Document Control Number: IQ-HM-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Installation Qualification Protocol for Hammer Mill
Objective: To establish documented evidence that the Hammer Mill is installed according to the manufacturer’s specifications and is functioning as intended for size reduction in the production of solid dosage forms.
Scope: This protocol applies to the Installation Qualification of the Hammer Mill used in the Production/Milling area for solid dosage forms, impacting product quality directly.
Responsibilities:
- Validation Team: Ensure the execution of the IQ protocol and documentation.
- Production Team: Provide access to the equipment and necessary documentation.
- Quality Assurance: Review and approve the protocol and results.
Prerequisites:
- All installation documentation from the manufacturer.
- Site preparation and utilities check completed.
- Personnel trained on equipment operation.
Equipment Description: The Hammer Mill is a size reduction machine used in the production of solid dosage forms. It operates by impacting materials with high-speed rotating hammers, allowing for controlled particle size reduction.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to manufacturer specifications. | All components installed as per the manufacturer’s manual. | Photographic evidence and installation checklist. |
| IQ-02 | Check utility connections (electric, air). | All connections secure and functioning. | Utility check report. |
| IQ-03 | Calibration of speed settings. | Speed settings within specified range. | Calibration report. |
| IQ-04 | Test screen output for particle size distribution (PSD). | PSD meets specifications in URS. | PSD analysis report. |
| IQ-05 | Monitor heat generation during operation. | Heat generation within acceptable limits. | Heat log data. |
Detailed Test Cases:
- Test ID: IQ-01
- Review installation manual.
- Inspect all components for proper installation.
- Test ID: IQ-02
- Verify electrical connections with a multimeter.
- Check air supply for pressure and leaks.
- Test ID: IQ-03
- Set speed to specified levels and verify with tachometer.
- Test ID: IQ-04
- Run the mill with specified feed material.
- Collect samples for PSD analysis.
- Test ID: IQ-05
- Run the mill for a defined period and log temperature.
Deviations: Any deviations from the acceptance criteria must be documented and justified. A root cause analysis may be required for significant deviations.
Approvals:
- Prepared By: [Name]
- Reviewed By: [Name]
- Approved By: [Name]