Document Number: IQ-OSD-MAG-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Installation Qualification Protocol for Inline Magnetic Separator
Objective: To verify that the Inline Magnetic Separator is installed according to specifications and functions as intended to remove ferrous contamination from the production line.
Scope: This protocol applies to the Installation Qualification of the Inline Magnetic Separator used in the Solid Dosage Form production area.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ documentation.
- Maintenance Team: Responsible for ensuring the equipment is installed according to specifications.
Prerequisites:
- Completion of equipment installation.
- Availability of installation manuals and specifications.
- Training of personnel on equipment operation and safety.
Equipment Description:
The Inline Magnetic Separator is designed to remove ferrous contamination from materials during production and material transfer processes. It operates by utilizing a magnetic field to attract and capture ferrous particles, ensuring product integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to manufacturer specifications. | All components installed as per specifications. | Installation checklist signed by the maintenance team. |
| IQ-02 | Check magnet strength using a calibrated gaussmeter. | Magnet strength meets or exceeds specified value. | Calibration report and measurement log. |
| IQ-03 | Evaluate capture efficiency with ferrous test particles. | Capture efficiency meets acceptance criteria as per URS. | Test results and efficiency report. |
Detailed Test Cases:
- IQ-01: Review installation documentation and confirm all components are installed as per the manufacturer’s specifications.
- IQ-02: Measure the magnet strength using a calibrated gaussmeter. Record the values and compare them to the specified requirements.
- IQ-03: Conduct a test using ferrous particles to determine the capture efficiency. Document the results and ensure they align with the acceptance criteria outlined in the URS.
Deviations: Any deviations from the acceptance criteria will be documented and assessed. A corrective action plan will be initiated if necessary.
Approvals:
- Validation Team Lead: ______________________ Date: ___________
- Quality Assurance Manager: ______________________ Date: ___________