Installation Qualification Protocol for Vibro Sifter
This document outlines the Installation Qualification (IQ) Protocol for the Vibro Sifter used in the production of solid dosage forms.
Document Number: IQ-VS-001
Version: 1.0
Date: 2023-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Objective
The objective of this protocol is to verify that the Vibro Sifter is installed correctly and operates according to specified requirements, ensuring its suitability for sifting and de-lumping powders and granules.
Scope
This protocol applies to the Installation Qualification of the Vibro Sifter in the Production/Sieving area and is relevant for all personnel involved in equipment validation.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol.
- Maintenance Team: Responsible for ensuring the equipment is installed as per specifications.
Prerequisites
- Installation of the Vibro Sifter must be completed.
- All relevant personnel must be trained on the equipment operation.
- Safety and operational manuals must be available for reference.
Equipment Description
The Vibro Sifter is designed for sifting and de-lumping powders and granules. It operates by utilizing vibration to facilitate the separation of particles based on size and density.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| IQ-01 | Verify screen integrity | No visible damage or tears | Inspection report |
| IQ-02 | Check RPM settings | Within specified range | Calibration log |
| IQ-03 | Measure vibration levels | Within operational limits | Vibration analysis report |
Detailed Test Cases
Test Case: Screen Integrity
Procedure: Inspect the screen for any visible damage or tears. Use a flashlight for better visibility.
Acceptance Criteria: No visible damage or tears should be present.
Evidence: Document findings in the inspection report.
Test Case: RPM Settings
Procedure: Use a tachometer to measure the RPM of the Vibro Sifter during operation.
Acceptance Criteria: RPM must be within the specified range as per the URS.
Evidence: Record measurements in the calibration log.
Test Case: Vibration Levels
Procedure: Utilize a vibration meter to assess the vibration levels during operation.
Acceptance Criteria: Vibration levels must be within operational limits as defined in the URS.
Evidence: Document results in the vibration analysis report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed to address any discrepancies found during the IQ process.
Approvals
Prepared By: [Your Name] – [Date]
Approved By: [Approver’s Name] – [Date]