Operational Qualification Protocol for Particle Size Classification System

Objective

The purpose of this Operational Qualification (OQ) protocol is to verify that the Particle Size Classification System operates within specified limits and is suitable for size fraction selection in the production of microspheres and microcapsules.

Scope

This protocol applies to the Particle Size Classification System utilized in the R&D and Production areas for the classification of microspheres and microcapsules. It covers the operational aspects and critical parameters affecting the performance of the equipment.

Responsibilities

The following personnel are responsible for executing this protocol:

• Validation Team: Conducts the qualification activities.
• Quality Assurance: Reviews and approves the protocol and results.
• Operations: Provides access to the equipment and assists in the execution of tests.

Prerequisites

• Completion of Installation Qualification (IQ) protocol.
• Training of personnel on the operation of the Particle Size Classification System.
• Availability of all necessary materials and documentation.

Equipment Description

The Particle Size Classification System consists of sieves and an air classifier designed to separate particles based on size. The critical parameter for this equipment is the sieve integrity cut size, which must be validated to ensure accurate size fraction selection.

Test Plan

Detailed Test Cases

Test Case OQ-01

Objective: To verify the integrity of the sieves and confirm the cut size.

Procedure: Inspect each sieve for physical damage and measure the cut size using calibrated measuring tools.

Acceptance Criteria: All sieves must meet the URS specified cut sizes.

Expected Result: All sieves pass the integrity test and meet the cut size specifications.

Test Case OQ-02

Objective: To ensure the air classifier operates within specified airflow parameters.

Procedure: Measure the airflow using an anemometer at designated points in the system.

Acceptance Criteria: Airflow must be within specified operational parameters.

Expected Result: Airflow measurements fall within acceptable limits.

Deviations

Any deviations from the protocol must be documented and approved by the Quality Assurance department. A root cause analysis should be performed for any critical deviations.

Approvals

Signature of Validation Team Lead: ___________________

Signature of Quality Assurance: ___________________

“`