Document Control:
Protocol Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Inline Magnetic Separator
Objective: To validate the operational performance of the Inline Magnetic Separator in the removal of ferrous contamination from solid dosage forms.
Scope: This protocol applies to the Inline Magnetic Separator used in the Production/Material Transfer area for solid dosage forms where direct product impact is critical.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Personnel: Ensure equipment is set up and maintained as per SOPs.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on equipment operation.
- Availability of required materials for testing.
Equipment Description:
The Inline Magnetic Separator is designed to remove ferrous contaminants from materials during production. It operates by utilizing a magnetic field to attract and capture ferrous particles, ensuring product safety and quality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Measure magnet strength using calibrated gaussmeter. | Magnet strength must be ≥ [Insert Value] Gauss as per URS. | Calibration report and measurement log. |
| OQ-001-02 | Perform capture efficiency test with known ferrous particles. | Capture efficiency must be ≥ [Insert Percentage]% as per URS. | Test results and analysis report. |
Detailed Test Cases:
- Test ID: OQ-001-01
- Procedure: Use a calibrated gaussmeter to measure the magnetic field strength at various points on the separator.
- Expected Result: The measurements should meet or exceed the specified value in the URS.
- Test ID: OQ-001-02
- Procedure: Introduce a known quantity of ferrous particles into the flow and measure the quantity captured post-separator.
- Expected Result: The captured quantity should meet or exceed the acceptance criteria defined in the URS.
Deviations: Any deviations from the protocol must be documented and justified. All deviations must be reviewed and approved by Quality Assurance.
Approvals:
__________________________
Validation Team Lead
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Quality Assurance