Design Qualification Protocol for Particle Size Classification System

Meta Description: This document outlines the Design Qualification (DQ) Protocol for the Particle Size Classification System used in the development of NDDS for microspheres and microcapsules.

Tags: Equipment Validation, DQ, NDDS, R&D, Production

Objective

The objective of this Design Qualification (DQ) protocol is to establish documented evidence that the Particle Size Classification System (Sieves/Air classifier) is designed and installed to meet the specified requirements for size fraction selection in the production of microspheres and microcapsules.

Scope

This protocol applies to the Particle Size Classification System used in the R&D and Production areas for the NDDS of microspheres and microcapsules. It encompasses the system’s design, installation, and intended use.

Responsibilities

• Validation Team: Responsible for executing the DQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
• Engineering: Responsible for ensuring the system is installed according to specifications.

Prerequisites

• Completion of User Requirement Specification (URS).
• Availability of equipment and installation documentation.
• Training of personnel on equipment operation and maintenance.

Equipment Description

The Particle Size Classification System consists of sieves and an air classifier designed to separate particles based on size. This system is critical for ensuring the integrity of the microspheres and microcapsules produced.

Test Plan

Detailed Test Cases

Test Case T1: Sieve Integrity and Cut Size Verification

Procedure: Inspect and measure the integrity of each sieve to ensure it meets the cut size requirements.

Acceptance Criteria: All sieves must meet the specified cut size as per URS.

Evidence: Calibration certificates and inspection reports must be maintained in the validation file.

Test Case T2: Air Classifier Functionality

Procedure: Operate the air classifier and record performance metrics to verify operational parameters.

Acceptance Criteria: Air classifier must operate within defined parameters.

Evidence: Operational logs and performance metrics must be documented.

Deviations

Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions must be implemented as necessary.

Approvals

This protocol requires approval from the Validation Team Lead and the Quality Assurance Manager prior to execution.