-002 | Check operational parameters during production. | All parameters must be within specified limits. | Operational log and parameter readings. |
Detailed Test Cases:
- Test ID: OQ-DC-001
- Objective: To ensure that the pulse cleaning mechanism operates effectively.
- Procedure: Activate the pulse cleaning system and measure containment levels using appropriate instrumentation.
- Expected Result: Containment levels must be below the limits defined in the URS.
- Test ID: OQ-DC-002
- Objective: To verify that the Dust Collector operates within specified parameters during production.
- Procedure: Monitor and record operational parameters during a production run.
- Expected Result: All parameters must remain within the defined limits.
Deviations: Any deviations from the acceptance criteria must be documented and justified. Appropriate corrective actions should be implemented.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance: ___________________ Date: ___________