Design Qualification Protocol for Centrifugal Sifter

Objective

The objective of this Design Qualification (DQ) Protocol is to establish documented evidence that the Centrifugal Sifter is designed and installed in accordance with the User Requirements Specification (URS) and is capable of performing its intended function in the production/sieving area.

Scope

This protocol applies to the validation of the Centrifugal Sifter used in the production of solid dosage forms. It encompasses the design specifications, installation qualifications, and operational parameters critical to the equipment’s performance.

Responsibilities

The responsibilities for this DQ Protocol are as follows:

• Validation Team: Ensure compliance with validation requirements and document findings.
• Quality Assurance: Review and approve the DQ Protocol and its execution.
• Operations: Provide input on equipment use and operational parameters.

Prerequisites

Prior to executing this DQ Protocol, the following prerequisites must be met:

• Completion of the User Requirements Specification (URS).
• Installation of the Centrifugal Sifter in the designated production area.
• Training of personnel on equipment operation.

Equipment Description

The Centrifugal Sifter is a high-throughput sifting device used to separate particles based on size. It utilizes a rotor mechanism to facilitate the sifting process, ensuring efficient and consistent product quality.

Test Plan

Detailed Test Cases

Test Case DQ-01: Verify Rotor Speed

Objective: To confirm that the rotor speed of the Centrifugal Sifter meets the specified requirements.

Procedure: Measure the rotor speed using a calibrated tachometer during operation.

Acceptance Criteria: The rotor speed must be within the limits defined in the URS.

Evidence: Document the measurements in the validation report.

Test Case DQ-02: Check Screen Integrity

Objective: To ensure that the screen used in the Centrifugal Sifter is free from any tears or damages.

Procedure: Perform a visual inspection of the screen prior to use.

Acceptance Criteria: The screen must be intact without any visible damage.

Evidence: Document findings in the inspection report.

Deviations

Any deviations from the acceptance criteria must be documented and justified in the validation report. A corrective action plan should be developed and executed to address any identified issues.

Approvals

All sections of this DQ Protocol must be reviewed and approved by the designated personnel to ensure compliance and accuracy.