Document Control
Document Number: IQ-ACM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Installation Qualification Protocol for Air Classifier Mill
Objective: To verify that the Air Classifier Mill is installed correctly and operates according to the specified requirements.
Scope: This protocol applies to the installation of the Air Classifier Mill in the Production/Milling area for controlled fine milling of solid dosage forms.
Responsibilities:
- Validation Team: Responsible for the execution of the IQ protocol.
- Quality Assurance: Responsible for the review and approval of the protocol.
- Engineering: Responsible for the installation of the equipment.
Prerequisites:
- Completion of Site Preparation
- Utility Connections Completed
- Equipment Delivery and Inspection
Equipment Description:
The Air Classifier Mill is designed for controlled fine milling of solid dosage forms, ensuring the desired particle size distribution (PSD) through adjustable classifier speed and airflow.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation location and utilities | Location matches URS specifications | Installation Report |
| IQ-02 | Check equipment alignment and leveling | Equipment is level and aligned as per specifications | Alignment Report |
| IQ-03 | Confirm utility connections (electric, air, etc.) | Utilities are connected as per URS | Utility Connection Checklist |
| IQ-04 | Test classifier speed and airflow parameters | Classifier speed and airflow meet URS requirements | Test Data Report |
Detailed Test Cases:
- Test ID: IQ-01 – Inspect the installation area to ensure compliance with URS specifications.
- Test ID: IQ-02 – Use a leveling tool to confirm the equipment is properly aligned.
- Test ID: IQ-03 – Verify utility connections against the approved design documents.
- Test ID: IQ-04 – Measure classifier speed and airflow using calibrated instruments.
Deviations:
Any deviations from the acceptance criteria must be documented, investigated, and resolved before the equipment can be approved for use.
Approvals:
Prepared by: ______________________ Date: ___________
Approved by: ______________________ Date: ___________