Document Control:
Document ID: PQ-OSD-MAG-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Inline Magnetic Separator
Objective: To validate the performance of the Inline Magnetic Separator in the removal of ferrous contamination from solid dosage forms, ensuring compliance with acceptance criteria outlined in the User Requirement Specification (URS).
Scope: This protocol applies to the Inline Magnetic Separator used in the production and material transfer areas within the solid dosage form manufacturing process.
Responsibilities:
- Validation Team: Responsible for executing the performance qualification protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for providing access to the equipment and necessary materials.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary materials for testing.
- Training of personnel on the operation of the Inline Magnetic Separator.
Equipment Description:
The Inline Magnetic Separator is designed to remove ferrous contaminants from the product stream during the production of solid dosage forms. The equipment features adjustable magnet strength and is integrated into the production line for continuous operation.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-1 | Measure magnet strength using calibrated gauge. | Magnet strength must be ≥ [Insert Value] Gauss. | Calibration report and measurement log. |
| PQ-2 | Conduct capture efficiency test with known ferrous contaminants. | Capture efficiency must be ≥ [Insert Percentage]% as per URS. | Test report and analysis data. |
Detailed Test Cases:
Test Case 1: Verify magnet strength
- Use a calibrated gauss meter to measure the magnetic field strength at the surface of the magnet.
- Document the readings and compare against acceptance criteria.
Test Case 2: Evaluate capture efficiency
- Introduce a known quantity of ferrous particles into the product stream.
- Collect samples before and after the magnetic separator.
- Analyze samples to determine the quantity of ferrous particles captured.
- Calculate capture efficiency and compare against acceptance criteria.
Deviations:
Any deviations from the protocol must be documented and justified. A deviation report must be submitted for approval prior to proceeding with retesting.
Approvals:
______________________________
Validation Team Lead
______________________________
Quality Assurance Manager