Installation Qualification Protocol for Centrifugal Sifter in Solid Dosage Form

Objective

The objective of this Installation Qualification (IQ) protocol is to verify that the Centrifugal Sifter is installed correctly and operates according to the specified requirements, ensuring compliance with regulatory standards and operational needs.

Scope

This protocol applies to the Installation Qualification of the Centrifugal Sifter used in the Production area for high-throughput sifting of solid dosage forms. It covers all aspects of the installation process, including equipment setup and verification of critical parameters.

Responsibilities

• Validation Team: Responsible for executing the IQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
• Maintenance Team: Responsible for ensuring the equipment is installed according to manufacturer specifications.

Prerequisites

• Completion of equipment installation by the maintenance team.
• Availability of all necessary documentation, including manufacturer specifications and user requirements.
• Training of personnel on the operation of the Centrifugal Sifter.

Equipment Description

The Centrifugal Sifter is designed for high-throughput sifting of solid dosage forms. It utilizes a rotor to separate particles based on size while maintaining screen integrity. The equipment is critical for ensuring product quality and compliance.

Test Plan

Detailed Test Cases

Test Case IQ-01: Verify Rotor Speed Settings

Procedure: Measure the rotor speed using a tachometer. Compare the measured speed to the specifications outlined in the User Requirements Specification (URS).

Acceptance Criteria: Rotor speed must be within the specified range.

Evidence: Documented tachometer readings and calibration logs.

Test Case IQ-02: Check Screen Integrity

Procedure: Inspect the sifter screen for any signs of damage or wear. Ensure that the mesh is intact and free from holes.

Acceptance Criteria: The screen must show no visible damage or wear.

Evidence: Inspection report with photographs, if applicable.

Deviations

Any deviations from the acceptance criteria must be documented and addressed according to the established deviation management process. A root cause analysis should be performed, and corrective actions must be implemented.

Approvals

By signing below, the approvers confirm that the Installation Qualification protocol has been reviewed and approved for execution.

__________________________ Prepared By

__________________________ Reviewed By

__________________________ Approved By