Operational Qualification Protocol for Vibro Sifter in Solid Dosage Form Equipment Validation

This document outlines the Operational Qualification (OQ) protocol for the Vibro Sifter used in the production of solid dosage forms, focusing on sifting and de-lumping powders and granules.

Equipment Validation, Vibro Sifter, OQ, Solid Dosage Form, Production, Sieving

Objective

The objective of this protocol is to demonstrate that the Vibro Sifter operates consistently and reliably within specified limits to ensure product quality during the sifting and de-lumping of powders and granules.

Scope

This protocol applies to the Vibro Sifter used in the production area for solid dosage forms (OSD). It covers the operational qualification of the equipment to ensure compliance with the User Requirement Specification (URS).

Responsibilities

The following personnel are responsible for the execution of this protocol:

• Validation Engineer: Responsible for protocol execution and documentation.
• Quality Assurance: Responsible for review and approval of the protocol and results.
• Production Operator: Responsible for operating the equipment during testing.

Prerequisites

• Installation Qualification (IQ) must be completed and approved.
• Training on Vibro Sifter operation must be completed for all personnel involved.
• All necessary materials and equipment must be available and prepared for testing.

Equipment Description

The Vibro Sifter is designed for the sifting and de-lumping of powders and granules in the production of solid dosage forms. It operates using a vibration mechanism to facilitate the separation of particles based on size.

Test Plan

Detailed Test Cases

Test Case OQ-01: Screen Integrity

Procedure: Conduct a visual inspection of the screen for any damage or tears.

Acceptance Criteria: No damage or tears in the screen.

Evidence: Document findings in the inspection report and capture photographs of the screen.

Test Case OQ-02: RPM Measurement

Procedure: Use a tachometer to measure the RPM of the Vibro Sifter during operation.

Acceptance Criteria: RPM must fall within the specified range as defined in the URS.

Evidence: Record tachometer readings and attach calibration report.

Test Case OQ-03: Vibration Monitoring

Procedure: Monitor and record vibration levels during the operation of the Vibro Sifter.

Acceptance Criteria: Vibration levels must remain within acceptable limits during operation.

Evidence: Provide vibration analysis report detailing the findings.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A formal deviation report must be generated, and corrective actions must be implemented as necessary.

Approvals

Prepared by: ________________________ (Validation Engineer)

Reviewed by: ________________________ (Quality Assurance)

Approved by: ________________________ (Department Head)